Medicare National Coverage
Decisions:
How is CMS Doing?
Presentation at the
National Health Policy Conference
February 2, 2005
Peter J. Neumann.
Harvard School of Public Health, Boston, MA
Overview
• How is Medicare doing?: analysis of
NCDs, 1999-2003
• Policy implications
• Why don’t Americans use costeffectiveness analysis
1
Key Dates for Medicare Coverage
ƒ 1965
Medicare established (“reasonable
and necessary” criteria)
ƒ 1989
Proposed coverage reg with CEA
ƒ 1998
MCAC created
ƒ ‘99-’03
CMS notices on cov’g process
ƒ 2003
Medicare Modernization Act
Recent Examples of NCDs
ƒ DrugDrug-eluting coronary stents ($2($2-4 billion)
ƒ ICD for sudden death prophylaxis ($1($1-3 billion)
ƒ PET for Alzheimer’s disease ($1 billion)
ƒ Verteporfin for macular degeneration ($750 million)
ƒ LeftLeft-ventricular assist devices ($1($1-7 billion)
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Number of National Decisions
Medicare National Coverage
Decisions, 1999-2003 (n=69)
30
25
20
Post Aug 2003
15
Pre Aug 2003
10
5
0
1999
2000
2001
2002
2003*
Year
* Only complete decisions memoranda available on the CMS website prior to
August 2003 were considered for the study
Definition of Evidence
Classification
Good ƒEvidence includes consistent results
from well-designed studies
Fair
ƒEvidence sufficient to determine
effect on health outcomes
ƒStrength of evidence is limited
Poor
ƒEvidence is insufficient to assess the
effects on health outcome
ƒStrength of evidence is very limited
Source: Adapted from USPSTF.
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Quality of Evidence (CMS view) n=69
42%
45%
Number of Decisions
40%
33%
35%
30%
25%
20%
16%
15%
9%
10%
5%
0%
Good
Fair
Poor
Could not be
Determined
Direction of Decision By Quality
of Evidence
Number of Decisions
40
Completely
Covered
30
Covered with
Conditions
20
Local
Contractor
Discretion
10
0
Good
Fair
Quality of Evidence
Poor
No National
Coverage*
*Includes decisions not to expand coverage of currently covered technologies (n=15) and not to cover the technology (n=5).
(Technologies with good evidence more likely to be covered vs those with fair or poor evidence, RR=1.46, p=0.004)
Source: Neumann et al., Health Affairs, 2005.
4
CMS review times by MCAC involvement
MCAC Involvement
Review times
Overall (n=69)
8.9 months
No-MCAC (n=54)
7.1 months
MCAC (n=15)
14.9 months*
* p<0.0001
Note: Review time from CMS acceptance of request to data final decision memo posted.
Time to Decision by MCAC
Participation and HTA
Proportion with no Decision
1. 00
0. 75
0. 50
MCAC and HTA
Neither
MCAC
nor HTA
MCAC or HTA
0. 25
0. 00
0
100
200
300
400
500
Time (days)
600
700
800
900
Log Rank (p=0.001)
5
Time to Decision by MCAC
Participation and Quality of Evidence
Proportion with no Decision
1. 00
0. 75
MCAC (Fair or Poor
Evidence)
No MCAC
(Fair or
Poor
Evidence)
0. 50
0. 25
No MCAC
(Good
Evidence)
0. 00
0
100
200
300
400
500
600
Time (days)
700
800
900
Log Rank (p=0.0033)
Key Findings
1.
2.
3.
4.
5.
6.
Medicare NCDs are more transparent.
Decisions are consistent with evidence.
Quality of evidence available is often poor.
Medicare seeks to cover with conditions.
CMS often does not meet time frames
MCAC and HTA add to review times.
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Policy Implications
ƒ Need for better evidence
– Pragmatic clinical trials
– Section 1013 of MMA
– Better coordination among CMS, FDA, NIH
ƒ
ƒ
ƒ
ƒ
Formal criteria for coverage
More resources for CMS?
Innovative coverage options
Include role for cost-effectiveness analysis
Selected cost-effectiveness ratios for
technologies covered by CMS
– LeftLeft-ventricular assist devices: $500,000$500,000-$1.4
million/QALY
– LungLung-volume reduction surgery: $98,000$98,000$330,000/QALY
– Implantable cardioverter defibrillators: $30,000$30,000$85,000/QALY
– PET for Alzheimer’s disease (> $500,000/QALY)
Source: Matchar, 2003; Gillick, 2004
7
Why don’t Americans
use CEA?
ƒ Mistrust of methods
– Methods vary
– Studies not relevant
ƒ
ƒ
ƒ
ƒ
Mistrust of motives
Legal and regulatory barriers
Distaste for (explicit) rationing
We ARE using CEA, just quietly
Thank you!
www.hsph.harvard.edu/cearegistry
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