Support from the Commonwealth Fund

1. Medicare Coverage of Technology, 1999-2007 How Evidence-Based, Timely, and Flexible?June 10, 2008Peter J. Neumann, Maki S. Kamae, Jennifer A. PalmerCenter 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 • 1965 Medicare establishes (“reasonable and necessary” criteria) • 1989 Proposed coverage reg with CEA • 1998 MCAC created (renamed MEDCAC) • 1999 CMS begins posting NCDs on web • 2003 Medicare Modernization Act • 2005-06 CED guidance

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

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 Source: Adapted from USPSTF.

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

9. Characteristics of National Coverage Decisions, 1999-2007

10. Direction of Decisions (n=119)

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

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

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

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

20. 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