R x Decision : A Decision S upport Tool for Choosing Prescription Drug Plans for Patients

Rx Decision: A Decision Support Tool for Choosing Prescription Drug Plans for Patients Chris Anderson Joey Fadul Anupam Menon Harold Terceros

Agenda • Context • Stakeholder Analysis • Insurance Terminology • Problem Statement • Needs Statement • Decision Support Tool • Task Analysis • Video Description • PUF Dataset • Output • Method of Analysis • Monte Carlo Analysis • Usability Test • Recommendations/Future Work • Project Management

Context • In 2009, the US spent $2.5 trillion dollars towards healthcare, almost 17% of gross domestic product (GDP) [1] • One step to reduce the total expenditure was the implementation of the Affordable Care Act, or “Obama-care” • Passed by Congress but currently being litigated in the Supreme Court • Constitutionality of un-insured fines • Medicaid expansions, etc. [1] Centers for Medicare & Medicaid Services-www.cms.gov

Context: Affordable Care Act • Affordable Care Act offered the following proposed changes: [2] • Incentives of $40,000 for physicians to use an Electronic Medical Record (EMR) System • Gradual discounts to covered drugs (brand name and generic) to lessen the burden on patients in the “doughnut hole” • Creation of Heath IT (HIT) Extension Programs that would facilitate regional adoption efforts • Provision of funds to states to coordinate and promote interoperable EMRs • Accelerated construction of the National Health Information Network (NHIN) [2] www.healthcare.gov/law

Context: Rx Costs • R & D phase has large attrition rate during development [5] • 5000 drugs screened • ONLY 5 enter testing • No income from this stage • Approximately 70% of cost during first 12 years (completion of clinical evaluations) [5] Rowberg, Richard. CRS Report for Congress, 2001 [6] Adapted from Center on an Aging Society, Georgetown University, 2004

Context: Chronic Conditions in America • In 2005, 7 out of 10 deaths were from chronic conditions • Heart disease, cancer, strokes accounts for 50% of deaths each year [7] • Population using more healthcare services, including: • Physician visits, hospital care, etc. [6] [6] Center on an Aging Society, Georgetown University, 2004 [7] Center for Disease Control (CDC)

Context: Patient Experience • The use of prescription drugs is a necessary component in our healthcare industry in order to treat/control America’s rising chronically ill population • Patients are expected to make health related decisions during encounters with their physician (mean encounter duration is ≈ 20 minutes) [8] • Doctor assesses patient’s concern and gives recommended course of action • Patient must make decision in the face of: • Uncertainty in outcome of prescribed course of action • Complexity of insurance decisions (coverage) [8] Medscape. Laurie Barclay, MD, 1 Nov. 2009. Web

Stakeholders: Cause & Effect

How Insurance Works • Insurance is analogous to a bet between you and the insurance company • They are betting that they will take in more money, in the form of premiums, than they will pay out in benefits • Policy is a contract that spells out what will be covered and how much the insurance will cover of your incurred medical costs

Key Terminology • Prescription Drug Plan (PDP)-Insurance plan used to cover prescription drugs as part of Medicare Part D • Doughnut Hole-Point at which PDP stops offering coverage of prescriptions; then offering coverage again to patients in “catastrophic coverage” phase of plan • Premium-Amount paid each term (i.e. per month) to purchase insurance • Deductible-Amount initially incurred by patient before insurance policy begins paying for covered expenses • Cost Sharing-Co-payment amount-Set dollar amount for services rendered. Co-insurance %-covered split between patient and insurance, after deductible is met • Formulary-Listing of covered drugs [10] Centers for Medicare & Medicaid Services, 2012

Medicare Terminology • Medicare-A national health program for those under age 65 with certain disabilities, above 65, and anyone with end stage renal disease (kidney disease requiring dialysis or a transplant) • Four parts to Medicare • Part A-Hospital insurance-covers inpatient care in hospitals, skilled nursing facilities, hospice, and home health care • Part B-Medical insurance-covers doctor services, outpatient care, durable medical equipment used in home healthcare • Part C-Advantage plans incorporating Parts A, B, and D (if elected); run by Medicare approved private insurance companies, and may include extra benefits for an extra cost • Part D-Prescription drug coverage-helps cover prescription costs and protect against higher costs associated with certain prescriptions, and run by Medicare approved private insurance companies [10] Centers for Medicare & Medicaid Services, 2012

Medicaid Terminology • Medicaid-A state administered health insurance program available to certain low-income individuals and families who fit into a recognized eligibility group. • Specific requirements must be met (vary from state to state): • Dual Status-Thoseunder age 65 who are eligible for Medicare because they receive Social Security or disability from the Railroad Retirement Board [11] Disabled Medicare Beneficiaries by Dual Eligible Status: California, 1996-2001 June F. O’Leary, Ph.D., Elizabeth M. Sloss, Ph.D., and Glenn Melnick, Ph.D.

Medicare Part D Pros Cons # of Insurance Providers Formulary Listing Drug Rates Plan Changes Out-of-pocket costs • Commonly Used Drugs • Generic or Brand Name • Mail Order (larger supply) • Out-of-pocket costs

Medicare Part D Out-of-Pocket Breakdown [10] Derived using Centers for Medicare & Medicaid Services, 2012

Problem Statement Patients are not able to make optimal health decisions regarding their physical AND financial well-being due to: • High level of complexity in the options with which they are faced • Insurance options and available coverage • High level of uncertainty in the prescribed course of action • Prescriptions/Procedures

Need Statement A decision support tool (DST) is needed to consolidate PDP information • Draw consolidated information across insurance carriers • Minimize patient time spent on initial research • Answer basic questions about Medicare plans, products, and the companies entrusted to serve the general public

Task Analysis: Preliminary

Task Analysis: Decision Support Tool Physician Prescribed Course of Action Decision Support Tool PatientCondition Personal Attributes Insurance Plan Preferences Ranked List of PDPs Graphical Interpretation of Rx Cost vs. PDP cost Public Use Files Prescription Drug Plans

Decision Support Tool: Walkthrough

Primary Data Source • Center for Medicare/Medicaid Services • Public Use Files (PUF) containing de-identified information for chronic diseases from year 2008 • Oracle 10g XE • Converted PUF data from .csv format into Oracle database • Manipulate and sift through data with SQL queries in order to obtain useful data • Lost roughly 25% of data due to lack of Medicare Part D data • End result: Medicare Part D data from 23.7 million beneficiaries

PUF Data Breakdown • PUF data provides information on patient profiles consisting of • Age ranges (5 year cohorts) • Whether or not the patient has a given chronic illness • Diabetes, Heart Failure, Cancer, etc. • Whether or not a patient is dual eligible • Information on each profile includes • Prescription drug costs per year • Number of prescriptions per year

Decision Support Tool: Sample Results

“Doughnut Hole” and “Catastrophic” Coverage Doughnut Hole Catastrophic Range

Weight Calculation • Mean Reciprocal Rank (MRR)is a statistical method to measure performance of the predicted results • MRR used in tool for weight calculation where users rank their personal preferences of insurance attributes • Tier I (coverage attributes) • Plan Cost, Previous Experience, Formulary Choices • Tier II (plan cost breakdown) • Deductible, GAP Coverage, Cost Sharing, Premium Payment

Utility Function • Insurance plans ranked in terms of Plan Cost, Formulary Choices, and Previous Experience • Plan Cost is further broken into Monthly Premium, Deductible, Cost Sharing, and GAP Coverage • Utility function determines ranking of 30 Virginia based Medicare Part D Prescription Drug Plans

Sensitivity Analysis • According to the customer’s preferences, each attribute was ranked and used to solve the weights • The following formula was used to solve the sensitivity analysis for weights of the ranked PDPs: • The weights were calculated for the attributes important to the user in order to rank the suitability of insurance plans

Sensitivity Analysis • There were three combinations under which the sensitivity analysis was conducted • When the insurance/cost attribute ranking was equally distributed • When the insurance/cost attribute ranking was incrementally distributed • When two of the insurance/cost attribute rankings were tied

Simulation • Crystal Ball was used to perform Monte Carlo simulation on the suggested insurance plans • Enters random values as inputs based on assigned distributions • Discrete Uniform Distributions • Random # generation for health profiles from PUF dataset • 10,000 trials Resulted in multiple plans remaining in top 10

Simulation: Outcome • Sensitivity # 30 Ranked PDP-Envision Rx Plus Silver • Never makes the top 10 by reducing the price • Ranked # 10 if formulary increases from 2,446 to 6,395 • (2.6 times its original formulary listing)

Simulation: Outcome Mitigation • Additional criterion defined by user; maximum monthly premium for insurance plan • Resulted in wider range of plan rankings

Simulation: Estimated User Savings • 95% Confidence Interval: $77.66 to $1877.99 • Range: -$332.40 to $1978.10 • Estimated Average Savings: $1,243.00 w/ 50% saving more than $1,389.74 per year

Usability Test: Human Subjects Review Board • The goal of the Human Subjects Review Board (HSRB) is to protect the rights of human research subjects [11] • Of the six exemptions to perform human studies without prior approval, item four qualified the following study to be done without approval of the HSRB [12] Office of Research Subject Protections-http://research.gmu.edu/ORSP/HumanSubjects.html

Usability Test: Design • Usability test designed to evaluate • Ease of use of tool (intuitiveness) • Understandability of tool • Was administered to subjects with minimum age of 55 years old • Subjects were asked to • Participate in timed run through decision tool • Complete timed checklist consisting of 8 questions regarding their results • Find costs, interpret graphical output, etc.

Usability Test: Hypotheses • Total time to use DST • Ho: μ = 20 minutes • HA: μ > 20 minutes • Evaluation of checklist • Ho: μ = 2 incorrect answers • HA: μ > 2 incorrect answers • Time to complete checklist • Ho: μ = 5 minutes • HA: μ > 5 minutes

Usability Test: Results n = 11

Usability Test: Results • Total time to use decision support tool • Ho: μ = 20 minutes • HA: μ > 20 minutes • Evaluation of checklist • Ho: μ = 2 incorrect answers • HA: μ > 2 incorrect answers • Time to complete checklist • Ho: μ = 5 minutes • HA: μ > 5 minutes • T-test Results: • to = -10.504 < t.05, 10 =1.812 • DO NOT REJECT Ho • to = -3.178 < t.05, 10= 1.812 • DO NOT REJECT Ho • to = 3.713 > t.05, 10= 1.812 • REJECT Ho • Since we reject estimated time to complete the checklist, but not the amount of errors in results interpretation and time to complete the tool, we can conclude that the tool is easy to use, results are easy to interpret, but the results tab is too complex to interpret given a 5 minute time limit. • If the time to complete the checklist was increased to 6 min, 30 sec we would not reject the null hypothesis

R x Decision : A Decision S upport Tool for Choosing Prescription Drug Plans for Patients