Medicare Part D: Lessons
for Implementing
Evidence-Based Policy
William Shrank, MD MSHS
Division
Di
i i off Ph
Pharmacoepidemiology
id i l
and
d
Pharmacoeconomics
Harvard Medical School
Brigham and Women’s Hospital
Are We Using
g Evidence to
Inform Health Policy?
What Should the Standard of
Evidence Be?

Standard is clear for medications and devices

Standard is evolving for practice level and
h lth system
health
t
llevell quality
lit iimprovementt
interventions

How should we think about the evidence
needed to support policy decisions?
How did we do with Part D?




Medicare Part D data available for just over 1
year – implemented in Jan 2006
Limitations in access to information about
specific benefit designs
No consideration of linking data before and
after implementation
Data too costly for many
Medication use after Part D in the previously
uninsured
Pharmacy claims data from retail pharmacies
 Identify seniors with no drug benefits in 2005 in pharmacy
claims form 3 large chains
 Seniors continuously filling at one pharmacy chain
 Estimated changes in utilization of drugs and copayments
under Medicare Part D
 Assess the consequences off reaching the coverage gap

Important Limitations: incomplete medication use data
and no health outcomes data
Schneeweiss, Shrank. Health Affairs, 2009
Patient co-payments
p y
among
g seniors who
received drug coverage under Medicare Part D
Start of Medicare
Part D
$140
$120
$100
$80
$60
$40
$20
Aug
g-06
Ju
ul-06
Jun
n-06
Mayy-06
Aprr-06
Mar-06
Feb
b-06
Jan
n-06
Decc-05
Novv-05
Oc t-05
Sep
p-05
Aug
g-05
Ju
ul-05
Jun
n-05
Mayy-05
Aprr-05
Mar-05
Feb
b-05
$0
Jan
n-05
Copay per 30 DDDs
Sample: 1.5
15
million seniors
Month
warfarin
total clopidogrel
branded omeprazole
total statins
generic clopidogrel
generic omeprazole
esomeprazole
generic statins
6
Schneeweiss, Shrank. Health Affairs, 2009
Utilization among seniors who received drug
coverage under Medicare Part D
Start of Medicare
Part D
180000
140000
120000
100000
80000
60000
40000
20000
Aug-06
Jul-06
Jun-06
May-06
Apr-06
Mar-06
Feb-06
Jan-06
Dec-05
Nov-05
Oct-05
Sep-05
Aug-05
Jul-05
Jun-05
May-05
Apr-05
Mar-05
Feb-05
0
Jan-05
Total D
DDDs dispens
sed
160000
Month
warfarin DDDs
clopidogrel DDDs
branded omeprazole DDDs
total statin DDDs (/10)
generic clopidogrel DDDs
generic omeprazole DDDs
esomeprazole ddds
generic statin DDDs
7
Schneeweiss, Shrank. Health Affairs, 2009
Utilization among seniors who reached the
coverage gap and had at least one fill of study
d
drugs
before
b f
the
h gap
Beginning of
coverage gap
Perc
cent filling prescriptio
on .
80
70
60
50
40
30
warfarin
20
statin
clopidogrel
l id
l
10
PPI
0
-8
-7
-6
-5
-4
-3
-2
-1
0
1
2
3
4
5
Time from donut hole (30-day intervals)
8
Schneeweiss, Shrank. Health Affairs, 2009
Interpretation: Among seniors
with no prior drug coverage…

Increased use for selected essential medications





Also saw increase for overused medications (PPIs)
Substantially reduced co-payments
Plans could do a better jjob in channeling
gp
patients
to generics (statins)
Plans could do a better job in channeling to
equally effective but less costly drugs (Nexium ->
p
)
omeprazole)
In the coverage gap drug use of essential drugs
y 10-14% for selected drugs
g
decreased by
9
Schneeweiss, Shrank. Health Affairs, 2009
The Effect of Transitioning to Medicare Part D Drug
Coverage In Seniors Dually Eligible for Medicare and
Medicaid - Methods
Data from a large pharmacy chain
 Obtained all prescription drugs dispensed to seniors
at operating in 34 states from 2004 – 2007.
2007
 Pt.s identified as Dual Eligibles if more than 80% of
their Rx claims were paid by Medicaid in 2005
 Evaluated patients who used on of :





3 cardiovascular medication classes (warfarin, clopidogrel,
or statins)
t ti ) or
1 essential GI medication class: PPIs
1p
psychotropic
y
p class: Benzodiazepines
p
Outcomes: Drug use and Copayments
Time trend analysis: Segmented linear regression
Shrank W. Journal of Geriatric Society, 2009
Mar-05
5
Apr-05
5
May-05
5
Jun-05
5
Jul-05
5
Aug-05
5
Sep-05
5
Oct-05
5
Nov-05
5
Dec-05
5
Jan-06
6
Feb-06
6
Mar-06
6
Apr-06
6
May-06
6
Jun-06
6
Jul-06
6
Aug-06
6
Sep-06
6
Oct-06
6
Nov-06
6
Dec-06
6
Mar-05
5
Apr-05
5
May-05
5
Jun-05
5
Jul-05
5
Aug-05
5
Sep-05
5
Oct-05
5
Nov-05
5
Dec-05
5
Jan-06
6
Feb-06
6
Mar-06
6
Apr-06
6
May-06
6
Jun-06
6
Jul-06
6
Aug-06
6
Sep-06
6
Oct-06
6
Nov-06
6
Dec-06
6
Copay p
per 30 day supply
Start of Medicare Part D
140000
6
5
120000
5
3
60000
2
40000
1
0
6
5
1
0
20000
1
0
0
Warfarin
Start of Medicare Part D
25000
20000
4
15000
3
10000
2
5000
0
4
60000
3
50000
40000
2
30000
M onth
M onth
6
Start of Medicare Part D
5
4
3
20000
15000
2
10000
1
5000
0
0
M onth
M onth
Days Covered
Start of Medicare Part D
Days
s Covered
Mar-05
Apr-05
May-05
Jun-05
Jul-05
Aug-05
Sep-05
Oct-05
Nov-05
Dec-05
Jan-06
Feb-06
Mar-06
Apr-06
May-06
Jun-06
Jul-06
Aug-06
Sep-06
Oct-06
Nov-06
Dec-06
6
Copay pe
er 30 day supply
100000
Copay p
per 30 day supply
80000
Days Covered
4
Days
s Covered
Mar-05
Apr-05
May-05
Jun-05
Jul-05
Aug-05
Sep-05
Oct-05
Nov-05
Dec-05
Jan-06
Feb-06
Mar-06
Apr-06
May-06
Jun-06
Jul-06
Aug-06
Sep-06
Oct-06
Nov-06
Dec-06
Copay pe
er 30 day supply
Statins
PPIs
90000
80000
70000
20000
10000
0
Clopidogrel
35000
30000
25000
Shrank W. Journal of Geriatric Society, 2009
Mar-05
5
Apr-05
5
May-05
5
Jun-05
5
Jul-05
5
Aug-05
5
Sep-05
5
Oct-05
5
Nov-05
5
Dec-05
5
Jan-06
6
Feb-06
6
Mar-06
6
Apr-06
6
May-06
6
Jun-06
6
Jul-06
6
Aug-06
6
Sep-06
6
Oct-06
6
Nov-06
6
Dec-06
6
Cop
pay per 30 day
y supply
6
4
30000
3
25000
20000
2
15000
0
Days Covere
ed
Results: Benzodiazepines
The “Uncovered” Class
Start of Medicare Part
45000
D
5
40000
35000
1
10000
5000
0
M onth
Shrank W. Journal of Geriatric Society, 2009
The Effect of Transitioning to Medicare Part D Drug
Coverage
g In Seniors Dually
y Eligible
g
for Medicare and
Medicaid - Results
Drug Use: Pharmacy Chain claims data:
 No statistically significant changes in the transition or
stable Part D periods for any study drug
drug.
Trends increased in all study drugs except
benzodiazepines (a non-significant decrease)
Copayments:
 Cumulative copayments decreased from Jan. – Dec.
2006 iin allll covered
dd
drugs:




-25% for PPIs
-51%
51% for clopidogrel
- 28% for statins
- 53% for warfarin
Copayments increased 91% for benzos
Shrank W. Journal of Geriatric Society, 2009
Patient Knowledge about Part D and their
Enrollment Decisions – A Systematic
Review


Identified 30 original articles (mostly surveys)
10 described beneficiaries' knowledge:



12 described enrollment and plan choices




Only 20-40% of seniors were aware of the Donut Hole in 2006
Only 12% of LIS-eligible beneficiaries in 2007 thought they
would qualify low-income subsidy
67%
% off those without insurance in 2005 enrolled in Part D
Only 6% to 9% chose the lowest cost plan for them
F
Few
expressed
d a willingness
illi
tto consider
id llower costt plans
l
att
the end of the year
8 described both
Polinski, Bhandari, Shrank, JAGS, 2010
Changes in Medication Use
after Part D Systematic review

26 articles met selection criteria:


13 regarding Part D’s overall impact on Rx use



6-13% increase in drug utilization, and
13-18% decrease in patients’ costs
7 describing the Part D transition period


Largely used data from retail pharmacy chains or from
Medicare Advantage programs and several surveys
Little evidence of problems for dual eligibles
6 concerning
i th
the coverage gap.

9-16% decrease in drug utilization and increases in costs of
up to 89%
Polinski, Shrank. In press, JAGS, 2010
Developing Data Sets – “Do-ityourself”



We linked data from CVS pharmacies to
Medicare Parts A and B to study the effect of
Part D on patients previously uninsured
We linked Caremark data to Medicare Parts
A and B to study how health was affected
d i th
during
the d
donutt h
hole
l
We g
geocoded these data sets to assess how
coverage affects disparities in care
Required substantial effort and financial investment
Lessons for Health Reform
Implementation and Evaluation



The barriers to data to conduct rigorous policy
evaluations should be minimal
 Other federal sources are supporting this research –
passing on the costs to other agencies
Clear plans for evaluation are essential prior to
implementation
 Consideration of control groups, analytic design
A timely, coherent strategy is essential so that we can
expand successful programs/policies and extinguish
ineffective ones
A call for evidence-based
policy



We must not settle for broad policy
implementation
p
without convincing
g evidence
to support its’ use
We must develop standards of evidence for
policy implementation that resemble those of
other aspects of the health care system
We must build rigorous evaluation plans into
new policy implementation