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Rx for Peril - The Health Insurance Impact and Risks of Epidemic ...

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<strong>Rx</strong> <strong>for</strong> <strong>Peril</strong><br />

<strong>The</strong> <strong>Health</strong> <strong>Insurance</strong> <strong>Impact</strong> <strong>and</strong> <strong>Risks</strong><br />

<strong>of</strong><br />

<strong>Epidemic</strong>-Level Prescription-Drug Diversion<br />

William J. Mahon<br />

<strong>The</strong> MAHON Consulting Group LLC<br />

PDMP Center <strong>of</strong> Excellence Conference<br />

Washington, DC<br />

December 3, 2012<br />

1


Promethazine with Codeine<br />

• DEA Schedule V narcotic—i.e.,<br />

lowest relative potential <strong>for</strong><br />

abuse<br />

• Retail price: $3 - $4 per ounce<br />

• Number 108 in 2010 script<br />

volume among US’ Top 200<br />

drugs<br />

• Number-9 in one client plan’s<br />

Top 10 scripts by total drug units<br />

2


Promethazine with Codeine—<strong>The</strong> Alter Ego<br />

• “Syrup. . . Sizerp. . .<br />

Purple Drank. . .<br />

Drank. . . Lean”<br />

• Street value: $7.50 -<br />

$10 per ounce<br />

• Abuse celebrated in<br />

rap/hip-hop music<br />

culture<br />

3


Three-Six Mafia: “Sippin’ on some siz-erp. . .”<br />

4


<strong>The</strong> Inevitable Knock<strong>of</strong>f. . .<br />

7


Houston: “City <strong>of</strong> Lean”<br />

8


Callie Hall-Herpin, MD<br />

9


Callie Hall-Herpin, MD<br />

• Fabricated <strong>and</strong> sold thous<strong>and</strong>s <strong>of</strong> prescriptions to street<br />

dealers in exchange <strong>for</strong> cash<br />

• 1,700,000 hydrocodone tablets<br />

• 2,500 gallons <strong>of</strong> promethazine with codeine<br />

• Proceeds: $1.7 million<br />

• Sentence:<br />

• 10 years federal prison + 3 years supervised release<br />

• $12.9 million restitution to Medicare program<br />

• Judge’s special order: May never again call herself “Doctor” & must<br />

immediately correct anyone who does so—OR be sent back to prison<br />

10


Alonzo Peters, MD<br />

• Allegedly taught Callie Hall-<br />

Herpin the prescription-mill<br />

business<br />

• Money-laundering (involving<br />

purchase <strong>of</strong> 33-carat<br />

diamond ring) + aiding <strong>and</strong><br />

abetting same<br />

• Sentence:<br />

• 5 years federal prison + 3 years<br />

supervised release<br />

• $10,000 assessment<br />

11


Florida: “<strong>The</strong> Colombia <strong>of</strong> Prescription Drugs”<br />

• DEA “Operation Pill Nation”:<br />

Two-year en<strong>for</strong>cement action<br />

• August, 2012 “pain clinic”<br />

arrests in Pompano Beach,<br />

Florida<br />

• 7 physicians, 3 clinic owners,<br />

one relative<br />

• Racketeering, drug trafficking,<br />

money laundering<br />

• Estimated physician <strong>Rx</strong><br />

revenue: $10,000 per week<br />

• 7 vehicles & 11 weapons<br />

seized<br />

12


“Drug Diversion” Defined. . .<br />

• U.S. Government Accountability Office:<br />

“Channeling <strong>of</strong> licit pharmaceuticals <strong>for</strong> illegal purposes or<br />

abuse”<br />

• UN Office on Drugs <strong>and</strong> Crime:<br />

“Non-Medical Use = Use by the person the drug was<br />

prescribed <strong>for</strong>, but not in the prescribed manner or dosage, as<br />

well as use by another person”<br />

13


Potential Diversion Perpetrators. . .<br />

• Patients—i.e., drug-seekers/“doctor shoppers”<br />

• Bogus patients—i.e., prescription buyers<br />

• Prescribers (MD/DOs, dentists, nurse practitioners,<br />

veterinarians) <strong>and</strong> prescriber employees<br />

• Dispensers <strong>and</strong> dispenser employees (pharmacists, pharmacy<br />

technicians)<br />

• Street dealers/patient recruiters<br />

• Pharmaceutical wholesalers<br />

• Large-scale pharmaceutical thieves<br />

• Various combinations <strong>of</strong> the above<br />

14


US: “A Perfect Storm <strong>of</strong> Abuse. . .”<br />

• 9% <strong>of</strong> US population age 12 or older—22.6 million persons—<br />

acknowledge illicit drug use in 2010<br />

• <strong>Rx</strong> abuse is second only to cannabis—exceeds cocaine, heroin<br />

& hallucinogen abuse combined<br />

• High incidence among teenagers (Vicodin, OxyContin,<br />

stimulants, sedatives)<br />

• 1/3 <strong>of</strong> all new abusers typically are 12 to 17-year-olds<br />

15


A Global Phenomenon<br />

• UN Office on Drugs <strong>and</strong> Crime: “Growing non-medical use<br />

<strong>of</strong> prescription drugs is a global health concern.”<br />

– Opioids, CNS depressants, CNS stimulants<br />

– “Drug traffickers responding to dem<strong>and</strong>”<br />

• Canada: 0.6% past-year non-medical use—opioid use<br />

exceeds heroin<br />

• Australia: Past-year non-medical opioid use by 2.5% <strong>of</strong> adult<br />

population—exceeds heroin & cocaine<br />

• South America: “Non-medical use <strong>of</strong> <strong>Rx</strong> opioids accounts <strong>for</strong><br />

most <strong>of</strong> the use <strong>of</strong> opioids”—Costa Rica annual prevalence =<br />

2.8% <strong>of</strong> population<br />

• Europe, Northern Irel<strong>and</strong>: “Highest annual prevalence <strong>of</strong><br />

<strong>Rx</strong> opioids anywhere in world” at 8.9% 17


A Global Phenomenon<br />

• Europe, France: “Buprenorphine diverted to illicit market <strong>and</strong><br />

<strong>of</strong>ten winds up in Finl<strong>and</strong>”<br />

• Europe, UK: 2011 GP survey indicates nearly 80% “routinely<br />

prescribe drugs to which they believe the patient may be<br />

addicted” (BBC)<br />

• Asia: Benzodiazepines predominate<br />

• India, Bangladesh, Nepal: “Illicit use <strong>of</strong> injected<br />

buprenorphine is common”<br />

• Gulf States, Dubai: 2010 overdose deaths spark new<br />

government warnings/en<strong>for</strong>cement initiatives<br />

• Singapore: Subutex/buprenorphine re-classified as illegal<br />

drug following surges in abuse<br />

18


http://www.guardian.co.uk/news/datablog/interactive/2012/jul/02/drug-use-map-world<br />

19


US: Not A New Phenomenon . . .<br />

• First observed in Civil War re: Morphine theft<br />

• 1987: Establishment <strong>of</strong> National Association <strong>of</strong> Drug Diversion<br />

Investigators (NADDI)<br />

• 1990: Cincinnati, Ohio Police Department establishes Drug Diversion<br />

Squad—500 Cases/Yr by 1993<br />

• 1992: GAO study cites diversion as “prevalent type <strong>of</strong> Medicaid<br />

fraud”<br />

• 1992: FBI “Operation Goldpill”—3 years, 50 cities, 200 pharmacists &<br />

other perpetrators<br />

20


US: However. . . A New Drug-Funding Equation<br />

• <strong>Rx</strong> Costs, 1990: " "$40.3 Billion!<br />

– Government: " "18%"<br />

– Private <strong>Insurance</strong>:" "26%"<br />

– Consumers: ! !56% !<br />

"<br />

• <strong>Rx</strong> Costs, 2005: " "$200.7 Billion!<br />

– Consumers: " "25%"<br />

– Government: " "28%"<br />

– Private <strong>Insurance</strong>: !47%!<br />

21


US Controlled-Substance Consumption<br />

1992 - 2002<br />

• U.S. Population: " " "+ 13%"<br />

" " ""<br />

• Non-Controlled Drugs:" " "+ 57%"<br />

"<br />

• Controlled Drugs: " " "+ 154%"<br />

"<br />

– Opioids: " " "+ 222%"<br />

"<br />

• Hydrocodone: " "+ 376%"<br />

• Oxycodone: " "+ 380%"<br />

– Benzodiazepines: " "+ 49%"<br />

– Stimulants: " " "+ 369% ""<br />

22


Drugs in Dem<strong>and</strong>. . .<br />

• Schedule II ! ! !Retail $! !Street $!<br />

!<br />

– Opana ER 40mg " "$7.75/tablet "$90/tablet"<br />

– Oxycontin 40mg " "$5.66/tablet "$20–$40/tablet"<br />

– oxycodone 40mg " "$4.54/tablet "$6–$8/tablet"<br />

– morphine 100mg " "$4.16/tablet "$60/tablet"<br />

– Actiq 400mg " "$26/lozenge "$30–$40/lozenge"<br />

– fentanyl 50mcg " $24/patch "$25–$40/patch"<br />

– methadone " " "$0.21/tablet "$10–$20/tablet"<br />

– Ritalin " " "$1.11/tablet $8–$15/tablet"<br />

– Adderal " " "$4.23/tablet "$5-$7/tablet"<br />

"<br />

• Schedule III!<br />

!<br />

– Vicodin* " " "$1.47/tablet "$6–$10/tablet"<br />

– hydrocodone/APAP " " $0.43/tablet " $6–$10/tablet"<br />

* Could become Schedule II following October, 2012 review"<br />

23


Drugs in Dem<strong>and</strong>. . .<br />

• Schedule IV ! ! !Retail $! !Street $!<br />

!<br />

– Valium " " "$3.30/tablet "$4/tablet"<br />

– diazepam " " "$0.39/tablet $4/tablet"<br />

– Adipex (phentermine) "$2.13/tablet $3–$6/tablet"<br />

– Xanax 2mg" " "$3.28/tablet "$4/tablet"<br />

– alprazolam " " "$0.42/tablet "$4/tablet"<br />

– carisoprodol/Soma* " "$0.20/tablet "$1 - $5/tablet*"<br />

• Schedule V!<br />

!<br />

– promethazine with codeine "$3.35/fl.oz. "$7.50–$10/fl.oz. <br />

* Became federal (DEA) controlled substance 1/12"<br />

24


Drugs to Watch. . .<br />

• Buprenorphine (Subutex/Suboxone)"<br />

"<br />

– May be prescribed by physicians <strong>for</strong> opioid dependency"<br />

– Enlarged patient base authorized 12/06"<br />

– DEA: Becoming a “primary drug <strong>of</strong> abuse”"<br />

"<br />

• Methadone (Dolophine/Methadose)"<br />

"<br />

– #1 fatal narcotic in 2004—<strong>and</strong> more so every year"<br />

– Bifurcated prescribing/dispensing scheme—heroin addiction/pain"<br />

– 2006 FDA Public <strong>Health</strong> Advisory: “Methadone Use <strong>for</strong> Pain Control"<br />

May Result in Death” (especially if combined with Xanax)"<br />

– Least expensive/most deadly"<br />

– Low cost appeals to public-assistance programs"<br />

• Newer narcotics"<br />

• Opana ER (“O-Bomb”)—abuse & overdose deaths surging in 2012"<br />

• Norco—”Vicodin on steroids”"<br />

25


Diversion’s Dire Consequences. . .<br />

• 2002: Fatal pain-med poisonings surpass cocaine & heroin deaths"<br />

"<br />

• 2009: At 37,485 fatalities, accidental drug overdose surpass traffic fatalities to"<br />

become #1 cause <strong>of</strong> unintentional-injury death in U.S."<br />

– Prescription-narcotic deaths exceed 15,500"<br />

– Up 78% between 1999 <strong>and</strong> 2004: Sedatives, Vicodin, Oxycontin cited as"<br />

principal factors"<br />

– Up more than 100% in 23 US states (e.g., 550% in West Virginia)"<br />

"<br />

2005: 43% <strong>of</strong> drug-abuse E.R. visits—600,000—involve pharmaceuticals"<br />

"<br />

• 2003: Acetaminophen poisoning becomes #1 cause <strong>of</strong> acute liver failure"<br />

in U.S."<br />

• 2005: Annual U.S. liver transplants up 20% since 2001. First-year costs:"<br />

$393,000"<br />

26


Key Observations. . .<br />

• Question not so much “What are payers finding when they"<br />

look” as it is “To what extent are payers looking”"<br />

• Most outsource <strong>Rx</strong> benefit/processing to pharmacy-benefit"<br />

management companies (PBMs)"<br />

• Widespread perception that few PBMs engage in true fraud-detection"<br />

<strong>and</strong> investigation activity (e.g., vs. routine pharmacy audits)"<br />

• Issue not addressed in many insurer - PBM relationships"<br />

"<br />

• Even some health insurers with captive PBMs don’t focus on <strong>Rx</strong> "<br />

27


Three-Dimensional Cost <strong>Impact</strong>. . .<br />

• Unnecessary, excessive or fraudulent prescriptions"<br />

• Related medical claims—legitimate or falsified"<br />

– Physician <strong>of</strong>fice visits & other treatments"<br />

– Diagnostic tests (imaging, nerve conduction)"<br />

– Emergency room/urgent care clinic exams/treatments"<br />

– Conditions caused by <strong>Rx</strong> abuse—e.g., liver damage/failure"<br />

– Treatment <strong>of</strong> affected family members"<br />

• Incalculable potential-liability cost"<br />

– Dangerous prescribers/prescription sellers"<br />

– Insured’s injury or death"<br />

– Insured’s injury <strong>of</strong> others"<br />

28


Key Observations. . .<br />

• Experts’ consensus: High-cost provider cases abound, but doctor"<br />

shopping is most common—<strong>and</strong> costly—<strong>for</strong>m <strong>of</strong> diversion "<br />

– Aetna: 48% <strong>of</strong> member-fraud investigations involve <strong>Rx</strong> "<br />

• Low-cost cases "<br />

– Natl. Assn. <strong>of</strong> Drug Diversion Investigators: Typical doctorshopper<br />

sees 5 - 10 prescribers, costs payer $10,000 -<br />

$15,000/yr <strong>Rx</strong> + medical"<br />

– MEDCO, 2005: “High-utilization” members’ <strong>Rx</strong> costs 7x norm"<br />

"<br />

• Sole focus on <strong>Rx</strong> costs overlooks the far-greater impact!<br />

29


WellPoint/Anthem BCBS <strong>of</strong> Virginia<br />

100 members with multiple narcotic <strong>Rx</strong> scripts from 5 or "more<br />

sources in 90-day period:"<br />

• Prescribers: " " "689"<br />

• Pharmacies: " " "608"<br />

• Narcotic Scripts:" " "1,217"<br />

• Paid Narcotic <strong>Rx</strong> claims: " "$20,233"<br />

• Medical claims <strong>for</strong> same 100 members, same 90-day"<br />

period:"<br />

• Office visits: " " "4,131"<br />

• Outpatient Facility Visits: " "958"<br />

• Total Medical Claim $: " "$832,172"<br />

• Average medical-to-<strong>Rx</strong> cost ratio: "$41 to $1"<br />

"<br />

• Full-year 100-member savings following intervention &"<br />

pharmacy restriction: $333,418 "<br />

30


<strong>The</strong> Analysis Group, Inc.<br />

“Direct Costs <strong>of</strong> Opioid Abuse In An Insured Population”"<br />

"—J Managed Care Pharmacy, July/August 2005"<br />

"—1998 - 2002 claim data from 2-million member database"<br />

—Aged 12 - 64, continuous enrollment 12 months <strong>of</strong> study"<br />

—”Abuser” = at least 1 non-heroin opioid abuse/dependence/poisoning ICD-9"<br />

code in claim history in or within 12 months pre- or post-study period "<br />

• Diagnosed opioid abusers’ “total health costs 8 times those <strong>of</strong> non-"<br />

abusers’”"<br />

" " "Non-Abusers " "Abusers"<br />

—Drug " "$386 " " "$2,034"<br />

—Inpatient " "$318 " " "$7,659"<br />

—Physician/OP "$928 " " "$5,398"<br />

—Other (E.R. +) "$198 " " "$793"<br />

"<br />

TOTAL " "$1,830 " " "$15,884"<br />

"<br />

Excess Annual Cost "(2003 $) " " " $14,054 " ""<br />

" " "(2012 $) " " " $17,499*"<br />

31


Sobering Scenarios: Insured Population. . .<br />

• “Fully Loaded”—1.9% insured opioid abusers @ avg. excess cost:"<br />

– 4.85 million x $16,485 = $79.9 billion/yr"<br />

• “More Conservative”—1.9% insured opioid abusers @ avg. excess cost,"<br />

less in-patient $:"<br />

– 4.85 million x $8,572 = $41.6 billion/yr"<br />

• Most Conservative—1% insured opioid abusers at reduced avg. excess"<br />

cost:"<br />

– 2.6 million x $8,572 = $22.3 billion/yr"<br />

32


Sobering Scenarios: Individual Plan-Level<br />

• “Most Conservative” excess-cost math applied to plan sizes:"<br />

– 10 million lives @ 1% abusers"<br />

• 100,000 members x $8,572 =<br />

"$857,000,000/yr"<br />

– 1 million lives @ 1% abusers:"<br />

• 10,000 members x $8,572 =<br />

"$85,700,000/yr"<br />

– 500,000 lives @ 1% abusers:"<br />

• 5,000 members x $8,572 =<br />

"$42,900,000/yr"<br />

– 250,000 lives @ 1% abusers:"<br />

• 2,500 members x $8,572 =<br />

"$21,400,000/yr!<br />

33


<strong>The</strong> Incalculable Payer Liability Risk. . .<br />

• Payers that fail to take an active approach to doctor-shopping <strong>and</strong> other"<br />

aspects <strong>of</strong> diversion face significant potential liability related to prescription-"<br />

drug addiction <strong>and</strong> overdose deaths: "<br />

!“<strong>The</strong> data was right under the prescription payer’s nose; had it only<br />

taken the trouble to look at what it was paying <strong>for</strong>, it could have prevented<br />

this addiction . . . liver failure . . . overdose death . . . fatal accident”!<br />

"<br />

• Precedent <strong>for</strong> “should have known” suit against pharmacy"<br />

– Florida court decision affirms pharmacy’s “duty to warn” <strong>and</strong> to be more than"<br />

“a passive dispenser”"<br />

"<br />

• Credentialing & network-admission/retention issues also come into play"<br />

• Awareness <strong>of</strong> risk is integral aspect <strong>of</strong> some companies’ active approaches"<br />

• “Passive-payer” approach is inadequate <strong>and</strong> very risky in face <strong>of</strong> “national"<br />

epidemic” & widespread mortality"<br />

34


Key Observations. . .<br />

• Matching <strong>Rx</strong> claim data to medical claim data is essential but is the"<br />

industry exception, not the rule"<br />

"<br />

– Many payers don’t do it at all"<br />

– Some do it only with difficulty—technical <strong>and</strong> procedural"<br />

– A few have exemplary capability"<br />

• Many payers face obstacles—real or perceived—to implementing"<br />

effective intervention/pharmacy restriction programs"<br />

• Insurers have opportunities to curtail payment <strong>for</strong> <strong>of</strong>f-label uses <strong>of</strong>"<br />

specific drugs—e.g., Actiq, Gabapentin/Neurontin"<br />

• Opportunities abound <strong>for</strong> stronger point-<strong>of</strong>-sale controls"<br />

35


Broad Best Practices <strong>for</strong> <strong>Rx</strong> Payers. . .<br />

• Pay more attention!!<br />

"<br />

– Increase awareness <strong>of</strong> true impact <strong>and</strong> potential exposure, including at<br />

senior management levels"<br />

– Avail selves <strong>of</strong> PBM tools/intervention programs (best case)"<br />

– Force the issue in PBM relationship (worst case)"<br />

– Educate <strong>and</strong> enlist support <strong>of</strong> self-insured group customers"<br />

!<br />

!<br />

– Enlist expert pain-management counsel to assist in striking <strong>and</strong>"<br />

maintaining appropriate balance"<br />

"<br />

–Establish <strong>and</strong> maintain relationships with law en<strong>for</strong>cement diversion"<br />

specialists—be equipped to address the hard-core criminal component"<br />

"<br />

– Better underst<strong>and</strong> options <strong>for</strong> appropriate action—addiction assistance vs."<br />

law en<strong>for</strong>cement referral"<br />

36


Broad Best Practices <strong>for</strong> <strong>Rx</strong> Payers. . .<br />

"<br />

• Support effective Prescription Drug Monitoring Programs (PDMPs)"<br />

"<br />

• Address obstacles—real or perceived—to implementing effective intervention"<br />

measures—e.g., pharmacy restriction"<br />

"<br />

– Policy/contract/program terms"<br />

– Communication with prescribers"<br />

• Review <strong>and</strong> consider narrowing coverage policies re: Prescriptions <strong>for</strong> <strong>of</strong>f-label"<br />

uses!<br />

!<br />

!<br />

37


Operational Best Practices <strong>for</strong> <strong>Rx</strong> Payers. . .<br />

• Address IT <strong>and</strong>/or other obstacles to matching medical <strong>and</strong> <strong>Rx</strong> claim data"<br />

• Review drug <strong>for</strong>mularies <strong>and</strong> improve up-front controls"<br />

– Prior Authorizations"<br />

– Quantity Limits"<br />

– Encourage—if not require—network prescribers to query PMP databases"<br />

• Review <strong>and</strong> improve point-<strong>of</strong>-sale controls"<br />

– Date <strong>of</strong> Birth queries"<br />

– Photo Identification"<br />

• Don’t overlook lower-pr<strong>of</strong>ile drugs"<br />

– Promethazine w/Codeine"<br />

– Methadone"<br />

– Buprenorphine (Subutex/Suboxone)"<br />

• Develop <strong>and</strong> implement patient-pharmacy restriction programs!<br />

38


www.insurancefraud.org<br />

–”Tools”<br />

–“Publications”<br />

39


https://www.unodc.org/<br />

documents/data-<strong>and</strong>analysis/WDR2012/<br />

WDR_2012_web_small<br />

.pdf<br />

40


UN ODC Discussion Paper, 2011:<br />

“<strong>The</strong> Non-Medical Use <strong>of</strong> Prescription Drugs—Policy<br />

Direction Issues”<br />

http://www.unodc.org/docs/youthnet/<br />

Final_Prescription_Drugs_Paper.pdf<br />

41

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