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Prescription drug use, health outcomes, and non-drug medical spending in the elderly –

Evaluation of changes in prescription drug benefits in Medicare

Kyoungrae Jung (Principal Investigator), Douglas Leslie, A. Marshall McBean

1. Keywords: Prescription drug benefits, health outcomes, non-drug medical spending, the

elderly, Medicare Part D

2. Abstract

Prescription drugs are cost-effective treatments for many health conditions, particularly for

chronic illnesses. Pharmacy coverage is thus an essential benefit of health insurance policies, and

developing programs to increase access to prescription drugs and thereby improve population

health has been an ongoing policy goal. The introduction of Medicare Part D (Medicare drug

benefits) in 2006 was a significant move toward this goal for the elderly and disabled

populations who often have multiple chronic conditions. The recent health care reform

legislation – the 2010 Affordable Care Act (ACA) – has further expanded prescription drug

coverage for Medicare beneficiaries by reducing cost sharing in a benefit phase in the standard

Part D benefit scheme. As pharmacy therapy plays an increasingly important role in treating

health problems, it is expected that the expansions of prescription drug coverage for Medicare

beneficiaries would potentially improve health outcomes of beneficiaries and thus save costs of

nondrug medical services, such as hospitalizations or skilled nursing facility use. However,

evidence on the relationship between drug benefit generosity and health outcomes is limited

particularly among high-risk Medicare beneficiaries with certain chronic conditions or high-cost

drug users. We propose to conduct exploratory analysis on the impacts of enhanced prescription

drug benefits on the use and spending on nondrug medical services and health outcomes, which

will be used for the preliminary analysis section in a grant application for external funding.

3. Specific Aims and Objectives

The objective of this proposal is to conduct exploratory analysis on prescription drug use and

health outcomes among the elderly Medicare beneficiaries with chronic conditions and to

develop a grant application to the Changes in Health Care Financing and Organization (HCFO)

program by Robert Wood Johnson Foundation (RWJF). This application would evaluate changes

in Medicare prescription drug benefits (Medicare Part D), addressing a series of research

questions on the relations between prescription drug benefits, non-drug medical spending, and

health outcomes in the elderly. A purpose of this proposal is also to facilitate collaboration

between researchers at Penn State (both from the Department of Health Policy and

Administration at University Park campus and the College of Medicine in Hershey) and a

researcher at the University of Minnesota for the development of a grant application for external

funding. Specifically, we will

1) Extract 12 years of Medicare Current Beneficiary Survey (MCBS) data (2000 – 2012) to

construct analytic data files

2) Analyze patterns of overall prescription drug use and brand-name drug utilization during the

study period

3) Explore changes in inpatient and outpatient service use and expenditures, as well as health

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status and functional outcomes during the study period

4) Check whether subgroup analyses by chronic condition group would be feasible

a) Obtain the number of beneficiaries with a chronic illness whose drug cost is high,

including cardiovascular diseases, depression, dementia, osteoporosis, and cancer etc.

b) Examine drug utilization and health outcomes in each condition group

5) Conduct a literature review on prescription drug use and health outcomes in the elderly

6) Develop an application for external funding for an evaluation of Part D with particular

attention to the impact of filling in the coverage gap –which is mandated by ACA.

4. Background, Rationale, and Methods

Medicare Part D, which was introduced in 2006, provides prescription drug coverage to 25.5

million elderly and disabled people. The program has been successful in increasing overall drug

utilization while decreasing beneficiaries’ out-of-pocket spending.1 However, evidence on whether

and how the improvement in drug benefits influences the use of other medical services among

Medicare beneficiaries is sparse. Several prior studies examined this issue using data from the

initial years of Part D (2006 and 2007).2 However, these studies are limited to examining a few

outcome measures (mostly hospitalization rates/costs) for a small group of beneficiaries from

one managed care organization or a survey, whose results may not be generalizable to a large

portion of beneficiaries or other outcomes. Further, evaluating the early years of Part D, those

studies may have captured pent-up demand for prescription drugs among those without drug

coverage prior to Part D. No information is available on long-term effects of Part D on health

outcomes. Moreover, little is known about the impacts of drug benefits on drug use and health

outcomes for high-risk Medicare beneficiaries or high-cost drug users, whose drug spending

accounts for a large share of Medicare spending and is a key policy issue in Medicare Part D.3

These issues highlight the need for studies on the relation between drug benefit generosity and

health outcomes. As pharmacy therapy plays an increasingly important role in treating health

problems, drug benefit designs that ensure access to cost-effective drugs, particularly among

high-risk consumers, have become critical elements of efficient health care systems. By

evaluating the Part D program, our study will provide information that can be used to design

such benefits.

Medicare Part D benefits:

While the Part D program is generally considered successful, the presence of a coverage gap in the

standard Part D benefit has been criticized as a limitation of the program. Under the standard Part

D benefit, after reaching an Initial Coverage Limit (ICL; total drug spending of $2,830 in 2010)

beneficiaries enter the coverage gap, where they become responsible for the full cost of drugs.

Studies reporting a decrease or discontinuation of prescription drug use in the gap raised

concerns about its adverse effect on beneficiaries’ health, particularly for high-risk beneficiaries

with chronic conditions. In response, the ACA stipulates that the gap will be gradually filled in

until it is fully closed by 2020. This ACA provision began in 2011 with 50% discounts on branded

1Polinski et al. (2010). Changes in drug utilization and out-of-pocket costs associated with Medicare Part D

implementation: A systematic review. Journal of American Geriatric Society, 58(9), 1764-1779 2 Zhang et al. (2009), The Effect of Medicare Part D on Drug and Medical Spending, New England Journal of

Medicine, 361: 52-61; Afendulis et al. (2011), The Impact of Medicare Part D on Hospitalization Rates, Health

Services Research, 46(4): 1022-1038; McWilliams et al. (2011), Medicare Part D and Nondrug Medical Spending

for Elderly Adults with Limited Prior Drug Coverage, Journal of American Medical Association, 306(4): 402-409 3Medicare Payment Advisory Committee. (MedPAC, 2012; 2013). Reports to Congress: Medicare payment policy.

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drugs from manufacturers and 7% discounts on generic drugs from the government. The

government subsidy will increase gradually until beneficiaries are responsible for 25% of the cost

for both generic and branded drugs in 2020. This is a significant change in Part D, which will

further increase beneficiaries’ prescription drug use and can potentially improve their health

outcomes. While filling in the gap will add costs to Part D, it may reduce spending on medical

care (e.g., hospitalizations). Our study will evaluate the changes in Medicare drug benefits – both

the introduction of Part D and the recent ACA expansion. Particularly, the ACA expansion offers

a unique opportunity to address several issues related to drug benefits, drug use and health

outcomes. First, serving as a natural experiment, it enables us to examine a causal effect of

enhanced drug benefits on health outcomes. Further, under the ACA provision, discounts in the

coverage gap are much more favorable for brand-name drugs than generic drugs. This allows us

to focus on high-risk beneficiaries with chronic conditions, who often rely on costly brand name

drugs that do not have substitutes.

Medicare Current Beneficiary Survey (MCBS) data (2000-2012):

The MCBS is a continuous survey of a nationally representative sample of the Medicare

population, which is conducted by the Center for Medicare and Medicaid Services (CMS). In any

year, more than 15,000 beneficiaries are interviewed. Each sample person is interviewed three

times a year over four years, and the sample is replenished with approximately twenty-five

percent new subjects each year. We will use two modules of MCBS data – Access to Care and

Cost and Use files – which will be purchased from CMS. The Access to Care file contains

information on demographic and economic characteristics of the sample population, as well as

self-reported health status and functional outcomes (e.g., independency in activities in daily

lives). The Cost and Use file is a source of data on all health care services, including

hospitalizations, physician office visits, and prescription drug use. With these two files, we will

explore how generous drug benefits influence prescription drug use and health outcomes in the

elderly. Further, using sampling weights provided in MCBS data, we will calculate sample sizes

for analyses that would be proposed in a grant application for external funding and assess

feasibility and power of those analyses.

Descriptive analysis:

Using 12 years of MCBS data, we will first examine patterns of prescription drug use in the

elderly over years – both overall utilization and by chronic condition. This descriptive analysis

will help assess whether the changes in prescription drug utilization after 2006(implementation

of Part D) and after 2011 (reduced cost sharing in the coverage gap) are large enough to indicate

that the enhanced drug benefit affects beneficiaries’ use of prescription drugs. Our primary focus

is on examining whether prescription drug use continuously increased during the later years of

Part D (the long-term effect of Part D) and whether a greater increase in prescription drug use

occurred after 2011 (the impact of the ACA expansion). It will also help identify subgroups – by

chronic condition – that are worth investigating. We will examine similar descriptive time trends

in diverse measures of health outcomes and non-drug medical service use, including self-

reported health status, functional outcomes, hospital admissions, length of stay per admission,

hospital admissions through emergency room, and acute-care sensitive hospitalizations, and

physician office visits etc. This descriptive analysis will inform us of potential impacts of the

enhanced drug benefit on health outcomes and nondrug medical spending.

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Exploring control-group strategies:

Next, we will explore control-group strategies for the RWJF application because the analysis

above may simply capture time trends in outcome measures rather than the impacts of the drug

benefit change. An appropriate control group would be beneficiaries who are not affected by the

change in Medicare drug benefits. To examine long-term effects of the implementation of Part D,

we will explore, as a possible control group, beneficiaries who did not have drug coverage prior

to 2006. To evaluate filling in the coverage gap in Part D (the ACA expansion), we will identify

beneficiaries who received low-income subsidies (LIS) and thus did not face the coverage gap

before 2011 (but after the implementation of Part D). We will first look at descriptive data, i.e.,

over-time changes in prescription drug use, medical service use/spending, and health outcomes

in those possible control groups. We will then explore a difference-in-difference approach, which

assesses whether changes in outcome measures in an experiment group are different than those in

a control group. This will help us gauge the magnitude of the effects of the drug benefit change

after controlling for a secular trend. Finally, we will explore the validity of those possible control

groups by comparing patterns of prescription drug use prior to any policy changes between the

experiment and control groups. In other words, if the time trends in prescription drug use before

any policy changes are different between the two groups, it would suggest that proposed control

groups might not be appropriate comparisons. If this would be the case, we would identify

beneficiaries who are relatively similar to the control groups (in demographic characteristics and

health conditions) and limit our analysis to these “relatively similar” groups.

Developing a grant application for external funding:

The preliminary analyses described above will provide information that will be used for the

development of an application for external funding. The application would propose to use

multiple years of a set of Medicare claims files, which provides comprehensive information on

the use and spending on inpatient, skilled nursing facility, outpatient care, and prescription drugs,

and mortality, for millions of beneficiaries. Using these large claims data will improve power of

analyses and generalizability of study findings. The application would ask:

1) What are the long-term effects of the implantation of Part D in the elderly beneficiaries?

a) Does the implementation of Part D increase prescription drug use in a long term?

b) Does the implementation of Part D improve health outcomes of the elderly and save costs of

other medical services in a long run?

2) How do the long-term effects of the introduction of Part D on the use prescription drugs and

health outcomes vary by beneficiaries’ health-risk or chronic condition(s)?

3) Does the reduced cost sharing in the coverage gap in Part D increase prescription drug use?

a) Does reduced cost sharing in the coverage gap in Part D lead beneficiaries with chronic

condition(s) to initiate a pharmacy therapy?

b) Does reduced cost sharing in the coverage gap in Part D improve medication compliance?

c) Are beneficiaries less likely to discontinue medications in the gap after 2011 than prior years?

d) Does reduced cost sharing in the coverage gap in Part D increase the use of brand name

drugs under the ACA provision that gives favorable discounts for branded drugs?

4) Does reduced cost sharing in the coverage gap in Part D influence the use and spending on

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nondrug medical services (e.g., in-patient admissions, skilled nursing facility admissions and

physician office visits) and health outcomes (e.g., reduced mortality)?

5) Do beneficiaries’ responses to filling in the coverage gap by ACA in the use prescription drugs

and other medical services vary by their health-risk or chronic conditions?

This proposed study would also begin a research partnership among researchers with diverse

skills, experience and expertise. Along with the collaboration on the proposed exploratory analysis,

the research team would discuss the following issues to develop an application for external funding.

1) Selection of chronic conditions to focus on: we would select several chronic conditions that

are clinically and economically important. Selection criteria would include: a) the number of

beneficiaries with the condition (sample size); b) total health care costs of the condition; and

c) whether health outcomes of patients with the condition are sensitive to prescription drug

use (e.g., non-adherence to osteoporosis drugs often leads to fractures).

2) Refining research design: the application would propose to utilize longitudinal data, which

allow us to use an interrupted time-series design and/or a difference-in-difference approach,

both of which are commonly-used methods to evaluate policy changes. We will further refine

research methods and control-group strategies based on findings from this proposed study.

3) Construction of outcome measures: we would discuss what outcome measures (both health

outcome and prescription drug utilization measures) to use in the application and how to

construct them. We will explore several health outcome measures in this proposed study and

select measures that produce informative results (e.g., overall hospital admissions vs. acute care

sensitive hospitalizations vs. hospital admissions through emergency room).

5. Relevance to the SSRI:

This research fits in the SSRI mission to promote research involving broad range of skills and

perspectives that are necessary to address social policy issues. The research team of this project

consists of researchers with diverse expertise and experience. As described below, this project

involves a medical doctor and epidemiologist from the University of Minnesota, a senior

economist from the Penn State College of Medicine, and a health policy researcher in the

Department of Health Policy and Administration (HPA) at Penn State. Health services research

is essentially built with an interdisciplinary approach, and our research team offers disciplines as

diverse as economics, epidemiology/public health, and health policy. Bringing together

investigators with diverse skills, experience and expertise, this project aims to address important

health care policy issues.

6. Anticipated Outcomes:

The product of this effort will be an application submitted to RWJF in spring 2014. If the

application is not well received by RWJF, we will submit an R01 application to the National

Institute of Aging (NIA) in June 2014. We will also consider the National Institute of Mental

Health (NIMH) or National Heart, Lung, and Blood Institute (NHLBI) or National Cancer

Institute (NCI), depending on findings from exploratory analyses. Over the long term, this project

would result in increased collaborations between the UP campus and the College of Medicine.

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Additional Information

1. External Funding Sources

a) Investigators Involved: see below (the same personnel for the proposed study and possibly a

few additional members)

b) Title of Proposal: Prescription drug use, health outcomes, and non-drug medical spending in

the elderly – Evaluation of changes in prescription drug benefits in Medicare

c) Time Frame of Proposal: the RWJF application will be submitted in spring 2014

d) External funding sources: the primary target agency at this stage is RWJF, but we will also

consider NIA, NIMH, NHLBI or NCI, depending on results from exploratory analysis.

2. Timeline:

July/August 2013 – Review literature; obtain MCBS data

Fall 2013 – Construct analytic files; perform data analysis

Spring 2014 – Write up a grant proposal

Spring 2014 – Submission of the application

3. Personnel

The principal investigator, Kyoungrae Jung, is an assistant professor of Health Policy and

Administration (HPA). She would supervise the entire process and would develop a research

plan and appropriate analytic techniques. She would also assume primary responsibility for

writing of the grant application for external funding.

Collaborating investigators:

Dr. Douglas Leslie is a professor of Public Health Sciences and director of Center for Applied

Studies in Health Economics at Penn State College of Medicine in Hershey. Dr. Leslie is a health

economist whose study areas include adherence to treatment guidelines for mental health patients

and the cost-effectiveness of antipsychotic medications. He would provide consultation on

research design, and would assist in developing a research plan, particularly in the area of the

impact of medication use on health outcomes.

A. Marshall McBean, MD, MSc., is a professor in the Department of Health Policy and

Management and director of the Research Data Assistance Center (a CMS contractor) at the

University of Minnesota. He has a background in epidemiology and expertise in access, quality

of care, and health outcomes of Medicare beneficiaries. Particularly, he has extensive expertise

in the data sets required for the application for external funding. He will advise the project on

clinical issues, as well as access to data and data management.

Others. During the coming year, we would hope to involve other Penn State faculty members.

Possible collaborators include Dennis Shea, a professor of Health Policy and Administration,

with expertise in Medicare policies, financing for long-term care, and prescription drug use

among the elderly. Another possibility is Frank Ahern, a senior research associate in the

Department of Biobehavioral Health, whose research focuses on prescription drug use/misuse

among the elderly and long-term care.

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4. Itemized Budget and Justification:

SSRI seed funds will be used to purchase MCBS data files, fund a graduate student during

summer/ fall 2013, and partially support Jung’s salary (buy-out of one course) in spring 2014 to

help her focus on the grant application for external funding. The graduate student will assist with

the necessary literature reviews and data analysis. Funding for Jung to make one trip to Hershey

to meet with Dr. Leslie is also requested.

Salary support for Jung: Spring 2014 $7,500

Research assistant (stipend only): Summer/Fall 2013

- $23.50 X 20 hours/week X 5 weeks (summer 2013) =$2,350

- 10 hours/week (fall 2013) = $4,650 (based on grade 14)

$7,000

Data sets (MCBS files 2009-2012): $600 per module per year

- Two modules/year X 4 years = $4,800

- Other years of data (2000-2008) are in house

$4,800

Travel to Hershey $200

Total $19,500

Name and phone number of your department's budget coordinator:

Stephen Bumbarger (Tel: 814-863-2860; Email: svb4@psu.edu)

Budget and fund number:

Administrative area number:

5. SSRI services to be used: None

6. Investigator Information

Lead Investigator:

Name: Kyoungrae Jung

Title: Assistant Professor

Address: 601E Ford Building

City: University Park

State: PA

Zip Code: 16802

Department/Organization: Department of Health Policy and Administration (HPA), The

Pennsylvania State University

College: College of Health and Human Development

Campus: University Park

Phone: 814-863-8129

Fax: 814-863-2905

Email: kuj11@psu.edu

Tenure Track - Yes. If Yes, please include tenure home department: HPA

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Collaborating Investigator:

Name: Douglas Leslie

Title: Professor of Public Health Sciences; Director of Center for Applied Studies in Health

Economics

Address: 500 University Drive

City: Hershey

State: PA

Zip Code: 17033

Department/Organization: Public Health Sciences, The Pennsylvania State University

College: College of Medicine

Campus: Hershey

Phone: 717-531-1259

Email: dll35@psu.edu

Tenure Track - Yes. If Yes, please include tenure home department: PHS

Collaborating Investigator:

Name: A. Marshall McBean

Title: Professor; Director of Research Data Assistance Center (ResDAC)

Address: 420 Delaware Street SE, MMC 729

City: Minneapolis

State: Minnesota

Zip Code: 55455

Department/Organization: Health Policy and Management, University of Minnesota

College: School of Public Health

Campus: Twin Cities

Phone: 612-625-6175

Fax: 612-624-2196

Email: mcbea002@umn.edu

Tenure Track - Yes. If Yes, please include tenure home department: HPM

7. Pre-Submission Checklist

1) Which agency or foundation officials (e.g., project officer) have you spoken with to

determine their interest in this project or project area? What feedback did you

receive on your concept and approach?

HCFO program by RWJF has a formal process to provide feedback on proposal ideas by

officially receiving a letter of intent. We will submit the letter in fall 2013. It usually takes

about two or three months to receive feedback on the letter. While it would be ideal to apply

for seed money and conduct exploratory analysis after we are invited to write a full proposal,

researchers are expected to submit a full proposal within only several weeks following

invitations. If we wait to hear about the invitation, we will not have sufficient time to write up

the full proposal. Therefore, we will start conducting preliminary analysis and preparing for the

full proposal right after submitting the letter of intent.

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In case the letter is not well received by RWJF, we will apply for an R01 grant application to

NIA. Depending on findings from our exploratory analyses, we will also consider NIMN,

NHLBI or NCI.

2) Are you responding to a specific request for proposal (RFP/RFA), program

announcement, or other special funding initiative? If yes, which one and how is

your Level 2 a good match for it?

We are responding to 2013 Call for Proposals (CFP) of the Changes in Health Care

Financing and Organization (HCFO) program funded by Robert Wood Johnson Foundation

(RWJF). Grants are awarded on a rolling basis; proposals may be submitted at any time.

More detailed information on the CFP is available at

http://www.hcfo.org/files/hcfo/cfp_HCFO_2013.pdf

The purpose of the HCFO program is described in the CFP as below, and our proposal,

which is to evaluate important current health care policy issues fits well in the program.

“Changes in Health Care Financing and Organization (HCFO) supports policy analysis,

research, and evaluation projects that provide policy leaders timely information on health

care policy and financing issues, which include “Examining significant issues and

interventions related to health care financing and organization and their effects on health care

costs, quality and access.”

3) Is this Level 2 being undertaken in response to feedback from a prior external

proposal? If so, how does this project address reviewer concerns?

No. Our proposal would be a new application.

4) How does your study compare with projects in similar domains that have been

funded by your targeted agency? In particular, how does the scope of your

methodology appear similar to other funded projects (in terms of the size and

representativeness of the sample, measurement strategies, design and planned

analytic approach, etc.)?

Below is a few examples of research projects funded by HCFO (RWJF) in recent years. The

priory areas of the HCFO program have included studies on evaluation of policy changes in

health care that would affect patient quality and health outcomes. With the recent health care

reform legislation, the 2010 Affordable Care Act (ACA), HCFO has funded studies that

evaluate the impacts of the ACA. Our proposal also assesses the impact of the ACA

expansion in prescription drug benefits, which should be an interesting topic to HCFO. The

full list of the projects funded is available at the HCFO Web site, http://www.hcfo.org/grants.

Title: Examining intended and unintended consequences of the hospital readmissions

reduction program for Medicare beneficiaries

Abstract: The researchers will identify hospital responses to the Hospital Readmissions

Reduction Program (HRRP) and examine whether these responses offset expected savings to

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Medicare. Specifically, the researchers will perform a series of logistic regressions in order

to analyze any changes in readmission rates and length of hospital stay for Medicare patients

admitted for heart attack, heart failure or pneumonia, the three conditions targeted under the

HRRP. The researchers will also examine any unintended adverse consequences of the

HRRP, including strategic behavior by hospitals that could reduce expected savings to

Medicare. The goal of this project is to provide policymakers with a more informed picture

of potential hospital responses to an important payment redesign under the Patient Protection

and Affordable Care Act (ACA).

Title: Impact of State Policies Supporting Medicare Part D for the Dually Eligible

Abstract: The project assesses two state Medicaid policies - co-payment assistance to reduce

cost sharing and beneficiary centered assignment. It examines the impact of these policies for

the dually eligible population on health outcomes (health care utilization and sentinel events),

beneficiary switching among plans, continuity of drug treatment, and Medicare program

costs. It also compares beneficiaries in six states that provide full co-payment assistance to

those states without such assistance, and beneficiaries in Maine, the only state with CMS-

approved beneficiary centered assignment for dually eligible beneficiaries, to similar

beneficiaries in other states. The objective of this project is to inform the Medicare program

and state policymakers on the impact of the Part D benefit on dually eligible beneficiaries.

5) What criteria will be used to evaluate your proposal and what do you know about

the likely reviewers?

The below is selection criteria described in the CFP of the HCFO program by RWJF. Based

on the information provided, we believe that our proposal is a strong candidate for the award.

Policy significance of the health care financing policy or issue being assessed or tested.

Our proposed study addresses an important policy issue in health care. We propose to

evaluate changes in prescription drug benefit polices. As pharmacy therapy plays an

increasingly important role in treating health problems, designing drug benefits that ensure

access to cost-effective drugs, particularly among high-risk consumers, is an ongoing policy

issue. By assessing the relations between drug benefits, drug use, and health outcomes in the

elderly, our study will provide information that can be used to design such benefits.

Quality and availability of data to be used and the strength

We propose to use an almost complete set of Medicare claims data, which can be

purchased from the Center for Medicare and Medicaid Services. The strength of these data

files is that the claims file contain rich information on all health care service use and

spending by a large number of Medicare beneficiaries, which enables researchers to study the

impacts of Medicare policy changes on service use and health outcomes of beneficiaries.

Applicant’s experience and qualifications

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As discussed in the proposal, our team consists of individual investigators with diverse

skills, experience and expertise to perform tasks required for the study. HCFO especially

encourages young researchers to team up with senior members and apply for the grant. The

primary investigator is a junior faculty member at Penn State, and she develops a research

team with senior researchers who have extensive research experience in the proposed

research area.

6) What input/advice/support have you received from your department head and/or

college research dean?

Yes, we have informed Dr. Dennis Shea, the head of the Department Head of Health Policy

and Administration, about our intent to submit this proposal. Dr. Shea has agreed to support

our efforts by covering the tuition of a graduate student who will work on the project in the

fall 2013.

8. Translational Research Potential:

Not applicable.

9. Letters of Support from All Collaborators

See the attached materials

10. Attach NIH or NSF biosketches

See the attached materials

Penn State Milton S. Hershey Medical Center • Penn State Hershey College of Medicine Department of Public Health Sciences, Mail Code A210, 600 Centerview Drive, Suite 2200, Hershey, PA 17033-0855 Tel: 717-531-4262 • Fax: 717-531-4359 Tel: 717-531-4262 • Fax: 717-531-4359

An Equal Opportunity University

Douglas L. Leslie, PhD Professor Department of Public Health Sciences Penn State Hershey College of Medicine douglas.leslie@psu.edu  

 

June  17,  2013  

 

SSRI  Review  Committee  Social  Science  Research  Institute  The  Pennsylvania  State  University  601  Oswald  Tower  University  Park,  PA  16802-­‐‑6211  

RE:  Level  II  Proposal  

Dear  SSRI  Review  Committee:  

I  am  very  pleased  to  write  in  support  of  Dr.  Jung’s  Level  II  Social  Science  Research  Institute  (SSRI)  proposal  titled,  “Prescription  drug  use,  health  outcomes,  and  non-­‐‑drug  medical  spending  in  the  elderly:  Evaluation  of  changes  in  prescription  drug  benefits  in  Medicare.”  This  interdisciplinary  proposal  seeks  to  explore  relations  between  drug  benefit  generosity,  non-­‐‑drug  medical  care  use,  and  health  outcomes.  Evaluation  of  the  Medicare  prescription  drug  coverage  program  is  an  important  project  to  pursue  as  pharmacy  therapy  becomes  a  critical  element  in  treatments  for  many  health  conditions  particularly  for  the  elderly.  The  project  will  also  facilitate  collaborations  among  researchers  with  different  disciplines  on  the  development  of  a  grant  application  for  external  funding.    

As  a  co-­‐‑investigator  for  the  project,  I  will  assist  in  developing  a  research  plan  for  a  grant  application  in  the  area  of  assessing  the  impact  of  prescription  drug  use  on  health  outcomes.  I  will  also  provide  consultation  on  research  designs  and  policy  implications  of  the  project.  

SSRI  funding  would  enhance  our  ability  to  secure  external  funds  by  allowing  us  to  prepare  materials  for  preliminary  data  and  power  calculation  through  exploratory  analyses.  

Penn State Milton S. Hershey Medical Center • Penn State Hershey College of Medicine Department of Public Health Sciences, Mail Code A210, 600 Centerview Drive, Suite 2200, Hershey, PA 17033-0855 Tel: 717-531-4262 • Fax: 717-531-4359 Tel: 717-531-4262 • Fax: 717-531-4359

An Equal Opportunity University

Thank  you  for  your  consideration  of  this  grant  application.  

Sincerely  yours,  

 Douglas  L.  Leslie,  Ph.D.  Professor  of  Public  Health  Sciences  and  Psychiatry  Director,  Center  for  Applied  Studies  in  Health  Economics  Department  of  Public  Health  Sciences  College  of  Medicine  Pennsylvania  State  University  

Twin Cities Campus Division of Health Policy and Management

School of Public Health

June 17, 2013

Dr. Kyoungrae Jung

Assistant Professor of Health Policy and Administration

604 Ford Building

The Pennsylvania State University

University Park, PA 16802

Dear Dr. Jung:

I am pleased to write in support of your Penn State Social Sciences Research Institute application

“Prescription drug use, health outcomes, and non-drug medical spending in the elderly:

Evaluation of changes in prescription drug benefits in Medicare.” This project will extend our

existing collaborations on medication adherence among Medicare beneficiaries to investigate

relations between drug benefit generosity, non-drug medical care use, and health outcomes. This

is an important area to study given the increasing clinical importance of prescription drugs and

expansion of prescription drug coverage.

As a co-investigator for the project, I will provide consultation on clinical issues, as well as

constructing outcome measures. I will also assist in acquiring or accessing data sets for the

development of a grant application for external funding.

I welcome the opportunity to collaborate with you in this important effort.

Sincerely,

A. Marshall McBean, MD, MSc.

UNIVERSITY OF MINNESOTA

For U.S. Mail:

Mayo Mail Code 729

420 Delaware Street S.E.

Minneapolis, MN 55455

For Courier/Deliver Service:

516 Delaware Street S.E.

15-200 PWB

Minneapolis, MN 55455

612-624-6151 Fax: 612-624-2196

http://www.hpm.umn.edu

PHS 398/2590 (Rev. 09/04) Page Biographical Sketch Format Page

Principal Investigator/Program Director (Last, First, Middle):

BIOGRAPHICAL SKETCH Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2.

Follow this format for each person. DO NOT EXCEED FOUR PAGES.

NAME

Kyoungrae Jung

POSITION TITLE

Assistant Professor of Health Policy and

Administration eRA COMMONS USER NAME

KYJUNG

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)

INSTITUTION AND LOCATION DEGREE

(if applicable) YEAR(s) FIELD OF STUDY

Seoul National University, Seoul, Korea B.S. 1995 Pharmacy

Seoul National University, Seoul, Korea M.P.H. 1999 Health Policy

University of Minnesota, Minneapolis, MN Ph.D. 2007 Health Services Research and Policy

A. Personal Statement Since receiving a PhD in health policy with concentration on health economics in 2007, my research has focused on examining consumer and provider incentives responding to changes in policies. As PI on an R03 sponsored by the National Institute of Aging, I examined selection incentives by home health agencies under a public reporting program. I have also looked at possible differences in health plans’ incentives to manage prescription drug utilization among their enrollees depending on the breadth of coverage offered by plans. I am currently examining enrollees’ responses to nonlinear pricing in prescription drug benefits. With this focus and experience, I am well suited to lead this proposed project. I will collaborate with Dr. Leslie to address all aspects of analyses of the project. I also have extensive experience in studying health care utilization, quality of care, and health outcomes using varied large claims data. This proposed project, which will use MCBS data, fits well with my experience. I will collaborate with Dr. McBean, who has clinical knowledge and 30 years of experience with Medicare data file, to explore data files that would be used for an application for external funding.

B. Positions and Honors. Positions and Employment 1995-1997 Clinical Research Associate, Janssen Korean Limited, Seoul, Korea 1997-1998 Research Assistant, Seoul National University, School of Public Health, Seoul, Korea 1999-2000 Research Associate, Korea Institute for Health and Social Affairs, Health Policy Team, Seoul,

Korea 2002-2007 Research Assistant, University of Minnesota, School of Public Health, Division of Health Policy

and Management and Research Data Assistance Center (ResDAC), Minneapolis, MN 2006 Instructor, University of Minnesota, School of Public Health, Division of Health Policy and

Management, Minneapolis, MN 2007-present Assistant Professor, The Pennsylvania State University, Department of Health Policy and

Administration, University Park, PA Other Experience and Professional Memberships 2006-present AcademyHealth 2006-present International Health Economics Association 2006-present American Society of Health Economists 2007-present Research Faculty, Center for Health Care and Policy Research, Pennsylvania State University,

State College, PA

Principal Investigator/Program Director (Last, First, Middle):

PHS 398/2590 (Rev. 09/04) Page Continuation Format Page

2008-present Scientific Committee, American Society for Health Economists (ASHE) 2011, 2013 Scientific Committee, International Health Economics Association (iHEA) Honors 1991-1994 Merit Award, College of Pharmacy, Seoul National University 1995 Cum Laude Graduate, College of Pharmacy, Seoul National University 1997-1998 Merit Award, School of Public Health, Seoul National University 1999 Summa Cum Laude Graduate, School of Public Health, Seoul National University 1999 Best Thesis Award, School of Public Health, Seoul National University 2000-2001 Graduate School Fellowship, University of Minnesota 2006 Juran Dissertation Fellowship Finalist, Juran Center for Leadership in Quality 2006 Professional Development Grant, School of Public Health, University of Minnesota 2007 Delta Omega Phi (The Honorary Public Health Society) 2008 Most Outstanding Abstract, AcademyHealth 2012 The Fran and Holly Soistman Faculty Development Endowment, Penn State University

C. Selected peer-reviewed publications (in chronological order). Jung, K., Moon, O. Cost-effectiveness Analysis of Pharmacological Treatments for Hyper-cholesterolemia, Korean Journal of Health Policy & Administration, vol. 9, No. 3, 1999 Kane, R.L., Kane, R.A., Bershadsky, B., Degenholtz, H., Kling, K., Totten, A., Jung, K., Proxy Sources for Information on Nursing Home Residents’ Quality of Life, Journals of Gerontology. Series B, Psychological Sciences and Social Sciences, Vol. 60, No. 6, Nov. 2005: S318-S325 McBean, M., Jung, K., Hebert, P., Decreasing Invasive Pneumococcal Disease in the Elderly: a state-level analysis, Vaccine, 2006, 29, 5609-5614 McBean, M., Jung, K., Virnig, B., Improved Care and Outcomes among Elderly Medicare Managed Care Beneficiaries with Diabetes, American Journal of Managed Care, 2005, 11:4, 213-222 Jung, K., Shea, D., Warner, C., Agency Characteristics and Quality Improvement after Home Health Compare, Journal of Aging and Health, 2010, 22:4, 454-476 Jung, K., Incentives for Voluntary Disclosure of Quality Information in HMO markets, Journal of Risk and Insurance, 2010, 77:1, 183-210 Jung, K., The Impact of Information Disclosure on Quality of Care in HMO Markets, International Journal for Quality in Health Care, 2010, 22(6), 461-468 Jung, K., Feldman, R., Scanlon, D., Where Would You Go for Your Next Hospitalization?, Journal of Health Economics, 2011, 30, 832– 841 Feldman, R., Jung, K., “Testing the Hirshleifer-Riley Model: The Values of Information Sources for a Future Hospital Stay,” Journal of Consumer Policy, 35:3 (2012), pp. 355-371 Jung, K., McBean, A. M., Kim, J. Comparison of Statin Adherence between MA-PD and stand-alone PDP enrollees, Journal of Managed Care Pharmacy, 2012, 18(2), pp. 106-115 Jung, K., Feldman, R., Public Reporting and Market-Area Exit Decisions by Home Health Agencies, submitted to Medicare & Medicaid Research Review, December 2012, 2(4), pp. 1-18

Principal Investigator/Program Director (Last, First, Middle):

PHS 398/2590 (Rev. 09/04) Page Continuation Format Page

Jung, K., Polsky, D., “Competition and Quality in Home Health Care Markets,” Health Economics, forthcoming Lim, D-Y., Jung, K., Shi., Y., “The Use of Antidepressants: Medicare Part D and National Trends” Psychiatric Services, forthcoming

D. Research Support.

Completed research support 1R03AG035098-01 (Jung) 5/10 - 4/13 NIH/NIA Public Reporting and Market Area Exit Decisions by Home Health Agencies

The aim of this project is to examine the impact of a public reporting program on access to home health care among socio-economically disadvantaged populations. Specifically, this project examines whether home health agencies discontinue service to market areas with disadvantaged populations after public reporting.

Role: Principal Investigator XXX (Jung) 6/08 - 5/11 Social Science Research Institute/Pennsylvania State University Public Reporting and Home Health Care Quality

This project examines whether home health care agencies have incentives to improve quality under Home Health Compare, a Medicare public reporting program in home health care.

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors.

Follow this format for each person. DO NOT EXCEED FOUR PAGES.

NAME

Leslie, Douglas L. POSITION TITLE

Professor, Public Health Sciences and Psychiatry

eRA COMMONS USER NAME (credential, e.g., agency login)

DLLESLIE

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.)

INSTITUTION AND LOCATION DEGREE

(if applicable) MM/YY FIELD OF STUDY

University of Virginia, Charlottesville, VA B.A. 05/90 Economics Yale University, New Haven, CT Ph.D. 05/98 Economics

A. Personal Statement The proposed project would investigate …. My broad background in health economics and health services research, with specific training and experience in working with large databases, provide me with the expertise to successfully collaborate on the proposed project. As a Professor at the Penn State College of Medicine and Director of the Center for Applied Studies in Health Economics at Penn State, I have extensive experience with working with administrative and clinical databases to study health care costs, services use, and their correlations with patient outcomes. As PI or co-Investigator on several previous NIH-funded grants, I have considerable experience collaborating with multi-disciplinary teams to explore issues of how patient and health care system factors affect clinical outcomes and costs. B. Positions and Honors Positions and Employment

1997 – 1999 Associate Research Scientist, Department of Psychiatry, Yale School of Medicine (YSM), New Haven, CT

1997 – 2007 Mental Health Economist, Northeast Program Evaluation Center, West Haven, CT 1999 – 2006 Assistant Professor, Department of Psychiatry, YSM, New Haven, CT 2000 – 2006 Assistant Professor, Department of Epidemiology and Public Health, YSM, New Haven, CT 2006 – 2007 Associate Professor, Department of Epidemiology and Public Health, YSM, New Haven, CT 2006 – 2007 Associate Professor, Department of Psychiatry, YSM, New Haven, CT 2007 – 2009 Associate Professor, Department of Health Administration and Policy, Medical University of

South Carolina, Charleston, SC 2009 – Present Professor, Department of Public Health Sciences, Penn State College of Medicine, Hershey,

PA 2011 – Present Director, Center for Applied Studies in Health Economics, Department of Public Health

Sciences, Penn State College of Medicine, Hershey, PA Other Experience and Professional Memberships

2005 – Present Charter Member, American Society of Health Economists 2005 – Present Editorial Board, Journal of the American Geriatrics Association 2007 – Present Standing member, NIMH SRSP review committee 2008 – Present Editorial Board, Medical Care Research and Review 2011 – Present Member, IOM Committee on the Assessment of Ongoing Efforts in the Treatment of PTSD

Honors

2001, 2002 MarketScan Investigator Award, The MEDSTAT Group 2005 Excellence in Mental Health Policy and Economics Research Award, ICMPE 2006 Research Mentorship Award, Interdisciplinary Postgraduate Training in Mental Health Policy

and Economics Research, International Center for Mental Health Policy and Economics 2008 Academic Co-Chair, 14th NIMH Research Conference on the Economics of Mental Health 2008 Medical University of South Carolina Scholar of the Year, College of Health Professions

C. Selected Peer-reviewed Publications (From a total of over 80) 1. Beam-Goulet J, Rosenheck RA and Leslie DL. “Effectiveness of a Targeted Mailing Outreach Program on

Supplemental Security Income Applications and Awards.” Social Service Review 1999; December: 579-587.

2. Rosenheck RA, Druss BG, Stolar M, Leslie DL and Sledge W. “Effect of Declining Mental Health Service Use among Employees of a Large Self-Insured Private Corporation.” Health Affairs 1999; 18(5): 193-203.

3. Leslie DL and Rosenheck RA. “Shifting to Outpatient Care? Mental Health Care Use and Costs under Private Insurance.” American Journal of Psychiatry 1999; 156(8): 1250-1257.

4. Leslie DL and Rosenheck RA. “Inpatient Treatment of Comorbid Psychiatric and Substance Abuse Disorders: A Comparison of Public Sector and Privately Insured Populations.” Administration and Policy in Mental Health 1999; 26(4): 253-268.

5. Leslie DL and Rosenheck RA. “Changes in Inpatient Mental Health Utilization and Costs in a Privately Insured Population, 1993-1995.” Medical Care 1999; 37(5): 457-468.

6. Striegel-Moore RH, Leslie DL, Garvin V, Petrill S and Rosenheck RA. “One-year Use and Cost of Inpatient and Outpatient Services among Female and Male Patients with an Eating Disorder: Evidence from a National Database of Health Insurance Claims.” International Journal of Eating Disorders 2000; 27(4): 381-389.

7. Leslie DL and Rosenheck RA. “Comparing Quality of Mental Health Care in Public Sector and Privately Insured Populations: First Efforts and Methodological Challenges.” Psychiatric Services 2000; 51(5):650-655.

8. Leslie DL, Rosenheck RA, and White WD. “Capitated Payments for Mental Health Patients: A Comparison of Potential Approaches in a Public Sector Population.” Journal of Mental Health Policy and Economics 2000; 3:35-44.

9. Rosenheck RA, Leslie DL and Sernyak MJ. “From Clinical Trials to Real-World Practice: Use of Atypical Antipsychotic Medication Nationally in the Department of Veterans Affairs.” Medical Care 2001; 39(3): 302-308.

10. Leslie DL, Rosenheck RA, and Horwitz SM. “Patterns of Mental Health Utilization and Costs among Children in a Privately Insured Population.” Health Services Research 2001; 36(1): 113-127.

11. Leslie DL and Rosenheck RA. “The Effect of Institutional Fiscal Stress on the Use of Atypical Antipsychotic Medications in the Treatment of Schizophrenia.” The Journal of Nervous and Mental Disease 2001; 189(6): 377-383.

12. Leslie DL and Rosenheck RA. “The Quality of Pharmacotherapy for Schizophrenia in a National Health Care System: Individual and Facility Predictors.” Medical Care 2001; 39(9): 923-933.

13. Sernyak MJ, Leslie DL, Alarcon R, Losonczy MF and Rosenheck RA. “Association of Diabetes Mellitus with the Use of Atypical Neuroleptics in the Treatment of Schizophrenia.” American Journal of Psychiatry 2002; 159(4): 561-566.

14. Leslie DL and Rosenheck RA. “From Conventional Antipsychotics to Atypicals and Back: Dynamic Processes in the Diffusion of New Medications.” American Journal of Psychiatry 2002; 159(9): 1534-1540.

15. Martin A, Sherwin T, Stubbe D, Van Hoof T, Scahill L, and Leslie D. “Use of Multiple Psychotropic Drugs by Medicaid-Insured and Privately Insured Children.” Psychiatric Services 2002; 53(12): 1508.

16. Sernyak M, Leslie DL and Rosenheck RA. “Use of System-Wide Outcomes Monitoring Data to Compare the Effectiveness of Atypical Neuroleptic Medications.” American Journal of Psychiatry 2003; 160(2): 310-315.

17. Martin A and Leslie DL. “Psychiatric inpatient, outpatient, and medication utilization and costs among privately insured youths, 1997-2000.” American Journal of Psychiatry, 2003; 160(4): 757-764.

18. Rosenheck RA, Doyle J, Leslie DL and Fontana A. “Changing Environments and Alternative Perspectives in Evaluating the Cost-effectiveness of New Antipsychotic Drugs.” Schizophrenia Bulletin 2003; 29(1): 81-93.

19. Sernyak MJ, Gulanski B, Leslie DL and Rosenheck RA. “Undiagnosed Hyperglycemia in Clozapine-Treated Patients with Schizophrenia.” Journal of Clinical Psychiatry 2003; 64(5): 605-608.

20. Rosenheck RA and Leslie DL. “Administrative Prescription Review Procedures and Use of Atypical Antipsychotic Medications in the Department of Veterans Affairs.” Mental Health Services Research 2003; 5(3): 149-153.

21. Rosenheck R, Leslie D and Woody G. “Fiscal Strain and Access to Opiate Substitution Therapy at Department of Veterans Affairs Medical Centers.” American Journal on Addictions 2003; 12(3): 220-228.

22. Petrakis IL, Leslie DL and Rosenheck RA. “The use of antidepressants in alcohol dependent veterans.”

Journal of Clinical Psychiatry 2003; 64(8): 865-870. 23. Martin A and Leslie DL. “Trends in psychotropic medication costs for children and adolescents, 1997-

2000.” Archives of Pediatrics and Adolescent Medicine 2003; 157(10): 997-1004. 24. Petrakis IL, Leslie DL and Rosenheck RA. “Use of naltrexone in the treatment of alcoholism nationally in

the Department of Veterans Affairs.” Alcoholism: Clinical and Experimental Research 2003; 27(11): 1780-1784.

25. Rosenheck R, Perlick D, Bingham S, Liu-Mares W, Collins J, Warren S, Leslie D, for the Department of Veterans Affairs Cooperative Study Group on the Cost-Effectiveness of Olanzapine. Effectiveness and Cost of Olanzapine and Haloperidol in the Treatment of Schizophrenia: A Randomized Controlled Trial. JAMA 2003; 290(20): 2693-2702.

26. Leslie DL and Rosenheck RA. “Benchmarking the quality of schizophrenia pharmacotherapy: A comparison of the Department of Veterans Affairs and the Private Sector.” Journal of Mental Health Policy and Economics 2003; 6(3): 113-121.

27. Martin A, Young C, Leckman JF, Mukonoweshuro C, Rosenheck R and Leslie D. “Age effects on antidepressant-induced manic conversion.” Archives of Pediatrics and Adolescent Medicine 2004; 158(8): 773-780.

28. Busch SH, Leslie DL and Rosenheck RA. “Measuring Quality of Pharmacotherapy for Depression in a National Health Care System.” Medical Care 2004; 42(6): 532-542.

29. Harpaz-Rotem I, Leslie DL and Rosenheck RA. “Treatment retention among children entering a new episode of mental health care.” Psychiatric Services 2004; 55(9): 1022-1028.

30. Leslie DL and Rosenheck RA. “Incidence of Newly Diagnosed Diabetes Attributable to Atypical Antipsychotic Medications.” American Journal of Psychiatry 2004; 161(9): 1709-1711.

31. Busch SH, Leslie DL and Rosenheck RA. “Comparing the Quality of Antidepressant Pharmacotherapy in the Department of Veterans Affairs and the Private Sector.” Psychiatric Services 2004; 55(12): 1386-1391.

32. Leslie DL and Rosenheck RA. “Adherence of Schizophrenia Pharmacotherapy to Published Treatment Recommendations: Patient, Facility and Provider Predictors.” Schizophrenia Bulletin 2004; 30(3): 649-658.

33. Sernyak MJ, Leslie DL and Rosenheck RA. “Predictors of antipsychotic medication change.” The Journal of Behavioral Health Services and Research 2005; 32(1): 85-94.

34. Inouye SK, Leo-Summers L, Zhang Y, Bogardus ST, Leslie DL, and Agostini JV. “A Chart-Based Method for Identification of Delirium: Validation Compared with Interviewer Ratings Using the Confusion Assessment Method.” Journal of the American Geriatrics Society 2005; 53(2): 312-318.

35. Leslie DL, Zhang Y, Bogardus ST, Holford TR, Leo-Summers LS, and Inouye SK. “Consequences of Preventing Delirium in Hospitalized Older Adults on Nursing Home Costs.” Journal of the American Geriatrics Society 2005; 53(3): 405-409.

36. Miller EA, Leslie DL and Rosenheck RA. “Incidence of New-Onset Diabetes Mellitus Among Patients Receiving Atypical Neuroleptics in the Treatment of Mental Illness: Evidence from a Privately Insured Population.” Journal of Nervous and Mental Disease 2005; 193(6): 387-395.

37. Leslie DL and Rosenheck RA. “Pharmacotherapy and Health Care Costs Among Patients with Schizophrenia and Newly Diagnosed Diabetes.” Psychiatric Services 2005; 56(7):803-809.

38. Leslie DL, Zhang Y, Holford TR, Bogardus ST, Leo-Summers LS, and Inouye SK. “Premature Death Associated with Delirium at 1-Year Follow-up.” Archives of Internal Medicine 2005; 165:1657-1662.

39. Harpaz-Rotem I, Leslie DL, Martin A and Rosenheck RA. “Changes in Child and Adolescent Inpatient Psychiatric Admission Diagnoses between 1995 and 2000.” Social Psychiatry and Psychiatric Epidemiology 2005; 40(8): 642-7.

40. Hoblyn J, Noda A, Yesavage JA, Brooks JO, 3rd, Sheikh J, Lee T, Tinklenberg JR, Schneider B, O’hara R, Leslie DL, Rosenheck RA, Kraemer HC. Factors in choosing atypical antipsychotics: Toward understanding the bases of physicians' prescribing decisions. Journal of Psychiatric Research 2006; 40(2):160-166.

41. Chwastiak L, Rosenheck RA and Leslie D. “Impact of Medical Co-morbidity on the Quality of Schizophrenia Pharmacotherapy in a National VA Sample.” Medical Care 2006; 44(1):55-61.

42. Petrakis IL, Leslie D, Finney JW and Rosenheck R. “Atypical antipsychotic medication and substance use-related outcomes in the treatment of schizophrenia.” American Journal on Addictions 2006; 15(1):44-49.

43. Rosenheck RA, Leslie D, Keefe R, McEvoy J, Swartz M, Perkins D, Stroup S, Hsiao J, and Lieberman J. “Barriers to Employment for People with Schizophrenia.” American Journal of Psychiatry 2006; 163(3):411-417.

44. McAvay GJ, Van Ness PH, Bogardus ST, Zhang Y, Leslie DL, Leo-Summers LS and Inouye SK. “Older

Adults Discharged from the Hospital with Delirium: 1-Year Outcomes.” Journal of the American Geriatrics Society 2006; 54:1245-1250.

45. Gore M, Dukes E, Rowbotham D, Tai KS and Leslie DL. “Clinical characteristics and pain management among patients with painful peripheral neuropathic disorders in general practice settings.” European Journal of Pain 2006; 6(4): 265-272.

46. Gore M, Dukes E, Rowbotham D, Tai KS and Leslie DL. “Prevalence of contraindicated medical conditions and use of precluded medications in patients with painful neuropathic disorders prescribed amitriptyline.” Pain Practice 2006; 6(4):265-72.

47. Rosenheck RA, Leslie DL, Sindelar J, Miller EA, Lin H, Stroup TS, McEvoy J, Davis S, Keefe RSE, Swartz M, Perkins D, Hsiao JK, Lieberman J for the CATIE Study Investigators. “Cost-Effectiveness of Second Generation Antipsychotics and Perphenazine in a Randomized Trial of Treatment for Chronic Schizophrenia.” American Journal of Psychiatry 2006; 163(12): 2080-2089.

48. Leslie DL and Martin A. “Health Care Costs Associated with Autism-Spectrum Disorders.” Archives of Pediatrics and Adolescent Medicine 2007 Apr; 161(4):350-355.

49. McAvay GJ, Van Ness PH, Bogardus ST, Zhang Y, Leslie DL, Leo-Summers LS and Inouye SK. “Depressive Symptoms and the Risk of Incident Delirium in Older Hospitalized Adults.” Journal of the American Geriatrics Society 2007 May; 55(5): 684-91.

50. Rosenheck RA, Leslie DL, Sindelar JL, Miller EA, Tariot PN, Dagerman KS, Davis SM, Lebowitz BD, Rabins P, Hsiao JK, Lieberman JA, Schneider LS; Clinical Antipsychotic Trial of Intervention Effectiveness-Alzheimer's Disease (CATIE-AD) investigators. "Cost-benefit analysis of second-generation antipsychotics and placebo in a randomized trial of the treatment of psychosis and aggression in Alzheimer disease." Archives of General Psychiatry 2007 Nov; 64(11):1259-68

51. Leslie DL, Marcantonio ER, Zhang Y, Leo-Summers L and Inouye SK. “One-Year Health Care Costs Associated with Delirium in the Elderly Population.” Archives of Internal Medicine 2008 Jan; 168(1): 27-32.

52. Rosenheck RA, Leslie DL, Busch S, Rofman ES and Sernyak M. “Rethinking Antipsychotic Formulary Policy.” Schizophrenia Bulletin 2008; 34(2): 375-380.

53. Braithwaite RS, Meltzer DO, King JT Jr, Leslie DL and Roberts MS. "What Does the Value of Modern Medicine Say About the $50,000 per Quality-Adjusted Life-Year Decision Rule?" Medical Care 2008; 46:349-356.

54. Rosenheck RA, Leslie DL and Doshi J. "Second-generation antipsychotics: cost-effectiveness, policy options, and political decision making." Psychiatric Services 2008; 59: 515-520.

55. Sernyak MJ, Leslie DL and Rosenheck RA. “Antipsychotic Use in the Treatment of Outpatients With Schizophrenia in the VA From Fiscal Years 1999 to 2006.” Psychiatric Services 2008; 59: 567-569.

56. Gore M, Sadosky A, Leslie DL and Sheehan AH. "Selecting an Appropriate Medication for Treating Neuropathic Pain in Patients with Diabetes: A Study Using the UK and Germany Mediplus Databases." Pain Practice 2008; 8(4): 253-262.

57. Leslie DL and Rosenheck RA. "Diversity versus concentration in drug selection" Journal of Mental Health Policy and Economics 2008; 11: 107-112.

58. Leslie DL, Kozma L, Martin A, Landeros A, Katsovich L, King RA and Leckman JF. "Neuropsychiatric Disorders Associated with Streptococcal Infection: A Case-Control Study among Privately Insured Children." Journal of the American Academy of Child and Adolescent Psychiatry 2008; 47(10): 1166-1172.

59. Mohamed S, Leslie DL and Rosenheck RA. “Use of antipsychotics in the treatment of major depressive disorder in the U.S. Department of Veterans Affairs.” Journal of Clinical Psychiatry 2009; 70(6): 906-912.

60. Leslie DL, Mohamed S, and Rosenheck RA. "Off-label use of antipsychotic medications in the Department of Veterans Affairs." Psychiatric Services 2009; 60(9): 1175-1181.

61. Mohamed S, Rosenheck R, Harpaz-Rotem I, Leslie D and Sernyak MJ. “Duration of pharmacotherapy with long-acting injectable risperidone in the treatment of schizophrenia.” Psychiatric Quarterly 2009; 80: 241-249.

62. Busch SH, Frank RG, Leslie DL, Martin A, Rosenheck RA, Martin EG and Barry CL. “Antidepressants and suicide risk: How did specific information in FDA safety warnings affect treatment patterns?” Psychiatric Services 2010; 61(1): 11-16.

63. Makarov DV, Loeb S, Landman A, Nielsen M, Gross C, Leslie DL, Penson DF, and Desai RA. "Regional variation in total cost per radical prostatectomy in the healthcare cost and utilization project nationwide inpatient sample database." The Journal of Urology 2010; 183(4): 1504-1509.

64. Gore M, Zlateva G, Tai KS, Chandran AB and Leslie D. “Retrospective evaluation of clinical characteristics, pharmacotherapy and healthcare resource use among patients prescribed pregabalin or duloxetine for

diabetic peripheral neuropathy in usual care.” Pain Practice 2010; 11(2): 167-179. 65. Wang L and Leslie DL. “Health care expenditures for children with autism spectrum disorders in Medicaid.”

Journal of the American Academy of Child and Adolescent Psychiatry 2010; 49(11): 1165-1171. 66. Haskell SG, Mattocks K, Goulet JL, Krebs EE, Skanderson M, Leslie D, Justice AC, Yano EM and Brandt

C. “The burden of illness in the first year home: do male and female VA users differ in health conditions and healthcare utilization.” Women’s Health Issues 2011; 21(1):92-7.

67. Gore M, Tai KS, Zlateva G, Bala Chandran A and Leslie D. “Clinical characteristics, pharmacotherapy, and healthcare resource use among patients with diabetic neuropathy newly prescribed pregabalin or gabapentin. Pain Practice 2011; March 16 epub ahead of print

68. Leslie DL, Goulet J, Skanderson M, Mattocks K, Haskell S, and Brandt C. “VA health care utilization and costs among male and female Veterans in the year after service in Afghanistan and Iraq.” Military Medicine 2011; 176(3): 265-269.

69. Kolanowski AM, Fick DM, Litaker MS, Clare L, Leslie D and Boustani M. “Study protocol for the recreational stimulation for elders as a vehicle to resolve delirium superimposed on dementia (RESERVE for DSD) trial.” Trials 2011; 12:119.

70. Druss BG, von Esenwein SA, Compton MT, Zhao L, Leslie DL. “Budget Impact and Sustainability of Medical Care Management for Persons with Serious Mental Disorders.” American Journal of Psychiatry 2011; June 15 epub ahead of print.

71. Gore M, Sadosky A, Leslie D, Tai K and Stacey B. “Clinical comorbidities, treatment patterns, and direct medical costs of patients with osteoarthritis in usual care: a retrospective claims database analysis.” Journal of Medical Economics 2011; 14(4): 497-507.

72. Gore M, Tai K, Chandran A, Zlateva G and Leslie D. “Clinical comorbidities, treatment patterns, and health care costs among patients with fibromyalgia newly prescribed pregabalin or duloxetine in usual care.” Journal of Medical Economics 2011; October 4 epub ahead of print.

73. Gore M, Tai K, Chandran A, Zlateva G and Leslie D. “Clinical characteristics, pharmacotherapy, and healthcare resource use among patients with fibromyalgia newly prescribed pregabalin or tricyclic antidepressants.” Journal of Medical Economics 2011; October 4 epub ahead of print.

74. Gore M, Sadosky A, Leslie D, Tai KS and Seleznick M. “Patterns of therapy switching, augmentation, and discontinuation after initiation of treatment with select pain medications in patients with osteoarthritis.” Clinical Therapeutics 2011; November 14 epub ahead of print.

75. Jablonski RA, Kolanowski AM, Therrien B, Mahoney EK, Kassab C and Leslie DL. “Reducing care-resistant behaviors during oral hygiene in persons with dementia.” BMC Oral Health 2011; 11:30.

76. Leslie DL and Inouye SK. “The importance of delirium: economic and societal costs.” Journal of the American Geriatrics Society 2011; 59:S241-S243.

77. Gore M, Sadosky A, Stacey BR, Tai KS, Leslie D. “The burden of chronic low back pain: clinical comorbidities, treatment patterns, and health care costs in usual care settings.” Spine 2012; 37(11): E668-E677.

78. Gore M, Sadosky A, Leslie D, Tai KS, Emery P. “Therapy Switching, Augmentation, and Discontinuation in Patients with Osteoarthritis and Chronic Low Back Pain.” Pain Practice 2012; epub ahead of print.

79. Gore M, Tai KS, Sadosky A, Leslie D, Stacey BR. “Use and Costs of Prescription Medications and Alternative Treatments in Patients with Osteoarthritis and Chronic Low Back Pain in Community-Based Settings.” Pain Practice 2012; epub ahead of print.

80. Leslie DL and Rosenheck RA. “Off label use of antipsychotic medications in Medicaid.” American Journal of Managed Care 2012; 18(3): e109-e117.

81. Stein BD, Sorbero MJ, Goswami U, Schuster J and Leslie DL. “Impact of a Private Health Insurance Mandate on Public Sector Autism Service Use in Pennsylvania.” Journal of the American Academy of Child and Adolescent Psychiatry 2012; 51: 771-779.

82. Wang L, Mandell DS, Lawer L, Cidav Z and Leslie DL. “Healthcare service use and costs for autism spectrum disorder: A comparison between Medicaid and private insurance.” Journal of Autism and Developmental Disorders 2012; epub ahead of print.

D. Research Support Ongoing Research Support

No Number Assigned (Leslie-Meyer) 3/1/2012-6/30/2013 Alkermes The Effectiveness of XR-NTX for Opioid Dependence in a Large Multi-State Treatment Network

The goal of this project is a retrospective data analysis of health records to examine the utilization of Vivitrol in the treatment of patients with opioid and/or alcohol dependence compared with other treatment modalities. Role: PI

1R01MH097298-01 (Leslie) 9/20/2012-8/31/2015 NIH/NIMH The Effects of State and Federal Insurance Policies on Quality of Care for Autism The goal of this project is to examine the effects of state Medicaid HCBS waivers on access to care, satisfaction and family burden among Medicaid-insured children with ASD and their families. Role: PI

VA Medical Center Grant (Brandt) 11/01/07–10/31/2013 Department of Veterans Affairs Women Veterans Cohort Study The goal is to investigate demographic, clinical, and healthcare utilization factors among the cohort of women veterans of OEF/OIF who have utilized VA clinics. Role: Site PI

1R01MH096711-01 (Wang) 9/12/2012-7/31/2015 NIH Do Access Barriers to Autism Care Persist Despite Autism Insurance Mandate? The goal of this project is to use post-mandate private insurance claims data to measure actual changes in autism service use, costs and health benefits after autism insurance mandates. Role: Co-Investigator

1 R01 MH 091453-01 (Leslie) 9/23/2010-6/30/2015 NIH/Yale University Effective and Cost Effectiveness of Peer Mentors in Reducing Hospital Use This study will be extremely useful in informing future policy and programmatic decisions related to the promotion of evidence-based practices in the care of individuals with serious mental illnesses.

Role: Site PI

1R01 NR012737 (Jablonski) 4/1/2011-2/28/2015 NIH Reducing Care-Resistant Behaviors during oral Hygiene in Persons with Dementia The goal of this study is to evaluate the efficacy of the mouth intervention for reducing Care-Resistant Behaviors in persons with dementia. Role: Co-Investigator

No Number Assigned (Leslie) 10/1/2010-9/30/2013 Veterans Affairs (VA) A Comparison of Fidelity Assessment Methods Role: PI

1R01DA032881-01A1 (Stein) 7/1/2012-6/30/2015 NIH/RAND Corporation Opioid Agonist Treatment Expansion in Medicaid: The Role of Buprenorphine The proposed project would use data from state Medicaid programs to examine factors affecting the diffusion of buprenorphine for the treatment of opiate abuse, both inside and outside of traditional substance abuse treatment settings. Role: Site PI

1 R01 NR012242 (Kolanowski) 9/1/2010-6/30/2015 NIH RESERVE for Delirium Superimposed on Dementia The goal of this project is to test the efficacy of an intervention to prevent delirium in elderly patients with dementia by means of a randomized controlled trial. Role: Co-Investigator

1 U54 RR026071-01A2 (Sinoway) 5/01/2011-02/29/2016 NIH The Penn State Clinical and Translational Science Institute The goal of Penn State CTSI is an engaged and responsive health science research and education enterprise that delivers on the promise of improved health. Role: Co-Director, Education Core Curriculum

1 K12 HD055882 (Weisman) 9/26/2007-6/30/2017 NIH Career Development Program in Women’s Health Research at Penn State The purpose of this BIRCWH project is to provide mentored research career development for junior faculty members, known as BIRCWH Scholars, who are conducting interdisciplinary research on women’s health or on sex/gender differences in health. Role: Mentor

Completed Research Support

1RC1MH088349 (Leslie) 10/1/2009-11/30/2011 NIH Economic Production Functions of Schizophrenia Treatment The goal of this project is to study the treatment of schizophrenia across various patterns of care. Role: Principal Investigator

R01-MH073884 (Leslie) 8/01/2006–5/30/2010 NIH/National Institute of Mental Health Patterns of Service Use and Costs Associated with Autism Grant supports secondary dataset analyses (private and Medicaid sources) aimed at understanding time trends and priorities associated with the costs of care for autism and related disorders. Role: Principal Investigator

VA Medical Center Grant (Eisen) 10/01/2007–6/30/2010 Department of Veterans Affairs Mechanisms of Action and Outcome in Peer Support Groups The goal is to determine cost estimates for adding peer-led vs. clinician-led groups to treatment plans to determine comparative costs of these two interventions. Role: Site PI

BIOGRAPHICAL SKETCH Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2.

Follow this format for each person. DO NOT EXCEED FOUR PAGES.

NAME

A. Marshall McBean POSITION TITLE

Professor eRA COMMONS USER NAME

mmcbean EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)

INSTITUTION AND LOCATION DEGREE

(if applicable) YEAR(s) FIELD OF STUDY

Yale College, New Haven, CT B.S. 1964 Biology

Harvard Medical, Boston, MA M.D. 1968 Medicine

University of London School of Hygiene &

Tropical Medicine M.Sc. 1976 Social Medicine

A. Personal Statement.

I am board certified in Preventive Medicine, and a Professor in the Division of Health Policy and Management in the School of Public Health at the University of Minnesota. I have over 35 years of research experience, the last 21 of which has focused on the analysis of secondary databases, primarily the Medicare and Medicaid data. I also have over 12 years experience training other researchers to use Medicare administrative data. Therefore, I have great knowledge of the strengths and weakness of the data as they would be used in model development and secondary data analysis.

B. Positions and Honors. Positions and Employment: 1968-1970 Intern & Resident, Boston City Hospital (Harvard Service) Boston, MA, Internal Medicine 1970-1971 Epidemic Intelligence Service (EIS) Officer, Smallpox Eradication Program, Center for Disease Control (CDC), Atlanta, GA 1971-1974 Medical Epidemiologist, OCEAC (Organization for the Coordination of fight against the Endemic Diseases in Central Africa), Yaounde’, Cameroun 1975-1976 Fellow, Harvard Center for Community Health and Medical Care, Boston, MA 1976-1978 Commissioner, Vermont State Health Department, Burlington, VT 1978-1987 Associate Professor, Department of Health Policy and Management, Johns Hopkins School of Hygiene and Public Health, Baltimore, MD 1987-1994 Medical Researcher and The Chief, Epidemiology Branch, Division of Beneficiary Studies, Office of Research, Health Care Financing Administration, Baltimore MD 1994-1995 Visiting Professor, School of Public Health, University of Minnesota, Minneapolis MN 1997-1998 Division Head, Health Management & Policy, University of Minnesota, Minneapolis, MN 1995- Professor, School of Public Health, University of Minnesota, Minneapolis, MN

Honors and Awards: Phi Beta Kappa Sigma Xi Delta Omega (Public Health Honor Society) HCFA Administrator’s Award - 1991 U.S. Public Health service Commendation Medal - 1992 DHHS Secretary’s Award for Distinguished Service - 1995 C. Selected peer-reviewed publications.

1. McBean AM, Warren JL, Babish JD. Measuring the incidence of cancer in the elderly Americans

using Medicare claims data. Cancer 1994;73:2417-25. 2. McBean AM, Gornick M. Differences in the use of surgical services by race among Medicare

beneficiaries. Health Care Financing Reviews. 1994;15:77-90. 3. Virnig BA, McBean AM. Using Administrative Data for Public Health Surveillance and Planning

Annual Review of Public Health, 22:213-230,2001 4. Virnig BA, Kind S, McBean AM, Fisher ES. Geographic Variation in Hospice Use Prior to Death.

Journal of the American Geriatrics Society, 48:1117-1125, 2000. . 5. McBean AM, Huang Z, Virnig BA, Lurie N. Musgrave D. Racial variation in the control of diabetes among elderly medicare managed care beneficiaries. Diabetes Care. 2003 Dec;26(12):3250-66. 6. McBean AM, Hebert PL, New estimates of influenza-related pneumonia and influenza hospitalizations among the elderly. Int J Infect Dis. 2004 Jul;8(4):227-35. 7. McBean AM, Li S, Gilbertson DT, Collins AJ, Differences in diabetes prevalence, incidence, and

mortality among the elderly of four racial/ethnic groups: whites, blacks, Hispanics, and Asians. Diabetes Care 2004 Oct; 27(10):2317-24

8. Hebert Pl, Frick KD, Kane RL, McBean AM, The causes of racial and ethnic differences in influenza vaccination rates among elderly Medicare beneficiaries. 2005 Apr;40(2):517-38. PMID:15762905 9. McBean AM, Jung, K, Virnig, B, Improved care and outcomes among elderly medicare managed care

beneficiaries with diabetes. Am J Manag Care. 2005 Apr;11(4):213-22. PMID: 15839182 [PubMed - indexed for MEDLINE].

10. Yu, McBean AM, Caldwell DS, Unequal use of new technologies by race: the use of new prostate surgeries among elderly Medicare beneficiaries. J Urol, 2006, May; 175(5):1830-5 discussion 1835. PMID: 16600772 [PubMed - indexed for MEDLINE]. 11. McBean AM, Jung K, Hebert PL, Decreasing invasive pneumococcal disease in the elderly: A state-level analysis.Vaccine. 2006 Jul 7;24(27-28):5609-14. Epub 2006 May 6. PMID: 16725240. [PubMed - indexed for MEDLINE]. 12. Cooner F, Banerjee S, McBean AM. Modeling geographically referenced survival data with a cure fraction. Stat Methods Med Res. 2006 Aug;15(4):307-24. PMID: 16886733 [PubMed - indexed for MEDLINE] 13. McBean AM, Yu X. The Underuse of Screening Services Among Elderly Women with Diabetes. Diabetes Care. 2007 Mar 10; [Epub ahead of print] PMID: 17351285 [PubMed - as supplied by publisher]. 14. McBean AM, Yu, X, Virnig BA. Physician visits, patient comorbidities, and mammography use among

elderly colorectal cancer survivors. J Cancer Surviv. 2007; 1:275-282. 15. McBean AM, Yu X, Virnig BA. The Use of Preventive Health Services Among Elderly Uterine Cancer

Survivors. Am J of Ob Gy. 2008 Jan;198(1)86.el-8 PMID: 18166316. D. Research Support.

Ongoing Research HHSM500-2005-00027I TO3 McBean (PI) 09/28/08-09/29/13 Center for Medicare and Medicaid Services (CMS) Research Data Assistance Center (ResDAC) The goal of ResDAC (Research Data Assistance Center) is to assist CMS in increasing the number of new researchers skilled in accessing and in use CMS data for studies, which will improve the Medicare and Medicaid programs and add value to current CMS activities. Role: PI ARRA / T.O.003, HHSM-500-2005-0027I 04/01/10-09/30/12 Center for Medicare and Medicaid Services (CMS) Research Data Assistance Center (ResDAC) Comparative Effectiveness Research (CER) The goal of ResDAC (Research Data Assistance Center) is to assist CMS in increasing the number of new researchers skilled in accessing and in use CMS data for projects relating to CER, which will improve the Medicare and Medicaid programs and add value to current CMS activities. Role: PI 500-2005-00027I, TO 2 (McBean) 09/01/11-12/31/12 Centers for Medicare and Medicaid Services (CMS) ACA Section 10332 Technical Assistance Contract The proposed contract will provide CMS data support to Qualified Entities (QEs)in using Medicare claims data. In addition, the team will provide education and training opportunities focused on better understanding Medicare claims data tailored to QEs. Role: PI

Completed Research 1R21DK081055-01 (McBean) 09/01/09-08/31/11 NIDDK Measuring the Impact of Rapid Expansion of MIST Procedures for BPH The major goal of the project is to understand how physician-related factors, as well as patient, organizational and societal factors interact in the diffusion of the MIST procedures and explain how these interactions affect the disparities during the diffusion of the new procedures. Role: PI 200-2011-M-40657 (McBean) 08/22/11-12/31/11 CDC Introduction to the Use of Medicare Data for Public Health Research The workshop will familiarize the CDC audience with the use of Medicare administrative data for research. Role: PI HHSM-500-2005-00271 McBean (PI) 09/27/05-01/31/2011 CMS DHHS MRAD Task Order 1 Conducting analytic studies designed to better understand the nature of chronic disease among Medicare beneficiaries and to improve the care of these populations. The 723 database will serve as the data source for the analytic studies to be conducted under this contract. Role: PI CA098974 McBean (PI) 09/01/04-08/31/09 NIH, National Cancer Institute Health Service Use in the elderly with Cancer Elderly persons with newly diagnosed cancer are under great personal stress, and they face a potentially rapidly changing relationship with health care professionals and the system. Prior to the diagnosis of cancer, many of these people will have routinely used recommended clinical preventive services and will have been followed appropriately for other chronic conditions such as diabetes, hypertension and other heart disease. However, because in their change in health status, treatment, and use of new services they may fail to continue to use the recommended services and treatment. This study will compare the use of recommended preventive and chronic disease treatment services between elderly persons who are newly diagnosed with cancer to those who do not have cancer. Role: PI NO1-DK-7-5002 Gilbertson (PI) 02/8/07-04/03/10 MMRF prime NIH United States Renal Data System (USRDS) The major goal of this project is to provide biostatistical, epidemiological and clinical expertise to development and implement innovative health policy studies using the United States Renal System (USRDS) databases. Role: Co-Investigator