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A	
  Tale	
  of	
  2	
  States	
  
                 Amy	
  Lee	
  
Special	
  Deputy	
  Commissioner,	
  Policy	
  
 and	
  Research,	
  Texas	
  Department	
  of	
  
   Insurance,	
  Division	
  of	
  Workers’	
  
              Compensa@on	
  

           Dr.	
  Gary	
  Franklin	
  	
  
Medical	
  Director,	
  Washington	
  State	
  
Department	
  of	
  Labor	
  and	
  Industries	
  	
  	
  
Learning	
  Objec@ves	
  

1.  State	
  what	
  is	
  needed	
  to	
  pass	
  regula@ons	
  
    and	
  legisla@ons	
  to	
  control	
  opioid	
  use.	
  
2.  Analyze	
  different	
  approaches	
  to	
  determine	
  
    what	
  would	
  work	
  in	
  their	
  jurisdic@on.	
  
3.  Formulate	
  ideas	
  you	
  can	
  implement	
  in	
  your	
  
    home	
  states.	
  


                                                                  2	
  
Disclosure	
  Statement	
  

•  Amy	
  Lee	
  has	
  no	
  financial	
  rela@onships	
  with	
  
   proprietary	
  en@@es	
  that	
  produce	
  health	
  care	
  
   goods	
  and	
  services.	
  	
  
•  Gary	
  Franklin	
  has	
  no	
  financial	
  rela@onships	
  
   with	
  proprietary	
  en@@es	
  that	
  produce	
  health	
  
   care	
  goods	
  and	
  services.	
  	
  



                                                                     3	
  
Third-­‐Party	
  Payer	
  Track:	
  
  A	
  Tale	
  of	
  Two	
  States	
  

                   Amy	
  Lee	
  
 Texas	
  Department	
  of	
  Insurance,	
  
Division	
  of	
  Workers’	
  Compensa@on	
  
Presenta@on	
  Highlights	
  
•  Overview	
  of	
  Texas	
  WC	
  system	
  

•  Pharmacy	
  Closed	
  Formulary	
  –	
  how	
  it	
  works	
  

•  Preliminary	
  impact	
  	
  

•  Transi@on	
  of	
  legacy	
  claims,	
  next	
  steps	
  

                                                                    5	
  
Overview	
  of	
  Texas	
  WC	
  System	
  
•  More	
  than	
  270	
  insurance	
  companies	
  ac@vely	
  wri@ng	
  WC	
  

•  $2	
  billion	
  in	
  direct	
  wriXen	
  premium	
  

•  Including	
  self-­‐insured	
  employers	
  and	
  governmental	
  en@@es,	
  more	
  
   than	
  800	
  insurance	
  carriers	
  with	
  WC	
  claims	
  

•  67%	
  of	
  private	
  year-­‐round	
  employers	
  have	
  WC	
  and	
  all	
  governmental	
  
   en@@es	
  have	
  WC	
  

•  About	
  225,000	
  new	
  claims	
  filed	
  each	
  year	
  (including	
  medical	
  only	
  
   claims)	
  and	
  about	
  340,000	
  claims	
  receiving	
  medical	
  and/or	
  indemnity	
  
   benefits	
  each	
  year	
  

•  Pharmacy	
  accounts	
  for	
  14%	
  of	
  medical	
  payments	
  
      –  Opioids	
  account	
  for	
  4.6%	
  of	
  medical	
  payments	
  
                                                                                                       6	
  
Overview	
  of	
  Texas	
  WC	
  System	
  
•  U@lizes	
  evidence-­‐based	
  medicine	
  treatment	
  guidelines,	
  Official	
  Disability	
  
   Guidelines	
  (ODG)	
  and	
  return-­‐to-­‐work	
  guidelines	
  (Medical	
  Disability	
  
   Advisor)	
  

•  Requires	
  certain	
  services	
  to	
  be	
  pre-­‐authorized	
  by	
  the	
  insurance	
  carrier/
   u@liza@on	
  review	
  agent	
  and	
  allows	
  retrospec@ve	
  u@liza@on	
  review	
  of	
  any	
  
   service	
  that	
  is	
  not	
  pre-­‐authorized	
  

•  Sets	
  fee	
  guidelines	
  for	
  professional,	
  inpa@ent/outpa@ent	
  hospital,	
  ASC	
  and	
  
   pharmacy	
  services	
  and	
  allows	
  pharmacy	
  contractual	
  discounts	
  

•  Has	
  administra@ve	
  dispute	
  resolu@on	
  process	
  for	
  medical	
  necessity	
  and	
  
   medical	
  fee	
  disputes	
  

•  Collects	
  medical	
  charges,	
  payments	
  and	
  u@liza@on	
  data	
  via	
  EDI	
  

•  Allows	
  cer@fied	
  networks,	
  which	
  require	
  employees	
  to	
  select	
  network	
  
   trea@ng	
  doctors,	
  but	
  allows	
  employees	
  choice	
  of	
  pharmacy	
  


                                                                                                           7	
  
Pharmacy	
  Formulary	
  Rules	
  


28	
  TAC	
  Chapter	
  134	
  	
  Benefits—Guidelines	
  for	
  Medical	
  
  Services,	
  Charges	
  and	
  Payments	
  

         Subchapter	
  F,	
  Pharmaceu=cal	
  Benefits	
  




                                     8	
  
Insert	
  open	
  formulary	
  
reference	
  here	
  




                                  9	
  
DefiniBons	
  
Exclusions	
  from	
  the	
  Closed	
  Formulary:	
  
    –  drugs	
  with	
  “N”	
  status	
  iden@fied	
  in	
  the	
  current	
  edi@on	
  
       of	
  the	
  Official	
  Disability	
  Guideline	
  (ODG)	
  Treatment	
  in	
  
       Workers’	
  Comp/	
  Appendix	
  A,	
  ODG	
  Workers’	
  
       Compensa=on	
  Drug	
  Formulary	
  and	
  any	
  updates	
  

    –  any	
  compounded	
  drugs	
  that	
  contains	
  a	
  drug	
  iden@fied	
  
       with	
  an	
  “N”	
  status	
  in	
  ODG;	
  and	
  

    –  inves@ga@onal	
  or	
  experimental	
  drugs	
  as	
  defined	
  in	
  
       Texas	
  Labor	
  Code	
  §413.014(a)	
  

                                          10	
  
“N”	
  Status	
  Drugs	
  
•  ODG’s	
  appendix	
  A	
  is	
  the	
  most	
  current	
  publica@on	
  
       for	
  “N”	
  status	
  drugs	
  
   	
  www.worklossdata.com	
  

•  TDI-­‐DWC	
  will	
  post	
  the	
  “N”	
  status	
  drugs	
  from	
  ODG’s	
  
   Appendix	
  A	
  on	
  its	
  website:	
  	
  hXp://
   www.tdi.state.tx.us/wc/dm/index.html	
  

•  “N”	
  status	
  drugs	
  is	
  updated	
  monthly	
  


                                        11	
  
Texas Department of Insurance
                       Division of Workers’ Compensation

  This table is provided as a convenience only and is not a substitute for the
   current edition of ODG Treatment in Workers' Comp / Appendix A: ODG
             Workers' Compensation Drug Formulary (see memo).
             ODG Texas Workers’ Compensation Status "N" Drugs
           (Excluded from the Closed Formulary as of May 31, 2012)
                                                             Generic
    Drug Class       Generic Name           Brand Name     Equivalency   Status
                                                                         N (for
Opioids           Buprenorphine          Suboxone®             No        pain)
                  Buprenorphine
Opioids           (transdermal)          Butrans™              No          N
                  Butalbital (a
Opioids           barbiturate)           Fioricet®            Yes          N
Opioids           Fentanyl buccal        Fentora®             No           N
Opioids           Fentanyl buccal film   Onsolis™             No           N
Opioids           Fentanyl lollipop      Actiq®               Yes          N
                  Fentanyl nasal
Opioids           spray                  Lazanda               No          N
                  Fentanyl sublingual
Opioids           spray                  Subsys®               No          N
                  Fentanyl
Opioids           transmucosal           Abstral               No          N
                  Hydrocodone/
Opioids           ibuprofen              Vicoprofen®          Yes          N
Opioids           Hydromorphone ER       Exalgo               No           N
                                                                                  12	
  
Preliminary	
  Impact	
  of	
  Closed	
  Pharmacy	
  
                  Formulary	
  




                                                    13	
  
Data	
  and	
  Methods	
  
•  Injury months: September – February
•  Injury years: 2009 – 2011
•  Injury year 2011 (Sept 2011 – Feb 2012): new injuries
   that occurred after the implementation of the pharmacy
   closed formulary
•  Nine months maturity per claim
•  N-drug list: approximately 150 drugs that require carrier
   preauthorization.



                                                           14	
  
Number	
  of	
  Claims	
  Receiving	
  an	
  N-­‐Drug,	
  
     by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
          10000	
  
                             8,957                       9,104
           9000	
  
           8000	
  
           7000	
  
           6000	
  
           5000	
  
           4000	
                                                                   3,616
           3000	
  
           2000	
  
                                                                                    -­‐60%	
  
           1000	
  
                0	
  
                             2009                       2010                        2011



Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                 15	
  
N-­‐drug	
  Claims,	
  as	
  a	
  Percentage	
  of	
  All	
  Pharmacy	
  
            Claims,	
  by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
              20.0%	
           18.9%                       18.2%
              18.0%	
  
              16.0%	
  
              14.0%	
  
              12.0%	
  
              10.0%	
  
               8.0%	
  
                                                                                        7.4%
               6.0%	
  
               4.0%	
  
                                                                                        -­‐59%	
  
               2.0%	
  
               0.0%	
  
                                 2009                       2010                        2011



    Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
    and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                     16	
  
Number	
  of	
  N-­‐drug	
  Prescrip@ons,	
  
          by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
          25000	
  

                            20,473                      20,895
          20000	
  


          15000	
  


          10000	
  
                                                                                    6,467
           5000	
  
                                                                                    -­‐69%	
  
                0	
  
                             2009                       2010                        2011



Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                 17	
  
N-­‐drugs	
  as	
  a	
  Percentage	
  of	
  All	
  Prescrip@ons	
  
              by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
             10.0%	
            9.5%
                                                            9.0%
              9.0%	
  
              8.0%	
  
              7.0%	
  
              6.0%	
  
              5.0%	
  
              4.0%	
  
                                                                                       3.0%
              3.0%	
  
              2.0%	
  
              1.0%	
                                                                   -­‐67%	
  
              0.0%	
  
                                2009                       2010                        2011



   Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
   and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                    18	
  
N-­‐drug	
  Costs,	
  
                      by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
        $3,000	
          $2,404
                           (000)                       $2,309
        $2,500	
                                        (000)

        $2,000	
  

        $1,500	
  

        $1,000	
                                                                     $470
                                                                                     (000)
          $500	
  
                                                                                    -­‐80%	
  
             $0	
  
                            2009                        2010                        2011



Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                 19	
  
N-­‐drug	
  Costs	
  as	
  a	
  Percentage	
  of	
  Total	
  Drug	
  Costs,	
  
                by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
                 25.0%	
  
                                  20.1%
                 20.0%	
                                       18.8%

                 15.0%	
  


                 10.0%	
  

                                                                                            4.6%
                  5.0%	
  


                  0.0%	
                                                                   -­‐76%	
  
                                    2009                       2010                        2011



       Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
       and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                        20	
  
N-­‐drug	
  Generic	
  Subs@tu@on	
  Rate,	
  
            by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  

                                  Brand                                  Generic


                                     5,150
                    4,821



                                                                                         2,595
                    48%	
             52%	
  
                                                                        1,214

                                                                         32%	
            68%	
  

                              2010                                               2011


Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                    21	
  
Other	
  Drugs	
  
•  Key measures:
       Claim counts
       Prescription utilization patterns
       Prescription costs
       Generic substitution rates
       Most prescribed drugs




                                            22	
  
Number	
  of	
  Claims	
  with	
  Prescrip@ons	
  for	
  
“Other”	
  Drugs,	
  by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
          60000	
  

                            46,265                      48,827                     48,406
          50000	
  


          40000	
  


          30000	
  


          20000	
  


          10000	
                                                                   -­‐1%	
  

                0	
  
                             2009                       2010                        2011



Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                23	
  
Claims	
  with	
  Prescrip@ons	
  for	
  “Other”	
  Drugs	
  as	
  
     a	
  Percentage	
  of	
  All	
  Pharmacy	
  Claims,	
  
              by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
              100.0%	
                                                                 93.6%
               90.0%	
           81.1%                       81.8%
               80.0%	
  
               70.0%	
  
               60.0%	
  
               50.0%	
  
               40.0%	
  
               30.0%	
  
               20.0%	
  
                                                                                        14%	
  
               10.0%	
  
                 0.0%	
  
                                  2009                       2010                       2011



    Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
    and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                    24	
  
Number	
  of	
  Prescrip@ons	
  for	
  “Other”	
  
    Drugs,	
  by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
          250000	
  
                                                        211,099                   210,593
                            195,111
          200000	
  


          150000	
  


          100000	
  


           50000	
  
                                                                                    -­‐<.1%	
  
                 0	
  
                              2009                       2010                       2011



Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                  25	
  
“Other”	
  Drugs,	
  as	
  a	
  Percentage	
  of	
  All	
  
Prescrip@ons,	
  by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
          120.0%	
  

                                                                                   97.0%
          100.0%	
           90.5%                       91.0%

           80.0%	
  


           60.0%	
  


           40.0%	
  


           20.0%	
  
                                                                                      7%	
  
             0.0%	
  
                              2009                       2010                       2011



Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                26	
  
“Other”	
  Drug	
  Costs,	
  
                          by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
          $12,000	
                                      $9,998	
                  $9,874	
  
                               $9,558	
  
                                                          (000)	
                   (000)	
  
          $10,000	
  
                                (000)	
  

           $8,000	
  

           $6,000	
  

           $4,000	
  

           $2,000	
  

                 $0	
                                                               -­‐	
  <1%	
  
                               2009                      2010                       2011



Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                     27	
  
“Other”	
  Drug	
  Costs	
  as	
  a	
  Percentage	
  of	
  Total	
  Drug	
  
           Costs,	
  by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
                 100.0%	
                                                                  95.4%
                  90.0%	
          79.9%                        81.2%
                  80.0%	
  
                  70.0%	
  
                  60.0%	
  
                  50.0%	
  
                  40.0%	
  
                  30.0%	
  
                  20.0%	
  
                  10.0%	
  
                    0.0%	
                                                                 17%	
  
                                     2009                       2010                       2011



       Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
       and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                       28	
  
“Other”	
  Drug	
  Generic	
  Subs@tu@on	
  Rate,	
  
       by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
                                   Brand                                 Generic
                                    85,360                                              82,231
                                    (91%)                                               (94%)




                    8,600                                               5,290
                    (9%)                                                (6%)


                             2010                                                2011


Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                 29	
  
Average	
  Number	
  of	
  Prescrip@ons	
  per	
  Claim,	
  
            by	
  Injury	
  Year	
  (Sept-­‐Feb)	
  
          N-drug prescriptions per claim                        Other-drug prescriptions per claim

      5                                                                                                 4.4
                                4.2                                 4.3
      4

      3
                     2.3                                 2.3
                                                                                             1.8
      2
                                                                                                        +2%	
  
      1
                                                                                           -­‐22%	
  
      0
                         2009                                2010                                 2011


  Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
  and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                                  30	
  
Transi@on	
  of	
  Legacy	
  Claims	
  to	
  Pharmacy	
  Closed	
  
                         Formulary	
  




                                                                 31	
  
Open	
  Formulary	
  for	
  Legacy	
  Claims	
  
•  Applies	
  to	
  both	
  network	
  and	
  non-­‐network	
  
   claims	
  with	
  dates	
  of	
  injury	
  prior	
  to	
  September	
  1,	
  
   2011	
  

•  A	
  legacy	
  claim	
  is	
  any	
  date	
  of	
  injury	
  prior	
  to	
  
   September	
  1,	
  2011	
  

•  Subject	
  to	
  the	
  open	
  formulary	
  un@l	
  September	
  
   1,	
  2013	
  

                                        32	
  
Open	
  Formulary	
  for	
  Legacy	
  Claims	
  

How	
  are	
  drugs	
  prescribed	
  in	
  an	
  open	
  formulary?	
  
  Non-­‐Network	
  
        •  According	
  to	
  the	
  ODG	
  treatment	
  guidelines	
  

    Network	
  
       •  According	
  to	
  the	
  cer@fied	
  network’s	
  
          treatment	
  guidelines	
  


                                   33	
  
Open	
  Formulary	
  

•  Drugs	
  included	
  in	
  an	
  open	
  formulary	
  do	
  not	
  
   require	
  preauthoriza@on,	
  but	
  are	
  subject	
  to	
  
   retrospec@ve	
  review	
  

•  However,	
  inves@ga@onal	
  or	
  experimental	
  drugs	
  
   require	
  preauthoriza@on	
  




                                  34	
  
TransiBon	
  of	
  Legacy	
  Claims	
  
	
  To	
  facilitate	
  the	
  transi@on,	
  the	
  prescribing	
  doctor	
  
    or	
  the	
  insurance	
  carrier	
  may:	
  
  •  Contact	
  each	
  other	
  to	
  discuss	
  ongoing	
  pharmacological	
  
     management	
  of	
  the	
  injured	
  employee’s	
  claim	
  

  •  When	
  the	
  par@es	
  contact	
  each	
  other,	
  they	
  must	
  provide	
  
     a	
  name,	
  phone	
  number,	
  date	
  and	
  @me	
  to	
  discuss	
  
     ongoing	
  pharmacological	
  management	
  of	
  the	
  injured	
  
     employee’s	
  claim	
  


                                        35	
  
TransiBon	
  of	
  Legacy	
  Claims	
  

	
  Beginning	
  no	
  later	
  than	
  March	
  1,	
  2013,	
  the	
  
    insurance	
  carrier	
  shall:	
  

      •  Iden@fy	
  legacy	
  claims	
  where	
  an	
  excluded	
  
         drug	
  has	
  been	
  prescribed	
  aqer	
  September	
  
         1,	
  2012	
  
      •  Provide	
  wriXen	
  no@fica@on	
  to	
  the	
  injured	
  
         employee,	
  prescribing	
  doctor	
  and	
  
         pharmacy,	
  if	
  known	
  
                                       36	
  
TransiBon	
  of	
  Legacy	
  Claims	
  

The	
  wriXen	
  no@fica@on	
  will	
  contain:	
  

   •  Date	
  the	
  closed	
  formulary	
  will	
  apply	
  
   •  Name,	
  telephone	
  number,	
  and	
  date	
  and	
  @me	
  
      to	
  discuss	
  ongoing	
  pharmacological	
  
      management	
  of	
  the	
  injured	
  employee’s	
  claim	
  




                                    37	
  
TransiBon	
  of	
  Legacy	
  Claims	
  

Agreement:	
  	
  	
  

     	
  	
  	
  During	
  the	
  discussion	
  the	
  insurance	
  carrier	
  and	
  
                 a	
  prescribing	
  doctor	
  may	
  enter	
  into	
  an	
  
                 agreement	
  on	
  the	
  applica@on	
  of	
  the	
  closed	
  
                 formulary	
  on	
  an	
  individual	
  claim-­‐by-­‐claim	
  basis	
  




                                           38	
  
TransiBon	
  of	
  Legacy	
  Claims	
  
Agreement	
  requirements:	
  
•  Must	
  be	
  documented	
  by	
  the	
  carrier	
  and	
  shared	
  
   with	
  the	
  prescribing	
  doctor	
  and	
  injured	
  employee	
  
•  Health	
  care	
  provided	
  as	
  a	
  result	
  of	
  the	
  agreement	
  
   is	
  not	
  subject	
  to	
  retrospec@ve	
  review	
  

If	
  an	
  agreement	
  is	
  not	
  reached:	
  
•  A	
  denial	
  of	
  a	
  request	
  for	
  an	
  agreement	
  is	
  not	
  
      subject	
  to	
  dispute	
  resolu@on	
  
•  Closed	
  formulary	
  applies	
  as	
  of	
  9/1/2013	
  
                                          39	
  
Medical	
  Interlocutory	
  Order	
  	
  
                             “MIO”	
  

•  When	
  the	
  preauthoriza@on	
  denial	
  of	
  a	
  drug	
  
   excluded	
  from	
  the	
  closed	
  formulary;	
  
•  Poses	
  an	
  unreasonable	
  risk	
  of	
  medical	
  
   emergency	
  to	
  the	
  injured	
  employee;	
  	
  
•  Provides	
  a	
  means	
  for	
  an	
  injured	
  employee	
  to	
  
   con@nue	
  use	
  of	
  the	
  previously	
  prescribed	
  and	
  
   dispensed	
  drug(s)	
  throughout	
  the	
  dura@on	
  of	
  
   the	
  appeals/dispute	
  process.	
  
                                                                     40	
  
Number	
  of	
  Legacy	
  Claims	
  Receiving	
  N-­‐
 Drugs,	
  by	
  Prescrip@on	
  Year	
  (Sept-­‐Nov)	
  
          18000	
  
                                  15,682	
  
          16000	
  

          14000	
  

          12000	
  

          10000	
  
                                                                            8,032	
  
           8000	
  

           6000	
  

           4000	
  
                                                                              -­‐49%	
  
           2000	
  

                0	
  
                                    2011                                     2012



Source:	
  Texas	
  Department	
  of	
  Insurance,	
  Workers’	
  Compensa@on	
  Research	
  
and	
  Evalua@on	
  Group,	
  2013.	
  
                                                                                                41	
  
Contact	
  Us	
  
•  www.tdi.texas.gov/wc/indexwc.html	
  

•  Medicalbenefits@tdi.texas.gov	
  

•  512-­‐804-­‐4000	
  or	
  800-­‐372-­‐7713	
  




                                                    42	
  
Guidelines	
  for	
  Prescribing	
  opioids	
  to	
  Treat	
  
           Pain	
  in	
  Injured	
  workers	
  	
  
        -­‐NaBonal	
  Rx	
  Drug	
  Abuse	
  Summit-­‐	
  
                         Orlando,	
  FL	
  
                    Wed	
  April	
  3,	
  2013	
  

                Gary	
  M.	
  Franklin,	
  MD,	
  MPH	
  
                        Medical	
  Director	
  
               WA	
  Dept	
  of	
  Labor	
  and	
  Industries	
  

                      Research	
  Professor	
  
                    University	
  of	
  washington	
  
"To	
  write	
  prescrip@ons	
  is	
  easy,	
  
but	
  to	
  come	
  to	
  an	
  understanding	
  with	
  	
  
people	
  is	
  hard."	
  
-­‐-­‐	
  Franz	
  Kaua,	
   A	
  Country	
  Doctor 	
  
“We can’t solve problems by
using the same kind of
thinking we used when we
created them”




                              !
Change in National Norms for Use of Opioids
           for Chronic, Non-cancer Pain

  By the late 1990s, at least 20 states
   passed new laws, regulations, or
   policies moving from near prohibition
   of opioids to use without dosing
   guidance
         WA law: No disciplinary action will be taken
          against a practitioner based solely on the
          quantity and/or frequency of opioids
          prescribed. (WAC 246-919-830, 12/1999)
  Laws were based on weak science and
   good experience with cancer pain


     WAC-Washington Administrative Code
46
Similarities Between Illicit & Prescription Drugs
  	
  Portenoy	
  and	
  Foley	
  
             	
  	
  	
  	
  	
  Pain	
  1986;	
  25:	
  171-­‐186	
  
  Retrospective case series chronic, non-cancer
   pain
  N=38; 19 Rx for at least 4 years
  2/3 < 20 mg MED/day; 4> 40 mg MED/day
  24/38 acceptable pain relief
  No gain in social function or employment could
   be documented
  Concluded: Opioid maintenance therapy can
   be a safe, salutary and more humane
   alternative…
Limitations of Long-term (>3 Months)
                       Opioid Therapy

  Overall,	
  the	
  evidence	
  for	
  long-­‐term	
  analgesic	
  efficacy	
  is	
  weak	
  
  PutaBve	
  mechanisms	
  for	
  failed	
  opioid	
  analgesia	
  may	
  be	
  
   related	
  to	
  rampant	
  tolerance	
  
  The	
  premise	
  that	
  tolerance	
  can	
  always	
  be	
  overcome	
  by	
  dose	
  
   escalaBon	
  is	
  now	
  quesBoned	
  
  100%	
  of	
  paBents	
  on	
  opioids	
  chronically	
  develop	
  dependence	
  
      More	
  than	
  50%	
  of	
  paBents	
  on	
  opioids	
  for	
  3	
  months	
  will	
  
       sBll	
  be	
  on	
  opioids	
  5	
  years	
  later	
  




     Ballantyne J. Pain Physician 2007;10:479-91; Martin BC et al. J Gen Intern Med 2011; 26:
     1450-57
49
Risk/Benefit	
  of	
  Opioids	
  for	
  Chronic	
  Non-­‐Cancer	
  Pain	
  
Dentists and Emergency Medicine Physicians were the main
          prescribers for patients 5-29 years of age
           5.5	
  million	
  prescripBons	
  were	
  prescribed	
  to	
  children	
  and	
  teens	
  (19	
  years	
  and	
  under)	
  in	
  2009	
  


                                                   900	
  

                                                   800	
  

                                                   700	
  

                                                   600	
  
            Rate	
  per	
  10,000	
  persons	
  




                                                                                                                                                                                                                                                                                                GP/FM/DO	
  
                                                   500	
                                                                                                                                                                                                                                        IM	
  
                                                   400	
                                                                                                                                                                                                                                        DENT	
  

                                                   300	
                                                                                                                                                                                                                                        ORTH	
  SURG	
  
                                                                                                                                                                                                                                                                                                EM	
  
                                                   200	
  

                                                   100	
  

                                                       0	
  
                                                               0-­‐4	
  	
  	
  	
  	
  	
  	
  	
   5-­‐9	
  	
  	
  	
  	
  	
  	
  	
   10-­‐14	
  	
  	
  	
  	
  	
  
                                                                                                                                                                      15-­‐19	
  	
  	
  	
  	
  	
  
                                                                                                                                                                                                 20-­‐24	
  	
  	
  	
  	
  	
  
                                                                                                                                                                                                                            25-­‐29	
  	
  	
  	
  	
  	
   30-­‐39	
   40-­‐59	
     60+	
  
                                                                                                                                                                                                 Age	
  Group	
  

Source:	
  IMS	
  Vector	
  ®One	
  Na@onal,	
  TPT	
  06-­‐30-­‐10	
  Opioids	
  Rate	
  2009	
  
Opioid-Related Deaths,
Washington State Workers Compensation, 1992–2005

       14
                                   Definite              Probable
       12
       10
        8
   Deaths




        6
        4
        2
        0
                       95            96            97    98    99   00   01   02

                                                        Year

       Franklin GM, et al, Am J Ind Med 2005;48:91-9

  52
UnintenBonal	
  and	
  Undetermined	
  Intent	
  Drug	
  Overdose	
  
               Death	
  Rates	
  by	
  State,	
  2007	
  

                                                                             MD	
      12.5	
  
                                                                             MA	
      12.5	
  
                                                                             NH	
      11.7	
  
                                                                             RI	
      11.1	
  
                                                                             CT	
      11.1	
  
                                                                             DE	
       9.8	
  
                                                                             DC	
       8.8	
  	
  
                                                                             VT	
       7.9	
  
                                                                             NJ	
       7.5	
  


                                                               Age-­‐adjusted	
  rate	
  per	
  	
  
                                                                100,000	
  populaBon	
  




     National Vital Statistics System, http://wonder.cdc.gov

53
UnintenBonal	
  Poisoning	
  Fatality	
  Rate,	
  1999-­‐2010,	
  
                                     WISQARS	
  NCHS	
  data	
  
                     16	
  
                     14	
  
Deaths/100,000	
  



                     12	
  
                     10	
  
                      8	
                                           California	
  n=3580	
  
                      6	
                                           Ohio	
  n=1678	
  
                      4	
  
                      2	
                                           Utah	
  n=273	
  
                      0	
                                           Washington	
  n=754	
  



                                          Year	
  
Evidence	
  linking	
  specific	
  doses	
  to	
  morbidity	
  
                        and	
  mortality	
  

Dunn et al, Ann Int Med 2010; 152: 85-92
 Risk of morbidity and mortality increased 8.9 fold at
  100 mg MED
 Editorial-McLellan-White House Office of National
  Drug Control Policy
     Smarter, more responsible (prescribing)
     practices are the only hope to avoid tragic,
     avoidable deaths
Braden et al, Arch Int Med 2010; 170: 1425-32
  Opioid doses >120 mg/day MED and use of long
  acting Schedule II opioids associated with
  incresed risk of alcohol- or drug- related ER visit

*
Evidence linking specific doses to morbidity
                    and mortality



Bohnert	
  et	
  al,	
  JAMA	
  2011;	
  305:	
  1315-­‐21	
  
•  Risk	
  of	
  mortality	
  7.18	
  (chronic	
  pain),	
  6.64	
  (acute	
  pain)	
  

Gomes	
  et	
  al,	
  Arch	
  Int	
  Med	
  2011;	
  171:	
  686-­‐91	
  
•  Risk	
  of	
  mortality	
  2.04	
  at	
  100	
  mg	
  and	
  2.88	
  at	
  200	
  mg	
  
Unintentional Overdose Deaths Involving
       Opioid Analgesics Parallel Opioid Sales
               United States, 1997–2007
  Distribution by drug
                                                                      Opioid sales * (mg/
   companies                                                               person)
        96	
  mg/person	
  in	
  1997	
                                                             627%	
  
        698	
  mg/person	
  in	
  2007	
                                                          increase	
  	
  
                Enough	
  for	
  every	
  American
                 to take 5 mg Vicodin
                 every 4 hrs for 3 weeks	
                                        Year



  Overdose deaths                                                      Opioid deaths

        2,901	
  in	
  1999	
                                                              296%	
  increase	
  	
  
        11,499	
  in	
  2007	
  


                                                                                  Year


     National Vital Statistics System, multiple cause of death data
     set and Drug Enforcement Administration ARCOS system;
57   2007 opioid sales figure is preliminary
Washington Agency Medical Directors
                    Opioid Dosing Guidelines

•     Developed with clinical pain experts in 2006
•     Implemented April 1, 2007
•     First guideline to emphasize dosing guidance
•     Educational pilot, not new standard or rule
•     National Guideline Clearinghouse
          –  http://www.guideline.gov/content.aspx?id=23792&search=wa+opioids




     58
                            www.agencymeddirectors.wa.gov	
  
Washington Agency Medical Directors
              Opioid Dosing Guidelines

•  Part I – If patient has not had clear improvement
   in pain AND function at 120 mg MED (morphine
   equivalent dose) , take a deep breath
   –  If needed, get one-time pain management
      consultation (certified in pain, neurology, or
      psychiatry)
•  Part II – Guidance for patients already on very
   high doses >120 mg MED




   59
                   www.agencymeddirectors.wa.gov	
  
Guidance for Primary Care Providers on Safe and
Effective Use of Opioids for Chronic Non-cancer Pain

  Establish	
  an	
  opioid	
  treatment	
  agreement	
  
  Screen	
  for	
  
       Prior	
  or	
  current	
  substance	
  abuse	
  	
  
       Depression	
  
  Use	
  random	
  urine	
  drug	
  screening	
  judiciously	
  
       Shows	
  pa@ent	
  is	
  taking	
  prescribed	
  drugs	
  
       Iden@fies	
  non-­‐prescribed	
  drugs	
  
  Do	
  not	
  use	
  concomitant	
  sedaBve-­‐hypnoBcs	
  
  Track	
  pain	
  and	
  funcBon	
  to	
  recognize	
  tolerance	
  
  Seek	
  help	
  if	
  dose	
  reaches	
  120	
  mg	
  MED,	
  and	
  pain	
  and	
  funcBon	
  have	
  
   not	
  substanBally	
  improved	
  	
  

     http://www.agencymeddirectors.wa.gov/opioiddosing.asp
     MED, Morphine equivalent dose
60
Open-source Tools Added to June 2010
   Update of Opioid Dosing Guidelines
  Opioid	
  Risk	
  Tool:	
  Screen	
  for	
  past	
  and	
  current	
  	
  	
  	
  	
  	
  	
  substance	
  abuse	
  
  CAGE-­‐AID	
  screen	
  for	
  alcohol	
  or	
  drug	
  abuse	
  
  PaBent	
  Health	
  QuesBonnaire-­‐9	
  screen	
  for	
  depression	
  
  2-question tool for tracking pain and function
  Advice on urine drug testing


                                                                         Available	
  as	
  mobile	
  app:	
  hXp://
                                                                         www.agencymeddirectors.wa.go
                                                                         v/opioiddosing.asp	
  




61   hXp://www.agencymeddirectors.wa.gov/opioiddosing.asp#DC	
  
Washington	
  State	
  Primary	
  Care	
  Survey	
  2009:
                                                                             	
  
                                   Physician	
  Concerns    	
  

             Please	
  check	
  the	
  statement	
  that	
  most	
  accurately	
  reflects	
  	
  
                       your	
  experience	
  when	
  prescribing	
  opioids	
  	
  
                                 for	
  chronic,	
  non-­‐cancer	
  pain
NO	
  concerns	
  about	
  development	
  of	
  psychological	
  dependence,	
  
                                                                                                                             2%
addicBon,	
  or	
  diversion	
  

OCCASIONAL	
  concerns	
  about	
  development	
  of	
  psychological	
  
                                                                                                                             45%
dependence,	
  addicBon,	
  or	
  diversion	
  

FREQUENT	
  concerns	
  about	
  development	
  of	
  psychological	
  
                                                                                                                             54%
dependence,	
  addicBon,	
  or	
  diversion	
  


           Interim	
  Evalua@on	
  of	
  the	
  Opioid	
  Dosing	
  Guidelines.	
  hXp://www.agencymeddirectors.wa.gov	
  

  62	
  
Washington	
  State	
  Primary	
  Care	
  Survey	
  2009:	
  
                 Adherence	
  to	
  State	
  Guidelines	
  
                                                                                                                                          Always	
  or	
  
                                                                                   Never	
  or	
  
                           Guidance	
                                                                                 SomeBmes     Olen    almost	
  
                                                                                 almost	
  never
                                                                                                                                           always

Use	
  treatment	
  agreement                                                              10%                               22%   20%        49%

Screen	
  for	
  substance	
  abuse                                                        <1%                               3%    15%        81%

Screen	
  for	
  mental	
  illness                                                         <1%                               12%   30%        58%

Use	
  random	
  urine	
  screen                                                           30%                               32%   18%        20%

Use	
  paBent	
  educaBon                                                                  34%                               38%   19%         9%

Track	
  pain	
                                                                            40%                               31%   15%        15%

Track	
  physical	
  funcBon                                                               69%                               20%   7%          5%

           Interim	
  Evalua@on	
  of	
  the	
  Opioid	
  Dosing	
  Guidelines.	
  hXp://www.agencymeddirectors.wa.gov	
  

  63	
  
2009 CDC recommendations

 For practitioners, public payers, and
  insurers
 Seek help at 120 mg/day MED if pain
  and function not improving
 http://www.cdc.gov/
  HomeandRecreationalSafety/pdf/poision-
  issue-brief.pdf
Franklin et al, Natural History of Chronic Opioid Use
Among Injured Workers with Low Back Pain-Clin J Pain,
•  694/1843	
  (37.6%)	
  received	
  opioid	
  early	
  
                             Dec, 2009
•  111/1843	
  (6%)	
  received	
  opioids	
  for	
  1	
  yr	
  
•  MED	
  increased	
  sign	
  from	
  1st	
  to	
  4th	
  qtr	
  
•  Only	
  minority	
  improved	
  by	
  at	
  least	
  30%	
  in	
  pain	
  (26%)	
  
   and	
  funcBon	
  (16%)	
  
•  Strongest	
  predictor	
  of	
  long	
  term	
  opioid	
  use	
  was	
  MED	
  
   in	
  1st	
  qtr	
  (40	
  mg	
  MED	
  had	
  OR	
  6)	
  
•  Avg	
  MED	
  42.5	
  mg	
  at	
  1	
  yr;	
  Von	
  Korff	
  55	
  mg	
  at	
  2.7	
  yrs	
  
Randomized	
  trial	
  Re	
  effec@veness	
  of	
  escala@ng	
  dose	
  
•  RCT	
  of	
  “hold	
  the	
  line”	
  vs	
  escala@ng	
  dose	
  strategies	
  
•  N=135,	
  parallel	
  group	
  pragma@c	
  study	
  




•  No	
  change	
  in	
  any	
  primary	
  pain	
  or	
  func@on	
  outcome	
  
•  27%	
  discharged	
  due	
  to	
  misuse/non-­‐compliance	
  

*Naliboff	
  et	
  al,	
  2011	
  (FEB);	
  12:	
  288-­‐96	
  
New	
  state	
  policies	
  

ConnecBcut	
  WC	
  policy-­‐7/1/2012	
  
   The	
  total	
  daily	
  dose	
  of	
  opioids	
  should	
  not	
  be	
  increased	
  above	
  90mg	
  oral	
  MED/day	
  
   (Morphine	
  Equivalent	
  Dose)	
  unless	
  the	
  pa@ent	
  demonstrates	
  measured	
  
   improvement	
  in	
  func@on,	
  pain	
  or	
  work	
  capacity.	
  Second	
  opinion	
  is	
  recommended	
  if	
  
   contempla@ng	
  raising	
  the	
  dose	
  above	
  90	
  MED/day.	
  

MaineCare	
  (Medicaid)-­‐4/1/2012	
  
   Total	
  45	
  day	
  maximum	
  for	
  non-­‐cancer	
  pain	
  

New	
  Mexico-­‐Rule	
  16.10.14-­‐Proposed	
  rules	
  Aug,	
  2012	
  
   	
  A	
  health	
  care	
  prac@@oner	
  shall,	
  before	
  prescribing,	
  ordering,	
  
   administering	
  or	
  dispensing	
  a	
  controlled	
  substance	
  listed	
  in	
  schedule	
  II,	
  III	
  
   or	
  IV,	
  obtain	
  a	
  pa@ent	
  PMP	
  report	
  for	
  the	
  preceding	
  twelve	
  (12)	
  months	
  
Yearly Trend of Scheduled Opioids
                                           (Franklin et al, Am J Ind Med 2012; 55: 325-31 )

                                 100,000
Number of Opioid Prescriptions




                                  90,000

                                  80,000

                                  70,000

                                  60,000

                                  50,000

                                  40,000

                                  30,000

                                  20,000

                                  10,000

                                      0




                                                  Schedule II   Schedule III   Schedule IV
Percent of Timeloss Claimants on Opioids
                       2000 - 2010
40.0%


35.0%


30.0%


25.0%


20.0%


15.0%


10.0%


 5.0%


 0.0%




                    Opioids   Highdose Opioids
Q1
                                                                                                                     10-
                                                                                                                     Q3
                                                                                                                     09-
                                                                                                                     Q1
                                                                                                                     09-
                                                                                                                     Q3
                                                                                                                     08-
                                                                                                                     Q1
                                                                                                                     08-
                                                                                                                     2010 Q1
                                                                                                                     Q3
                                                                                                                     2009 Q3
Washington Workers Compensation, 1996–2010




                                                                                                                     07-
                                                                                                                     2009 Q1
                                                                                                                     Q1
                                                                                                                     07-
                                                                                                                     2008 Q3
                                                                                                                     Q3
                                                                                                                     2008 Q1
                                                                                                                     06-
                                                                                                                     2007 Q3
     Average Daily Dosage for Opioids,




                                                                                                                     Q1
                                                                                                                     06-
                                                                                                                     2007 Q1
                                                                                                                     Q3
                                                                                                                     2006 Q3
                                                                                                                     05-
                                                                                                                     2006 Q1
                                                                                                                     Q1
                                                         Long-acting opioids




                                                                                                                     05-
                                                                                                                     2005 Q3
                                                                                          Short-acting opioids




                                                                                                                     2005 Q1
                                                                                                                     Q3
                                                                                                                     04-
                                                                                                                     2004 Q3
                                                                                                                     Q1
                                                                                                                     2004 Q1
                                                                                                                     04-
                                                                                                                     2003 Q3
                                                                                                                     Q3
                                                                                                                     03-
                                                                                                                     2003 Q1


                                                                                                                           Year/Quarter
                                                                                                                     Q1
                                                                                                                     2002 Q3
                                                                                                                     03-
                                                                                                                     2002 Q1
                                                                                                                     Q3
                                                                                                                     02-
                                                                                                                     2001 Q3
                                                                                                                     Q1
                                                                                                                     2001 Q1
                                                                                                                     02-
                                                                                                                     2000 Q3
                                                                                                                     Q3
                                                                                                                     01-
                                                                                                                     2000 Q1
                                                                                                                     Q1
                                                                                                                     1999 Q3
                                                                                                                     01-
                                                                                                                     1999 Q1
                                                                                                                     Q3
                                                                                                                     00-
                                                                                                                     1998 Q3
                                                                                                                     Q1
                                                                                                                     1998 Q1
                                                                                                                     00-
                                                                                                                     1997 Q3
                                                                                                                     Q3
                                                                                                                     1997 Q1
                                                                                                                     99-
                                                                                                                     1996 Q3
                                                                                                                     Q1
                                                                                                                     99-
                                                                                                                     1996 Q1
                                                                                                                     Q3
                                                                                                                     98-




                                             140
                                                   120
                                                           100
                                                                               80
                                                                                    60
                                                                                         40
                                                                                                      20
                                                                                                                 0




                                                                                                                                          70
                                                                                                                     Q1
                                                                                                                     98-
                                                     MED (mg/day)
                                                                                                                     Q3
                                                                                                                     97-
                                                                                                                     Q1
                                                                                                                     97-
                                                                                                                     Q3
                                                                                                                     96-
                                                                                                                     Q1
                                                                                                                     96-
WA Workers' Compensation Opioid-related
                                   Deaths 1995-2010
                       35

                       30
Opioid-related Death




                       25

                       20

                       15

                       10

                        5

                        0




                                      Possible   Probable   Definite
Unintentional Prescription Opioid Overdose Deaths
                                             Washington 1995-2010

                             600

                             500
                                                                                                              420
          Number of deaths


                             400

                             300

                             200

                             100   24

                               0
                                   95
                                        96
                                             97
                                                  98
                                                       99
                                                            00
                                                                 01
                                                                      02
                                                                           03
                                                                                04
                                                                                     05
                                                                                          06
                                                                                               07
                                                                                                    08
                                                                                                         09
                                                                                                              10
                                                   Prescription Opioid + alcohol or illicit drug

                                                   Prescription Opioid +/- Other Prescriptions



* Tramadol only deaths included in 2009, but not in prior years.
Source: Washington State Department of Health, Death Certificates
There	
  is	
  substanBal	
  clustering	
  among	
  providers	
  on	
  
                            dosing	
  and	
  mortality	
  	
  

CA	
  CWCI	
  study-­‐Swedlow	
  et	
  al,	
  March,	
  2011:	
  3%	
  of	
  prescribers	
  
        account	
  for	
  55%	
  of	
  Schedule	
  II	
  opioid	
  Rxs:
        hXp://www.cwci.org/research.html	
  
Dhalla	
  et	
  al,	
  	
  Clustering	
  of	
  opioid	
  prescribing	
  and	
  opioid-­‐related	
  
        mortality	
  among	
  family	
  physicians	
  in	
  Ontario.	
  Can	
  Fam	
  
        Physician	
  2011;	
  57:	
  e92-­‐96	
  
    	
  Upper	
  quin@le	
  of	
  frequent	
  opioid	
  prescribers	
  associated	
  with	
  
        last	
  opioid	
  Rx	
  in	
  62.7%	
  of	
  public	
  plan	
  beneficiary	
  uninten@onal	
  
        poisoning	
  deaths	
  
DLI	
  sent	
  leXers	
  to	
  all	
  prescribers	
  with	
  any	
  pa@ent	
  on	
  opioid	
  doses	
  
at	
  or	
  above	
  120	
  mg/day	
  MED-­‐ONLY	
  N=60	
  
•  Call	
  their	
  aXen@on	
  to	
  AMDG	
  Guidelines	
  and	
  new	
  WA	
  state	
  
        regula@ons	
  
•  Associate	
  medical	
  director	
  will	
  meet	
  with	
  these	
  docs	
  
        personally	
  
Early	
  opioids	
  and	
  disability	
  in	
  WA	
  WC.	
  	
  Spine	
  
                      2008;	
  33:	
  199-­‐204	
  

 Popula@on-­‐based,	
  prospec@ve	
  cohort	
  
 N=1843	
  workers	
  with	
  acute	
  low	
  back	
  injury	
  and	
  at	
  
  least	
  4	
  days	
  lost	
  @me	
  
 Baseline	
  interview	
  within	
  18	
  days(median)	
  	
  
 14%	
  on	
  disability	
  at	
  one	
  year	
  
 Receipt	
  of	
  opioids	
  for	
  >	
  7	
  days,	
  at	
  least	
  2	
  Rxs,	
  or	
  	
  >	
  150	
  
  mg	
  MED	
  doubled	
  risk	
  of	
  1	
  year	
  disability,	
  aqer	
  
  adjustment	
  for	
  pain,	
  func@on,	
  injury	
  severity	
  
38% Increase since 2001
What can PCP do to safely and effectively use
           opioids for CNCP?
  Opioid treatment agreement
  Screen for prior or current substance abuse/
   misuse (alcohol, illicit drugs, heavy tobacco use)
  Screen for depression
  Prudent use of random urine drug screening
   (diversion, non-prescribed drugs)
  Do not use concomitant sedative-hypnotics or
   benzodiazepines
  Track pain and function to recognize tolerance
  Seek help if MED reaches 120 mg and pain and
   function have not substantially improved
  Use PDMP!
Concrete steps to take
•  Track high MED and prescribers
•  Reverse permissive laws and set dosing and best practice standards
   for chronic, non-cancer pain
•  Implement AMDG Opioid Dosing Guidelines (
   http://www.agencymeddirectors.wa.gov/opioiddosing.asp)
•  Implement effective Prescription Monitoring Program; check the PDMP
   on every new injured worker who receives opioid Rx
•  Encourage/incent use of best practices (web-based MED calculator,
   use of state PMPs)
•  DO NOT pay for office dispensed opioids
•  ID high prescribers and offer assistance
•  Incent community-based Rx alternatives (activity coaching and
   graded exercise early, opioid taper/multidisciplinary Rx later)
•  Offer assistance (academic detailing, free CME,ECHO)
Nov,	
  2012	
  	
  WA	
  Workers	
  Compensa@on	
  
                             Opioid	
  Guideline	
  

•  Adop@on	
  of	
  the	
  2010	
  AMDG	
  Interagency	
  
   Guideline	
  on	
  Opioid	
  Dosing	
  for	
  Chronic	
  Non-­‐
   cancer	
  Pain	
  	
  
•  This	
  Supplement	
  provides	
  addi@onal	
  
   informa@on	
  and	
  guidance	
  for	
  trea@ng	
  work-­‐
      DOH	
  pain	
  management	
  rules,	
  2010	
  AMDG	
  Guideline	
  and	
  
   related	
  injuries	
   reflec@ve	
  of	
  the	
  prac@ce	
  standard	
  for	
  
     this	
  Supplement	
  are	
  
             prescribing	
  opioids	
  for	
  a	
  work-­‐related	
  injury	
  or	
  
                             occupa@onal	
  disease.	
  


                                                                                        79	
  
Proper	
  and	
  	
  
                                                             Necessary	
  Care	
      Stop	
  and	
  Take	
  a	
  Deep	
  
                                                                  for	
  	
           Breath	
  at	
  6	
  weeks	
  and	
  
                             Clinically	
  Meaningful	
  
                                                                Opioid	
                      before	
  COT	
  
                                Improvement	
  in	
  
                                                              Prescribing	
  	
  
                                    Func@on	
  




                            Case	
  Defini@on	
  	
  
Managing	
  Surgical	
               &	
  	
           Addic@on	
  Treatment	
  
    Pain	
  in	
  	
  
 Workers	
  on	
  COT	
       Algorithms	
  
                                  for	
  	
  
                             Discon@nuing	
  	
  
                                  COT	
  




                                                                                                                        80	
  
Disability Prevention is the Key
                             Health Policy Issue	
  
                             100


                              80
%	
  of	
  cases	
  on	
  
    Bme	
  loss




                              60


                              40


                              20


                                   0
                                       0      1     2     3       4    5     6     7     8    9     10   11   12
                                                              Time	
  loss	
  duraBon	
  (months)
                                           Adapted from Cheadle et al. Am J Public Health 1994; 84:190–196.!
Opioid	
  Use	
  in	
  Workers’	
  Compensa@on	
  


   •  Measuring	
  the	
  Impact	
  of	
  Opioid	
  Use	
  
         –  Beyond	
  acute	
  phase,	
  effec@ve	
  use	
  should	
  result	
  in	
  
               clinically	
  meaningful	
  improvement	
  in	
  func@on	
  
               (CMIF)	
  
         –  CMIF	
  is	
  an	
  improvement	
  in	
  func@on	
  of	
  at	
  least	
  30%	
  
               compared	
  to	
  start	
  of	
  treatment	
  or	
  in	
  response	
  to	
  a	
  
               dose	
  change	
  	
  
Con@nuing	
  to	
  prescribe	
  opioids	
  in	
  the	
  absence	
  of	
  CMIF	
  or	
  aqer	
  the	
  development	
  of	
  
         –  Evalua@on	
  of	
  clinically	
  meaningful	
  improvement	
  
a	
  severe	
  adverse	
  outcome	
  is	
  not	
  proper	
  and	
  necessary	
  care.	
  In	
  addi@on,	
  the	
  use	
  of	
  
 escala@ng	
  doses	
  to	
  tccur	
  at	
  3dcri@cal	
  phases	
  (acute,	
  subacute	
   and	
  
               should	
  o he	
  point	
  of	
   	
   eveloping	
  opioid	
  use	
  disorder	
  is	
  not	
  proper	
  
               and	
  during	
  COT)	
   necessary	
  care.	
  
                                                                                                                         1	
  
THANK	
  YOU!	
  

For electronic copies of this
presentation, please e-mail
        Laura Black
        ljl2@uw.edu
For questions or feedback,
            please
    e-mail Gary Franklin
 meddir@u.washington.edu

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A tale of_two-states-final

  • 1. A  Tale  of  2  States   Amy  Lee   Special  Deputy  Commissioner,  Policy   and  Research,  Texas  Department  of   Insurance,  Division  of  Workers’   Compensa@on   Dr.  Gary  Franklin     Medical  Director,  Washington  State   Department  of  Labor  and  Industries      
  • 2. Learning  Objec@ves   1.  State  what  is  needed  to  pass  regula@ons   and  legisla@ons  to  control  opioid  use.   2.  Analyze  different  approaches  to  determine   what  would  work  in  their  jurisdic@on.   3.  Formulate  ideas  you  can  implement  in  your   home  states.   2  
  • 3. Disclosure  Statement   •  Amy  Lee  has  no  financial  rela@onships  with   proprietary  en@@es  that  produce  health  care   goods  and  services.     •  Gary  Franklin  has  no  financial  rela@onships   with  proprietary  en@@es  that  produce  health   care  goods  and  services.     3  
  • 4. Third-­‐Party  Payer  Track:   A  Tale  of  Two  States   Amy  Lee   Texas  Department  of  Insurance,   Division  of  Workers’  Compensa@on  
  • 5. Presenta@on  Highlights   •  Overview  of  Texas  WC  system   •  Pharmacy  Closed  Formulary  –  how  it  works   •  Preliminary  impact     •  Transi@on  of  legacy  claims,  next  steps   5  
  • 6. Overview  of  Texas  WC  System   •  More  than  270  insurance  companies  ac@vely  wri@ng  WC   •  $2  billion  in  direct  wriXen  premium   •  Including  self-­‐insured  employers  and  governmental  en@@es,  more   than  800  insurance  carriers  with  WC  claims   •  67%  of  private  year-­‐round  employers  have  WC  and  all  governmental   en@@es  have  WC   •  About  225,000  new  claims  filed  each  year  (including  medical  only   claims)  and  about  340,000  claims  receiving  medical  and/or  indemnity   benefits  each  year   •  Pharmacy  accounts  for  14%  of  medical  payments   –  Opioids  account  for  4.6%  of  medical  payments   6  
  • 7. Overview  of  Texas  WC  System   •  U@lizes  evidence-­‐based  medicine  treatment  guidelines,  Official  Disability   Guidelines  (ODG)  and  return-­‐to-­‐work  guidelines  (Medical  Disability   Advisor)   •  Requires  certain  services  to  be  pre-­‐authorized  by  the  insurance  carrier/ u@liza@on  review  agent  and  allows  retrospec@ve  u@liza@on  review  of  any   service  that  is  not  pre-­‐authorized   •  Sets  fee  guidelines  for  professional,  inpa@ent/outpa@ent  hospital,  ASC  and   pharmacy  services  and  allows  pharmacy  contractual  discounts   •  Has  administra@ve  dispute  resolu@on  process  for  medical  necessity  and   medical  fee  disputes   •  Collects  medical  charges,  payments  and  u@liza@on  data  via  EDI   •  Allows  cer@fied  networks,  which  require  employees  to  select  network   trea@ng  doctors,  but  allows  employees  choice  of  pharmacy   7  
  • 8. Pharmacy  Formulary  Rules   28  TAC  Chapter  134    Benefits—Guidelines  for  Medical   Services,  Charges  and  Payments   Subchapter  F,  Pharmaceu=cal  Benefits   8  
  • 9. Insert  open  formulary   reference  here   9  
  • 10. DefiniBons   Exclusions  from  the  Closed  Formulary:   –  drugs  with  “N”  status  iden@fied  in  the  current  edi@on   of  the  Official  Disability  Guideline  (ODG)  Treatment  in   Workers’  Comp/  Appendix  A,  ODG  Workers’   Compensa=on  Drug  Formulary  and  any  updates   –  any  compounded  drugs  that  contains  a  drug  iden@fied   with  an  “N”  status  in  ODG;  and   –  inves@ga@onal  or  experimental  drugs  as  defined  in   Texas  Labor  Code  §413.014(a)   10  
  • 11. “N”  Status  Drugs   •  ODG’s  appendix  A  is  the  most  current  publica@on   for  “N”  status  drugs    www.worklossdata.com   •  TDI-­‐DWC  will  post  the  “N”  status  drugs  from  ODG’s   Appendix  A  on  its  website:    hXp:// www.tdi.state.tx.us/wc/dm/index.html   •  “N”  status  drugs  is  updated  monthly   11  
  • 12. Texas Department of Insurance Division of Workers’ Compensation This table is provided as a convenience only and is not a substitute for the current edition of ODG Treatment in Workers' Comp / Appendix A: ODG Workers' Compensation Drug Formulary (see memo). ODG Texas Workers’ Compensation Status "N" Drugs (Excluded from the Closed Formulary as of May 31, 2012) Generic Drug Class Generic Name Brand Name Equivalency Status N (for Opioids Buprenorphine Suboxone® No pain) Buprenorphine Opioids (transdermal) Butrans™ No N Butalbital (a Opioids barbiturate) Fioricet® Yes N Opioids Fentanyl buccal Fentora® No N Opioids Fentanyl buccal film Onsolis™ No N Opioids Fentanyl lollipop Actiq® Yes N Fentanyl nasal Opioids spray Lazanda No N Fentanyl sublingual Opioids spray Subsys® No N Fentanyl Opioids transmucosal Abstral No N Hydrocodone/ Opioids ibuprofen Vicoprofen® Yes N Opioids Hydromorphone ER Exalgo No N 12  
  • 13. Preliminary  Impact  of  Closed  Pharmacy   Formulary   13  
  • 14. Data  and  Methods   •  Injury months: September – February •  Injury years: 2009 – 2011 •  Injury year 2011 (Sept 2011 – Feb 2012): new injuries that occurred after the implementation of the pharmacy closed formulary •  Nine months maturity per claim •  N-drug list: approximately 150 drugs that require carrier preauthorization. 14  
  • 15. Number  of  Claims  Receiving  an  N-­‐Drug,   by  Injury  Year  (Sept-­‐Feb)   10000   8,957 9,104 9000   8000   7000   6000   5000   4000   3,616 3000   2000   -­‐60%   1000   0   2009 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   15  
  • 16. N-­‐drug  Claims,  as  a  Percentage  of  All  Pharmacy   Claims,  by  Injury  Year  (Sept-­‐Feb)   20.0%   18.9% 18.2% 18.0%   16.0%   14.0%   12.0%   10.0%   8.0%   7.4% 6.0%   4.0%   -­‐59%   2.0%   0.0%   2009 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   16  
  • 17. Number  of  N-­‐drug  Prescrip@ons,   by  Injury  Year  (Sept-­‐Feb)   25000   20,473 20,895 20000   15000   10000   6,467 5000   -­‐69%   0   2009 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   17  
  • 18. N-­‐drugs  as  a  Percentage  of  All  Prescrip@ons   by  Injury  Year  (Sept-­‐Feb)   10.0%   9.5% 9.0% 9.0%   8.0%   7.0%   6.0%   5.0%   4.0%   3.0% 3.0%   2.0%   1.0%   -­‐67%   0.0%   2009 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   18  
  • 19. N-­‐drug  Costs,   by  Injury  Year  (Sept-­‐Feb)   $3,000   $2,404 (000) $2,309 $2,500   (000) $2,000   $1,500   $1,000   $470 (000) $500   -­‐80%   $0   2009 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   19  
  • 20. N-­‐drug  Costs  as  a  Percentage  of  Total  Drug  Costs,   by  Injury  Year  (Sept-­‐Feb)   25.0%   20.1% 20.0%   18.8% 15.0%   10.0%   4.6% 5.0%   0.0%   -­‐76%   2009 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   20  
  • 21. N-­‐drug  Generic  Subs@tu@on  Rate,   by  Injury  Year  (Sept-­‐Feb)   Brand Generic 5,150 4,821 2,595 48%   52%   1,214 32%   68%   2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   21  
  • 22. Other  Drugs   •  Key measures:   Claim counts   Prescription utilization patterns   Prescription costs   Generic substitution rates   Most prescribed drugs 22  
  • 23. Number  of  Claims  with  Prescrip@ons  for   “Other”  Drugs,  by  Injury  Year  (Sept-­‐Feb)   60000   46,265 48,827 48,406 50000   40000   30000   20000   10000   -­‐1%   0   2009 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   23  
  • 24. Claims  with  Prescrip@ons  for  “Other”  Drugs  as   a  Percentage  of  All  Pharmacy  Claims,   by  Injury  Year  (Sept-­‐Feb)   100.0%   93.6% 90.0%   81.1% 81.8% 80.0%   70.0%   60.0%   50.0%   40.0%   30.0%   20.0%   14%   10.0%   0.0%   2009 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   24  
  • 25. Number  of  Prescrip@ons  for  “Other”   Drugs,  by  Injury  Year  (Sept-­‐Feb)   250000   211,099 210,593 195,111 200000   150000   100000   50000   -­‐<.1%   0   2009 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   25  
  • 26. “Other”  Drugs,  as  a  Percentage  of  All   Prescrip@ons,  by  Injury  Year  (Sept-­‐Feb)   120.0%   97.0% 100.0%   90.5% 91.0% 80.0%   60.0%   40.0%   20.0%   7%   0.0%   2009 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   26  
  • 27. “Other”  Drug  Costs,   by  Injury  Year  (Sept-­‐Feb)   $12,000   $9,998   $9,874   $9,558   (000)   (000)   $10,000   (000)   $8,000   $6,000   $4,000   $2,000   $0   -­‐  <1%   2009 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   27  
  • 28. “Other”  Drug  Costs  as  a  Percentage  of  Total  Drug   Costs,  by  Injury  Year  (Sept-­‐Feb)   100.0%   95.4% 90.0%   79.9% 81.2% 80.0%   70.0%   60.0%   50.0%   40.0%   30.0%   20.0%   10.0%   0.0%   17%   2009 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   28  
  • 29. “Other”  Drug  Generic  Subs@tu@on  Rate,   by  Injury  Year  (Sept-­‐Feb)   Brand Generic 85,360 82,231 (91%) (94%) 8,600 5,290 (9%) (6%) 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   29  
  • 30. Average  Number  of  Prescrip@ons  per  Claim,   by  Injury  Year  (Sept-­‐Feb)   N-drug prescriptions per claim Other-drug prescriptions per claim 5 4.4 4.2 4.3 4 3 2.3 2.3 1.8 2 +2%   1 -­‐22%   0 2009 2010 2011 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   30  
  • 31. Transi@on  of  Legacy  Claims  to  Pharmacy  Closed   Formulary   31  
  • 32. Open  Formulary  for  Legacy  Claims   •  Applies  to  both  network  and  non-­‐network   claims  with  dates  of  injury  prior  to  September  1,   2011   •  A  legacy  claim  is  any  date  of  injury  prior  to   September  1,  2011   •  Subject  to  the  open  formulary  un@l  September   1,  2013   32  
  • 33. Open  Formulary  for  Legacy  Claims   How  are  drugs  prescribed  in  an  open  formulary?   Non-­‐Network   •  According  to  the  ODG  treatment  guidelines   Network   •  According  to  the  cer@fied  network’s   treatment  guidelines   33  
  • 34. Open  Formulary   •  Drugs  included  in  an  open  formulary  do  not   require  preauthoriza@on,  but  are  subject  to   retrospec@ve  review   •  However,  inves@ga@onal  or  experimental  drugs   require  preauthoriza@on   34  
  • 35. TransiBon  of  Legacy  Claims    To  facilitate  the  transi@on,  the  prescribing  doctor   or  the  insurance  carrier  may:   •  Contact  each  other  to  discuss  ongoing  pharmacological   management  of  the  injured  employee’s  claim   •  When  the  par@es  contact  each  other,  they  must  provide   a  name,  phone  number,  date  and  @me  to  discuss   ongoing  pharmacological  management  of  the  injured   employee’s  claim   35  
  • 36. TransiBon  of  Legacy  Claims    Beginning  no  later  than  March  1,  2013,  the   insurance  carrier  shall:   •  Iden@fy  legacy  claims  where  an  excluded   drug  has  been  prescribed  aqer  September   1,  2012   •  Provide  wriXen  no@fica@on  to  the  injured   employee,  prescribing  doctor  and   pharmacy,  if  known   36  
  • 37. TransiBon  of  Legacy  Claims   The  wriXen  no@fica@on  will  contain:   •  Date  the  closed  formulary  will  apply   •  Name,  telephone  number,  and  date  and  @me   to  discuss  ongoing  pharmacological   management  of  the  injured  employee’s  claim   37  
  • 38. TransiBon  of  Legacy  Claims   Agreement:            During  the  discussion  the  insurance  carrier  and   a  prescribing  doctor  may  enter  into  an   agreement  on  the  applica@on  of  the  closed   formulary  on  an  individual  claim-­‐by-­‐claim  basis   38  
  • 39. TransiBon  of  Legacy  Claims   Agreement  requirements:   •  Must  be  documented  by  the  carrier  and  shared   with  the  prescribing  doctor  and  injured  employee   •  Health  care  provided  as  a  result  of  the  agreement   is  not  subject  to  retrospec@ve  review   If  an  agreement  is  not  reached:   •  A  denial  of  a  request  for  an  agreement  is  not   subject  to  dispute  resolu@on   •  Closed  formulary  applies  as  of  9/1/2013   39  
  • 40. Medical  Interlocutory  Order     “MIO”   •  When  the  preauthoriza@on  denial  of  a  drug   excluded  from  the  closed  formulary;   •  Poses  an  unreasonable  risk  of  medical   emergency  to  the  injured  employee;     •  Provides  a  means  for  an  injured  employee  to   con@nue  use  of  the  previously  prescribed  and   dispensed  drug(s)  throughout  the  dura@on  of   the  appeals/dispute  process.   40  
  • 41. Number  of  Legacy  Claims  Receiving  N-­‐ Drugs,  by  Prescrip@on  Year  (Sept-­‐Nov)   18000   15,682   16000   14000   12000   10000   8,032   8000   6000   4000   -­‐49%   2000   0   2011 2012 Source:  Texas  Department  of  Insurance,  Workers’  Compensa@on  Research   and  Evalua@on  Group,  2013.   41  
  • 42. Contact  Us   •  www.tdi.texas.gov/wc/indexwc.html   •  Medicalbenefits@tdi.texas.gov   •  512-­‐804-­‐4000  or  800-­‐372-­‐7713   42  
  • 43. Guidelines  for  Prescribing  opioids  to  Treat   Pain  in  Injured  workers     -­‐NaBonal  Rx  Drug  Abuse  Summit-­‐   Orlando,  FL   Wed  April  3,  2013   Gary  M.  Franklin,  MD,  MPH   Medical  Director   WA  Dept  of  Labor  and  Industries   Research  Professor   University  of  washington  
  • 44. "To  write  prescrip@ons  is  easy,   but  to  come  to  an  understanding  with     people  is  hard."   -­‐-­‐  Franz  Kaua,   A  Country  Doctor  
  • 45. “We can’t solve problems by using the same kind of thinking we used when we created them” !
  • 46. Change in National Norms for Use of Opioids for Chronic, Non-cancer Pain   By the late 1990s, at least 20 states passed new laws, regulations, or policies moving from near prohibition of opioids to use without dosing guidance   WA law: No disciplinary action will be taken against a practitioner based solely on the quantity and/or frequency of opioids prescribed. (WAC 246-919-830, 12/1999)   Laws were based on weak science and good experience with cancer pain WAC-Washington Administrative Code 46
  • 47. Similarities Between Illicit & Prescription Drugs
  • 48.    Portenoy  and  Foley            Pain  1986;  25:  171-­‐186     Retrospective case series chronic, non-cancer pain   N=38; 19 Rx for at least 4 years   2/3 < 20 mg MED/day; 4> 40 mg MED/day   24/38 acceptable pain relief   No gain in social function or employment could be documented   Concluded: Opioid maintenance therapy can be a safe, salutary and more humane alternative…
  • 49. Limitations of Long-term (>3 Months) Opioid Therapy   Overall,  the  evidence  for  long-­‐term  analgesic  efficacy  is  weak     PutaBve  mechanisms  for  failed  opioid  analgesia  may  be   related  to  rampant  tolerance     The  premise  that  tolerance  can  always  be  overcome  by  dose   escalaBon  is  now  quesBoned     100%  of  paBents  on  opioids  chronically  develop  dependence     More  than  50%  of  paBents  on  opioids  for  3  months  will   sBll  be  on  opioids  5  years  later   Ballantyne J. Pain Physician 2007;10:479-91; Martin BC et al. J Gen Intern Med 2011; 26: 1450-57 49
  • 50. Risk/Benefit  of  Opioids  for  Chronic  Non-­‐Cancer  Pain  
  • 51. Dentists and Emergency Medicine Physicians were the main prescribers for patients 5-29 years of age 5.5  million  prescripBons  were  prescribed  to  children  and  teens  (19  years  and  under)  in  2009   900   800   700   600   Rate  per  10,000  persons   GP/FM/DO   500   IM   400   DENT   300   ORTH  SURG   EM   200   100   0   0-­‐4                 5-­‐9                 10-­‐14             15-­‐19             20-­‐24             25-­‐29             30-­‐39   40-­‐59   60+   Age  Group   Source:  IMS  Vector  ®One  Na@onal,  TPT  06-­‐30-­‐10  Opioids  Rate  2009  
  • 52. Opioid-Related Deaths, Washington State Workers Compensation, 1992–2005 14 Definite Probable 12 10 8 Deaths 6 4 2 0 95 96 97 98 99 00 01 02 Year Franklin GM, et al, Am J Ind Med 2005;48:91-9 52
  • 53. UnintenBonal  and  Undetermined  Intent  Drug  Overdose   Death  Rates  by  State,  2007   MD   12.5   MA   12.5   NH   11.7   RI   11.1   CT   11.1   DE   9.8   DC   8.8     VT   7.9   NJ   7.5   Age-­‐adjusted  rate  per     100,000  populaBon   National Vital Statistics System, http://wonder.cdc.gov 53
  • 54. UnintenBonal  Poisoning  Fatality  Rate,  1999-­‐2010,   WISQARS  NCHS  data   16   14   Deaths/100,000   12   10   8   California  n=3580   6   Ohio  n=1678   4   2   Utah  n=273   0   Washington  n=754   Year  
  • 55. Evidence  linking  specific  doses  to  morbidity   and  mortality   Dunn et al, Ann Int Med 2010; 152: 85-92  Risk of morbidity and mortality increased 8.9 fold at 100 mg MED  Editorial-McLellan-White House Office of National Drug Control Policy   Smarter, more responsible (prescribing) practices are the only hope to avoid tragic, avoidable deaths Braden et al, Arch Int Med 2010; 170: 1425-32 Opioid doses >120 mg/day MED and use of long acting Schedule II opioids associated with incresed risk of alcohol- or drug- related ER visit *
  • 56. Evidence linking specific doses to morbidity and mortality Bohnert  et  al,  JAMA  2011;  305:  1315-­‐21   •  Risk  of  mortality  7.18  (chronic  pain),  6.64  (acute  pain)   Gomes  et  al,  Arch  Int  Med  2011;  171:  686-­‐91   •  Risk  of  mortality  2.04  at  100  mg  and  2.88  at  200  mg  
  • 57. Unintentional Overdose Deaths Involving Opioid Analgesics Parallel Opioid Sales United States, 1997–2007   Distribution by drug Opioid sales * (mg/ companies person)   96  mg/person  in  1997   627%     698  mg/person  in  2007   increase       Enough  for  every  American to take 5 mg Vicodin every 4 hrs for 3 weeks   Year   Overdose deaths Opioid deaths   2,901  in  1999   296%  increase       11,499  in  2007   Year National Vital Statistics System, multiple cause of death data set and Drug Enforcement Administration ARCOS system; 57 2007 opioid sales figure is preliminary
  • 58. Washington Agency Medical Directors Opioid Dosing Guidelines •  Developed with clinical pain experts in 2006 •  Implemented April 1, 2007 •  First guideline to emphasize dosing guidance •  Educational pilot, not new standard or rule •  National Guideline Clearinghouse –  http://www.guideline.gov/content.aspx?id=23792&search=wa+opioids 58 www.agencymeddirectors.wa.gov  
  • 59. Washington Agency Medical Directors Opioid Dosing Guidelines •  Part I – If patient has not had clear improvement in pain AND function at 120 mg MED (morphine equivalent dose) , take a deep breath –  If needed, get one-time pain management consultation (certified in pain, neurology, or psychiatry) •  Part II – Guidance for patients already on very high doses >120 mg MED 59 www.agencymeddirectors.wa.gov  
  • 60. Guidance for Primary Care Providers on Safe and Effective Use of Opioids for Chronic Non-cancer Pain   Establish  an  opioid  treatment  agreement     Screen  for     Prior  or  current  substance  abuse       Depression     Use  random  urine  drug  screening  judiciously     Shows  pa@ent  is  taking  prescribed  drugs     Iden@fies  non-­‐prescribed  drugs     Do  not  use  concomitant  sedaBve-­‐hypnoBcs     Track  pain  and  funcBon  to  recognize  tolerance     Seek  help  if  dose  reaches  120  mg  MED,  and  pain  and  funcBon  have   not  substanBally  improved     http://www.agencymeddirectors.wa.gov/opioiddosing.asp MED, Morphine equivalent dose 60
  • 61. Open-source Tools Added to June 2010 Update of Opioid Dosing Guidelines   Opioid  Risk  Tool:  Screen  for  past  and  current              substance  abuse     CAGE-­‐AID  screen  for  alcohol  or  drug  abuse     PaBent  Health  QuesBonnaire-­‐9  screen  for  depression     2-question tool for tracking pain and function   Advice on urine drug testing Available  as  mobile  app:  hXp:// www.agencymeddirectors.wa.go v/opioiddosing.asp   61 hXp://www.agencymeddirectors.wa.gov/opioiddosing.asp#DC  
  • 62. Washington  State  Primary  Care  Survey  2009:   Physician  Concerns   Please  check  the  statement  that  most  accurately  reflects     your  experience  when  prescribing  opioids     for  chronic,  non-­‐cancer  pain NO  concerns  about  development  of  psychological  dependence,   2% addicBon,  or  diversion   OCCASIONAL  concerns  about  development  of  psychological   45% dependence,  addicBon,  or  diversion   FREQUENT  concerns  about  development  of  psychological   54% dependence,  addicBon,  or  diversion   Interim  Evalua@on  of  the  Opioid  Dosing  Guidelines.  hXp://www.agencymeddirectors.wa.gov   62  
  • 63. Washington  State  Primary  Care  Survey  2009:   Adherence  to  State  Guidelines   Always  or   Never  or   Guidance   SomeBmes Olen almost   almost  never always Use  treatment  agreement 10% 22% 20% 49% Screen  for  substance  abuse <1% 3% 15% 81% Screen  for  mental  illness <1% 12% 30% 58% Use  random  urine  screen 30% 32% 18% 20% Use  paBent  educaBon 34% 38% 19% 9% Track  pain   40% 31% 15% 15% Track  physical  funcBon 69% 20% 7% 5% Interim  Evalua@on  of  the  Opioid  Dosing  Guidelines.  hXp://www.agencymeddirectors.wa.gov   63  
  • 64. 2009 CDC recommendations  For practitioners, public payers, and insurers  Seek help at 120 mg/day MED if pain and function not improving  http://www.cdc.gov/ HomeandRecreationalSafety/pdf/poision- issue-brief.pdf
  • 65. Franklin et al, Natural History of Chronic Opioid Use Among Injured Workers with Low Back Pain-Clin J Pain, •  694/1843  (37.6%)  received  opioid  early   Dec, 2009 •  111/1843  (6%)  received  opioids  for  1  yr   •  MED  increased  sign  from  1st  to  4th  qtr   •  Only  minority  improved  by  at  least  30%  in  pain  (26%)   and  funcBon  (16%)   •  Strongest  predictor  of  long  term  opioid  use  was  MED   in  1st  qtr  (40  mg  MED  had  OR  6)   •  Avg  MED  42.5  mg  at  1  yr;  Von  Korff  55  mg  at  2.7  yrs  
  • 66. Randomized  trial  Re  effec@veness  of  escala@ng  dose   •  RCT  of  “hold  the  line”  vs  escala@ng  dose  strategies   •  N=135,  parallel  group  pragma@c  study   •  No  change  in  any  primary  pain  or  func@on  outcome   •  27%  discharged  due  to  misuse/non-­‐compliance   *Naliboff  et  al,  2011  (FEB);  12:  288-­‐96  
  • 67. New  state  policies   ConnecBcut  WC  policy-­‐7/1/2012   The  total  daily  dose  of  opioids  should  not  be  increased  above  90mg  oral  MED/day   (Morphine  Equivalent  Dose)  unless  the  pa@ent  demonstrates  measured   improvement  in  func@on,  pain  or  work  capacity.  Second  opinion  is  recommended  if   contempla@ng  raising  the  dose  above  90  MED/day.   MaineCare  (Medicaid)-­‐4/1/2012   Total  45  day  maximum  for  non-­‐cancer  pain   New  Mexico-­‐Rule  16.10.14-­‐Proposed  rules  Aug,  2012    A  health  care  prac@@oner  shall,  before  prescribing,  ordering,   administering  or  dispensing  a  controlled  substance  listed  in  schedule  II,  III   or  IV,  obtain  a  pa@ent  PMP  report  for  the  preceding  twelve  (12)  months  
  • 68. Yearly Trend of Scheduled Opioids (Franklin et al, Am J Ind Med 2012; 55: 325-31 ) 100,000 Number of Opioid Prescriptions 90,000 80,000 70,000 60,000 50,000 40,000 30,000 20,000 10,000 0 Schedule II Schedule III Schedule IV
  • 69. Percent of Timeloss Claimants on Opioids 2000 - 2010 40.0% 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 5.0% 0.0% Opioids Highdose Opioids
  • 70. Q1 10- Q3 09- Q1 09- Q3 08- Q1 08- 2010 Q1 Q3 2009 Q3 Washington Workers Compensation, 1996–2010 07- 2009 Q1 Q1 07- 2008 Q3 Q3 2008 Q1 06- 2007 Q3 Average Daily Dosage for Opioids, Q1 06- 2007 Q1 Q3 2006 Q3 05- 2006 Q1 Q1 Long-acting opioids 05- 2005 Q3 Short-acting opioids 2005 Q1 Q3 04- 2004 Q3 Q1 2004 Q1 04- 2003 Q3 Q3 03- 2003 Q1 Year/Quarter Q1 2002 Q3 03- 2002 Q1 Q3 02- 2001 Q3 Q1 2001 Q1 02- 2000 Q3 Q3 01- 2000 Q1 Q1 1999 Q3 01- 1999 Q1 Q3 00- 1998 Q3 Q1 1998 Q1 00- 1997 Q3 Q3 1997 Q1 99- 1996 Q3 Q1 99- 1996 Q1 Q3 98- 140 120 100 80 60 40 20 0 70 Q1 98- MED (mg/day) Q3 97- Q1 97- Q3 96- Q1 96-
  • 71. WA Workers' Compensation Opioid-related Deaths 1995-2010 35 30 Opioid-related Death 25 20 15 10 5 0 Possible Probable Definite
  • 72. Unintentional Prescription Opioid Overdose Deaths Washington 1995-2010 600 500 420 Number of deaths 400 300 200 100 24 0 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 Prescription Opioid + alcohol or illicit drug Prescription Opioid +/- Other Prescriptions * Tramadol only deaths included in 2009, but not in prior years. Source: Washington State Department of Health, Death Certificates
  • 73.
  • 74. There  is  substanBal  clustering  among  providers  on   dosing  and  mortality     CA  CWCI  study-­‐Swedlow  et  al,  March,  2011:  3%  of  prescribers   account  for  55%  of  Schedule  II  opioid  Rxs: hXp://www.cwci.org/research.html   Dhalla  et  al,    Clustering  of  opioid  prescribing  and  opioid-­‐related   mortality  among  family  physicians  in  Ontario.  Can  Fam   Physician  2011;  57:  e92-­‐96    Upper  quin@le  of  frequent  opioid  prescribers  associated  with   last  opioid  Rx  in  62.7%  of  public  plan  beneficiary  uninten@onal   poisoning  deaths   DLI  sent  leXers  to  all  prescribers  with  any  pa@ent  on  opioid  doses   at  or  above  120  mg/day  MED-­‐ONLY  N=60   •  Call  their  aXen@on  to  AMDG  Guidelines  and  new  WA  state   regula@ons   •  Associate  medical  director  will  meet  with  these  docs   personally  
  • 75. Early  opioids  and  disability  in  WA  WC.    Spine   2008;  33:  199-­‐204    Popula@on-­‐based,  prospec@ve  cohort    N=1843  workers  with  acute  low  back  injury  and  at   least  4  days  lost  @me    Baseline  interview  within  18  days(median)      14%  on  disability  at  one  year    Receipt  of  opioids  for  >  7  days,  at  least  2  Rxs,  or    >  150   mg  MED  doubled  risk  of  1  year  disability,  aqer   adjustment  for  pain,  func@on,  injury  severity  
  • 77. What can PCP do to safely and effectively use opioids for CNCP?   Opioid treatment agreement   Screen for prior or current substance abuse/ misuse (alcohol, illicit drugs, heavy tobacco use)   Screen for depression   Prudent use of random urine drug screening (diversion, non-prescribed drugs)   Do not use concomitant sedative-hypnotics or benzodiazepines   Track pain and function to recognize tolerance   Seek help if MED reaches 120 mg and pain and function have not substantially improved   Use PDMP!
  • 78. Concrete steps to take •  Track high MED and prescribers •  Reverse permissive laws and set dosing and best practice standards for chronic, non-cancer pain •  Implement AMDG Opioid Dosing Guidelines ( http://www.agencymeddirectors.wa.gov/opioiddosing.asp) •  Implement effective Prescription Monitoring Program; check the PDMP on every new injured worker who receives opioid Rx •  Encourage/incent use of best practices (web-based MED calculator, use of state PMPs) •  DO NOT pay for office dispensed opioids •  ID high prescribers and offer assistance •  Incent community-based Rx alternatives (activity coaching and graded exercise early, opioid taper/multidisciplinary Rx later) •  Offer assistance (academic detailing, free CME,ECHO)
  • 79. Nov,  2012    WA  Workers  Compensa@on   Opioid  Guideline   •  Adop@on  of  the  2010  AMDG  Interagency   Guideline  on  Opioid  Dosing  for  Chronic  Non-­‐ cancer  Pain     •  This  Supplement  provides  addi@onal   informa@on  and  guidance  for  trea@ng  work-­‐ DOH  pain  management  rules,  2010  AMDG  Guideline  and   related  injuries   reflec@ve  of  the  prac@ce  standard  for   this  Supplement  are   prescribing  opioids  for  a  work-­‐related  injury  or   occupa@onal  disease.   79  
  • 80. Proper  and     Necessary  Care   Stop  and  Take  a  Deep   for     Breath  at  6  weeks  and   Clinically  Meaningful   Opioid   before  COT   Improvement  in   Prescribing     Func@on   Case  Defini@on     Managing  Surgical   &     Addic@on  Treatment   Pain  in     Workers  on  COT   Algorithms   for     Discon@nuing     COT   80  
  • 81. Disability Prevention is the Key Health Policy Issue   100 80 %  of  cases  on   Bme  loss 60 40 20 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Time  loss  duraBon  (months) Adapted from Cheadle et al. Am J Public Health 1994; 84:190–196.!
  • 82. Opioid  Use  in  Workers’  Compensa@on   •  Measuring  the  Impact  of  Opioid  Use   –  Beyond  acute  phase,  effec@ve  use  should  result  in   clinically  meaningful  improvement  in  func@on   (CMIF)   –  CMIF  is  an  improvement  in  func@on  of  at  least  30%   compared  to  start  of  treatment  or  in  response  to  a   dose  change     Con@nuing  to  prescribe  opioids  in  the  absence  of  CMIF  or  aqer  the  development  of   –  Evalua@on  of  clinically  meaningful  improvement   a  severe  adverse  outcome  is  not  proper  and  necessary  care.  In  addi@on,  the  use  of   escala@ng  doses  to  tccur  at  3dcri@cal  phases  (acute,  subacute   and   should  o he  point  of     eveloping  opioid  use  disorder  is  not  proper   and  during  COT)   necessary  care.   1  
  • 83. THANK  YOU!   For electronic copies of this presentation, please e-mail Laura Black ljl2@uw.edu For questions or feedback, please e-mail Gary Franklin meddir@u.washington.edu