1. Medicare Coverage of Technology, 1999-2007 How Evidence-Based, Timely, and Flexible? June 10, 2008 Peter J. Neumann, Maki S. Kamae, Jennifer A. Palmer Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, Boston, MA Support from the Commonwealth Fund

2. Key Dates in Medicare National Coverage 1965Medicare establishes (“reasonable and necessary” criteria) 1989Proposed coverage reg with CEA 1998MCAC created (renamed MEDCAC) 1999CMS begins posting NCDs on web 2003Medicare Modernization Act 2005-06CED guidance

3. Quality of evidence available to Medicare Consistency of decisions with evidence; Timeliness of Medicare coverage Factors impacting decisions & review times CMS use of CED Objectives

4. Data and Methods Reviewed all complete Medicare NCDs from 1999-2007 (n=119) Each NCD memo reviewed independently by 2 investigators Detailed information extracted (~30 variables each)

5. CMS Coverage Page

6. Recent Examples of NCDs ICD for sudden death prophylaxis Artificial hearts Erythropoiesis stimulating agents Lumbar artificial disc replacement CPAP for obstructive sleep apnea

7. Definition of Evidence Classification Good Evidence includes consistent results from well-designed studies Fair Evidence sufficient to determine effect on health outcomes Strength of evidence is limited Poor Evidence is insufficient to assess the effects on health outcome Strength of evidence is very limited Source: Adapted from USPSTF.

8. Number of NCDs by Year (N=119) Medicare Modernization Act (MMA) Number of NCDs

9. Characteristics of National Coverage Decisions, 1999-2007 Type of technology Total (n=119) Medical procedure24% Medical device18% Laboratory test14% Imaging12% Surgical procedure11% Other medical therapy10% Drugs8% Health education/behavior3%

10. Direction of Decisions (n=119)

11. Type of conditions placed on favorable coverage decisions a Total (n=119) Restricted to patients with defined disease severity56% Diagnostic test restricted by specific test threshold25% Restricted to patients receiving care in specific care settings17% Restricted to patients meeting clinical trial criteria12% Coverage with evidence development Other 6% 16% Characteristics of National Coverage Decisions, 1999-2007 a Not mutually exclusive.

12. Strength of Evidence (n=119)

13. Strength of Evidence and Direction of Decision Number of decisions

14. MEDCAC use, 1999-2007 MEDCAC = Medicare Evidence Development & Coverage Advisory Committee

15. HTA = Health Technology Assessment

16. Time to decision by MEDCAC and HTA Proportion with no Decision MEDCAC or HTA Neither MEDCAC nor HTA MEDCAC and HTA Time (days) Median 233 days Median 350 days Median 457 days PET (FDG) for Alzheimer's Disease/Dementia Radioimmunotherapy for Non- Hodgkin's Lymphoma Cardiac Catheterization Performed In Other Than A Hospital Setting

17. Proportion with no Decision Time (days) Good evidence, No MEDCAC/HTA Fair/Poor evidence, No MEDCAC/HTA Good evidence, with MEDCAC/HTA Fair/Poor evidence, with MEDCAC/HTA Log Rank P <.0001 Time to Decision by Strength of Evidence and MEDCAC/HTA Median 233 days Median 251 days Median 432 days Median 359 days

18. Time to Decision by before / after MMA Proportion with no Decision Before MMA Time (days) Median 249 days Median 265 days N=119 Log Rank P=0.029 After MMA

19. Time to Decision by Direction of Coverage Time (days) Proportion with no Decision Covered (with or without restriction) No National Coverage Log Rank P =0.1823 Median 269 days Median 255 days

20. National Coverage DeterminationDate Lung volume reduction surgery2003 PET for dementia2004 Cochlear implantation2005 Implantable defibrillators2005 Chemotherapy for colorectal cancer2005 PET for cancer2005 Home use of oxygen2006 CED Cases, 1999-2007

21. Key Findings The quality of evidence available to CMS for most technologies is no better than fair. Still, CMS has covered in 60% of cases, though almost always with conditions. Involvement of MEDCAC is relatively infrequent and prolongs review times. Since MMA all decisions have met review time standards. CMS has issued 7 CED decisions, 5 with active trials or registries.

22. Policy Implications Need for better evidence Tradeoffs between rigor and timeliness CED promising but implementation challenges No explicit cost-effectiveness but $$ matter