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

204/19/2023

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.

3

[1] Centers for Medicare & Medicaid Services-www.cms.gov

04/19/2023

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)

4

[2] www.healthcare.gov/law

04/19/2023

04/19/2023 5

Context: Rx Costs

[5] Rowberg, Richard. CRS Report for Congress, 2001[6] Adapted from Center on an Aging Society, Georgetown University, 2004

• 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)

Private Insur-ance

Medicare/ Med-icaid

Uninsured

Percent 5 20 22

2.5

7.5

12.5

17.5

22.5

Proportion of Chronically Ill Who Have Taken Fewer Rx Drugs Due to Cost

Pe

rce

nt

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

[6] Center on an Aging Society, Georgetown University, 2004[7] Center for Disease Control (CDC)

04/19/2023

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)

704/19/2023

[8] Medscape. Laurie Barclay, MD, 1 Nov. 2009. Web

Agenda




804/19/2023

Stakeholders: Cause & Effect

04/19/2023 9

Runaway Healthcare Cost

Physicians

Pharmaceutical Companies

Patients

Insurance Companies

Assess and PrescribeCourse of Action

Awareness of Rx InteractionsOr Availability

Awareness of InsuranceCoverage

Research & Development

GovernmentRegulated

Large Attrition Rate

PBM

Negotiate Pricing w/Insurance Co’s

Pharmaceutical SalesTo Physicians

Uncertainty ofPrescribed Outcomes Complexity in

Decision-MakingPrescriptions, Procedures,

Behavioral Changes

Finding InformationWill Ins. CoverNext Action

Trouble ComparingQualitative Data

Patients Don’tPick Optimal

PlanPricing

Availability

PBM Negotiation

CoverageOffering

Districting

Physician Accepted

Lawsuits

Agenda




1004/19/2023

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

1104/19/2023

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 drugs04/19/2023 12

[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

13


04/19/2023

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-Those under age 65 who are eligible for Medicare because they receive Social Security or disability from the Railroad Retirement Board

14

[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.

-Age -Pregnancy Status

-Disability -Blindness

-Income -Resources

-U.S. Citizen / Lawfully admitted immigrant

04/19/2023

Medicare Part D

Pros

• Commonly Used Drugs• Generic or Brand Name• Mail Order (larger supply)• Out-of-pocket costs

Cons

• # of Insurance Providers• Formulary Listing• Drug Rates• Plan Changes• Out-of-pocket costs

1504/19/2023

Medicare Part D Out-of-Pocket Breakdown

Deductible Cost Sharing Doughnut Hole Catastrophic Cov-erage

Patient 1 0.25 1 0.0500000000000001

Medicare 0 0.750000000000001

0 0.950000000000001

5%15%25%35%45%55%65%75%85%95%

Medicare Part D Cost Responsibility

Prescription Drug Plan Cost Stage

Co

st

Re

sp

on

sib

ility

Sp

lit (

%)

16

[10] Derived using Centers for Medicare & Medicaid Services, 2012

04/19/2023

Medicare Part D Out-of-Pocket Breakdown

17

Deductible Cost Sharing Doughnut Hole Catastrophic Coverage

Patient 320 652.5 3727.5 667.125

Total Drug Cost 320 2930 6657.5 20000

Cumulative Pa-tient Outlay

320 972.5 4700 5367.12500000001

$2,500.00

$7,500.00

$12,500.00

$17,500.00

$22,500.00

Medicare Part D Cost Breakdown(Example Using $20,000 in Drug Cost)

Prescription Drug Plan Cost Stage

Do

llars

($

)

[10] Derived using Centers for Medicare & Medicaid Services, 2012

04/19/2023

Agenda




1804/19/2023

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

1904/19/2023

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

2004/19/2023

Agenda




2104/19/2023

Task Analysis: Preliminary

04/19/2023 22

Task Analysis: Decision Support Tool

23

Decision Support Tool

Ranked List of PDPs

Graphical Interpretation of Rx Cost vs. PDP cost

Public Use Files

Prescription Drug Plans

PatientCondition

Personal Attributes

Insurance Plan Preferences

Physician Prescribed Course of Action

04/19/2023

Decision Support Tool: Walkthrough

04/19/2023 24

Agenda




2504/19/2023

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

2604/19/2023

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

2704/19/2023

Decision Support Tool: Sample Results

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2904/19/2023


3004/19/2023


3104/19/2023


3204/19/2023


3304/19/2023

“Doughnut Hole” and “Catastrophic” Coverage

3404/19/2023

Doughnut Hole

Catastrophic Range

Agenda




3504/19/2023

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

36

ofRanks

RankMRR

n

i i

#

1

=

∑1=

04/19/2023

Utility Function

37

• 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

]•[Σ=4

1=AttributeCostAttributeCost

nUWUtilityCost

]•[Σ=3

1=AttributeCoverageAttributeCoverage

nUWUtilityCoverage

04/19/2023

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

1 ,oj

j i ok

k i

ww w j i

w

04/19/2023 38

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

04/19/2023 39

Agenda




4004/19/2023

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

4104/19/2023

Simulation: Outcome

4204/19/2023

• 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

4304/19/2023

Simulation: Estimated User Savings

04/19/2023 44

• 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

Agenda




4504/19/2023

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

46

[12] Office of Research Subject Protections-http://research.gmu.edu/ORSP/HumanSubjects.html

04/19/2023

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.

4704/19/2023

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 minutes4804/19/2023

04/19/2023 49

1 2 30

5

10

15

20

25

12.39

8.43

1.09

Expected

Actual

Time to Complete Decision Tool

Time to Complete Results Checklist

Number of Errors in Checklist

n = 11

Usability Test: Results

Usability Test: Results

04/19/2023 50

Total time to use decision support toolHo: μ = 20 minutesHA: μ > 20 minutes

Evaluation of checklistHo: μ = 2 incorrect answersHA: μ > 2 incorrect answers

Time to complete checklistHo: μ = 5 minutesHA: μ > 5 minutes

T-test Results:to = -10.504 < t.05, 10 =1.812DO NOT REJECT Ho

to = -3.178 < t.05, 10 = 1.812DO NOT REJECT Ho

to = 3.713 > t.05, 10 = 1.812REJECT 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

Agenda




5104/19/2023

Recommendation

• We recommend the designed DST be implemented in the waiting rooms of physician offices; given the ease of use, and relatively quick time to complete the tool

• Secondly, we recommend the DST be implemented on insurance broker websites in order to give user’s an unbiased, no obligation estimate…allowing the user to compare all plans in their selected region; thus breaking the barrier to the insurance industry

5204/19/2023

Future Work

• Implement prescription lookup system• Medicare Part C (Advantage Plans)• Special Needs Plans (SNPs)• Expand beyond Virginia• Expand data files to include health outcome data• Dynamic health behavior for patients

04/19/2023 53

Agenda




5404/19/2023

Work Breakdown Structure (WBS)

04/19/2023 55

HCAS Project

1.0 Research

4.0Analysis

2.0Design

3.0Management

5.0Communicate Results

Budget Breakdown

04/19/2023 56

• Budget calculated with a rate of $60 per hour• Hours determined by task length from Gantt chart and

which group members will working on each task

Task Total Hours Total Cost

1.0 Research 65 $3,900

2.0 Development/Design 622 $37,320

3.0 Management 115 $6,900

4.0 Analysis 242 $14,520

5.0 Communicate Results 296 $17,760

Total Project 1340 $80,400

Earned Value and Hours Management

04/19/2023 57

• Beginning of Semester

• SPI = 0.67• CPI = 1.21

• Today• SPI = 1.05• CPI = 1.52

0 1 2 3 4 5 6 7 8 9 10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

0.00

0.20

0.40

0.60

0.80

1.00

1.20Earned Value Tracking

Earned Value

Estimated Earned Value

Time (Weeks)

% C

om

ple

te

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 340

200

400

600

800

1000

1200

1400

1600Hours Management

Planned Hours

Actual Hours

Time (Weeks)

Ho

urs

Wo

rke

d

Gantt Chart

04/19/2023 58

• Start of Fall semester through Briefing # 2 (October, 24)

Gantt Chart

04/19/2023 59

• Briefing #2 (October, 24) through Faculty Presentation (December, 2)

Gantt Chart

• Spring Semester through SIEDS Competition (April, 27)

04/19/2023 60

Questions?

6104/19/2023

References

[1] Centers for Medicare & Medicaid Services-www.cms.gov

[2] www.healthcare.gov/law

[3] Congressional Budget Office-Technological Change and the Growth of Health Care Spending

[4] www.globalsecurity.org-Russian Military Budget

[5] Rowberg, Richard. CRS Report for Congress: Pharmaceutical Research and Development: A Description and Analysis of the Process, 2001

[6] Center on an Aging Society, Georgetown University, 2004

[7] Center for Disease Control (CDC)

[8] Medscape. Laurie Barclay, MD, 1 Nov. 2009. Web

[9] Testimony of David A. Balto To the Committee on the Judiciary, Subcommittee on Antitrust, Competition Policy and Consumer Rights United States Senate, Dec. 2011


[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.

[12] Office of Research Subject Protections-http://research.gmu.edu/ORSP/HumanSubjects.html

04/19/2023 62

BACKUP SLIDES

6304/19/2023

Context: Collapse & Increased Spending

64

The Soviet Union’s collapse due to military spending occurred at a point where their military expenditure reached $33 billion/year [15-17% of its GDP], but western authorities believed this only reflected the operations and maintenance costs, and that the expenditure was actually double the amount reported [due to weapon/ship building being coded as “free goods to the Ministry of Defense”]. [4]

[3] Congressional Budget Office-Technological Change and the Growth of Health Care Spending[4] www.globalsecurity.org-Russian Military Budget

04/19/2023

Context: Rx Costs

65

• Rx attrition rate during development• 5000 drugs screened• ONLY 5 enter testing• No income from this stage

[5] Rowberg, Richard. CRS Report for Congress: Pharmaceutical Research and Development: A Description and Analysis of the Process, 2001

• Correlating the two graphs show that almost 70% of cost is reached by year 12 in R&D process

• ~34% cost due to clinical evaluations

04/19/2023

Context-U.S. Percent Excess in Prescription Pricing

66

[8] Socolar, D., Sager, A. Boston University School of Public Health. Calculations from Patented Medicine Prices Review Board annual reports (2000 & 2002).

04/19/2023

Insurance Terminology

• Individual Coverage-Most expensive; offered to people who don’t have employer coverage

• Group Coverage-More cost effective due to the larger number of people in the group. Typically seen in employer context

• Premium-Amount paid each term (i.e. per month) to purchase insurance

• Provider-Insurance company providing coverage in return for premium payment

• Co-Pay-Fee associated with services rendered• Deductible-Amount initially incurred by patient before insurance

policy begins paying for covered expenses• Co-Insurance-Amount of covered split between patient and

insurance, after deductible is met• Reasonable & Customary Charges-Amount that insurance is

willing to pay for a procedure performed

67


04/19/2023

Medicare Part D

• Stand Alone Plan:• Prescription Drug Plan (PDP)-additional plan to

cover prescription drugs• Packaged Plans (Medicare Approved/Privately

Insured Plans):• Advantage Plans (Medicare Part C)-Packaged

with Part A/B, and offer further benefits for extra cost

• Special Needs Plans (SNP)-Packaged with Part A/B, and cover chronic conditions specifically

• Has emphasis on the needs of a chronic condition

68


04/19/2023

Stakeholder Diagram

Government Regulators

Pharmaceutical Companies

General Public

Private Insurance Companies

Patients

Prescription Drug Plan

Doctors Medicare

PBM

FDA

R&DSpecial Needs

Plan

Voting

Patients use Medicare, Made Available by Gov’t

Regulations on Drugs

FDA Accepts or Rejects Drugs

Approach Insurance & Doctor’s for Pricing Structures

Contracts w/ Private Ins. Co’s

Patients Seek Information Alone

69

[9] Adapted from Deloitte, Life Sciences Division

04/19/2023

Stakeholders: Pharmacy Benefit Managers (PBMs)

• The PBM market has an expensive history of lawsuits brought on by unethical conduct

• Between 2004-2008, a coalition of 30 state Attorneys General have brought cases against the “big three” PBMs securing over $370 million in damages and penalties

• Fraud• Misrepresentation to plan sponsors, patients, and providers• Unjust enrichment through secret kickback schemes• Failures to meet ethical and safety standards

70

Case Damages Reason(s) for

United States v. Merck & Co., Inc. $184.1 million Government fraud, secret rebates, drug switching, and failure to meet state quality of care standards.

United States v. AdvancePCS (now part of CVS/Caremark)

$137.5 million Kickbacks, submission of false claims, and other rebate issues

United States v. Caremark, Inc. Pending Submission of reverse false claims to government-funded programs.

State Attorneys General v. Caremark, Inc.

$41 million Deceptive trade practices, drug switching, and repacking.

State Attorneys General v. Express Scripts

$9.5 million Drug switching and illegally retaining rebates and spread profits and discounts from plans.

04/19/2023

r x decision : a decision s upport tool for choosing prescription drug plans for patients

Documents

hospital care

drugs screenedonly

georgetown university

drugs brand

healthcare industry

healthcare services

aging society

health related decisions