rx15 tpp tues_330_1_gavin_2nader_3jeter

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.

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 5

6

This presentation:1. Outlines the care settings and technologies used for urine

drug monitoring2. 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

Agenda

8

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.

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

Review of Test Settings & Technologies

Point 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.

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10

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

11Longitudinal 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

1 2 3 4 5 6400

800

1,200

1,600 191%

Quarters Since Injury

Avg.

Qua

rter

ly M

ED p

er C

laim

2003 2004 2005 2006 2007 2008 2009 2010 2011 $150

$200

$250

$300

58%

Service Year

Dolla

rs P

aid

per M

edica

l Cla

im

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, 20122. NCCI Research Brief, 2013

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Observations

Illicits Found Rx Not Found Found, No Rx0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

40.00%

45.00%

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.

1. Data collected from Ameritox drug monitoring accessions.

14

Observations

Illicits Rx Not Found Found, No Rx0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

40.00%

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

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

12-17 18-24 25-34 35-44 45-54 55-64 65-70 Above 710%

5%

10%

15%

20%

25%

IllicitsBy Age By Year

2006 2007 2008 2009 2010 2011 2012 2013 2014


16

Observations

Commercial Medicaid Medicare Workers Comp5%

7%

9%

11%

13%

15%

17%

19%

21%

Illicits

2010 2011 2012 2013 2014

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


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

12-17 18-24 25-34 35-44 45-54 55-64 65-70 Above 710%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Rx Not FoundBy Age By Year

2006 2007 2008 2009 2010 2011 2012 2013 2014


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Observations


27%

29%

31%

33%

35%

37%

39%

41%

Rx Not Found

2010 2011 2012 2013 2014

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


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

12-17 18-24 25-34 35-44 45-54 55-64 65-70 Above 710%

5%

10%

15%

20%

25%

30%

35%

40%

Found, No RxBy Age By Year

2006 2007 2008 2009 2010 2011 2012 2013 2014


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Observations


22%

24%

26%

28%

30%

32%

34%

36%

38%

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.


21Too 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.

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, 20142. WCRI, Long Term Use of Opioids, 2nd Edition, May 2014

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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

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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

24Proactive Patient IdentificationData from multiple systems needs to be consolidated and analyzed to identify patients indicated for UDM.

25Compliant 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

26Utilization 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

NoneAlaska, 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.

27Coordinated 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

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

ClientMedical 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 Scenari

o Exampl

es

Relationships, patterns and scenarios

Advanced Analytics

IDENTIFY AND REVIEW OUTLIERS

Multiple physicians Multiple

drugs; one therapy

Multiple pharmacie

s

High risk specialties

# of GCNS

Distance traveled

Short days

supplies# of short acting meds High ER

utilization

Drug Spend

Multiple pharmacie

s

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 prescriptions 1 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 only most expensive ingredient

• ‘Blind’ summation of all ingredients submitted and paid

COMPOUND CLAIMS PROCESS

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

2010 AWP 2011 AWP 2012 AWP 2013 AWP 2014 AWP$0

$10

$20

$30

$40

$50

$60

AWP (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 abuse

3

Optimizing Utilization and Outcomes of Urine Drug Testing

Elaine K Jeter, MDPalmetto GBA

Disclosures

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.

Medicare Administrative Contractors (MACs)

• 10 Jurisdictions – multiple states• 8 Contractors

• Palmetto • Noridian • Novitas • NGS - • WPS• First Coast• CGS• Cahaba

Problems

• Blanket UDT orders • 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• Cup testing, followed by IA, referral to partnered

lab arrangement with change of DOS repeat IA and definitive testing

Elizabeth Jeter

UDT Policy

• L35105 – Controlled Substances Monitoring and Drugs of Abuse Testing

• Provides covered indications and testing frequency for:– Symptomatic patients, multiple drug ingestions

and/or patients with unreliable history– Patients with substance abuse or dependence– Patients on chronic opioid therapy

“G” Code Proposal

• HCPCS – quarterly update• Gxxxx – Definitive drug testing by mass

spectroscopy, with confirmation when indicated, >40 drugs, metabolites and illicits; per encounter; includes specimen validity testing (pH, specific gravity, oxidants, creatinine)

• Asked CMS not to recognize existing 21 quant codes and 58 new codes

What Happened to Comprehensive “G” code?

• 2015 CPT drug codes – not adopted by CMS• Palmetto’s G code proposal – not adopted by

CMS• CMS cross-walked 2014 CPT codes to “G” codes• Palmetto issued Coding/Billing Guidelines• Requires short text string in SV101-7 claim field• Created CSPAN text string with # of drugs > 8• Tiered reimbursement: 8-14; 15-34; >35

[email protected]

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

rx15 tpp tues_330_1_gavin_2nader_3jeter

Healthcare

health care goods

urine drug monitoring

proprietary entities

care settings

drug waste solutions

drug overdose death

abuse of prescription

urine testing