Third-Party Payer Track: Rx Drugs and Urine Testing: Knowing What’s Too Much, Too Little and Just Right

1. 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

2. 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.

3. 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

4. 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.

5. Urine Drug Monitoring
Too Much or Too Little

6. 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

7. 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

8. • Industry Context
• Data and Observations
• Best Practices
Agenda
8

9. 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

10. 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
personnel
1. 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

11. 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

12. Longitudinal
AnalysisThe availability of information to assist with assessing likely adherence
over time is of critical importance in light of chronic opioid therapy.
12

13. MEDs1
Rx Spend2
191%
400
800
1,200
1,600
1 2 3 4 5 6
Avg.QuarterlyMEDperClaim
Quarters Since Injury
58%
$150
$200
$250
$300
2003 2004 2005 2006 2007 2008 2009 2010 2011
DollarsPaidperMedicalClaim
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

14. 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.

15. 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.

16. Observations
The 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
Illicits
By Age By Year
2006 2007 2008 2009 2010 2011 2012 2013 2014
16
1. Data collected from Ameritox drug monitoring accessions.

17. 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.

18. Observations
Potential 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 Found
By Age By Year
2006 2007 2008 2009 2010 2011 2012 2013 2014
18
1. Data collected from Ameritox drug monitoring accessions.

19. 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.

20. Observations
Among 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 Rx
By Age By Year
2006 2007 2008 2009 2010 2011 2012 2013 2014
20
1. Data collected from Ameritox drug monitoring accessions.

21. 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.

22. 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 logistics
2. Patient complaints: not covered by
insurance.
3. High Deductible/High Copay
4. Patient compliance
5. Lack of clear protocol or protocols
emerging (Work Comp)
6. Fraud
7. 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

23. Best Practices
The 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

24. Guidelines
Evidence-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
Behavior
Monitoring 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

25. Proactive Patient
Identification
Data from multiple systems needs to be consolidated and
analyzed to identify patients indicated for UDM.
25

26. 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 patient
3. Free goods (e.g., testing cups)
4. Profit sharing models (e.g., physician owns % of lab)
5. Education on billing
6. Free legal advice
Some doctors and/or labs engage in inappropriate business practices
for which payers should be vigilant
26

27. Utilization Review
Strength of UR Rules Jurisdiction
Strong Alabama, California, Florida, Mississippi, Tennessee, Texas
Medium
Arkansas, Illinois, Kentucky, Louisiana, Massachusetts,
Montana, Nevada, New York, North Dakota, Ohio, Oklahoma,
Utah, Washington, West Virginia, Wyoming
Weak
Colorado, 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

28. Coordinated
Interventions
Managed 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 Review
Utilization Review
Case Management
28

29. Misuse, Abuse & Compounding
Jo-Ellen Abou Nader, CFE, CIA, CRMA
Senior Director, Drug Waste Solutions

30. 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

31. Agenda
• Fraud, Waste & Abuse Issues: Opioids and
compounds
• Express Scripts Research: Emerging challenges
• Solutions: PBM tools to safeguard members and
payers

32. 50 AMERICANS DIE EVERY DAY FROM RX POISONING
Opioid Misuse Puts Patients at Risk

33. Compounds Drive Wasteful Spending
MORE THAN $3 BILLION COST TO U.S. IN 2014

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

35. Data & Analytics Dig Deeper

36. 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

37. Intervene Early
Mine Pharmacy and Medical Data
Follow Evidence-Based Protocol
Communicate Clearly and Often
Increase Collaboration
Opioid Insights and Best Practices

38. 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

39. 43 prescriptions1 patient
17 prescribers 5 pharmacies
Case Study: Abuse Intervention

40. • 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

41. Cost of Compounds Skyrocket
Utilization Unit Cost
187.3%31.1%
218% INCREASE IN TOTAL TREND IS UNSUSTAINABLE

42. 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

43. $0
$10
$20
$30
$40
$50
$60
2010 AWP 2011 AWP 2012 AWP 2013 AWP 2014 AWP
AWP
(Average Wholesale Price)
1
Two options for
pharmacy prescription
submission:
Gabapenti
n
Flurbiprofe
nKetamine
U&C
(Usual and Customary)
2
BULK POWDER MAKERS DRASTICALLY BOOSTED AWP PRICES
Taking Advantage of a Loophole

44. 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

45. 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

46. 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

47. Takeaways
The right data analytics can spot costly and dangerous
issues1
New threats are constantly emerging2
PBMs are uniquely positioned to identify and prevent
fraud, waste and abuse3

48. RX Drugs and Urine Testing:
Knowing What’s Too Much, Too
Little & Just Right
Elaine K Jeter, MD
Palmetto GBA

49. 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.

50. 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

51. 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

52. 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 Services
by HICN and DOS
Maximum Allowed
Services by HICN and DOS

53. 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 Allowed
Charge by HICN and
DOS
Maximum (HIGH)
Allowed Charge by
HICN and DOS

54. #ofclaims
0100002000030000
80154
Assay of benzodiazepines
Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011 2012 2013 2014 2015
52 / 186 Providers

55. #ofclaims
050001000015000
82101
Assay of urine alkaloids
Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011 2012 2013 2014 2015
39 / 69 Providers

56. 0100002000030000
82145
Assay of amphetamines
Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011 2012 2013 2014 2015
39 / 178 Providers

57. #ofclaims
050001500025000
82205
Assay of barbiturates
Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011 2012 2013 2014 2015
18 / 75 Providers

58. #ofclaims
010000200003000040000
82520
Assay of cocaine
Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011 2012 2013 2014 2015
41 / 174 Providers

59. #ofclaims
050001500025000
82541
Column chromotography qual
Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011 2012 2013 2014 2015
9 / 16 Providers

60. #ofclaims
0200004000060000
82542
Column chromotography quant
Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011 2012 2013 2014 2015
70 / 198 Providers

61. #ofclaims
05000100001500020000
82646
Assay of dihydrocodeinone
Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011 2012 2013 2014 2015
66 / 114 Providers

62. #ofclaims
050001500025000
83805
Assay of meprobamate
Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011 2012 2013 2014 2015
55 / 133 Providers

63. #ofclaims
01000030000
83840
Assay of methadone
Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011 2012 2013 2014 2015
44 / 177 Providers

64. 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?

65. 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