1. Medicare Prescription Drug Program and Using Part D Data for Research Becky Briesacher, PhD Associate Professor, Medicine Division of Geriatric Medicine 1

2. Funding and COI Supported by grants R01AG028745 and R01AG022362 from the National Institute on Aging (NIA), and the Harvard Pilgrim Health Care Foundation. Dr Briesacher is also supported by a Research Scientist Development Award from the NIA (K01AG031836. I declare no conflict of interest. 2

3. 3 "75% of older Americans lack decent, dependable, private-sector coverage of prescription drugs. That’s three out of every four seniors. To those who think prescription drug coverage isn’t a problem for most Medicare beneficiaries, I say, think again." President Bill Clinton July 1999

4. Career in Part D Research 1) identified high predictability of prescription drug expenditures from one year to the next 2 ; 2) demonstrated selection into prescription drug coverage is also predictable, based almost exclusively on observable health status 3 ; 3) created elasticity estimates that reducing medication costs by 10% would increase drug utilization by 5.4%- 6.6%; 3 and 4) established Part D effects differ in nursing home setting.

5. Overview of Presentation Brief overview of Medicare Part D Brief overview of Part D data Description of Medicare Part D evaluation 5

6. 6 History of Drug Coverage in Medicare Medicare is health care insurance for elderly and disabled Americans since 1965 Medicare had 2 notable coverage gaps: LTC and prescription drugs –Alternatives include employer/retiree benefits, self-purchased Medigap plans, Medicare HMO option, Medicaid for the poor, Military & VA Medicare Catastrophic Coverage Act of 1988 – first prescription drug program in Medicare, repealed before implemented. Part D passed in 2003 and implemented in 2006 ~65%-80% of population had drug coverage in 2005

7. 7 Medicare Part D Drug Benefit Voluntary enrollment unless in Medicaid –Choose from dozens (~40) of private Rx coverage plans and Medicare Advantage organizations –premiums are heavily subsidized, late penalty for late enrollment Auto-enrolled into Part D if in Medicaid

8. NOTE: Percentages do not sum to 100% due to rounding. 1 Includes Veterans Affairs, retiree coverage without RDS, Indian Health Service, state pharmacy assistance programs, employer plans for active workers, Medigap, multiple sources, and other sources. 2 Includes Retiree Drug Subsidy (RDS) coverage and FEHBP and TRICARE retiree coverage. SOURCE: Centers for Medicare & Medicaid Services, 2009 Enrollment Information (as of February 1, 2009). Total Number of Medicare Beneficiaries = 45.2 Million Total in Part D Plans: 26.7 Million (59%) Medicare Advantage Drug Plan Retiree Drug Coverage 2 No Drug Coverage Other Drug Coverage 1 4.5 million 10% 7.9 million 18% 6.2 million 14% Prescription Drug Coverage Among Medicare Beneficiaries, 2009 9.2 million 20% Stand-Alone Prescription Drug Plan 17.5 million 39%

9. Medicare’s “Standard” Drug Benefit in 2009 … Most plans do not offer the “standard” benefit, and coverage varies across most dimensions, including: –Monthly premiums –Deductibles –The “doughnut hole” –Covered drugs and utilization management restrictions –Cost sharing for covered drugs $295 Deductible $2,700 in Total Drug Costs $3,454 Coverage Gap (“Doughnut Hole”) Plan Pays 75% Plan Pays 15%; Medicare Pays 80% $6,154 in Total Drug Costs ($4,350 out-of-pocket) Enrollee Pays 25% 5%

10. Part D data for research Since June 2008, Part D data are available to researchers. Chronic Condition Data Warehouse (CCW) contains 100% Part D data and is official data source. –CCW offers chronic disease indicators (21 conditions) to ID disease cohorts but has data on all Part D enrollees Researchers may request random 10% or 20% sample Part D data are linkable to other Medicare data 10

11. Part D data Part D data include information about drug (NDC), cost, pharmacy, provider and benefit information Data are de-identified to protect identity of beneficiary, prescriber, pharmacy and plan. Researchers must select each variable and provide variable-level justification Assistance offered through ResDAC 11

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13. Part D data Constructed variables “may not exactly represent the beneficiary experience at the time of the prescription fill.” Part D data differ from pharmacy claims –Contains only final status record Will not include drugs excluded from Part coverage or filled through 3 rd party, or not filed as claim (e.g., 100% cash). 2-year lag in availability E.g., OPTIMIZING CHRONIC DISEASE PREVENTION AND MANAGEMENT IN ADVANCED DEMENTIA R21HS019579-01: PI Tjia –$20,000, 9 month lag = Part D data linked to Part A, MDS, and OSCAR on 200,000 Medicare enrollees with end-stage dementia in NHs. 13

14. NOTE: Percentages do not sum to 100% due to rounding. 1 Includes Veterans Affairs, retiree coverage without RDS, Indian Health Service, state pharmacy assistance programs, employer plans for active workers, Medigap, multiple sources, and other sources. 2 Includes Retiree Drug Subsidy (RDS) coverage and FEHBP and TRICARE retiree coverage. SOURCE: Centers for Medicare & Medicaid Services, 2009 Enrollment Information (as of February 1, 2009). Total Number of Medicare Beneficiaries = 45.2 Million, 2009 Total in Part D Plans: 26.7 Million (59%) Medicare Advantage Drug Plan Retiree Drug Coverage 2 No Drug Coverage Other Drug Coverage 1 4.5 million 10% 7.9 million 18% 6.2 million 14% Part D Data available only on Part D enrollees 9.2 million 20% Stand-Alone Prescription Drug Plan 17.5 million 39%

15. 15 Medicare Part D and Changes in Prescription Drug Use and Cost Burden: National Estimates for the Medicare Population, 2000-2007 Becky A. Briesacher, PhD (2) Yanfang Zhao, MA (4) Jeanne Madden, PhD (1) Fang Zhang, PhD (1) Alyce S. Adams, PhD (3) Jennifer Tjia, MD, MSCE (2) Dennis Ross-Degnan, ScD (1) Jerry H. Gurwitz, MD (2) Stephen B. Soumerai, ScD (1) (1) Harvard Medical School and Harvard Pilgrim Health Care Institute; (2) Div of Geriatric Medicine, Meyers Primary Care Institute and UMass Medical School; (3) Kaiser Permanente Division of Research; (4) Duke Translational Nursing Institute, Duke University School of Nursing

16. Evaluations of Medicare Part D Previous evaluations used –Pharmacy chain data –Regional Medicare Advantage plan data Important gap in research on Part D to date: –Lack of nationally-representative evaluations 16

17. Study Design Overall Methods Examined study outcomes over 8 years (2000-2007) Compared actual post-Part D (2006-2007) outcomes to projected values (using 2000-2005 data) Projections based on time-series regressions and parametric bootstrapping techniques and 10,000 simulations of post-Part D outcomes. Standardized estimates by fixing population characteristics Subgroup analyses -- by demographic & health status 3-year continuous cohort for sensitivity analyses 17

18. 18 Study Design Data from MCBS CMS conducts the Medicare Current Beneficiary Survey –Since 1991, continuous face-to-face panel survey –3-year rotating panels –>12,000 community-dwelling and institutionalized, elderly and disabled per year Rich variety of measures: –Demographics, income, assets, living arrangements, family supports, health status and functioning –Health insurance and drug coverage –Utilization of services – self-reported and FFS claims –Costs, copayments, deductibles –Access to medical care, satisfaction –Medications self-reported and Part D data, beginning in 2006

19. Study Design Sample and Variables Community-dwelling Medicare enrollees, 2000-2007 –~11.5K persons/year; total unique individuals, n = 38,777 Study Variables: –Prescription fills and OOP costs from MCBS Cost and Use file self-reported fills (disregarding Part D claims) –Prescription drug coverage categorized by coverage status between 2005 and 2007 –no drug coverage in all three years –gained drug coverage after Part D (in 2006 or 2007) –had drug coverage in all three years 19

20. 20 Annual Drug Use and Out-of-Pocket Drug Costs unadjusted means for overall population, 2000-2007 Prescription Drug FillsOOP Drug Costs Medical Care. 49(9):834-41, 2011 Sep.

21. 21 Changes in Annual Rx Fills and OOP Drug Costs Following Part D Implementation (overall population) Means (95% Confidence Intervals) Difference between Standardized Observed and Predicted Outcome measure N Observed Actual Observed Mean Standardized Observed* Mean Standardized Predicted Mean P value 2006Rx fills34,79834.332.8 31.0 (30.3 to 31.7) 1.8 (1.1 to 2.5) <.001 OOP drug costs 34,798499.4474.9 617.7 (578.1 to 657.4) -142.80 (-182.5 to -103.1) <.001 2007Rx fills38,77736.535.0 31.6 (30.9 to 32.3) 3.4 (2.7 to 4.1) <.001 OOP drug costs 38,777500.9475.9 623.7 (590.0 to 657.1) -147.8 (-181.2 to -114.1) <.001 Standardization to hold 2000 population characteristics stable Standardization to hold 2000 population characteristics stable Predictions used autoregressive models based on 2000-2005 historical trends Predictions used autoregressive models based on 2000-2005 historical trends Confidence intervals were constructed by creating 10,000 simulated outcomes using bootstrap method Confidence intervals were constructed by creating 10,000 simulated outcomes using bootstrap method Medical Care. 49(9):834-41, 2011 Sep.

22. 22 Subgroup Analyses: Annual Prescription Drug Fills absolute differences between observed and predicted means Medical Care. 49(9):834-41, 2011 Sep.

23. 23 Subgroup Analyses: Annual OOP Drug Costs absolute differences between observed and predicted means Medical Care. 49(9):834-41, 2011 Sep.

24. 24 Changes in Annual Fills and OOP Rx Costs among 3-year Cohorts, by Insurance Status, 2005-2007 Gained drug coverage after Part D Always had drug coverage Mean Rx FillsMean Rx OOP Costs Medical Care. 49(9):834-41, 2011 Sep.

25. My Current Part D Research NIH-National Institute on Aging(R01AG028745) (Co-Investigator) Changes in Cardiovascular Care and Outcomes in Eight Years after Medicare Part D   Developing R01 to conduct clinical trial on Part D enrollment protocols in nursing home setting 25