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