Third-Party Payer Track

Rx Drugs and Urine Testing:Knowing What’s Too Much, Too

Little and Just Right

Presenters:• Michael Gavin, President, PRIUM• Jo-Ellen Abou Nader, CFE, CIA, CRMA, Senior Director,

Drug Waste Solutions, Express Scripts, Inc.• Elaine Jeter, MD, MolDX Medical Director, Palmetto GBA

Moderator: Daniel Blaney-Koen, JD, Senior Legislative Attorney, American Medical Association Advocacy Resource Center, and Member, Rx Summit National Advisory Board

Disclosures

• Michael Gavin has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

• Jo-Ellen Abou Nader, CFE, CIA, CRMA, has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

• Elaine Jeter, MD, has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

• Daniel Blaney-Koen, JD, has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

Disclosures

• All planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

• The following planners/managers have the following to disclose:– Kelly Clark – Employment: Publicis Touchpoint Solutions;

Consultant: Grunenthal US– Robert DuPont – Employment: Bensinger, DuPont &

Associates-Prescription Drug Research Center– Carla Saunders – Speaker’s bureau: Abbott Nutrition

Learning Objectives

1. Describe how the PBM identifies, investigates and resolves Rx fraud, waste and abuse.

2. Compare appropriate with fraudulent and wasteful usage of UDT.

3. Advocate strategies that optimize usage of UDT.

Urine Drug Monitoring

Too Much or Too Little

Michael Gavin wishes to disclose he is the President of PRIUM, a wholly-owned subsidiary of Ameritox. He will present this content in a fair and balanced manner.

Disclosure 6

This presentation:

1. Outlines the care settings and technologies used for urine drug monitoring

2. Illustrates the clinical rationale for urine drug monitoring

3. Examines why appropriate testing does not always occur

Learning

Objectives

7

• Industry Context

• Data and Observations

• Best Practices

Agenda8

Societal

BurdenMisuse and abuse of prescription drugs is hugely expensive from a financial and socioeconomic perspective

• In the United States, prescription opioid abuse costs were about $55.7 billion in 2007.1 Of this amount, 46% was attributable to workplace costs, 45% to healthcare costs, and 9% to criminal justice costs.

• Drug overdose was the leading cause of injury death in 2012. Among people 25 to 64 years old, drug overdose caused more deaths than motor vehicle traffic crashes.2

• The drug overdose death rate has more than doubled from 1999 through 2013.3

1. Birnbaum HG, White AG, Schiller M, Waldman T, Cleveland JM, and Roland CL. Societal costs of prescription opioid abuse, dependence, and misuse in the United

States. Pain Medicine 2011; 12: 657-667

2. Centers for Disease Control and Prevention. Web-based Injury Statistics Query and Reporting System (WISQARS) [online]. (2014) Available from URL:

http://www.cdc.gov/injury/wisqars/fatal.html.

3. Centers for Disease Control and Prevention. National Vital Statistics System mortality data. (2015) Available from URL: http://www.cdc.gov/nchs/deaths.htm.

9

Review of Test Settings & TechnologiesPoint of Care Cups / Dipsticks

(Presumptive)

Desktop Analyzers

(Presumptive)

Commercial Analyzers

(Presumptive)

Mass Spectrometry

(Definitive)

Setting Physician Offices Commercial Labs Mostly Commercial Labs

Technology Enzyme Immunoassay Enzyme Immunoassay Liquid/Gas Chromatography

with Mass Spectrometry

Est. Device Cost <$10 <$30,000 ~$295,000-$690,000 ~$200,000 - $400,000

Results & Reliability Qualitative result

Detects drug class

Low to moderate degree

of reliability(1)

Qualitative result

Typically detects drug

class(2)

Moderate to high degree

of reliability

Quality highly variable

Qualitative results

Detects drug class

High degree of reliability

FDA approve Reagent

kits

95% confidence level

Quantitative (ng / mL)

result

Detects specific

compound

High degree of reliability

Lab Certification CLIA-waiver CLIA certificate –

Moderate complexity lab

CLIA certificate –

Moderate complexity lab

Rigorous lab audits

Requires moderate to

highly trained personnel

CLIA certificate – High

complexity lab

Rigorous lab audits

Requires highly trained

personnel1. In a recent comparison of POCT and confirmation results performed by Ameritox POCT devices produced an incorrect result over 50% of the time.

2. Assays exist for some specific compounds.

Not Created

EqualNot all testing technologies and settings are created equal; the quality and quantity of data differs by setting.

6

Why Monitor?Urine drug monitoring informs clinical decision making by prompting new conversations between doctors and patients.

What Drug Monitoring Tells Us

• Presence of prescribed substances• Identification of non-prescribed

substances• Identification of illicits• Uncover possible misuse/abuse and

cross-reactivity risk

What Drug Monitoring Doesn’t Tell Us

• The amount of drug ingested or taken

• When last dose was taken• Source of the medication.• Proof of misuse/abuse

11

Longitudinal

AnalysisThe availability of information to assist with assessing likely adherence over time is of critical importance in light of chronic opioid therapy.

12

MEDs1 Rx Spend2

191%

400

800

1,200

1,600

1 2 3 4 5 6

Avg

. Qu

arte

rly

MED

per

Cla

im

Quarters Since Injury

58%

$150

$200

$250

$300

2003 2004 2005 2006 2007 2008 2009 2010 2011

Do

llars

Pai

d p

er M

edic

al C

laim

Service Year

Increasing Rx

SpendThe need for UDM has become more critical as prescription drug spend for chronic pain (and related conditions) has skyrocketed.

1. NCCI Research Brief, 2012

2. NCCI Research Brief, 2013

13

Observations

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

40.00%

45.00%

Illicits Found Rx Not Found Found, No Rx

Overall Testing Results Over Time

2006 2007 2008 2009 2010 2011 2012 2013 2014

Many samples show multiple issues; just 33.9% of samples show no abnormalities.

14

1. Data collected from Ameritox drug monitoring accessions.

Observations

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

40.00%

Illicits Rx Not Found Found, No Rx

Overall Testing Results by Age

12-17 18-24 25-34 35-44 45-54 55-64 Above 65

Despite the declination of illicit medications with age, adherence does not follow this same trend – even beyond 65.

15

1. Data collected from Ameritox drug monitoring accessions.

ObservationsThe uptick in illicit use may potentially be driven by multiples factors including payer mix, adverse selection, or a rise in use of illicits.

0%

5%

10%

15%

20%

25%

12-17 18-24 25-34 35-44 45-54 55-64 65-70 Above 71

IllicitsBy Age By Year

2006 2007 2008 2009 2010 2011 2012 2013 2014

16

1. Data collected from Ameritox drug monitoring accessions.

Observations

5%

7%

9%

11%

13%

15%

17%

19%

21%

Commercial Medicaid Medicare Workers Comp

Illicits

2010 2011 2012 2013 2014

The use of illicits among Medicaid patients significantly greater than other payer categories.

17

1. Data collected from Ameritox drug monitoring accessions.

ObservationsPotential non-adherence among older Americans is much more pronounced.

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

12-17 18-24 25-34 35-44 45-54 55-64 65-70 Above 71

Rx Not FoundBy Age By Year

2006 2007 2008 2009 2010 2011 2012 2013 2014

18

1. Data collected from Ameritox drug monitoring accessions.

Observations

25%

27%

29%

31%

33%

35%

37%

39%

41%

Commercial Medicaid Medicare Workers Comp

Rx Not Found

2010 2011 2012 2013 2014

In fact Medicare population shows the highest incidence of prescriptions not found.

19

1. Data collected from Ameritox drug monitoring accessions.

ObservationsAmong non-medical opioid users, 64% cite “Friends or relatives” as their source; 59% cite a “doctor’s prescription.”

0%

5%

10%

15%

20%

25%

30%

35%

40%

12-17 18-24 25-34 35-44 45-54 55-64 65-70 Above 71

Found, No RxBy Age By Year

2006 2007 2008 2009 2010 2011 2012 2013 2014

20

1. Data collected from Ameritox drug monitoring accessions.

Observations

20%

22%

24%

26%

28%

30%

32%

34%

36%

38%

Commercial Medicaid Medicare Workers Comp

Found, No Rx

2010 2011 2012 2013 2014

The growth of this particular inconsistency is more pronounced in the Medicaid, Medicare, and Workers’ Comp populations.

21

1. Data collected from Ameritox drug monitoring accessions.

Too Much, Too

Little

What’s driving too much testing?

1. Physician Self Referral• Point of Care Testing • Physician owned lab

2. Variable Reliability from POC testing.

What’s driving too little testing?

1. Physician office logistics2. Patient complaints: not covered by

insurance.3. High Deductible/High Copay4. Patient compliance5. Lack of clear protocol or protocols

emerging (Work Comp)6. Fraud7. Physician fear of patient confrontation

Significant financial and clinical forces combine to create scenarios that result in both over-testing and under-testing.

22

NC Pain Specialist Dr. Robert Wadley’s % of practice revenue from UDM: 82%

Median % of nonsurgical, long term opioid cases that had UDT: 25%2

1. “Doctors Cash In on Drug Tests for Seniors, and Medicare Pays the Bill”, WSJ, Nov. 10, 2014

2. WCRI, Long Term Use of Opioids, 2nd Edition, May 2014

Best PracticesThe effective deployment of drug monitoring by payors requires planning and coordination with managed care resources.

I. Guidelines driven testing

II. Patient centered care

III. Proactive patient identification

IV. Partners and providers compliant with all regulations

V. Utilization Review for UDT

VI. Coordinated clinical interventions

23

GuidelinesEvidence-based guidelines call for monitoring medication compliance with testing protocols that align with the risk level of the patient.

1. Work Loss Data Institute. Official Disability Guidelines “Evidenced-Based Decision Support.

Risk of Addiction/Aberrant

BehaviorMonitoring Recommendation

Low• Tested within 6 months of therapy initiation• Yearly testing thereafter

Medium• Point-of-contact screening 2 to 3 times yearly• Confirmatory testing for inappropriate/unexplained

results

High• Testing as frequently as once per month.• Confirmatory testing for inappropriate/unexplained

results

24

Proactive Patient

IdentificationData from multiple systems needs to be consolidated and analyzed to identify patients indicated for UDM.

25

Compliant Providers

What’s driving too much testing?

1. Overuse of Point-of-Care testing and in-office analyzers (physician self-referral)

2. Too many tests per patient3. Free goods (e.g., testing cups)4. Profit sharing models (e.g., physician owns % of lab)5. Education on billing6. Free legal advice

Some doctors and/or labs engage in inappropriate business practices for which payers should be vigilant

26

Utilization Review

Strength of UR Rules Jurisdiction

Strong Alabama, California, Florida, Mississippi, Tennessee, Texas

MediumArkansas, Illinois, Kentucky, Louisiana, Massachusetts, Montana, Nevada, New York, North Dakota, Ohio, Oklahoma,Utah, Washington, West Virginia, Wyoming

WeakColorado, Connecticut, DC, Delaware, Georgia, Indiana,Maine, New Hampshire, New Mexico, North Carolina, Pennsylvania

None

Alaska, Arizona, Hawaii, Idaho, Iowa, Kansas, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Oregon, Rhode Island, South Carolina, South Dakota, Vermont, Virginia, Wisconsin

Utilization review is the evaluation of medical necessity, appropriateness, and reasonableness of medical treatment.

27

Coordinated

InterventionsManaged care tools are all essential components to ensuring compliance with medication regimens.

What was dispensed?

What’s the patient taking?

What should they be taking?

Pharmacy Benefit Manager

Urine Drug Monitoring

Peer ReviewUtilization ReviewCase Management

28

Misuse, Abuse & CompoundingJo-Ellen Abou Nader, CFE, CIA, CRMA

Senior Director, Drug Waste Solutions

Jo-Ellen Abou Nader, CFE, CIA, CRMA, has disclosed no relevant, real or apparent personal or professional

financial relationships with proprietary entities that produce health care

goods and services

Agenda

• Fraud, Waste & Abuse Issues: Opioids and

compounds

• Express Scripts Research: Emerging challenges

• Solutions: PBM tools to safeguard members and

payers

50 AMERICANS DIE EVERY DAY FROM RX POISONING

Opioid Misuse Puts Patients at Risk

Compounds Drive Wasteful Spending

MORE THAN $3 BILLION COST TO U.S. IN 2014

Pharmacy Network

POS Edits

Pharmacy Claims

Network Audit

Medical Claims

Fraud Case Work

Physician

& Member

Network

Client Medical Vendor

Best Practices: Fraud, Waste & Abuse

Data & Analytics Dig Deeper

CHRONIC USE

Troubling Findings About Opioid Use

• Fewer Americans are using opioids, but total amounts taken continue to increase

• Of patients taking an opioid pain medication for at least 30 days, nearly half will still be taking opioids 3 years later

• Nearly half of long-term users are taking short-acting formulations only, increasing risk of addiction

• Women are 30% more likely to use opioids than men

• Only 3% prescribed by pain specialists

PRESCRIBING PATTERNS

Intervene Early

Mine Pharmacy and Medical Data

Follow Evidence-Based Protocol

Communicate Clearly and Often

Increase Collaboration

Opioid Insights and Best Practices

Member Scenario Examples

Relationships, patterns and scenarios Advanced Analytics

IDENTIFY AND REVIEW OUTLIERS

Multiple

physicians Multiple

drugs; one

therapy

Multiple

pharmacies

High risk

specialties

# of GCNS

Distance

traveled

Short

days

supplies# of short acting meds High ER

utilization

Drug

Spend

Multiple

pharmacies

Multiple

physicians

Multiple

drugs; one

therapy

Fraud Analytics Scenarios

• Doctor shopping

• Drug combinations

• High-cost drugs

• HIV medications

• Geographic concerns

• Cough syrups

• ADHD medications

43 prescriptions1 patient

17 prescribers 5 pharmacies

Case Study: Abuse Intervention

• Member restricted to 1

pharmacy and/or 1 physician

for all controlled substances

and muscle relaxers

• Efficiently manages and

reduces risk within membership

• Completed through a series of

letters to member

Solution: Lock-In Pharmacy, Provider

CLIENTS WITH AUTO LOCK-IN EXPERIENCE 4X MORE SAVINGS

Cost of Compounds Skyrocket

Utilization Unit Cost

187.3%31.1%

218% INCREASE IN TOTAL TREND IS UNSUSTAINABLE

OLD

• Only most expensive ingredient submitted

• Coverage based on onlymost expensive ingredient

• ‘Blind’ summation of all ingredients submitted and paid

COMPOUND CLA IMS PR OCESS

NEW

• All ingredients submitted

• Coverage based on all ingredients

• Each ingredient cost must be submitted for reimbursement

• Expanded reject oversight

2011(through 12/31/11)

2012(1/1/12 and beyond)

A Tale of Unintended Consequences

INCREASING TRANSPARENCY CREATED A DISTURBING TREND

$0

$10

$20

$30

$40

$50

$60

2010 AWP 2011 AWP 2012 AWP 2013 AWP 2014 AWP

AW P(Average Wholesale Price)

1

Two options for pharmacy prescription submission:

Gabapentin

FlurbiprofenKetamine

U&C(Usual and Customary)

2

BULK POWDER MAKERS DRASTICALLY BOOSTED AWP PRICES

Taking Advantage of a Loophole

Compound Example Count of Tablets

Zolmitriptan ODT 5mg 792

Tramadol HCL 50mg 396

Pentoxifylline 400mg 49.5

Dexamethasone 0.5mg 792

Gabapentin 800mg 74.25

TOTAL

2,103.75

Example: Migraine Treatment

COST OF STANDARD GENERIC MEDICATION (IMITREX): $20

Using PBM Tools to Eliminate Waste

REDUCING SPEND BY 95% SAVES CLIENTS $2 BILLION THIS YEAR

• Formulary Exclusions:

>1,000 bulk powders

• Prior Authorization:

Ensuring access for

patients who need it

• Dollar Thresholds

• Compound Prescription

Limits

New Areas of Focus Emerge

• Sales Force

• Doctor Collusion / Kickbacks

• Tele-Docs

• Co-Pay Waiving

• Coupons

• Tablets vs. Bulk Powders

OUR SOLUTIONS EVOLVE IN RESPONSE TO CHANGING SCHEMES

Takeaways

The right data analytics can spot costly and dangerous issues 1

New threats are constantly emerging2

PBMs are uniquely positioned to identify and prevent fraud, waste and abuse3

RX Drugs and Urine Testing: Knowing What’s Too Much, Too

Little & Just Right

Elaine K Jeter, MD

Palmetto GBA

Disclosure

Elaine Jeter, MD, has disclosed no relevant, real

or apparent personal or professional financial

relationships with proprietary entities that

produce health care goods and services.

Overutilization

• Blanket UDT orders

• Same panel on every patient in practice

• Absent medical record documentation of tests

ordered, results of cup or IA, clinical history

• Self-referral testing to maximize reimbursement

• Semi-quant IA billed with specific quant codes

Overutilization

• Q 1/3 wk – G0434/G0431 – single/multiple

providers in practice

• Doc & lab each billing G0434 and/or G0431 -

same DOS

• Reference lab – billing 80102 - IA “confirmation”

• Definitive testing on + & - presumptive tests

Average and Maximum Services per HICN per DOS

0

10

20

30

40

50

60

Cat 2 NC Cat 2 SC Cat 2 VA Cat 2 WV Cat 3 NC Cat 3 SC Cat 3 VA Cat 3 WV

Average Allowed Servicesby HICN and DOS

Maximum AllowedServices by HICN and DOS

Average & Maximum Allowed Charge per HICN per DOS

0.00

200.00

400.00

600.00

800.00

1,000.00

1,200.00

1,400.00

Cat 2 NC Cat 2 SC Cat 2 VA Cat 2 WV Cat 3 NC Cat 3 SC Cat 3 VA Cat 3 WV

Average AllowedCharge by HICN andDOS

Maximum (HIGH)Allowed Charge byHICN and DOS

# o

f cla

ims

0

10000

20000

30000

80154

Assay of benzodiazepines

Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan

2011 2012 2013 2014 2015

52 / 186 Providers

# o

f cla

ims

0

5000

10000

15000

82101

Assay of urine alkaloids

Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan

2011 2012 2013 2014 2015

39 / 69 Providers

0

10000

20000

30000

82145

Assay of amphetamines

Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan

2011 2012 2013 2014 2015

39 / 178 Providers

# o

f cla

ims

0

5000

15000

25000

82205

Assay of barbiturates

Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan

2011 2012 2013 2014 2015

18 / 75 Providers

# o

f cla

ims

0

10000

20000 3

0000 4

0000

82520

Assay of cocaine

Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan

2011 2012 2013 2014 2015

41 / 174 Providers

# o

f cla

ims

0

5000

15000

25000

82541

Column chromotography qual

Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan

2011 2012 2013 2014 2015

9 / 16 Providers

# o

f cla

ims

0

20000

40000

60000

82542

Column chromotography quant

Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan

2011 2012 2013 2014 2015

70 / 198 Providers

# o

f cl

aim

s

0

5000

10000 1

5000 2

0000

82646

Assay of dihydrocodeinone

Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan

2011 2012 2013 2014 2015

66 / 114 Providers

# o

f cla

ims

0 5

000

15000

25000

83805

Assay of meprobamate

Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan

2011 2012 2013 2014 2015

55 / 133 Providers

# o

f cla

ims

0

10000

30000

83840

Assay of methadone

Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan

2011 2012 2013 2014 2015

44 / 177 Providers

What’s Next?

• Has all this testing improved patient outcomes?

• Is random testing occurring?

• Medicare patients – cocaine, PCP, methadone?

• Should comprehensive LC-MS technology be testing standard?

• Should reimbursement be severely cut to disincentivize overutilization?

• Should pain docs demand definitive testing

prior to evaluating a patient?

Third-Party Payer Track

Rx Drugs and Urine Testing:Knowing What’s Too Much, Too

Little and Just Right

Presenters:• Michael Gavin, President, PRIUM• Jo-Ellen Abou Nader, CFE, CIA, CRMA, Senior Director,

Drug Waste Solutions, Express Scripts, Inc.• Elaine Jeter, MD, MolDX Medical Director, Palmetto GBA

Moderator: Daniel Blaney-Koen, JD, Senior Legislative Attorney, American Medical Association Advocacy Resource Center, and Member, Rx Summit National Advisory Board