right drug right_test_right_time_final_rev

Right Drug, Right Test, Right Time Ms. Dongchun Wang

Economist, Workers’ Compensa3on Research Ins3tute

Dr. Lenox Abbo: Director, Laboratory Opera3ons and Na3onal Standards, Quest

Diagnos3cs

Tron Emptage Chief Clinical Officer, Progressive Medical

April 2 – 4, 2013 Omni Orlando Resort at ChampionsGate

Learning Objec?ves

•  Outline how clinical programs can iden3fy excessive use or misuse of opioids

•  Describe the impact of behavioral interven3ons in chronic opioid cases

•  Explain the value of urine and drug screening

Disclosure Statement

•  Ms. Dongchun Wang has no rela3onships with proprietary en33es that produce health care goods and services.

•  Dr. Lenox AbboS has no rela3onships with proprietary en33es that produce health care goods and services.

•  Tron Emptage has no rela3onships with proprietary en33es that produce health care goods and services.

Opioids In Workers’ Compensa3on

WCRI Annual Conference

February 2013

Today’s Discussion

•  Prescribing paSerns of opioids in workers’ compensa3on – Overall use of opioids – Longer-‐term use of opioids

Opioids In Workers’ Compensa3on: Key Findings From WCRI Studies

•  Most injured workers received opioids for pain relief, over 80% in some states studied

•  Amount of opioids received per claim unusually high in several study states

•  1 in 6 or 7 injured workers in Louisiana and New York who received opioids had them on a longer-‐term basis

•  Few longer-‐term users of opioids received services for monitoring and management

•  Longer-‐term opioid use in MA fell a_er pain guidelines

Opioids Commonly Received By Injured Workers, Paid Under WC

Generic Name (Brand Name) Federal Schedule

% Claims w/ Pain Meds

(Median State)

Hydrocodone-‐Acetaminophen (Vicodin®) 3* 58%

Oxycodone w/Acetaminophen (Percocet®) 2 28%

Propoxyphene-‐N w/APAP (Darvocet-‐N®) 4 18%

Tramadol HCL (Ultram®) -‐ 17%

Oxycodone HCL (OxyCon3n®) 2 4%

Fentanyl (Duragesic®) 2 1%

Claims With > 7 Days Of Lost Time, Injuries From October 2005 To September 2006, Opioid Prescrip?ons Filled Through March 2008 (Data

From 2011 Prescrip?on Benchmarks, 2nd Edi?on)

* The FDA And DEA Are Currently Considering Rescheduling Hydrocodone Products (e.g., Vicodin®) From Schedule 3 To Schedule 2.

Opioids Commonly Received By Injured Workers, Paid Under WC (Cont.)

Generic Name (Brand Name) Federal Schedule

% Of Rx For Pain Meds

(Median State)

Hydrocodone-‐Acetaminophen (Vicodin®) 3* 36%

Oxycodone w/Acetaminophen (Percocet®) 2 10%

Tramadol HCL (Ultram®) -‐ 6%

Propoxyphene-‐N w/APAP (Darvocet-‐N®) 4 6%

Oxycodone HCL (OxyCon3n®) 2 2%

Fentanyl (Duragesic®) 2 <1%

Claims With > 7 Days Of Lost Time, Injuries From October 2005 To September 2006, Opioid Prescrip?ons Filled Through March 2008 (Data

From 2011 Prescrip?on Benchmarks, 2nd Edi?on)

* The FDA And DEA Are Currently Considering Rescheduling Hydrocodone Products (e.g., Vicodin®) From Schedule 3 To Schedule 2.

Most Injured Workers With Pain Medica3ons Received Opioids

Nonsurgical Claims With > 7 Days Of Lost Time, Injuries From October 2008 To September 2009, Prescrip?ons Filled Through March 2011

* Texas Closed Formulary Went Into Effect On September 1, 2011, Which Is Expected To Reduce Use And Longer-‐Term Use Of Opioids

*

Amount Of Opioids Received Per Claim Unusually High In NY, LA, PA & MA

Nonsurgical Claims With > 7 Days Of Lost Time, Injury Year 2006, Prescrip?ons Filled Through March 2008 (Data From 2011 Narco?cs Study)


Database Suppor3ng Latest WCRI Study On Opioids

•  300,000+ claims, 1.1 million pain medica3on Rx filled through March 2011

•  Nonsurgical claims with > 7 days of lost 3me

•  21 states represen3ng two-‐thirds of workers’ compensa3on medical benefits in the U.S. – 20–47% of claims in each state

•  Snapshots of an average 24-‐month experience

Prescrip3ons For Opioids

•  Rx for opioids – Dispensed by physicians or pharmacies

– Paid under workers’ compensa3on

•  Excluded – Hospital-‐dispensed opioids – Opioids administered by medical providers (e.g., injectables, infusions, etc.)




 1 in 6 or 7 injured workers in Louisiana and New York who received opioids had them on a longer-‐term basis

 Few longer-‐term users of opioids received services for monitoring and management

•  Longer-‐term opioid use in MA fell a_er pain guidelines

Longer-‐Term Use Of Opioids •  Study defini3on

– First opioid Rx filled within first 3 months a_er injury

– Opioids con3nued a_er 6 months pos3njury

– 3+ Rx fills during months 7–12

•  Nonsurgical cases

One In 6 Or 7 Workers With Opioids In LA And NY Had Longer-‐Term Use


Nonsurgical Claims With > 7 Days Of Lost Time, Injuries From October 2008 To September 2009, Narco?c Prescrip?ons Filled Through March 2011

*

Longer-‐Term Use Of Opioids Also Prevalent In Several Other States

*


Nonsurgical Claims With > 7 Days Of Lost Time, Injuries From October 2008 To September 2009, Narco?c Prescrip?ons Filled Through March 2011

Medical Treatment Guidelines For Chronic Opioid Management Recommend

•  Urine drug tes3ng •  Psychological and psychiatric evalua3ons and treatment

•  Ac3ve physical therapy

Note: Guideline recommenda3ons are based on widely-‐accepted medical treatment guidelines, including ACOEM, APS/AAPM, ODG, and state guidelines (CO, UT, WA). See Appendix A of WCRI’s Longer-‐Term Use of Opioids.

Frequency Of Drug Tes3ng Was Low, Even A_er Considerable Increases

% Of Claims With Longer-‐Term Use Of Opioids That Received Drug Tes3ng In…

21-‐State Median

Most States (Range)

2007/2009 14% 9–24%

2009/2011 24% 18–30%

Nonsurgical Claims With > 7 Days Of Lost Time That Were Iden?fied As Longer-‐Term Users Of Opioids, Injury Years 2007 & 2009, Prescrip?ons Filled Through March 2011, Average 24-‐Month

Snapshots

Psychological Evalua3ons And Treatment Performed Infrequently

% Of Claims With Longer-‐Term Use Of Opioids That Received…

21-‐State Median

Most States (Range)

Psychological Evalua3ons

2007/2009 6% 4–9%

2009/2011 7% 3–9%

Psychological Treatment

2007/2009 6% 3–7%

2009/2011 4% 2–6%

Nonsurgical Claims With > 7 Days Of Lost Time That Were Iden?fied As Longer-‐Term Users Of Opioids, Injury Years 2007 & 2009, Prescrip?ons

Filled Through March 2011, Average 24-‐Month Snapshots




•  1 in 6 or 7 injured workers in Louisiana and New York who received opioids had them on a longer-‐term basis

•  Few longer-‐term users of opioids received services for monitoring and management

 Longer-‐term opioid use in MA fell a_er pain guidelines

Longer-‐Term Opioid Use In MA Fell A_er Pain Guidelines

2007/2009 To 2009/2011 Nonsurgical Claims With > 7 Days Of Lost Time, Injury Years 2007 To 2009,

Prescrip?ons Filled Through March 2011, 24-‐Month Maturi?es


Conclusions

•  Opioid problem is BIG in workers’ compensa3on, especially in some states

•  Doctors prescribe opioids more o_en in some states than others, overall and on longer-‐term basis

•  Opportuni3es to eliminate unnecessary opioid prescrip3ons

Right Drug, Right Test, Right Time.

•  Chronic opioid therapy management •  Prescrip3on drug monitoring guidelines & protocol

development •  Prescrip3on drug monitoring result trends •  Balancing costs

Discussion Points

Management of chronic pain pa?ents – 10 steps of universal precau?ons

| 25 Gourlay DL, Heit HA, Almahrezi A. Universal Precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005;6:107-112. Gourlay DL, Heit HA. Universal precautions revisited: managing the inherited pain patient. Pain Med. 2009;10(suppl 2):S115-S123.

1 Make a diagnosis with appropriate differen3al and a plan for further evalua3on and inves3ga3on of underlying condi3ons to try to address the medical condi3on that is responsible for the pain

2 Psychologic assessment, including risk of addic3ve disorders

3 Informed consent

4 Treatment agreement

5 Pre-‐/post-‐treatment assessment of pain level and func3on

6 Appropriate trial of opioid therapy +/-‐ adjunc3ve medica3on

7 Reassessment of pain score and level of func3on

8 Regularly assess the “Four As” of pain medicine • Analgesia, Ac3vity, Adverse reac3ons, and Aberrant behavior

9 Periodically review management of the underlying condi3on that is responsible for the pain, the pain diagnosis and comorbid condi3ons rela3ng to the underlying condi3on, and the treatment of pain and comorbid disorders

10 Documenta3on of medical management and of pain management according to state guidelines and requirements for safe prescribing

Prescrip?on drug monitoring – objec?ve evidence to assist in pa?ent management

Confidential – Do not copy or distribute | 26

Prescrip3on Drug Monitoring Urine drug tes3ng which is used to detect the presence of the prescribed drug in the urine, specifically controlled medica3ons, as an indicator of the pa3ent’s adherence or compliance to their treatment plan

 Presence of the drug or the drug’s metabolites indicates that the pa3ent is taking the drug

 Absence of the drug or the drug’s metabolites indicates that the pa3ent is probably not taking the drug

 Presence of an illicit drug or prescrip3on drug not prescribed by the physician indicates that the pa3ent is supplemen3ng his treatment

Tes?ng Road Map

Science and What’s Supported by Data

State Laws, Rules & Professional Standards

Pain Addic?on/Recovery

Local Coverage Determina?ons and Medical Policies

Other Regulatory Requirements and Policies

27

| 28 ¹Chou R, Fanciullo GJ, et al. (2009) Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. The Journal of Pain, 10 (2): 113-130.

Guidelines have common themes but are not defini?ve

APS/AAPM Guidance ¹ ACOEM Guidelines Universal Precau?ons

High risk pa3ents or who have engaged in aberrant drug-‐related behaviors, clinicians should periodically obtain urine drug screens or other informa3on to confirm adherence to the COT plan of care.

“There is evidence that urine drug screens can iden3fy aberrant opioid use and other substance use that otherwise is not apparent to the trea3ng physician.”

MODERATE TO HIGH Risk of Misuse May be periodically eligible for monitoring at each visit, with a minimum of one test conducted every three months (4x/year)

Pa3ents not at high risk and not known to have engaged in aberrant drug-‐related behaviors, clinicians should consider periodically obtaining urine drug screens or other informa3on to confirm adherence to the COT plan of care

Screening is recommended: -‐  At baseline -‐  Randomly at least 2-‐4

3mes/year -‐  At termina3on “for

cause”

LOW Risk of Misuse

May be periodically eligible for monitoring at each visit, with a minimum of one test conducted every six months (2x/year).

Protocol must be defined by prac?ce

29

Who to test? Which drugs? How frequently?

Clinical response to test results?

Goal: Patient, Practice & Community Safety

Initial PDM Test Prior to _____RX

Risk Assessment using ___________tool

Low-Risk Perform random PDM testing minimum of

______ times per______

Consistent Result

Modify testing

frequency to ______ times

per _____

Continue Testing at low-risk

rate

High-Risk Perform random PDM testing

minimum of ______ times per______

Inconsistent

Result

Consistent Result

Inconsistent

Result

Modify testing frequency to ______ times

per _____

Continue testing

frequency for _______ period

Broad spectrum

testing: pain medication, illicit drugs,

potential drug interactions

Targeted testing based on results &

other risk factors

What to order Practice Protocol

•  The majority of pa3ents tested misused their prescrip3on medica3ons (60%)

•  Many pa3ents took drugs or combined drugs without physician oversight

•  A large number of pa3ents showed no drug in their specimen

•  Recrea3onal marijuana users are more likely than non-‐users to misuse other drugs

•  Anyone is at risk of misuse. 70% Medicaid, 58% Medicare, 59% Private

•  Inconsistent results declined by 10% in pa3ents tested 30 days or more a_er ini3al screen

| 31

Most pa?ent drug tests are inconsistent with expecta?ons

| 31

Quest Diagnostics Health Trends, Prescription Drug Monitoring Report 2013

| 32

Inconsistent results driven by a number of factors

•  One-‐third (33%) of inconsistent results showed presence of drug(s) not specified by the ordering physician in addi3on to prescribed medica3on.

•  25% showed presence of a drug different than the one prescribed by the ordering physician.

•  In 42% of inconsistent cases, no drug was detected.

•  Non-‐prescribed marijuana was the most frequently detected drug, found in 26% of pa3ent specimens with inconsistent results.

•  These findings confirm other data sugges3ng marijuana is the most commonly abused illicit drug in the United States.

•  The next most frequently misused drugs detected in tes3ng were opiates (22%) and benzodiazepines (16%).

Marijuana was the most frequently detected non-‐prescribed drug

Recrea?onal marijuana users were more likely to use other non-‐prescribed medica?ons than non-‐users

•  45% of specimens posi3ve for non-‐prescribed marijuana were also posi3ve for at least one other non-‐prescribed drug – 10% higher than non-‐users (36%).

•  Pa3ents who used marijuana illicitly are 1.3 3mes more likely to use drugs not prescribed by an ordering physician.

•  Among illicit marijuana users, seda3ve medica3ons and narco3c pain killers were the most frequently detected non-‐prescribed drugs.

| 34

Cost of tes?ng can vary widely based on provider prac?ce Scenario 1

| 35

26 year old female patient •  Neck pain – post accident •  5 mg Hydrocodone 4 times

day •  20 mg Adderall daily •  Moderate Risk- consistent

results

Assumptions •  Screen reimbursement - CA WC schedule

(120% of MC) •  Use of G0434 for POCT & G0431 for lab-

based immunoassay •  Quantitative reimbursement - opiate CPT

code Provider A Jan. April Jul. Oct. Annual

12 Drug POC Test Cup 1*$24 1*$24 1*$24 1*$24 $96

12 Quant. Confirma3ons 12*$32 12*$32 12*$32 12*$32 $1,536

Total $408 $408 $408 $408 $1,632

Provider B Jan. April Jul. Oct. Annual

10 Drug Lab Test + SVT 1*$146 1*$146 1*$146 1*$146 $584

2 Quant. Confirma3ons 2*$32 2*$32 2*$32 2*$32 $256

Total $210 $210 $210 $210 $840

Delta per Pa?ent

$792 annually

| 36

40 year old male patient •  Lower back pain – post work

injury •  100 mg Tapentadol 4 times/day •  0.5 mg Clonazepam daily •  Moderate Risk- consistent

results

Assumptions •  Screen reimbursement - CA WC schedule

(120% of MC) •  Use of G0434 for POCT & G0431 for lab-

based immunoassay •  Quantitative reimbursement - opiate CPT

code Provider A Jan. April Jul. Oct. Annual

12 Drug POC Test Cup 1*$24 1*$24 1*$24 1*$24 $96

10 Quant. Confirma3ons + SVT + 5 Direct to Quant.

$26 + 15*$32

$26 + 15*$32

$26 + 15*$32

$26 + 15*$32

$2,024

Total $530 $530 $530 $530 $2,120

Provider B Jan. April Jul. Oct. Annual

10 Drug Lab Test + SVT 1*$146 1*$146 1*$146 1*$146 $584

2 Direct to Quant. 2*$32 2*$32 2*$32 2*$32 $256

Total $210 $210 $210 $210 $840

Delta per Pa?ent

$1,280 annually

Cost of tes?ng can vary widely based on provider prac?ce Scenario 2

Providers and payers must work together to op?mize outcomes and minimize cost to system

•  Educate physicians on state rules, regula3ons & guidelines

•  Implement reasonable tes3ng frequency & reimbursement policies

•  Link pharmacy and laboratory data

•  U3liza3on evalua3ons & clinical interven3on, as appropriate

| 37

Next fron?er: using gene?cs to individualize pain drug selec?on

Glucuronida?on

Drug

CYP 3A metabolism CYP 2D, 2C metabolism

Gene3c varia3ons in the DNA can affect rate and extent of cytochrome P450 enzyme metabolism:

CYP 2D6 CYP 2C19 CYP 3A4 CYP 3A5

Cytochrome P450 enzymes are commonly associated with drug metabolism.

Approximately 90% of individual differences in liver CYP 3A ac3vity are from gene3c varia3on

The P450 variants can drama3cally alter enzyma3c ac3vity.

Tron Emptage, RPh, Chief Clinical Officer

Progressive Medical, Inc.

Right Drug, Right Test, Right Time.

Learning Objec?ves

•  Outline how clinical programs can iden3fy excessive use or misuse of opioid.

•  Describe the impact of behavioral interven3ons in chronic opioid cases.

•  Explain the value of urine and drug screening

Discussion Points

•  Pharmacy Benefit Management Solu3ons •  Prevent through Connec3vity •  Monitor U3liza3on

•  Intervene through Clinical Review •  Leverage Analy3cs

Workers’ Compensa?on Facts

Top 1% account for ~40% of all narco3c costs

Top 10% account for ~80%

of all workers’ compensa3on narco3c costs

Source: NCCI Narco3cs in Workers’ Compensa3on

U?liza?on

Medica?on Quan?ty x Length of Use

1-‐2 year old claims = 3% of total medical costs

Source: NCCI Drug Study: 2011 Update

11 year old claims = 40% of total medical costs

Right Drug, Right Test, Right Time

Prevent Alert Monitor Intervene

Case Study: The Beginning

A framer with a construction company was injured when pulling a pallet of bricks on the job from one site to another for use of the materials.

His injury, a low back strain, occurred in August of 1989 and in 1990 had a percutaneous 3-level lumbar discectomy. He continued with residual pain and the following therapies were initiated:

•  TENS therapy – effective •  Nerve blocks – ineffective •  OT/PT with Activity Restriction •  Biofeedback and Counseling •  Medication Therapy – minimally effective

PHARMACY BENEFIT MANAGEMENT

SOLUTIONS

Total Pharmacy Management

ONGOING COMMUNICATION

U?liza?on Management

Clinical & Diagnos?c Interven?ons

Educa?on & Analy?cs

NETWORK PENETRATION

Follow the Prescrip?on in Workers’ Compensa?on

Injured Worker Retail

Pharmacy

Iden?fy PBM

Alternate Filling Site

Billing Agent PBM

Payor

NO

Out of Network

YES

In Network

Processing and Eligibility Solu?ons

Capture Rx at First Fill

Reduce OON Bills

Home Delivery

Capture Rx at First Fill

•  Nearly 65,000 retail pharmacies

•  PBMs contract with these pharmacies to bring efficiencies •  First fills are the beginning to network penetra3on and

guideline adherence

•  Early fill capture allows for early aler3ng of poten3al problems

In Network Processing Increases Informa?on

•  Monitor for guideline adherence

•  Direct-‐to-‐pharmacy connec3vity processing brings conflict alerts to the pharmacist

•  Reduces risk of duplicate therapy •  Alert for high dose •  Mul3ple prescribers •  Reduce informa3on delay associated with paper claims

Home Delivery

•  Offer convenience to injured workers •  Order online, via phone and mail •  Offers physician increase in control of maintenance medica3ons

•  Brings claims professional and payor prescrip3on informa3on on long-‐term claims

•  Follows long-‐term claims more closely

Mul?faceted Approach

Prevent Alert Monitor Intervene

Prevent

•  First fill plans developed with guidelines at First No3ce of Loss

•  High retail network penetra3on means more prescrip?ons through program at point of sale

•  Iden?fy claims needing early Urine Drug Screening •  Con3nual drug informa?on review through analy3cs

Alert

•  Applica3on of guidelines through medica3on plans based on injury type, date of injury and body part

•  Drive point-‐of-‐sale informa3on to dispensing pharmacist to alert to dispensing problems

•  Clinical audits and triggers alert claims professional, prescriber and injured worker to addi3onal cau3ons within the claim based on analy3cs

•  Injured worker alerts can be set to allow for Urine Drug Screening

Formulary Development

•  Use of evidence-‐based medica3on prac3ces

•  Na3onal and state-‐specific guideline applica3on •  Injury and disease treatments •  Use of body part and nature of injury •  Dura3on of use limits •  Quan3ty limits •  Step therapy allowances for proper medica3on allowance

•  Off-‐label prescribing

Dispensing Edits and Alerts

•  Industry standards from Na3onal Council of Prescrip3on Drug Programs, D.0 standards

•  Alerts and edits – Therapeu3c duplica3on – Early refills – Drug – drug interac3ons – Drug – disease interac3ons – Mul3ple prescriber alerts – High dose, over use alerts

Follow the Prescrip?on in Workers’ Compensa?on

Injured Worker Retail

Pharmacy

Iden?fy PBM

Alternate Filling Site

Billing Agent PBM

Payor

NO

Out of Network

YES

In Network

Opioid Strategies

•  Ini3a3on of narco3c therapy no3fies medical and claims professionals when injured workers receive mul3ple opioid medica3ons especially when mul3ple physicians are involved

•  Targeted alerts inform claims professionals of: o  Specific prescrip3ons that may not be appropriate for

severity or chronicity of injury

o  When morphine equivalents exceed a set amount o  Narco3c duplica3on o  Excessive APAP

Case Study: More Informa?on

•  Medica3on regimen in late 2007 included: o  Venlafaxine 75mg -‐ 3 per day o  Lyrica 150mg -‐ 3 per day

o  Clonazepam 1mg -‐ 4 per day o  Carisoprodol 350mg -‐ 3 per day

o OxyCon3n 80mg ER -‐ 8 per day o Oxycondone 30mg IR -‐ 6 per day

Case Study: Concerns

•  Claimant receiving well above 1,000mg morphine equivalents per day

•  Claimant consistently reported pain scores of 7-‐9 out of 10

•  Claimant began to have high blood pressure readings •  Urine drug monitoring was ini3ated and compounds represen3ng illicit drugs were found present in the urine, as well as opioid compounds

•  Claimant was discharged from physician due to broken opioid medica3on contract

Monitor

•  Monthly clinical audits assist in physician monitoring to find misuse

•  Urine drug screening program to find claims that may benefit from regular analysis

•  Narco3c use and overu3liza3on reports using analy3cal tools and processes to find poten3al problems early

Monitoring Strategies

•  Ini3a3on of urine drug screening and monitoring

•  Guidelines suggest: o Baseline tes3ng o Randomized tes3ng

o Daily morphine equivalents requirements o Therapy guidelines

•  Opioid contract implica3ons •  Prescrip3on drug monitoring programs •  Other screening tools

Intervene

•  Con3nual clinical pharmacist reviews allow for iden3fica3on of the need for interven3on

•  Drug u?liza?on evalua?ons allow for the pinpoin3ng of early drug regimen changes

•  Pharmacists at point of dispense help inform injured workers of poten3al issues

•  Use of Le:ers of Medical Necessity

•  Pharmacist reviews and consulta?on recommending poten3al treatment changes

•  Peer-‐to-‐peer consulta?on assists in making therapy regimen changes

•  Pharmacist Only Review –  Review of medica3ons –  Summary of past and current medical history

– Medica3on therapy recommenda3ons

•  Physician Review –  Above, with physician review and comment

•  Peer-‐to-‐Peer Reviews –  Above, with conversa3on

Clinical Interven?on Reports

•  Compared six months pre-‐ and post-‐interven3on

•  Prescribing physicians reviewed therapies and made changes with the following results

-‐  24% # of Prescrip3ons

-‐  22% Morphine Equivalency

-‐  28% Spend per Claim

Interven?on Results CASE STUDY: 628 INTERVENTION CLAIMS

Case Study: Results

•  Claimant referred for medica3on review in early 2009

•  Results of successful peer-‐to-‐peer consulta3on and weaning of medica3ons: o  Lyrica 600mg per day

o  OxyCon3n 80mg ER – 2 per day

o  Oxycondone 5mg IR -‐ 6 per day

•  While s3ll well above many guidelines, morphine equivalents reduced by more than 1,000mg per day

•  Claimant has increased func3onality and decreased pain scores

•  Urine drug monitoring has been con3nued and claimant has been adherent to therapy

Thank you

right drug right_test_right_time_final_rev

Health & Medicine