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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.
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
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
Pharmacy Network
POS Edits
Pharmacy Claims
Network Audit
Medical Claims
Fraud Case Work
Physician
& Member
Network
Client Medical Vendor
Best Practices: Fraud, Waste & Abuse
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
• 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