A Crisis in Health Care: Access to Osteoporosis Diagnosis and Treatment is Endangered

1. A Crisis in Health Care:Access to Osteoporosis Diagnosis and Treatment is Endangered A Primer for Healthcare Providers from the ISCD; Part I As presented at the ISCD Annual Meeting, Tampa , FL March 16 -17, 2007

2. What You Need To Know What are the reasons for the reimbursement cuts? What has the ISCD done so far to address this? What is the ISCD planning to do in the future? How can you help?

3. Osteoporosis Economic Burden

4. The Ability to Identify and Treat Patients With Osteoporosis is Threatened Despite: a projected increase in incidence and economic burden of osteoporotic fractures a recognized test (axial DXA) to identify those at increased risk for fracture multiple Federal initiatives to increase screening rates (using axial DXA) to identify individuals with osteoporosis a variety of FDA-approved medications with documented efficacy in reducing fracture risk in patients with low bone mass

5. Why is Osteoporosis Care Endangered ? Cuts in reimbursement for axial DXA and VFA from the Medicare Physician Fee Schedule Cuts in reimbursement for axial DXA to physicians in private practice because of the Deficit Reduction Act Result: Levels of reimbursement for DXA and VFA (in the office setting) already below operating cost for many in 2007 and for all by 2010.

6. Consequences Patient access to care is restricted Prevention efforts are undermined Yet another women�s health care issue is under assault

7. MPFS Proposed Changes to 77082 (VFA: total, non-facility) including BN adjustor of 10.1% and SGR reduction of 5.0% /yr Because the technical non-facility payment is lower than the technical OPPS payment for the next 4 years, DRA has no effect on VFA.Because the technical non-facility payment is lower than the technical OPPS payment for the next 4 years, DRA has no effect on VFA.

8. MPFS Changes to 77080 (central DXA: total, non-facility) including BN adjustor of 10.1% and SGR reduction of 5.0%/yr This slides summarizes the decline in RVUs for central DXA due to the change in the Medicare Physician Fee Schedule (MPFS) as part of the 3rd Five Year Review. The 77080 code took effect 1.1.2007 (previously 76075). This code includes both the technical component (77080-TC) and the professional component (77080-26). The Federal Register published the RVUs for more than 500 CPT codes and provides RVU values for Work, PE and MP RVU in the transitional year (2007) and the final year (2010). Figures for 2008 and 2009 are based on 25% reductions/yr starting in 2007. The Work RVU refers to the Physician Work component. It was decreased from 0.3 to 0.2 by the AMA Relative Value Update Committee (RUC) despite objections by the American College of Radiology who performed the physician work survey. The drop from 0.2 to 0.18 is due to CMS� plan to decrease all Work RVUs by 10.1% to preserve Budget Neutrality. The Practice Expense (PE) RVU drops from 3.2 to 0.79. A 75% cut not seen by any other procedure. The ISCD believes the inputs and assumptions leading to this number are faulty at multiple levels. Total RVU is the sum of the three (Work, PE and MP) which is then multiplied by the conversion factor (which was frozen at 2006 levels for 2007) but would have to drop by 10% in 2070 to stay on tract (budget-wise ). This slides summarizes the decline in RVUs for central DXA due to the change in the Medicare Physician Fee Schedule (MPFS) as part of the 3rd Five Year Review. The 77080 code took effect 1.1.2007 (previously 76075). This code includes both the technical component (77080-TC) and the professional component (77080-26). The Federal Register published the RVUs for more than 500 CPT codes and provides RVU values for Work, PE and MP RVU in the transitional year (2007) and the final year (2010). Figures for 2008 and 2009 are based on 25% reductions/yr starting in 2007. The Work RVU refers to the Physician Work component. It was decreased from 0.3 to 0.2 by the AMA Relative Value Update Committee (RUC) despite objections by the American College of Radiology who performed the physician work survey. The drop from 0.2 to 0.18 is due to CMS� plan to decrease all Work RVUs by 10.1% to preserve Budget Neutrality. The Practice Expense (PE) RVU drops from 3.2 to 0.79. A 75% cut not seen by any other procedure. The ISCD believes the inputs and assumptions leading to this number are faulty at multiple levels. Total RVU is the sum of the three (Work, PE and MP) which is then multiplied by the conversion factor (which was frozen at 2006 levels for 2007) but would have to drop by 10% in 2070 to stay on tract (budget-wise ).

9. MPFS Changes to 77080 (central DXA: total, non-facility) including BN adjustor of 10.1%, SGR reduction of 5.0%/yr and DRA The impact of the Deficit Reduction Act drops this to $82 in2007 Red highlighted area demonstrates when DRA would be in effect (where OPPS facility charge for technical (TC) component is lower than the TC component for non-facility). . The impact of the Deficit Reduction Act drops this to $82 in2007 Red highlighted area demonstrates when DRA would be in effect (where OPPS facility charge for technical (TC) component is lower than the TC component for non-facility). .

10. DXA Reimbursement Overview See slides 53-55 for details of �DXA Cost� AnalysisSee slides 53-55 for details of �DXA Cost� Analysis

11. How Did This Happen? Is CMS concerned that an increase in DXA claims is part of a larger problem of excessive diagnostic studies?

12. Medicare Claims for Axial DXA: Office (non-facility) and Hospital Setting  1994 77,133 1999 1,265,496 2004 2,426,361 The marked increase in number of DXA studies performed over the last decade is driven in part by Federal initiatives to improve screening for osteoporosis. Nevertheless, testing remains underutilized with less than 20% of affected individuals being tested within a 2 year interval. In contrast, mammography has screening rates of ~ 69% based on 2 year interval data.The marked increase in number of DXA studies performed over the last decade is driven in part by Federal initiatives to improve screening for osteoporosis. Nevertheless, testing remains underutilized with less than 20% of affected individuals being tested within a 2 year interval. In contrast, mammography has screening rates of ~ 69% based on 2 year interval data.

13. Federal Initiatives to Increase DXA Testing 1997 Balanced Budget Act (Bone Mass Measurement Act) 2002 US Preventive Services Task Force DXA testing for all women 65 and older DXA testing for all women 60 and older if specific risk factors 2004 Surgeon General�s Report on Osteoporosis DXA �one of the most significant advances in the last quarter century� 2005 Welcome to Medicare Exam Osteoporosis evaluation with DXA part of key preventive services 2006 Modifications to BMMA (CMS 1321-P) Axial DXA the only reimbursable technology to measure response to therapy over time Quality and precision are introduced as important Over the past decade the Federal government has actively promoted the importance of osteoporosis screening and treatment using DXA.Over the past decade the Federal government has actively promoted the importance of osteoporosis screening and treatment using DXA.

14. 1994 CMS Claims for Axial DXA in the Office Setting The next 3 slides look at CMS claims for 76075 (not 76075-26 or 76075-TC). The N in each of the next 3 slides is lower than the N shown on slide 12 which also includes claims submitted by hospital facility. Data provided here is confined to non-facility or private practice setting. For 1994 claims data, 100% of claims submitted for 76075 are from the non-facility or office setting. As one follows claims from 1994 to 2004, the percentage of primary care physicians submitting claims increases dramatically (OB-GYN and FP are at less than 1% in 1994); specialists such as endocrinology and rheumatology decline and radiology increases from 1994 to 1999 but since has remained relatively constant.The next 3 slides look at CMS claims for 76075 (not 76075-26 or 76075-TC). The N in each of the next 3 slides is lower than the N shown on slide 12 which also includes claims submitted by hospital facility. Data provided here is confined to non-facility or private practice setting. For 1994 claims data, 100% of claims submitted for 76075 are from the non-facility or office setting. As one follows claims from 1994 to 2004, the percentage of primary care physicians submitting claims increases dramatically (OB-GYN and FP are at less than 1% in 1994); specialists such as endocrinology and rheumatology decline and radiology increases from 1994 to 1999 but since has remained relatively constant.

15. 1999 CMS Claims for Axial DXA in the Office Setting 94.5% of 76075 claims depicted here are from non-facility or office setting. 94.5% of 76075 claims depicted here are from non-facility or office setting.

16. 2004 CMS Claims for Axial DXA Testing in the Office Setting 99.7% of 76075 claims depicted here are from non-facility or office setting 99.7% of 76075 claims depicted here are from non-facility or office setting

17. 1994 CMS Claims for Axial DXA in the Hopsital Setting The next 3 slides look at claims in the hospital setting. In contrast to the office (non-facility) setting, the vast majority of studies in the hospital are performed by radiologists.The next 3 slides look at claims in the hospital setting. In contrast to the office (non-facility) setting, the vast majority of studies in the hospital are performed by radiologists.

18. 1999 CMS Claims for Axial DXA in the Hospital Setting

19. 2004 CMS Claims for Axial DXA Testing in the Hospital Setting

20. CMS Claims for Axial DXA Two thirds of all CMS claims for DXA are performed in the office setting. Two thirds of all CMS claims for DXA are performed in the office setting.

21. Impact on Patient Care of Changes to MPFS for DXA and VFA Axial DXA (77080) reimbursement drops by ~75%. VFA (77082) reimbursement drops by ~50%. Unable to cover operating costs, DXA and VFA testing disappear from the physician office setting.

22. Impact on Patient Care of Changes to MPFS for DXA and VFA Patient access to DXA and VFA testing is severely compromised especially in medically underserved areas (urban and rural). Cost to patient is increased (40% co-pay vs 20%) Federal initiatives to increase screening rates fail. Number of untreated patients increase with an associated increase in health care costs.

23. A CLOSER LOOK Deficit Reduction Act Medicare Physician Fee Schedule

24. Deficit Reduction Act of 2005(Section 5102: Adjustments in Payments for Imaging Services) A mechanism to pay for the freeze in payment cuts for the Medicare Physician Fee Schedule. Took effect January 1, 2007.

25. Deficit Reduction Act of 2005(Section 5102: Adjustments in Payments for Imaging Services) Results in Medicare payment for technical component of an imaging service be set at the Hospital Outpatient Department (HOPD) payment rate, if the HOPD rate is lower than the Physician Fee Service (PFS) payment rate. Imaging service affected include: DXA, ultrasound, CT and MRI but not mammography.

26. DXA and the DRA The recent marked increase in CMS claims for advanced imaging services is viewed by some as excessive. DXA is unfairly lumped with advanced imaging services. DXA reimbursement is penalized as hospital reimbursement rates do not accurately reflect costs in the physicians office.

27. Medicare Physician Fee Schedule (MPFS)

28. Medicare Physician Fee Schedule (PFS) Prior to 1992 Medicare payments to physicians were based on reasonable charges. Since January 1992, Medicare has paid for physician�s services (section 1848 of the Social Security Act) based on a predetermined fee schedule. Requires that payments under the MPFS be based on national uniform relative value units (RVUs) for three distinct components: physician work, practice expense and malpractice.

30. Medicare Physician Fee Schedule (PFS) Revisions to relative value units (RVU) were first proposed and published June 21, 2006. Part of scheduled 5-year review (3rd since implemented 1992). Purpose: To identify and correct services that CMS believes are either under or over valued. Revisions to MPFS finalized November 1, 2006 and took effect on January 1,2007.

31. Medicare Physician Fee Schedule (PFS) New to this review is a different mechanism of determining practice expense (PE) Adjustments to RVUs must be budget neutral. May not cause total PFS payments to differ by more than $20 x106 from baseline. If so other adjustments must be made. RVUs are also adjusted by a geographical practice cost index (GPCI)

32. MPFS Changes to 77080 (central DXA: total, non-facility) including BN adjustor of 10.1% and SGR reduction of 5.0%/yr This slides summarizes the decline in RVUs for central DXA due to the change in the Medicare Physician Fee Schedule (MPFS) as part of the 3rd Five Year Review. The 77080 code took effect 1.1.2007 (previously 76075). This code includes both the technical component (77080-TC) and the professional component (77080-26). The Federal Register published the RVUs for more than 500 CPT codes and provides RVU values for Work, PE and MP RVU in the transitional year (2007) and the final year (2010). Figures for 2008 and 2009 are based on 25% reductions/yr starting in 2007. The Work RVU refers to the Physician Work component. It was decreased from 0.3 to 0.2 by the AMA Relative Value Update Committee (RUC) despite objections by the American College of Radiology who performed the physician work survey. The drop from 0.2 to 0.18 is due to CMS� plan to decrease all Work RVUs by 10.1% to preserve Budget Neutrality. The Practice Expense (PE) RVU drops from 3.2 to 0.79. A 75% cut not seen by any other procedure. The ISCD believes the inputs and assumptions leading to this number are faulty at multiple levels. Total RVU is the sum of the three (Work, PE and MP) which is then multiplied by the conversion factor (which was frozen at 2006 levels for 2007) but would have to drop by 10% in 2070 to stay on tract (budget-wise ).This slides summarizes the decline in RVUs for central DXA due to the change in the Medicare Physician Fee Schedule (MPFS) as part of the 3rd Five Year Review. The 77080 code took effect 1.1.2007 (previously 76075). This code includes both the technical component (77080-TC) and the professional component (77080-26). The Federal Register published the RVUs for more than 500 CPT codes and provides RVU values for Work, PE and MP RVU in the transitional year (2007) and the final year (2010). Figures for 2008 and 2009 are based on 25% reductions/yr starting in 2007. The Work RVU refers to the Physician Work component. It was decreased from 0.3 to 0.2 by the AMA Relative Value Update Committee (RUC) despite objections by the American College of Radiology who performed the physician work survey. The drop from 0.2 to 0.18 is due to CMS� plan to decrease all Work RVUs by 10.1% to preserve Budget Neutrality. The Practice Expense (PE) RVU drops from 3.2 to 0.79. A 75% cut not seen by any other procedure. The ISCD believes the inputs and assumptions leading to this number are faulty at multiple levels. Total RVU is the sum of the three (Work, PE and MP) which is then multiplied by the conversion factor (which was frozen at 2006 levels for 2007) but would have to drop by 10% in 2070 to stay on tract (budget-wise ).

33. Summary of PFS Changes for Bone Mass Measurement Reimbursement No other procedure saw declines in RVU/reimbursement as great as DXA. QCT for bone density measurement actually increased 55%.No other procedure saw declines in RVU/reimbursement as great as DXA. QCT for bone density measurement actually increased 55%.

34. MPFS Changes to 77080 (central DXA: total, non-facility) including BN adjustor of 10.1% and SGR reduction of 5.0%/yr The Work RVU refers to the Physician Work component. It was decreased from 0.3 to 0.2 by the AMA Relative Value Update Committee (RUC) despite objections by the American College of Radiology who performed the physician work survey. The drop from 0.2 to 0.18 is due to CMS� plan to decrease all Work RVUs by 10.1% to preserve Budget Neutrality. The Work RVU refers to the Physician Work component. It was decreased from 0.3 to 0.2 by the AMA Relative Value Update Committee (RUC) despite objections by the American College of Radiology who performed the physician work survey. The drop from 0.2 to 0.18 is due to CMS� plan to decrease all Work RVUs by 10.1% to preserve Budget Neutrality.

35. Reduction in Physician Work RVU(DXA) Drop from 0.3 to 0.2 because of an AMA Relative Value Update Committee (RUC) ruling. �less intense and more mechanical than the specialty society�s description of the work involved� Drop from 0.2 to 0.18 because of the Budget Neutrality (BN) clause of 10.1% applied to all physician Work RVUs

36. (Physician) Work RVU Axial DXA = 0.2 RA = 0.2 pDXA = 0.22 Based on the new Medicare Physician Fee Schedule, the physician work component for axial DXA is the same as for Radiographic Absorptiometry and less than peripheral DXA. This is an example of a rank order anomaly , a term CMS uses to identify inequities in the values assigned to different procedures. Based on the new Medicare Physician Fee Schedule, the physician work component for axial DXA is the same as for Radiographic Absorptiometry and less than peripheral DXA. This is an example of a rank order anomaly , a term CMS uses to identify inequities in the values assigned to different procedures.

37. MPFS Changes to 77080 (central DXA: total, non-facility) including BN adjustor of 10.1% and SGR reduction of 5.0%/yr The Practice Expense (PE) RVU drops from 3.2 to 0.79, a 75% cut not seen by any other procedure. The ISCD believes the inputs and assumptions leading to this number are faulty at multiple levels. The Practice Expense (PE) RVU drops from 3.2 to 0.79, a 75% cut not seen by any other procedure. The ISCD believes the inputs and assumptions leading to this number are faulty at multiple levels.

38. Practice Expense is comprised of both direct and indirect costs. Direct cost inputs are examined in the next several slides. Indirect costs are calculated based on a variety of inputsPractice Expense is comprised of both direct and indirect costs. Direct cost inputs are examined in the next several slides. Indirect costs are calculated based on a variety of inputs

39. Direct Practice Expense RVU Variables Minutes per year = maximum minutes per year if usage was continuous Usage = equipment utilization assumption (0.5) Price = price of particular equipment Interest rate Maintenance = factor for maintenance; 0.05 Life of equipment = useful life of particular piece of equipment

40. Direct PE Inputs Cost of machine: CMS initially listed this at $41,000 based on the cost of an older technology (pencil beam) which amounts to approximately 7% of all machines in use in the US. The newer fan beam DXA units list for $85,000 which is what CMS cited as the cost for VFA (the software addition to DXA that allows for assessment of vertebral fracture.) Utilization rate: CMS applies a 50% utilization rate to all imaging technologies. Some feel that utilization rates for multi-disease state devices such as CT are far higher, approaching 75-90%. Utilization rates for single disease state imaging devices such as DXA are far lower. The ISCD Clinical Society Survey demonstrated a utilization rate of 21% based on a survey of 453 physicians. Calculation of utilization rate requires assigning a value to minutes per year. We applied the 150,000 figure CMS uses for this calculation, although we have argued that the number should be lowered to 115,000 (see below). Maintenance: CMS cites a 5% maintenance, yet the ISCD survey demonstrated a maintenance of approximately 10% of the cost of the machine including service contracts and software upgrades. Time per test: CMS based the 31 minutes on results of an American College of Radiology Survey of 31 ???? Members. The 46 minutes recommended by the ISCD was based on the median time interval of the Clinical Society Survey of non-physician time. Minutes per year: CMS uses a figure of 150,000 minutes/yr. This is approximately equal to working all 52 weeks in the year, 6 days a week, 8 hours a day. The ISCD has recommended using 115,000 minutes per year based on a more realistic clinic schedule of 48 weeks/year, 5 day week and 8 hour days.Cost of machine: CMS initially listed this at $41,000 based on the cost of an older technology (pencil beam) which amounts to approximately 7% of all machines in use in the US. The newer fan beam DXA units list for $85,000 which is what CMS cited as the cost for VFA (the software addition to DXA that allows for assessment of vertebral fracture.) Utilization rate: CMS applies a 50% utilization rate to all imaging technologies. Some feel that utilization rates for multi-disease state devices such as CT are far higher, approaching 75-90%. Utilization rates for single disease state imaging devices such as DXA are far lower. The ISCD Clinical Society Survey demonstrated a utilization rate of 21% based on a survey of 453 physicians. Calculation of utilization rate requires assigning a value to minutes per year. We applied the 150,000 figure CMS uses for this calculation, although we have argued that the number should be lowered to 115,000 (see below). Maintenance: CMS cites a 5% maintenance, yet the ISCD survey demonstrated a maintenance of approximately 10% of the cost of the machine including service contracts and software upgrades. Time per test: CMS based the 31 minutes on results of an American College of Radiology Survey of 31 ???? Members. The 46 minutes recommended by the ISCD was based on the median time interval of the Clinical Society Survey of non-physician time. Minutes per year: CMS uses a figure of 150,000 minutes/yr. This is approximately equal to working all 52 weeks in the year, 6 days a week, 8 hours a day. The ISCD has recommended using 115,000 minutes per year based on a more realistic clinic schedule of 48 weeks/year, 5 day week and 8 hour days.

41. Direct PE Inputs The ISCD was successful in getting CMS to change the cost of the DXA machine from a $41,000 pencil beam to a $85,000 fan beam.The ISCD was successful in getting CMS to change the cost of the DXA machine from a $41,000 pencil beam to a $85,000 fan beam.

42. Direct PE Inputs The ISCD had obtained agreement from the AMA PERC (Practice Expense Review Committee) and from RUC (Relative Value Update Committee) that non-physician work should be 46 minutes not 31 minutes. However, a subsequent vote by the RUC to reconsider, tabled this for review until the next AMA RUC meeting in Chicago in April 2007 based on the question of whether vital signs (height and weight) were necessary and actually measured as part of the procedure. The ISCD has submitted their response that height and weight are critical to interpreting study results.The ISCD had obtained agreement from the AMA PERC (Practice Expense Review Committee) and from RUC (Relative Value Update Committee) that non-physician work should be 46 minutes not 31 minutes. However, a subsequent vote by the RUC to reconsider, tabled this for review until the next AMA RUC meeting in Chicago in April 2007 based on the question of whether vital signs (height and weight) were necessary and actually measured as part of the procedure. The ISCD has submitted their response that height and weight are critical to interpreting study results.

43. Direct PE Inputs The AMA RUC agreed that utilization rate was worthy of further discussion but no changes were made at this time.The AMA RUC agreed that utilization rate was worthy of further discussion but no changes were made at this time.

44. Correcting Direct PE Inputs Even if the appropriate Direct Practice Expense inputs were used, based on the ISCD Clinical Society Survey, the end result would still be a reimbursement rate of ~ $69.

45. Direct Practice Expense (PE) This slide looks at the effect of changing different direct Practice Expense inputs on the total reimbursement for central DXA (77080) based on the current Conversion Factor, physician work RVU and malpractice RVU. Calculations of direct PE, indirect PE, and total PE are based on a spreadsheet/formula provided by CMS. The initial equipment cost was listed as $41,000 but changed in the final document (CMS 1321-FC) to $85,000 based on the fact that fan beam DXA rather pencil beam DXA is the standard. Utilization rate changed from 0.5 to 0.2 Maintenance changed from 0.05 to 0.1 Time /study changed from 30 minutes to 46 minutes. Minutes/year changed from 150,000 to 115,000. All of above: examines effect on reimbursement if machine cost, utilization rate, maintenance, time/study, and minutes/year are all changed. Even if all the direct PE inputs are corrected the total reimbursement for central DXA remains below the operating cost for most practitioners. This implies that there are additional errors in input for indirect PE. This slide looks at the effect of changing different direct Practice Expense inputs on the total reimbursement for central DXA (77080) based on the current Conversion Factor, physician work RVU and malpractice RVU. Calculations of direct PE, indirect PE, and total PE are based on a spreadsheet/formula provided by CMS. The initial equipment cost was listed as $41,000 but changed in the final document (CMS 1321-FC) to $85,000 based on the fact that fan beam DXA rather pencil beam DXA is the standard. Utilization rate changed from 0.5 to 0.2 Maintenance changed from 0.05 to 0.1 Time /study changed from 30 minutes to 46 minutes. Minutes/year changed from 150,000 to 115,000. All of above: examines effect on reimbursement if machine cost, utilization rate, maintenance, time/study, and minutes/year are all changed. Even if all the direct PE inputs are corrected the total reimbursement for central DXA remains below the operating cost for most practitioners. This implies that there are additional errors in input for indirect PE.

46. Indirect PE: Inputs Direct PE and its components (adjusted and converted) Practice Cost Index Indirect Percentage Direct Percentage Average indirect percentage

47. Indirect PE: Inputs Direct PE and its components (adjusted and converted) Practice Cost Index Indirect Percentage Direct Percentage Average indirect percentage

48. Direct vs Indirect PE as it Pertains to DXA Direct PE (�bottom up�) values change when: Service is refined (time to perform study, utilization rate etc) Prices are updated (equipment costs, maintenance contracts, phantom etc) Indirect PE (�top down�) values change when: There are changes to the mix of specialties performing the service (with documented changes in type of specialties performing DXA this is particularly critical). If new service data for indirect costs are utilized CMS is transitioning their determination of practice expense from a �top down� to a �bottom up� approach. The later is felt to provide a more accurate assessment of practice expense since input is based on specific costs for a procedure and is uniform regardless of the specialty performing the procedure. The older �top down� approach could have assigned different values to the same expense for different specialties based on older survey data. Currently only direct PE is determined by the �bottom up� approach. Indirect PE is still determined by the �top down� approach. As central DXA has seen a significant shift in the type of physicians performing the study (see slides 14-16), one would anticipate that indirect PE inputs might be erroneous if the correct specialty mix was not accurately identified. CMS is transitioning their determination of practice expense from a �top down� to a �bottom up� approach. The later is felt to provide a more accurate assessment of practice expense since input is based on specific costs for a procedure and is uniform regardless of the specialty performing the procedure. The older �top down� approach could have assigned different values to the same expense for different specialties based on older survey data. Currently only direct PE is determined by the �bottom up� approach. Indirect PE is still determined by the �top down� approach. As central DXA has seen a significant shift in the type of physicians performing the study (see slides 14-16), one would anticipate that indirect PE inputs might be erroneous if the correct specialty mix was not accurately identified.

49. What Has ISCD Done So Far? Organized and conducted a Clinical Society Survey Performed a cost analysis Briefed other clinical societies on changes to PFS Responded to CMS in writing Met with CMS officials Presented to the Refinement Panel: physician work RVU Presented at the AMA RUC Meeting: practice expense RVU Organized an Osteoporosis Task Force

50. ISCD Clinical Society Survey ISCD in conjunction with ASBMR, AACE, TES, NAMS and ACRheum completed a physician Work and Practice Expense (PE) survey for codes 76075 (77080) and 76077 (77082). Survey was performed in August 2006 and distributed electronically. 2884 members sent electronic survey 453 fully completed surveys returned The survey looked at both physician work and Practice Expense. The ISCD argued that RVU for Physician Work should not have been reduced from 0.3 to 0.2; using comparison to key reference codes, the 453 physicians surveyed, rated the physician work component of DXA at an RVU of 0.5 (most frequently comparing the work and intensity to E/M codes 99212-99214). The results of this survey are public record and submitted by the ISCD in response to CMS-1512. The ISCD presented this data at the AMA Refinement Panel and in person to CMS staff in Baltimore, MD in October 2006. The survey looked at both physician work and Practice Expense. The ISCD argued that RVU for Physician Work should not have been reduced from 0.3 to 0.2; using comparison to key reference codes, the 453 physicians surveyed, rated the physician work component of DXA at an RVU of 0.5 (most frequently comparing the work and intensity to E/M codes 99212-99214). The results of this survey are public record and submitted by the ISCD in response to CMS-1512. The ISCD presented this data at the AMA Refinement Panel and in person to CMS staff in Baltimore, MD in October 2006.

51. ISCD Clinical Society Survey Geographic Practice Setting 42% urban 42% suburban 16% rural Type of practice 39% single specialty 24% multi-specialty 28% solo 9% medical school Specialty 30% Primary care 11% IM 9% OB-GYN 7% FP 37% Rheumatology 22% Endocrinology 5% Radiology 3% Orthopedics

52. ISCD Clinical Society Survey Type of axial DXA equipment 93% Fan beam 7% Pencil beam Axial DXA manufacturer 53% Hologic 44% GE Lunar 2% Norland The data obtained on instrument type was used to refute the CMS equipment cost of a pencil beam DXA at $41,000. In the original proposal (CMS 1512) when calculating the equipment cost of VFA, a fan beam DXA was used by CMS and assigned a value by CMS of $85,000. The same document listed the equipment cost of central DXA at $41,000 based on a pencil beam machine. This appeared to based on older survey data that had not been updated to reflect current machine costs.The data obtained on instrument type was used to refute the CMS equipment cost of a pencil beam DXA at $41,000. In the original proposal (CMS 1512) when calculating the equipment cost of VFA, a fan beam DXA was used by CMS and assigned a value by CMS of $85,000. The same document listed the equipment cost of central DXA at $41,000 based on a pencil beam machine. This appeared to based on older survey data that had not been updated to reflect current machine costs.

53. ISCD Clinical Society Survey: Number of Studies Performed per Machine per Month Based on Practice Location and Type These data come from the ISCD Clinical Society survey of 453 members obtained in August 2006.These data come from the ISCD Clinical Society survey of 453 members obtained in August 2006.

54. ISCD DXA Cost Analysis Looked at real world practices (office setting) for both primary and specialty care. Take in to account true operating costs using data generated from ISCD Clinical Society Survey: Maintenance (service) contracts Space set aside for DXA Overhead associated with practice Variety of personnel used Physician time to read study The ISCD DXA Cost Analysis looked at real world costs to operate a DXA. Similar to figuring out the cost of a new car purchase, we looked at not just the car itself but what it would take to operate for a year (title, tax, insurance, gas, repairs, etc.).The ISCD DXA Cost Analysis looked at real world costs to operate a DXA. Similar to figuring out the cost of a new car purchase, we looked at not just the car itself but what it would take to operate for a year (title, tax, insurance, gas, repairs, etc.).

55. Axial DXA Estimated Operating Costs The range of operating costs for N studies per month was obtained from data provided by private practices in geographic diverse areas throughout the US (3 rheumatology, 2 endocrine, 1 internal medicine) Assumptions: Fan beam DXA at $85,000 Overhead calculated as % of total clinic overhead (minus biologics and infusions) that is associated with DXA. % is derived from DXA revenue/ total clinic revenues (minus biologics and infusions) Physician time of 25 min is based on ISCD specialty society survey. Salary of $150K -$250K is $72.16 -$120.19/hr Divide number of DXA studies done/ yr in to total fixed costs to determine total fixed costs/ DXA then add that to total variable costs/ DXA for total expenses/ DXAThe range of operating costs for N studies per month was obtained from data provided by private practices in geographic diverse areas throughout the US (3 rheumatology, 2 endocrine, 1 internal medicine) Assumptions: Fan beam DXA at $85,000 Overhead calculated as % of total clinic overhead (minus biologics and infusions) that is associated with DXA. % is derived from DXA revenue/ total clinic revenues (minus biologics and infusions) Physician time of 25 min is based on ISCD specialty society survey. Salary of $150K -$250K is $72.16 -$120.19/hr Divide number of DXA studies done/ yr in to total fixed costs to determine total fixed costs/ DXA then add that to total variable costs/ DXA for total expenses/ DXA

56. Range of Axial DXA Operating Costs Based on Number of Studies Performed 2006 axial DXA reimbursement $139.46 not including Geographic Practice Cost Index (GPCI). DXA reimbursement for 1/2007 approximately $82.33 not including GPCI. Includes 10.1% Budget neutrality adjustment to work RVU, Deficit Reduction Act and freeze on Conversion Factor at $37.90.2006 axial DXA reimbursement $139.46 not including Geographic Practice Cost Index (GPCI). DXA reimbursement for 1/2007 approximately $82.33 not including GPCI. Includes 10.1% Budget neutrality adjustment to work RVU, Deficit Reduction Act and freeze on Conversion Factor at $37.90.

57. ISCD Clinical Society Survey: Range of Estimated Operating Costs per DXA Based on Practice Location and Type The ISCD Clinical Society Survey for median number of studies per machine per month in different practice settings is combined with the ISCD cost analysis from preceding slides.The ISCD Clinical Society Survey for median number of studies per machine per month in different practice settings is combined with the ISCD cost analysis from preceding slides.

58. ISCD Clinical Society Survey: Range of Estimated Operating Costs per DXA Based on Practice Location and Type (1. 2007) Shown in red are the settings where reimbursement rates currently fail to meet operating costs. Only practices performing more than 90 studies per month per machine are able to meet operating costs based on model assumptions shown in previous slides.Shown in red are the settings where reimbursement rates currently fail to meet operating costs. Only practices performing more than 90 studies per month per machine are able to meet operating costs based on model assumptions shown in previous slides.

59. ISCD Clinical Society Survey: Range of Estimated Operating Costs per DXA Based on Practice Location and Type (1. 2010) Performing 120 studies per machine per month does not cover operating costs with reimbursement rates projected for January 2010. The only ways to meet operating costs at a reimbursement rate of $35.48 would be if: There were no fixed costs (DXA is paid for, no maintenance, don�t count space or overhead for DXA) OR Fixed costs are offset by large volume (e.g. 2000 studies a month or 24,000 in a year reduces fixed costs to $1.58 - $3.05 per study) AND Variable costs are reduced: Physician time to read study is not counted Ancillary personnel are not counted Performing 120 studies per machine per month does not cover operating costs with reimbursement rates projected for January 2010. The only ways to meet operating costs at a reimbursement rate of $35.48 would be if: There were no fixed costs (DXA is paid for, no maintenance, don�t count space or overhead for DXA) OR Fixed costs are offset by large volume (e.g. 2000 studies a month or 24,000 in a year reduces fixed costs to $1.58 - $3.05 per study) AND Variable costs are reduced: Physician time to read study is not counted Ancillary personnel are not counted

60. ISCD Presentations to CMS Regarding PFS 08.18.06 written comments to CMS-1512 sent 10.10.06 written comments to CMS-1321-P sent 10.04.06 meeting with Director McClellan 10.16.06 meeting with CMS staff Outcome: 11.01.06 machine cost increased from $41,000 to $85,000. 02.01.07 CMS referred PE for further review to AMA RUC

61. ISCD Presentations to the AMA Regarding PFS 09.26.06 Refinement Panel: argue for increased physician Work RVU of 0.5 based on Clinical Society Survey 02.01.07 AMA RUC meeting regarding Practice Expense: argue for non-physician time increase from 31 min to 46 min. based on Clinical Society Survey Outcome: Physician Work retained at 0.2. 45 minutes initially approved by PERC and RUC but then tabled for reconsideration at 4. 07 meeting Indicate a willingness to look at utilization rate at a later date

62. What are ISCD Plans for the Future?

63. Osteoporosis Task Force Coalition of clinical societies and patient advocacy groups representing over 200,000 members: AACE, ASBMR, ACRheum, ISCD, TES NOF, Bone and Joint Decade, National Council of Women�s Organizations, National Association of Chronic Disease Directors (Osteoporosis Council) Media campaign Survey data Legislative AACE: American Association of Clinical Endocrinologists ASBMR: American Society for Bone and Mineral Research ACRheum: American College of Rheumatology TES: The Endocrine Society NOF: National Osteoporosis FoundationAACE: American Association of Clinical Endocrinologists ASBMR: American Society for Bone and Mineral Research ACRheum: American College of Rheumatology TES: The Endocrine Society NOF: National Osteoporosis Foundation

64. Legislative Approach HR 1293 �The Access to Medical Imaging Act of 2007� introduced 3.1.2007 DRA cuts be limited to �advanced diagnostic imaging services� (would exclude DXA and VFA) 2 year moratorium in cuts enacted from DRA for advanced diagnostic imaging General Accounting Office (GAO) to do an impact analysis Osteoporosis Task Force drafting a bill that would: Freeze MPFS reimbursement for DXA and VFA at 2006 levels Impact analysis study

65. In Summary Based on the Deficit Reduction Act, DXA reimbursement in the physician�s office was reduced from ~ $140 to ~$82 as of January 1,2007. Even more importantly, based on changes in the Medicare Physician Fee Schedule, DXA reimbursement will be incrementally further reduced to ~ $35 by January 1, 2010. At current reimbursement, only high volume practices are covering their costs. By 2010, no physician�s office practice will be able to cover the cost of performing DXA. It can be expected that central DXA will disappear from the physician�s office setting resulting in reduced access to care, failure of osteoporosis prevention efforts and ultimately increased fractures.

66. We have a terrific challenge ahead of us. Because we are passionate about osteoporosis we must get the word out to our patients, legislators and the media. Our story is an important one to tell and it should resonate. Access to quality care Prevention Women�s health Conflicting messages from the Federal government There is light at the end of the tunnel� but it may take some time to get there.

67. Here�s What We Need You to Do Help Us Help You

68. Help Us Complete the Grassroots Volunteer Form We need to know where you live so we can match you with your congressional district Patient vignettes We are also looking for a contact person in each state to help us coordinate activities. Contact your Congressional representative and Senators Phone call to respective Health Care aide Visit in the home district Obtain contact information for follow up

69. Help You Legislative Fact Sheet Talking Points Primer for a Congressional visit

70. Legislative Talking Points The incidence and economic burden of osteoporosis (fact sheet) A critical women�s health care issue Osteoporosis screening for prevention is important but under-utilized (15%-20%)

71. Legislative Talking Points Reimbursement cuts to DXA from both Deficit Reduction Act and Physician Fee Schedule: 40% 2007 75% 2010 Access to care is threatened. How will it impact your constituents?

72. Talking Points:Support Legislation HR 1293 �The Access to Medicare Imaging Act of 2007� introduced 3.1.2007 Addresses the Deficit Reduction Act Sign on as a co-sponsor Support legislation that would reverse the reimbursement cuts to osteoporosis testing Addresses the Medicare Physician Fee Schedule

73. A Crisis in Health Care:Access to Osteoporosis Diagnosis and Treatment is Endangered Part II March 17, 2007

74. Public Policy Issues CMS DXA reimbursement Closed panels for DXA reading Licensure, Examination and Certification challenges VFA reimbursement: CMS private insurance Independent Diagnostic Testing Facilities

75. MPFS Changes to 77080 (central DXA: total, non-facility) including BN adjustor of 10.1% and SGR reduction of 5.0%/yr The next 2 slides compare the reimbursement of DXA in 2007. This slide looks at the effect of MPFS only.The next 2 slides compare the reimbursement of DXA in 2007. This slide looks at the effect of MPFS only.

76. MPFS Changes to 77080 (central DXA: total, non-facility) including BN adjustor of 10.1%, SGR reduction of 5.0%/yr and DRA This slide looks at the further drop in reimbursement from the Deficit Reduction Act. .This slide looks at the further drop in reimbursement from the Deficit Reduction Act. .

77. DXA Coverage: Medicare A number of carriers have not yet factored in the DRA: Reimbursement was 20 % higher reflecting PFS cuts only Medicare carriers will identify this error Your office will be required to pay the difference

78. DXA Coverage: State Level Private insurers initially setting DXA reimbursement at 2010 Medicare levels California: BCBS Ohio: CareSource These appear to be administrative errors that when identified have been readily corrected by insurance company.

79. DXA Coverage: Private InsuranceClosed Panels AMI, a pre-certification group, has been hired by several HMOs including CIGNA to control radiologic costs. In NJ, CIGNA is proposing to restrict DXA reimbursement to radiologists only 4/5ths of all DXA machines in NJ are operated by non-radiologists In California, Anthem (BC/BS) has sent letters to providers indicating that only radiologists will be reimbursed for DXA procedure and interpretation.

80. Licensure, Examination and Certification The American Registry of Radiologic Technologists (ARRT) has been active to try to ensure that their educational and certification programs are recognized as the gold standard for not only testing and certification, but in some states, for licensing as well. By establishing new educational curriculum using ARRT courses. By setting up new Boards to review licensing requirements populated with ARRT members.

81. Licensure, Examination and Certification State requirements differ: state application be submitted prior to the administration of an examination, and, as part of that application process an applicant meets certain educational requirements, before taking an examination. state may only require examination results and may exempt tech from licensing if tech has taken certain courses and examinations with a passing grade (usually of 75% or higher )

82. Licensure, Examination and Certification:Pending Legislation Where ISCD Is Not Recognized Alaska California # Kansas Maryland # Minnesota # Missouri # Nebraska # New Jersey Oklahoma # Oregon Tennessee West Virginia

84. Independent Diagnostic Testing Facilities (IDTFs) Suppliers of diagnostic tests that are independent of a hospital or a physician office. May be a fixed location, a mobile entity, or an individual non-physician practitioner. Can not bill for therapeutic or interventional radiology procedures such as vascular access procedures or biopsies. Must provide at least one "general supervision" physician who is responsible for overall direction and quality control of the services performed in the IDTF. Supervising physician must be on premises and immediately available.

85. Wisconsin Physicians Services (WPS) and IDTFs WPS is Medicare carrier for WS, MN, IL, MI New proposed LCD would require certification for techs who perform DXA at IDTFs Must be licensed or certified by appropriate State Health or Education Dept In absence of a State licensing board, tech must be certified by appropriate national credentialing body recognized by National Commission for Certifying Agencies ISCD is not recognized as a national credentialing body

86. National Organization for Competency Assurance (NOCA) Sets quality standards for credentialing organizations The National Commission for Certifying Agencies (NCCA) is the accreditation body of NOCA. Certification programs may apply and be accredited by the NCCA if they demonstrate compliance with each accreditation standard.

87. VFA

88. ISCD Clinical Society Survey ISCD in conjunction with ASBMR, AACE, TES, NAMS and ACRheum completed a physician Work and Practice Expense (PE) survey for codes 76075 (DXA) and 76077 (VFA). Survey was performed in August 2006 and distributed electronically. Survey instrument was minimally modified from that provided by the American College of Radiology.

89. ISCD Clinical Society Survey 2884 members sent electronic survey 453 fully completed surveys returned 313 (69%) had VFA capability 181 (58%) of those read VFA

90. Issues Associated with VFA Limited Medicare coverage since no national legislation Some carriers have withdrawn coverage or require review on case by case basis Trailblazer :TX, MD,VA, DE, DC First Coast Service Option: FL,CT One carrier has created new coverage requirements based on ISCD VFA Position Statement Palmetto : OH, WV, SC

91. Issues Associated with VFA Where there is coverage, CMS reimbursement will decrease 50% by 2010 associated with change in MPFS, SGR and Budget Neutrality Not altered by DRA.

92. MPFS Proposed Changes to 77082 (VFA: total, non-facility) including BN adjustor of 10.1% and SGR reduction of 5.0% /yr Similar calculations for Vertebral Fracture Assessment. Because the technical non-facility payment is lower than the technical OPPS payment for the next 4 years, DRA has not effect on VFA.Similar calculations for Vertebral Fracture Assessment. Because the technical non-facility payment is lower than the technical OPPS payment for the next 4 years, DRA has not effect on VFA.

93. Summary National (CMS): MPFS reductions in reimbursement for DXA and VFA DRA reductions in reimbursement for DXA State (CMS): Failure to reimburse for VFA IDTFs and certification requirements State Licensure and certification requirements Private insurance: Closed panels

94. Proposed new organizational structure for ISCD Public Policy Committee.Proposed new organizational structure for ISCD Public Policy Committee.

95. Help Us Help You Please turn in your grassroots volunteer form Please provide us with your business card and e-mail address Let us know if you are interested in: being a state representative Serving on one of the 3 committees (state,federal, insurance) Let us know of patient vignettes related to access to care

96. THANK YOU FOR YOUR SUPPORT !!