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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
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
• 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
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)
CMS Coverage PageCMS Coverage Page
Recent Examples of NCDs
• ICD for sudden death prophylaxis
• Artificial hearts
• Erythropoiesis stimulating agents
• Lumbar artificial disc replacement
• CPAP for obstructive sleep apnea
Definition of Evidence Classification
Good Evidence includes consistent results from well-designed studies
Fair Evidence sufficient to determine effect on health outcomesStrength of evidence is limited
Poor Evidence is insufficient to assess the effects on health outcomeStrength of evidence is very limited
Source: Adapted from USPSTF.
Number of NCDs by Year (N=119)
0
2
4
6
8
10
12
14
16
18
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
Medicare Modernization Act (MMA)
Nu
mb
er o
f N
CD
s
Characteristics of National Coverage Decisions, 1999-2007
Type of technologyTotal
(n=119)
Medical procedure 24%
Medical device 18%
Laboratory test 14%
Imaging 12%
Surgical procedure 11%
Other medical therapy 10%
Drugs 8%
Health education/behavior 3%
Direction of Decisions (n=119)
0%
10%
20%
30%
40%
50%
60%
70%
Covered Completely Covered w ithConditions
Not Covered No National Decision
Type of conditions placed on favorable coverage decisionsa Total (n=119)
Restricted to patients with defined disease severity 56%
Diagnostic test restricted by specific test threshold 25%
Restricted to patients receiving care in specific care settings 17%
Restricted to patients meeting clinical trial criteria 12%
Coverage with evidence development Other
6%
16%
Characteristics of National Coverage Decisions, 1999-2007
a Not mutually exclusive.
Strength of Evidence (n=119)
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Good Fair Poor
Strength of Evidence and Direction of Decision
Number of decisions
0
10
20
30
40
50
60
Good Fair Poor
Completely Covered
Covered w ith Conditions
Local Contractor Discretion
No National Coverage
Strength of evidence
MEDCAC use, 1999-2007
MEDCAC = Medicare Evidence Development & Coverage Advisory Committee
Assignment to MEDCAC
Yes (16%)
No (84%)
No (73%)
Yes (28%)
Assignment to MEDCAC
Yes (16%)
No (84%)
No (73%)
Yes (28%)
HTA Conducted
Yes (16%)
No (84%)
No (73%)
Yes (28%)
HTA Conducted
Yes (16%)
No (84%)
No (73%)
Yes (28%)
HTA = Health Technology Assessment
Time to decision by MEDCAC and HTA
0. 00
0. 25
0. 50
0. 75
1. 00
decl engt h
0 200 400 600 800 1000 1200
STRATA: gr oup=MCAC and HTA gr oup=MCAC or HTA gr oup=Nei t her MCAC
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
0. 00
0. 25
0. 50
0. 75
1. 00
decl engt h
0 200 400 600 800 1000 1200
STRATA: gr oup=Fai r / Poor , MC gr oup=Fai r / Poor , Nogr oup=Good, MCACHTA gr oup=Good, No MCAC
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
0. 00
0. 25
0. 50
0. 75
1. 00
decl engt h
0 200 400 600 800 1000 1200
STRATA: dat abase=Af t er MMA dat abase=Bef or e MMA
Time to Decision by before / after MMA
Proportion with no Decision
Before MMA
Time (days)Median 249 days
Median 265 daysN=119
Log Rank P=0.029
After MMA
Time to Decision by Direction of Coverage
0. 00
0. 25
0. 50
0. 75
1. 00
decl engt h
0 200 400 600 800 1000 1200
STRATA: gr oup=Cover ed gr oup=No Nat iTime (days)
Proportion with no Decision
Covered (with or without restriction)
No National Coverage
Log Rank P =0.1823
Median 269 days
Median 255 days
National Coverage Determination DateLung volume reduction surgery 2003
PET for dementia 2004
Cochlear implantation 2005
Implantable defibrillators 2005
Chemotherapy for colorectal cancer 2005
PET for cancer 2005
Home use of oxygen 2006
CED Cases, 1999-2007
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.
Policy Implications
• Need for better evidence• Tradeoffs between rigor and timeliness• CED promising but implementation
challenges• No explicit cost-effectiveness but $$
matter