LT-130-Rev7_Reimbursement-Guide-2017

ReimbursementGuide2017Overview, Billing, and Coding for Pain ManagementProcedures, Drugs, and Devices

Meredith George, SCP-PM Director of Physician Services Email: [email protected] Office: (972)-349-8812 Cell: (817) 845-5558 Fax: (972) 241-6263 Epimed International 13958 Diplomat Drive Dallas, TX 75324 Your Clinical Sales Consultant is:    Notes:

   Welcome  to  2017!          Epimed’s  Physician  Services  Department  is  pleased  to  offer  you  our  2017  Pain  Management  Reimbursement  Guide.    We  want  to  make  our  reimbursement  resources  easy  for  you  and  your  staff.    This  guide  is  just  one  way  we  can  help  provide  information  relative  to  coding  support,  appeals,  payer  contract  negotiations,  etc.        As  we  begin  2017,  a  major  focus  for  our  Pain  Management  community  is  the  addition  and  deletion  of  several  epidural  steroid  codes.    Please  make  sure  your  systems  have  been  updated  to  reflect  these  changes  to  avoid  unnecessary  claim  denials.    You  can  refer  to  the  “miscellaneous  pain  code”  section  of  this  guide  for  full  descriptions.    Epimed  continues  to  focus  on  the  the  development  of  safer  products.    In  addition  to  our  full  line  of  Racz®  Catheters  and  Radiofrequency,  we  are  excited  now  to  offer  the  PainBlocker™  cryoanalgesia  system.  We  also  offer  numerous  educational  opportunities  in  our  effort  to  support  the  growing  specialty  of  Pain  Management.    As  always,  we  appreciate  the  opportunity  to  assist  you  and  we  look  forward  to  serving  all  of  your  Pain  Management  needs.    I  can  be  reached  at  any  time  via  email  at  [email protected]  or  by  phone  (972)  349-­8812.    Let’s  continue  to  make  our  practices  and  specialty  thrive  in  2017.              Meredith  George,  SCP-­PM  Director  of  Physician  Services              Epimed  has  made  every  effort  to  ensure  the  accuracy  of  the  information  contained  within  this  guide.  However,  users  who  rely  on  this  information  do  so  at  their  own  risk;;  it  is  up  to  each  practice  and/or  facility  to  determine  what  they  feel  is  appropriate  within  their  organization.      LT-­130  Rev  7       www.epimed.com 1

CONTENTS2

NEGOTIATING CONTRACTS 4 Negotiating RF CODING 8 ContractsMISCELLANEOUS PAIN CODES 10 RF Coding CRYOANALGESIA 12 Miscellaneous Pain Codes CryoablationEPIDURAL LYSIS OF ADHESIONS Epidural Lysis Of Adhesions SAMPLE OPERATIVE REPORTS 16 Sample Operative Reports MEDICATION / SUPPLY CODES 32 Medication / Supply CodesAPPEALS / INDEPENDENT Appeals / Independent EXTERNAL REVIEW 36 External Review www.epimed.com 3

NEGOTIATING CONTRACTS4

  Negotiating Contracts Negotiating  YOUR  contract  with  health  plans    Most  Provider  contracts  are  renewable  annually  (based  on  the  date  the  contract  was  originally  signed).    It  is  in  the  best  interest  of  the  practice  to  re-­evaluate  those  contracts  each  year  as  new  technologies  and  additional  procedures  are  incorporated  into  the  practice.  If  you  don't  negotiate,  the  health  plan  could  keep  paying  you  the  same  amount  of  money  for  the  next  two  decades!  Some  key  points  to  consider  are:   •   Know  your  territory.  What  percentage  of  patients  do  you  have  per  Payer?   •   Make  sure  that  contract  rates  are  higher  than  50%  of  billed  charges  OR  set  bill   charges  to  a  level  where  50%  of  bill  charges  will  always  be  acceptable.   •   Make  sure  each  procedure  CPT  code  is  specifically  identified.   •   Surgical  supplies  over  a  specified  dollar  amount  are  paid  in  full/at  cost  or  that  a   set  fee  is  established  per  procedure  for  said  supplies.   •   Does  the  contract  allow  you  to  bill  patients  (unless  prohibited  by  law):  (a)  when   the  Health  Plan  or  the  payer  fails  or  is  unable  to  pay  or,  (b)  for  services  not   covered  by  the  Contract  and  (c)  when  you  have  advised  the  patient  that   the  Health  Plan  has  determined  that  proposed  services  are  not  medically   necessary.   •   Counter  offer  and  be  patient  –  NEVER  SIGN  “as  is”  contract    Set  your  practice  apart.  Point  out  your  practice's  cutting-­edge  technology,  its  desirable    geographic  location,  the  patient  base,  the  depth  and  breadth  of  the  practice,  or  the  high    rate  of  incoming  referrals.          LT-­130  Rev  7       www.epimed.com 5

SAMPLE  NEGOTIATION  TIMELINE               LT-­130  Rev  7      6

www.epimed.com Negotiating Contracts7

RF CODING8

RADIOFREQUENCY  CODING   RF Coding    64600  -­  Destruction  by  neurolytic  agent  (Chemical,  Thermal,  Electrical  or                  Radiofrequency),  trigeminal  nerve;;  supraorbital,  infraorbital,  mental  or  inferior                  alveolar  branch  64605  -­  Second  and  third  division  branches  at  foramen  ovale  64610  -­  Second  and  third  division  branches  at  foramen  ovale  under      radiologic  monitoring  64620  -­  Destruction  by  neurolytic  agent,  intercostal  nerve  64633  -­  Destruction  by  neurolytic  agent,  paravertebral  facet  joint  nerve(s)  with                            imaging  guidance  fluoroscopy  or  CT);;  cervical  or  thoracic,  single  facet  joint                            (for  bilateral  procedure,  report  with  modifier  50)  64634  -­  Cervical  or  thoracic,  each  additional  facet  joint    64635  -­  Lumbar  or  sacral,  single  facet  joint  (for  bilateral  procedure,  report                            with  modifier  50)  64636  -­  Lumbar  or  sacral,  each  additional  facet  joint  (list  separately  in  addition  to                              code  for  primary  procedure)  64640  -­  Other  peripheral  nerve  or  branch  64680  -­  Celiac  plexus  64681  -­  Superior  hypogastric  plexus  64999  -­  Pulsed  rf                                LT-­130  Rev  7       www.epimed.com 9

MISCELLANEOUS PAIN CODES10

Miscellaneous  Pain  Procedure  Codes   Miscellaneous Pain Codes  62302  -­  Myelography  via  lumbar  injection,  including  radiological  supervision  and   interpretation;;  cervical  62304  -­  Lumbosacral  62320  -­  Injection(s),  of  diagnostic  or  therapeutic  substance(s)  (eg,  anesthetic,   antispasmodic,  opioid,  steroid,  other  solution),  not  including  neurolytic   substances,  including  needle  or  catheter  placement,  interlaminar,  epidural  or   subarachnoid,  cervical  or  thoracic;;  without  image  guidance  62321  -­  ESI  cervical  or  thoracic  with  image  guidance    62322  -­  Injection(s),  of  diagnostic  or  therapeutic  substance(s)  (eg,  anesthetic,   antispasmodic,  opioid,  steroid,  other  solution),  not  including  neurolytic   substances,  including  needle  or  catheter  placement,  interlaminar,  epidural  or   subarachnoid,  lumbar  or  sacral  (caudal);;  without  image  guidance  62323  -­  ESI  lumbar  or  sacral  (caudal)  with  image  guidance  62350  -­  Implantation,  revision  or  repositioning  of  tunneled,  intrathecal  or  epidural   catheter  for  long  term  medication  administration  via  an  external  pump  or   implantable  reservoir/infusion  pump,  without  laminectomy  63650  -­  Percutaneous  implantation  of  neurostimulator  electrode  array,  epidural  64405  -­  Introduction/injection  of  anesthetic  agent  (diagnostic)  greater  occipital  nerve  64416  -­  Injection,  anesthetic  agent,  brachial  plexus,  continuous  infusion  by  catheter   (including  catheter  placement)  64449  -­  Injection,  anesthetic  agent;;  lumbar  plexus;;  posterior  approach,        continuous  infusion  by  catheter  (including  catheter  placement)    64479  -­  Injection(s),  anesthetic  agent  and/or  steroid,  transforaminal  epidural,                        with  imaging  guidance  (fluoroscopy  or  CT);;    cervical  or  thoracic,  single  level  64480  -­  Cervical  or  thoracic,  each  additional  level  64483  -­  Lumbar  or  sacral,  single  level  64484  -­  Lumbar  or  sacral,  each  additional  level    64505  -­  Injection,  anesthetic  agent;;  sphenopalatine  ganglion  64510  -­  Injection,  anesthetic  agent,  stellate  ganglion  (cervical  sympathetic)    64999  -­  Unlisted  procedure  (used  for  pain  mapping)          LT-­130  Rev  7       www.epimed.com 11

CRYOANALGESIA12

Cryoanalgesia   Cryoablation    64600  -­  Destruction  by  neurolytic  agent  (Chemical,  Thermal,  Electrical  or                  Radiofrequency),  trigeminal  nerve;;  supraorbital,  infraorbital,  mental  or  inferior                  alveolar  branch  64605  -­  Second  and  third  division  branches  at  foramen  ovale  64610  -­  Second  and  third  division  branches  at  foramen  ovale  under      radiologic  monitoring  64620  -­  Destruction  by  neurolytic  agent,  intercostal  nerve  64633  -­  Destruction  by  neurolytic  agent,  paravertebral  facet  joint  nerve(s)  with                            imaging  guidance  fluoroscopy  or  CT);;  cervical  or  thoracic,  single  facet  joint                            (for  bilateral  procedure,  report  with  modifier  50)  64634  -­  Cervical  or  thoracic,  each  additional  facet  joint    64635  -­  Lumbar  or  sacral,  single  facet  joint  (for  bilateral  procedure,  report                            with  modifier  50)  64636  -­  Lumbar  or  sacral,  each  additional  facet  joint  (list  separately  in  addition  to                              code  for  primary  procedure)  64640  -­  Other  peripheral  nerve  or  branch  64680  -­  Celiac  plexus  64681  -­  Superior  hypogastric  plexus  64999  -­  Pulsed  rf            Possible  Probe/Needle  Code    C2618  –  Probe/needle,  cryoablation  (subject  to  Medicare  guidelines)  LT-­130  Rev  7       www.epimed.com 13

LT-­130  Rev  7      14

Cryoablationwww.epimed.com 15

EPIDURAL LYSIS OF ADHESIONS SAMPLE OPERATIVE REPORTS16

Epidural  Lysis  of  Adhesions  Overview   Epidural Lysis Of Adhesions   Sample Operative ReportsLysis  of  Adhesions,  Percutaneous  Neuroplasty,  Racz®  Procedure,  and  Adhesiolysis  are  several  names  for  the  same  procedure.    Most  widely  recognized  as  the  Racz®   17Procedure  or  Epidural  Lysis  of  Adhesions,  this  procedure  was  developed  back  in  the  early  80’s  by  Dr.  Gabor  Racz  at  Texas  Tech  University  in  Lubbock,  Texas.    Epidural  Lysis  of  Adhesions  has  been  proven  effective  in  treating  chronic  pain  due  to  scar  tissue  formation*.    Most  often,  patients  present  with  failed  back  surgery  syndrome,  spinal  stenosis,  and  radiculopathy  (not  an  all-­inclusive  list).    Epidural  Lysis  can  also  benefit  those  patients  who  have  movement  related  injuries  such  as  a  leaky  disc  and  chronic  back  pain  resulting  from  excessive  scarring  in  the  anterior  lateral  epidural  space.      The  procedure  involves  having  the  patient  consciously  sedated.    A  needle  and  Racz®  catheter  are  placed  into  the  epidural  space,  under  the  assistance  of  fluoroscopic  guidance,  into  the  scarring.    The  delivery  of  medications  such  as  corticosteroids,  hyaluoronidase  or  hypertonic  solution,  will  allow  restrictive  tissues  to  free  compromised  nerve  roots  and  relieve  pain.      Typically  patients  are  taken  to  the  recovery  area,  where  they  will  begin  basic  stretching  exercises  (neuroflossing).    The  procedure,  in  most  cases  is  done  on  an  outpatient  basis  where  the  patient  is  released  the  same  day.    Patients  who  present  with  more  severe  scarring,  the  physician  may  choose  to  do  a  series  of  2-­3  injections  over  the  course  of  several  days.        Most  patients  will  begin  to  experience  improvement  in  a  few  days  following  the  procedure.  However,  some  will  experience  immediate  improvement  and  some  patients  can  take  as  long  as  a  few  weeks  to  obtain  full  relief.    Most  patients  will  return  to  work  the  day  after  the  catheter  is  removed.                      *Gerdesmeyer  et  al,  2013;;  Veihelmann  et  al,  2006;;  Manchikanti  et  al,  2004          LT-­130  Rev  7       www.epimed.com

Physician  Billing    Appropriate  coding  is  imperative  in  any  practice.    The  use  of  HCPCS  (HCFA  Common  Procedure  Coding  System),  CPT  (Current  Procedural  Terminology)  and  ICD-­10  (International  Classification  of  Diseases)  are  the  standard  systems  used  today.    Below  is  a  list  of  possible  diagnosis  and  procedure  codes  to  be  used  when  billing  Epidural  Lysis  of  Adhesions.    It  is  always  the  responsibility  of  the  provider  to  determine  appropriate  diagnosis,  as  well  as  coding.      Before  submitting  your  claim,  it  is  always  suggested  to  contact  the  carrier  to  determine  if  they  have  any  specific  coding,  place  of  service  or  diagnosis  requirements.    Commonly  Used  ICD-­10  Diagnosis  Codes  (others  may  be  applicable)  M96.1     Post  laminectomy  syndrome,  not  elsewhere  classified     Spinal  stenosis,  lumbar  region  M48.06   Other  spondylosis  with  radiculopathy,  lumbar  region     Other  spondylosis  with  radiculopathy,  lumbosacral  region  M47.26   Chronic  pain  syndrome     Meningeal  adhesions  (cerebral)  (spinal)  M47.27   Radiculopathy,  lumbar  region    G89.4      G96.12    M54.16         LT-­130  Rev  7      18

  Epidural Lysis Of Adhesions Sample Operative ReportsCPT  Codes  for  Epidural  Lysis  of  Adhesions      *62263  –  Percutaneous  lysis  of  epidural  adhesions  using  solution  injection  (e.g.,  hypertonic  saline,  enzyme)  or  mechanical  means  (e.g.  catheter)  including  radiological  location  (includes  contrast  when  administered),  multiple  adhesiolysis  sessions;;  2  or  more  days.    *62264  –  1-­day  adhesiolysis    *Per  AMA  CPT  Epidural  Lysis  of  Adhesions  is  a  catheter  based  procedure  Codes  62263  and  62264  describe  a  catheter-­based  treatment  involving  targeted  injection  of  various  substances  (hypertonic  saline,  enzyme,  and  steroid,  anesthetic).  Included  in  this  procedure  is  injection  of  contrast  for  epidurography  and  fluoroscopic  guidance)    When  billing  any  of  the  Racz®  Spring  Guided  Epidural  Catheters,  there  is  no  specific  code.    Miscellaneous  codes  can  be  used  in  most  scenarios  for  claim  submission.    Again,  it  is  always  best  to  verify  with  each  carrier  to  ensure  no  specific  requirement  must  be  met.    Attaching  a  copy  of  the  invoice  with  your  claim  submission  will  often  eliminate  any  questions  raised  about  the  charge,  but  does  not  guarantee  payment.    Possible  Catheter  Codes  C1755  –  Catheter,  intraspinal,  CANNOT  BE  BILLED  IN  OFFICE  SETTING    99070  –  Supplies  and  materials  (except  spectacles),  provided  by  the  physician  over   and  above  those  usually  included  with  the  office  visit  or  other  services  rendered             (list  drugs,  trays,  supplies  or  materials  provided)    A4649  –  Surgical  Supply;;  miscellaneous              Based  on  current  (2017)  AMA  recommendations  LT-­130  Rev  7       www.epimed.com 19

Facility  Billing  Information     Most  facilities  will  typically  bill  for  their  facility  fee  as  well  as  any  supplies,  including  the   Racz®  catheters  and  needle.    The  facility  should  obtain  prior  authorization  for  the  facility   fee  and  the  catheter  (outside  the  global  base  rate)  even  if  the  physician  has  received   prior  authorization  for  his  or  her  professional  services.   Reimbursement  for  ASC  (Ambulatory  Surgical  Center)  and  HOPD  (Hospital  Outpatient   Department)  services  will  be  determined  by  use  of  ICD-­10  and  CPT  coding.    It  is  very   important  that  both  the  facility  and  Physician  utilize  the  same  CPT  codes  to  ensure   appropriate  payments.   When  billing  the  Racz®  catheter,  there  is  no  specific  code.    Miscellaneous  codes  can  be   used  in  most  scenarios  for  claim  submission.    Again,  it  is  always  best  to  verify  with  each   carrier  to  ensure  no  specific  requirement  must  be  met.    Attaching  a  copy  of  the   invoice  with  your  claim  submission  may  often  eliminate  any  questions  raised   about  the  charge,  but  does  not  guarantee  payment.     Possible  Catheter  Codes     C1755  –  Catheter,  intraspinal  CANNOT  BE  BILLED  IN  OFFICE  SETTING   99070  –  Supplies  and  materials  (except  spectacles),  provided  by  the  physician  over        and  above  those  usually  included  with  the  office  visit  or  other  services        rendered  (list  drugs,  trays,  supplies  or  materials  provided)   A4649  –  Surgical  Supply;;  miscellaneous                             LT-­130  Rev  7      20

Sample  Letter  of  Medical  Necessity  for  Lysis  of  Adhesions  <Date>      Name  Address  City,  State  Attn:    Appeal  Department    Re:        Patient  Name  ID#:      To  Whom  It  May  Concern:     Epidural Lysis Of AdhesionsI  am  requesting  authorization/precertification  on  behalf  of  my  patient  (patient  name)  for  the  outpatient   Sample Operative Reportsprocedure,  Epidural  Lysis  of  Adhesions.    (Patient  name)  has  been  a  patient  of  mine  for  approximately…………..    I  have  been  treating  (patient  name)  for  (diagnosis).      This  patient  presents  with  (DESCRIBE  HISTORY).    (Patient  name)  has  tried  and  failed  (CONSERVE  TRMT,  SURGERIES,  ETC.  –  YOU’RE  TRYING  TO  PROVE  WHY  THIS  PATIENT  NEEDS  THIS  PROCEDURE).  Epidural  Lysis  of  Adhesions  (Lysis)  is  an  Interventional  Pain  Management  technique  which  emerged  in  the  late  80’s.    To  date,  there  have  been  in  excess  of  1.7  million  Lysis  procedures  done  in  the  US  and  in  over  32  countries  internationally.    Lysis  was  developed  as  a  means  of  removing  epidural  scarring  leading  directly  or  indirectly  to  compression,  inflammation,  swelling,  or  a  decreased  nutritional  supply  of  nerve  roots.  It  utilizes  a  number  of  modalities  in  the  effort  to  break  up  epidural  scarring,  including  the  use  of  a  spring  wound  catheter,  placement  of  the  catheter  in  the  ventro-­lateral  aspect  of  the  epidural  space  at  the  site  of  the  exiting  nerve  root,  and  the  use  of  high  volumes  of  injectate,  including  local  anesthetics  and  saline,  either  hypertonic  or  isotonic,  along  with  steroids.    Lysis  is  a  minimally  invasive  procedure  that  is  a  useful,  cost  effective  alternative,  providing  relief  for  patients  suffering  chronic  pain  as  a  result  of  conditions  such  as  failed  back  surgery,  stenosis,  radiculopathy,  epidural  adhesions  and/or  disc  disruption.    Typically,  additional  surgery  is  not  effective  in  relieving  pain  after  previous  surgery.  While  therapies  have  been  developed  to  treat  pain  due  to  spinal  stenosis,  no  therapy  other  than  Lysis  will  treat  pain  due  to  nerve  root  adhesions.    An  added  benefit  to  the  Lysis  procedure  is  the  lack  of  serious  complications  in  the  aging  population.            In  February  2016  a  Systematic  Review  and  Meta-­analysis  of  Lysis  was  published7.    This  review  identified  45  studies  with  7  of  those  being  randomized  controlled  trials  and  3  observational  studies.    Based  upon  7  randomized  controlled  trials  showing  efficacy,  with  no  negative  trials,  there  is  Level  1  or  strong  evidence  of  the  efficacy  of  percutaneous  adhesiolysis  in  the  treatment  of  chronic  refractory  low  back  and  lower  extremity  pain.    In  a  2013  study,  results  reflect  50%  of  patients  will  reduce  or  resolve  their  pain  at  1  year1.    In  a  2012  study  reflected  an  82%  improvement  over  a  2  year  period2.      In  a  2009  peer-­reviewed  published  study,  patients  who  underwent  Lysis  had  a  50%  decrease  in  pain  at  1  year4.      In  July  2006,  a  randomized  blinded  study  was  published  showing  significant  alleviation  of  pain  and  functional  disability  in  patients  with  chronic  low  back  pain  and  sciatica  based  on  disc  protrusion/prolapse  or  failed  back  surgery  at  1  year5.              LT-­130  Rev  7       www.epimed.com 21

Re:        Patient  Name   ID#:     I  will  be  performing  this  procedure  (location).    The  CPT  code  used  for  billing  will  be  62264.    In  addition,   billing  will  be  submitted  for  the  epidural  catheter  outside  the  global  fee  with  a  copy  of  the  invoice  attached.     I  have  attached  all  clinical  information  for  (patient  name)  (attach  patient  chart  notes,  diagnostics,   conserve  trmt,  etc.).      I  am  extremely  confident  that  Epidural  Lysis  of  Adhesions  will  help  my  patient,   thus  avoiding  more  costly  and  invasive  procedures.         If  you  have  any  questions,  please  feel  free  to  contact  me  at  (…….).  Thank  you  for  your  consideration.     Sincerely       Dr.  Doctor,  MD         1**Percutaneous  epidural  lysis  of  adhesions  in  chronic  lumbar  radicular  pain:  a  randomized,  double-­blind,  placebo-­controlled  trial.     Gerdesmeyer  L,  Wagenpfeil  S,  Birkenmaier  C,  Veihelmann  A,  Hauschild  M,  Wagner  K,  Muderis  MA,  Gollwitzer  H,  Diehl  P,  Toepfer   A.          Pain  Physician.  2013  May-­Jun;;16(3):185-­96.     2**Results  of  2-­year  follow-­up  of  a  randomized,  double-­blind,  controlled  trial  of  fluoroscopic  caudal  epidural  injections  in  central   spinal  stenosis.    Manchikanti  L,  Cash  KA,  McManus  CD,  Pampati  V,  Fellows  B.      Pain  Physician.  2012  Sep-­Oct;;15(5):371-­84.     3**A  comparative  effectiveness  evaluation  of  percutaneous  adhesiolysis  and  epidural  steroid  injections  in  managing  lumbar  post-­ surgery  syndrome:  a  randomized,  equivalence  controlled  trial.      Manchikanti  L,  Singh  V,  Cash  KA,  Pampati  V,  Datta  S.      Pain   Physician.  2009  Nov-­Dec;;12(6):E355-­68.     4**The  preliminary  results  of  a  comparative  effectiveness  evaluation  of  adhesiolysis  and  caudal  epidural  injections  in  managing   chronic  low  back  pain  secondary  to  spinal  stenosis:  a  randomized,  equivalence  controlled  trial.        Manchikanti  L,  Cash  KA,  McManus   CD,  Pampati  V,  Singh  V,  Benyamin  R.    Pain  Physician.  2009  Nov-­Dec;;12(6):E341-­54.   5**Epidural  neuroplasty  versus  physiotherapy  to  relieve  pain  in  patients  with  sciatica:  a  prospective  randomized  blinded  clinical  trial.     Andreas  Veihelmann,  C.  Devens,  H.  Trouillier,  C.  Birkenmaier,  L.  Gerdesmeyer,  and  H.J.  Refior;;      J  Orthop  Sci  (2006)  11:365–369   6**One  day  lumbar  epidural  adhesiolysis  and  hypertonic  saline  neurolysis  in  treatment  of  chronic  low  back  pain:  a  randomized,   double-­blind  trial.        Manchikanti  L,  Rivera  JJ,  Pampati  V,  Damron  KS,  McManus  CD,  Brandon  DE,  Wilson  SR.        Pain  Physician.   2004  Apr;;  7(2):177-­86.   7**  Percutaneous  and  Endoscopic  Adhesiolysis  in  Managing  Low  Back  and  Lower  Extremity  Pain:  A  Systematic  Review  and  Meta-­ analysis.    Standiford  Helm,  MD,  Gabor  B.  Racz,  MD,,  Ludger  Gerdesmeyer,  MD,  Rafael  Justiz,  MD,  Salim  Hayek,  MD5,  Eugene  D.   Kaplan,  MD6,  Mohamed  Ahamed  El  Terany,  MD7,  and  Nebojsa  Nick  Knezevic,  MD,  PhD.       Pain  Physician  2016;;  19:E245-­E281   LT-­130  Rev  7      22

FOR MEDICARE ADVANTAGE PARTICIPANTS Sample  Letter  of  Medical  Necessity  for  Lysis  of  Adhesions      <Date>   EXAMPLE:    Be  sure  to  put    Name   your  own  MACs  LCD#.    Address   Enclosing  a  copy  of  the  LCD  City,  State  Attn:    Appeal  Department   may  be  helpful.      Re:        Patient  Name  ID#:    To  Whom  It  May  Concern:    I  am  requesting  authorization/precertification  on  behalf  of  my  patient  (patient  name)  for  the  outpatient  procedure,  Epidural  Lysis  of  Adhesions.    This  patient  is  currently  covered  under  a  Medicare  Advantage  plan;;  “Blue  Cross  Medicare  Advantage”.    The  local  MAC  is  Novitas  and  their  current  LCD  (35033)  does  provide  coverage  for  this  procedure  (see  attached).      (Patient  name)  has  been  a  patient  of  mine  for  approximately…………..    I  have  been  treating  (patient   Epidural Lysis Of Adhesionsname)  for  (diagnosis).      This  patient  presents  with  (DESCRIBE  HISTORY).    (Patient  name)  has  tried   Sample Operative Reportsand  failed  (CONSERVE  TRMT,  SURGERIES,  ETC.  –  YOU’RE  TRYING  TO  PROVE  WHY  THIS  PATIENT  NEEDS  THIS  PROCEDURE).  Epidural  Lysis  of  Adhesions  (Lysis)  is  an  Interventional  Pain  Management  technique  which  emerged  in  the  late  80’s.    To  date,  there  have  been  in  excess  of  1.7  million  Lysis  procedures  done  in  the  US  and  in  over  32  countries  internationally.    Lysis  was  developed  as  a  means  of  removing  epidural  scarring  leading  directly  or  indirectly  to  compression,  inflammation,  swelling,  or  a  decreased  nutritional  supply  of  nerve  roots.  It  utilizes  a  number  of  modalities  in  the  effort  to  break  up  epidural  scarring,  including  the  use  of  a  spring  wound  catheter,  placement  of  the  catheter  in  the  ventro-­lateral  aspect  of  the  epidural  space  at  the  site  of  the  exiting  nerve  root,  and  the  use  of  high  volumes  of  injectate,  including  local  anesthetics  and  saline,  either  hypertonic  or  isotonic,  along  with  steroids.    Lysis  is  a  minimally  invasive  procedure  that  is  a  useful,  cost  effective  alternative,  providing  relief  for  patients  suffering  chronic  pain  as  a  result  of  conditions  such  as  failed  back  surgery,  stenosis,  radiculopathy,  epidural  adhesions  and/or  disc  disruption.    Typically,  additional  surgery  is  not  effective  in  relieving  pain  after  previous  surgery.  While  therapies  have  been  developed  to  treat  pain  due  to  spinal  stenosis,  no  therapy  other  than  Lysis  will  treat  pain  due  to  nerve  root  adhesions.    An  added  benefit  to  the  Lysis  procedure  is  the  lack  of  serious  complications  in  the  aging  population.            In  February  2016  a  Systematic  Review  and  Meta-­analysis  of  Lysis  was  published7.    This  review  identified  45  studies  with  7  of  those  being  randomized  controlled  trials  and  3  observational  studies.    Based  upon  7  randomized  controlled  trials  showing  efficacy,  with  no  negative  trials,  there  is  Level  1  or  strong  evidence  of  the  efficacy  of  percutaneous  adhesiolysis  in  the  treatment  of  chronic  refractory  low  back  and  lower  extremity  pain.    In  a  2013  study,  results  reflect  50%  of  patients  will  reduce  or  resolve  their  pain  at  1  year1.    In  a  2012  study  reflected  an  82%  improvement  over  a  2  year  period2.      In  a  2009  peer-­reviewed  published  study,  patients  who  underwent  Lysis  had  a  50%  decrease  in  pain  at  1  year4.      In  July  2006,  a  randomized  blinded  study  was  published  showing  significant  alleviation  of  pain  and  functional  disability  in  patients  with  chronic  low  back  pain  and  sciatica  based  on  disc  protrusion/prolapse  or  failed  back  surgery  at  1  year5.        LT-­130  Rev  7       www.epimed.com 23

    Re:        Patient  Name   ID#:       I  will  be  performing  this  procedure  (location).    The  CPT  code  used  for  billing  will  be  62264.    In  addition,   billing  will  be  submitted  for  the  epidural  catheter  outside  the  global  fee  with  a  copy  of  the  invoice  attached.     I  have  attached  all  clinical  information  for  (patient  name)  (attach  patient  chart  notes,  diagnostics,   conserve  trmt,  etc.).      I  am  extremely  confident  that  Epidural  Lysis  of  Adhesions  will  help  my  patient,   thus  avoiding  more  costly  and  invasive  procedures.         If  you  have  any  questions,  please  feel  free  to  contact  me  at  (…….).  Thank  you  for  your  consideration.   Sincerely       Dr.  __________,    MD         1**Percutaneous  epidural  lysis  of  adhesions  in  chronic  lumbar  radicular  pain:  a  randomized,  double-­blind,  placebo-­controlled  trial.     Gerdesmeyer  L,  Wagenpfeil  S,  Birkenmaier  C,  Veihelmann  A,  Hauschild  M,  Wagner  K,  Muderis  MA,  Gollwitzer  H,  Diehl  P,  Toepfer   A.          Pain  Physician.  2013  May-­Jun;;16(3):185-­96.     2**Results  of  2-­year  follow-­up  of  a  randomized,  double-­blind,  controlled  trial  of  fluoroscopic  caudal  epidural  injections  in  central   spinal  stenosis.    Manchikanti  L,  Cash  KA,  McManus  CD,  Pampati  V,  Fellows  B.      Pain  Physician.  2012  Sep-­Oct;;15(5):371-­84.     3**A  comparative  effectiveness  evaluation  of  percutaneous  adhesiolysis  and  epidural  steroid  injections  in  managing  lumbar  post   surgery  syndrome:  a  randomized,  equivalence  controlled  trial.      Manchikanti  L,  Singh  V,  Cash  KA,  Pampati  V,  Datta  S.      Pain   Physician.  2009  Nov-­Dec;;12(6):E355-­68.     4**The  preliminary  results  of  a  comparative  effectiveness  evaluation  of  adhesiolysis  and  caudal  epidural  injections  in  managing   chronic  low  back  pain  secondary  to  spinal  stenosis:  a  randomized,  equivalence  controlled  trial.        Manchikanti  L,  Cash  KA,  McManus   CD,  Pampati  V,  Singh  V,  Benyamin  R.    Pain  Physician.  2009  Nov-­Dec;;12(6):E341-­54.   5**Epidural  neuroplasty  versus  physiotherapy  to  relieve  pain  in  patients  with  sciatica:  a  prospective  randomized  blinded  clinical  trial.     Andreas  Veihelmann,  C.  Devens,  H.  Trouillier,  C.  Birkenmaier,  L.  Gerdesmeyer,  and  H.J.  Refior;;      J  Orthop  Sci  (2006)  11:365–369   6**One  day  lumbar  epidural  adhesiolysis  and  hypertonic  saline  neurolysis  in  treatment  of  chronic  low  back  pain:  a  randomized,   double-­blind  trial.        Manchikanti  L,  Rivera  JJ,  Pampati  V,  Damron  KS,  McManus  CD,  Brandon  DE,  Wilson  SR.        Pain  Physician.   2004  Apr;;7(2):177-­86.   7**  Percutaneous  and  Endoscopic  Adhesiolysis  in  Managing  Low  Back  and  Lower  Extremity  Pain:  A  Systematic  Review  and  Meta-­ analysis.    Standiford  Helm,  MD,  Gabor  B.  Racz,  MD,,  Ludger  Gerdesmeyer,  MD,  Rafael  Justiz,  MD,  Salim  Hayek,  MD5,  Eugene  D.   Kaplan,  MD6,  Mohamed  Ahamed  El  Terany,  MD7,  and  Nebojsa  Nick  Knezevic,  MD,  PhD.       Pain  Physician  2016;;  19:E245-­E281     LT-­130  Rev  7      24

  OPERATIVE  REPORT  ANESTHESIA:          PREOPERATIVE  DIAGNOSIS:   IV  sedation  and  local.                       1.    Lumbar  degenerative  disc  disease             2.    Lumbar  radiculopathy     3.    Lumbar  spondylosis   4.    Lumbar  HNP  POSTOPERATIVE  DIAGNOSIS:   Same    NAME  OF  PROCEDURE:     1.    Caudal  epidurogram             2.    Decompressive  caudal  neuroplasty             3.    Bilateral  lumbar  facet  blocks,  L3  through  S1    COMPLICATIONS:       None    ESTIMATED  BLOOD  LOSS:     None    IV  FLUIDS:         100  cc   Epidural Lysis Of Adhesions Sample Operative Reports  SUMMARY  OF  PROCEDURE:    The  patient  was  brought  to  the  OR  informed  consent  was  obtained,  vital  signs  were  checked  and  found  to  be  within  normal  limits,  and  IV  access  was  established.  Following  this,  the  patient  was  placed  prone  and  the  lumbosacral  area  was  prepped  and  draped  in  the  sterile  manner.    Utilizing  AP  and  lateral  fluoroscopic  guidance,  the  sacral  hiatus  was  identified.    The  skin  was  anesthetized  with  lidocaine  1.5%  using  a  #25  gauge  needle.  Following  this,  a  #15  gauge  RX  needle  was  inserted  through  the  sacral  hiatus.    Following  this,  epidurogram  was  performed  with  10  cc  of  Isovue-­200  contrast  showing  a  filling  defect  in  the  ventral  lateral  epidural  space  on  the  left  at  L5-­S1.  Following  this,  a  Brevi  catheter  was  placed  into  the  ventral  lateral  epidural  space  on  the  left  at  L5-­S1.    1  cc  of  Isovue-­200  contrast  was  injected  which  now  showed  an  open  ventral  lateral  epidural  space  at  L4-­5  and  L5-­S1  with  open  nerve  root  on  the  left  at  L5-­S1.  Following  this,  the  patient  underwent  injection  of  Wydase  1,500  units,  10  cc,  after  negative  aspiration.    Following  this,  the  patient  underwent  injection  of  local  anesthetic  solution  with  Naropin  0.2%  and  Aristocort  40  mg  after  negative  aspiration  and  negative  3  cc  test  dose.    Total  volume  used  was  10  cc.    LT-­130  Rev  7       www.epimed.com 25

    PAGE  TWO         Following  this,  the  needle  was  removed  and  the  catheter  was  secured  in  place.     Following  this,  L3  on  the  right  was  identified.    The  camera  was  oblique’d  in  a  right  and   craniocaudal  manner.    The  skin  was  anesthetized  with  lidocaine  1.5%  using  a  #25  gauge   needle.     Following  this,  a  #22  gauge  B-­beveled  needle  was  inserted.    Bony  contact  was  made  and  it  was   walked  off  laterally  and  confirmed  on  the  lateral  view  to  be  at  the  level  of  the  facet,  below  the   level  of  the  neural  foramen,  below  the  level  of  the  disc.     Following  this,  the  patient  underwent  injection  of  local  anesthetic  solution  with  Naropin  0.2%  and   Aristocort  40  mg  after  negative  aspiration.    Volume  used  was  1  cc.     The  procedure  as  above  was  then  repeated  on  the  right  at  L4,  L5  and  S1  at  the  ala  and  on  the   left  at  L3,  L4,  L5  and  S1  at  the  ala.     Following  this,  the  patient  was  taken  to  the  recovery  room  where,  30  minutes  later,  sensory  and   motor  resting  were  within  normal  limits.    She  underwent  an  infusion  of  hypertonic  saline  10%  10   cc  over  30  minutes  without  any  complications.     The  catheter  was  removed  with  the  tip  intact.    Wounds  were  bandaged  sterilely.    The  patient   recovered  without  incident  and  was  discharged  in  satisfactory  condition.   LT-­130  Rev  7      26

   PREOPERATIVE  DIAGNOSIS:   1.    Right  L4  radiculopathy             2.    Lumbar  degenerative  disc  disease             3.    Intractable  right  leg  pain    PROCEDURE:       Percutaneous  epidurogram  and  neurolytic  infusion    ANESTHESIA:       IV  sedation  and  local.     None    ESTIMATED  BLOOD  LOSS:      IV  FLUIDS:         200  cc    INDICATIONS:       As  above    COMPLICATIONS:       None    SUMMARY  OF  PROCEDURE:    The  patient  was  brought  into  the  hospital.    Informed  consent   Epidural Lysis Of Adhesionsand  IV  access  were  obtained.    The  patient  was  given  preoperatively,  1  gram  of  Ancef  and  taken   Sample Operative Reportsto  the  OR  suite  and  placed  in  the  prone  position  where  the  back  was  prepped  and  draped  in  a  sterile  fashion.    Using  fluoroscopic  guidance,  the  sacral  hiatus  was  identified  and  the  skin  was  anesthetized  in  the  left  lateral  sacral  hiatus  with  3  cc  of  0.25%  Marcaine  with  epi.    Through  the  anesthetized  area,  a  16-­gauge  RK  needle  was  placed  into  the  epidural  space  through  the  sacral  hiatus  under  fluoroscopic  guidance.    There  was  no  heme,  CSF,  or  parenthesis  and  a  24  XL  catheter  was  threaded  to  the  S1  level  and  after  negative  aspirations,  5  cc  of  200  Isovue  was  injected  showing  truncation  of  filling  above  the  L5  level  bilaterally.    Catheter  was  then  manipulated  into  the  ventral  space  at  the  area  of  obstruction  and  10  cc  of  preservative-­free  normal  saline  was  injected  vigorously  for  hydrostatic  dissection.    The  catheter  was  manipulated  to  the  pedicle  of  L5  in  AP  projection  and  then  after  negative  aspiration,  a  repeat  aliquot  of  Isovue  showed  good  filling  in  the  cephalad  and  caudad  fashion,  but  still  limited  filling  at  the  neural  foramen.    There  was  some  obstruction  to  catheter  passage  in  the  lateral  recess  at  L4  as  well.    The  catheter  was  left  at  this  level  where  1500  units  of  Wydase  was  injected  followed  by  a  2-­cc  test  dose  of  0.2%  Naropin.    After  the  test  dose  of  Naropin,  the  remaining  8  cc  and  40  mg  of  triamcinolone  were  placed.    The  needle  was  removed  over  the  catheter  and  a  catheter-­locking  dressing  was  placed  on  the  skin  with  a  filter.    The  patient  was  taken  to  the  recovery  room  in  stable  condition  where  after  no  evidence  of  a  motor  block,  a  10-­cc  infusion  of  10%  hypertonic  saline  was  given  over  30  minutes.    The  patient  tolerated  the  infusion  without  side-­effects.    The  catheter  was  removed  with  the  tip  intact.    The  patient  was  discharged  in  stable  condition.    Follow  up  in  a  month.  LT-­130  Rev  7       www.epimed.com 27

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MEDICATION / SUPPLY CODES32

**SUPPLY  MEDICATION  CODING   Medication / Supply Codes    A4212  -­  Non-­coring  needle  or  stylet  with  or  without  catheter     May  be  used  when  billing  for  blunt  needles,  however,  it  is  at  carrier  discretion  as  to   whether  they  will  reimburse  A4215  -­  Needles  only,  sterile,  any  size,  each   Can  be  used  for  billing  needles,  however,  it  is  at  carrier  discretion  as  to  whether  they   will  reimburse  A4550  -­  Surgical  Tray  (not  payable  by  Medicare)  A4930  -­  Gloves,  sterile,  per  pair  A4649  -­  Surgical  supply;;  miscellaneous  C1755  -­  Catheter;;  intraspinal    C1730  -­  Catheter,  electrophysiology,  diagnostic,  other  than  3D  mapping   Can  be  used  for  billing  stimulating  catheter,  however,  it  is  at  carrier  discretion  as  to   whether  they  will  reimburse  99070  -­  Miscellaneous  surgical  supply    Miscellaneous  codes  can  be  used  in  most  scenarios  for  claim  submission  in  a  Physician  office.    Again,  it  is  always  best  to  verify  with  each  carrier  to  ensure  no  specific  requirement  must  be  met.    Attaching  a  copy  of  the  invoice  with  your  claim  submission  will  often  eliminate  any  questions  raised  about  the  charge,  but  does  not  guarantee  payment.                    **The  above  codes  are  intended  as  “suggested  codes”.      It  is  up  to  each  Provider  to  decide  appropriateness  for  his/her  practice.      Medicare/Local  Carrier  may  offer  additional  guidelines.        LT-­130  Rev  7       www.epimed.com 33

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Medications   Medication / Supply Codes  A4248  -­  Chlorhexidine  containing  antiseptic,  1  ml  (Chloraprep)  J0702  -­   Injection,  betamethasone  acetate,  3  mg  and  betamethasone  sodium         phosphate  3  mg  (Celestone  Soluspan)  J7131  -­   Hypertonic  Saline  Solution,  1  ml  J3470  -­   Injection,  hyaluronidase,  up  to  150  units  (Amphadase,  Vitrase,  Wydase)  J3471  -­   Injection,  hyaluronidase,  ovine,  preservative  free,  per  1  USP  unit  (up  to  999   USP  units)  (Vitrase)  J3472  -­   Injection,  hyaluronidase,  ovine,  preservative  free,  per  1000  USP  units    J3473  -­   Injection,  hyaluronidase,  recombinant,  1  USP  unit  (Hylenex)  J2795  -­   Ropivacaine  hydrochloride,  1  mg  (Naropin)  S0020  -­  Bupivacaine,  30  ml  J2250  -­   Injection,  midazolam  HCI,  per  1  mg  (Versed)  Q9965  -­ L  ow  osmolar  contrast  material,  100-­199  mg/ml  iodine  concentration,  per  ml   (Omnipaque  140,  Omnipaque  180,  Optiray  160,  Ultravist  150)  Q9966  -­ L  ow  osmolar  contrast  material,  200-­299  mg/ml  iodine  concentration,  per  ml   (Isovue-­200,  Isovue-­250,  Isovue-­M-­200,  Isovue-­250  Prefilled  Syringes,   Omnipaque  240,  Optiray  240,  Ultravist  240,  Visipaque,  Visipaque  270,  Ultravist   300)  J7999  -­   Compounded  drug,  not  otherwise  classified                                            LT-­130  Rev  7       www.epimed.com 35

APPEALS / INDEPENDENT EXTERNAL REVIEW36

 The  Importance  of  Appealing  a  Denial    As  healthcare  changes  and  new  technologies  emerge,  Physicians  and  patients  are  given  more  options  for  minimally  invasive  procedures  with  lower  risks  and  shorter  recovery  periods.    Unfortunately,  insurance  companies  are  not  as  quick  to  embrace  these  procedures.    When  your  insurance  carrier  makes  a  decision  to  deny  your  request  for  a  procedure,  it’s  important  to  know  what  options  are  available.  Most  insurance  companies  have  two  (2)  levels  of  appeal.  The  appeal  process  should  be  outlined  in  your  initial  denial  letter.  Your  first  level  appeal  will  typically  take  between  30-­45  days  for  a  response  from  the  insurance  carrier.    If  you  receive  another  denial,  send  your  second  level  appeal.    A  second  level  appeal  is  your  basic  appeal  with  any  additional  chart  notes  or  testing.  According  to  a  study  done  by  the  American  Association  of  Health  Plans  on  the  external  review  process  throughout  the  US,  out  of  every  12,000  individuals  eligible  for  appeal,  only  1  appeal  was  received.    However,  of  those  received,  40%  of  the  cases  appealed,  reviewers  agreed  with  the  consumer.  It  is  very  important  to  appeal  cases  that  are  denied  as  experimental  and  investigational,  as  most  health  plans  will  make  a  coverage  policy  decision  based  on  how  many  requests  they  receive.    It  is  imperative  that  we  keep  pursuing  these  cases.      The  following  forms  can  be  utilized  to  help  your  staff  with  this  process. Appeals / Independent External ReviewLT-­130  Rev  7       www.epimed.com 37

Sample  Appeal  Letter  for  Lysis  of  Adhesions     <Date>     Name   Address   City,  State   Attn:    Appeal  Department     Re:        Patient  Name   ID#:     To  Whom  It  May  Concern:     I  am  requesting  a  formal  appeal  of  your  denial  of  Epidural  Lysis  of  Adhesions  (Epidural  Adhesiolysis)  for  my    patient,  (patient  name).      I  have  been  treating  (patient  name)  for  (diagnosis)  for  the  past  (duration).           DESCRIBE  HISTORY,  CONSERVE  TRMT,  SURGERIES,  ETC.  –  YOU’RE  TRYING  TO  PROVE  WHY  THIS     PATIENT  NEEDS/NEEDED  THIS  PROCEDURE.     Epidural  Lysis  of  Adhesions  (Lysis)  is  an  Interventional  Pain  Management  technique  which  emerged  in   the  late  80’s.    To  date,  there  have  been  in  excess  of  1.7  million  Lysis  procedures  done  in  the  US  and  in   over  32  countries  internationally.    Lysis  was  developed  as  a  means  of  removing  epidural  scarring  leading   directly  or  indirectly  to  compression,  inflammation,  swelling,  or  a  decreased  nutritional  supply  of  nerve   roots.  It  utilizes  a  number  of  modalities  in  the  effort  to  break  up  epidural  scarring,  including  the  use  of  a   spring  wound  catheter,  placement  of  the  catheter  in  the  ventro-­lateral  aspect  of  the  epidural  space  at  the   site  of  the  exiting  nerve  root,  and  the  use  of  high  volumes  of  injectate,  including  local  anesthetics  and   saline,  either  hypertonic  or  isotonic,  along  with  steroids.     Lysis  is  a  minimally  invasive  procedure  that  is  a  useful,  cost  effective  alternative,  providing  relief  for   patients  suffering  chronic  pain  as  a  result  of  conditions  such  as  failed  back  surgery,  stenosis,   radiculopathy,  epidural  adhesions  and/or  disc  disruption.    Typically,  additional  surgery  is  not  effective  in   relieving  pain  after  previous  surgery.  While  therapies  have  been  developed  to  treat  pain  due  to  spinal   stenosis,  no  therapy  other  than  Lysis  will  treat  pain  due  to  nerve  root  adhesions.    An  added  benefit  to  the   Lysis  procedure  is  the  lack  of  serious  complications  in  the  aging  population.             In  February  2016  a  Systematic  Review  and  Meta-­analysis  of  Lysis  was  published7.    This  review   identified  45  studies  with  7  of  those  being  randomized  controlled  trials  and  3  observational   studies.    Based  upon  7  randomized  controlled  trials  showing  efficacy,  with  no  negative  trials,   there  is  Level  1  or  strong  evidence  of  the  efficacy  of  percutaneous  adhesiolysis  in  the  treatment  of   chronic  refractory  low  back  and  lower  extremity  pain.    In  a  2013  study,  results  reflect  50%  of  patients   will  reduce  or  resolve  their  pain  at  1  year1.    In  a  2012  study  reflected  an  82%  improvement  over  a  2  year   period2.      In  a  2009  peer-­reviewed  published  study,  patients  who  underwent  Lysis  had  a  50%  decrease  in   pain  at  1  year4.      In  July  2006,  a  randomized  blinded  study  was  published  showing  significant  alleviation   of  pain  and  functional  disability  in  patients  with  chronic  low  back  pain  and  sciatica  based  on  disc   protrusion/prolapse  or  failed  back  surgery  at  1  year5.                             LT-­130  Rev  7      38

Re:        Patient  Name   Appeals / Independent External Review        ID#:          Please  review  all  of  the  attached  information  for  (patient  name)  (attach  patient  chart  notes,  diagnostics,  conserve  trmt,  etc.).      I  am  extremely  confident  that  Epidural  Lysis  of  Adhesions  (Epidural  Adhesiolysis)  will    help  my  patient,  thus  avoiding  a  more  invasive  procedure.        If  you  have  any  questions,  please  feel  free  to  contact  me  at  (…….).  Thank  you  for  your  consideration.    Sincerely          (Dr.  Name)                    1**Percutaneous  epidural  lysis  of  adhesions  in  chronic  lumbar  radicular  pain:  a  randomized,  double-­blind,  placebo-­controlled  trial.    Gerdesmeyer  L,  Wagenpfeil  S,  Birkenmaier  C,  Veihelmann  A,  Hauschild  M,  Wagner  K,  Muderis  MA,  Gollwitzer  H,  Diehl  P,  Toepfer  A.          Pain  Physician.  2013  May-­Jun;;16(3):185-­96.    2**Results  of  2-­year  follow-­up  of  a  randomized,  double-­blind,  controlled  trial  of  fluoroscopic  caudal  epidural  injections  in  central  spinal  stenosis.    Manchikanti  L,  Cash  KA,  McManus  CD,  Pampati  V,  Fellows  B.      Pain  Physician.  2012  Sep-­Oct;;15(5):371-­84.    3**A  comparative  effectiveness  evaluation  of  percutaneous  adhesiolysis  and  epidural  steroid  injections  in  managing  lumbar  post  surgery  syndrome:  a  randomized,  equivalence  controlled  trial.      Manchikanti  L,  Singh  V,  Cash  KA,  Pampati  V,  Datta  S.      Pain  Physician.  2009  Nov-­Dec;;12(6):E355-­68.    4**The  preliminary  results  of  a  comparative  effectiveness  evaluation  of  adhesiolysis  and  caudal  epidural  injections  in  managing  chronic  low  back  pain  secondary  to  spinal  stenosis:  a  randomized,  equivalence  controlled  trial.        Manchikanti  L,  Cash  KA,  McManus  CD,  Pampati  V,  Singh  V,  Benyamin  R.    Pain  Physician.  2009  Nov-­Dec;;12(6):E341-­54.  5**Epidural  neuroplasty  versus  physiotherapy  to  relieve  pain  in  patients  with  sciatica:  a  prospective  randomized  blinded  clinical  trial.    Andreas  Veihelmann,  C.  Devens,  H.  Trouillier,  C.  Birkenmaier,  L.  Gerdesmeyer,  and  H.J.  Refior;;      J  Orthop  Sci  (2006)  11:365–369  6**One  day  lumbar  epidural  adhesiolysis  and  hypertonic  saline  neurolysis  in  treatment  of  chronic  low  back  pain:  a  randomized,  double-­blind  trial.        Manchikanti  L,  Rivera  JJ,  Pampati  V,  Damron  KS,  McManus  CD,  Brandon  DE,  Wilson  SR.        Pain  Physician.  2004  Apr;;7(2):177-­86.  7**  Percutaneous  and  Endoscopic  Adhesiolysis  in  Managing  Low  Back  and  Lower  Extremity  Pain:  A  Systematic  Review  and  Meta-­analysis.    Standiford  Helm,  MD,  Gabor  B.  Racz,  MD,,  Ludger  Gerdesmeyer,  MD,  Rafael  Justiz,  MD,  Salim  Hayek,  MD5,  Eugene  D.  Kaplan,  MD6,  Mohamed  Ahamed  El  Terany,  MD7,  and  Nebojsa  Nick  Knezevic,  MD,  PhD.      Pain  Physician  2016;;  19:E245-­E281    LT-­130  Rev  7       www.epimed.com 39

Independent  External  Reviews     Most  people  receive  their  health  care  through  some  type  of  managed  care  plan  (HMO,   PPO,  POS).    Most  of  the  time,  we  receive  the  care  we  need,  however,  the  potential   exists  for  disagreements  over  the  services  that  will  be  provided  or  paid  for  by  health   plans.     Each  health  plan  is  required  to  follow  state  and  federal  rules  for  handling  their  enrollee’s   complaints  and  appeals  inside  the  health  plan,  known  as  an  “internal  review”.  Many   states  have  legislated  additional  procedures  outside  of  the  health  plan,  called  “external   reviews”  or  “independent  reviews,”  to  provide  an  unbiased  way  to  resolve  disputes   between  patients  and  their  health  plans.  An  external  review  is  a  reconsideration  of  your   health  plan’s  denial  of  service.    This  review  will  typically  be  conducted  by  a  person  or   panel  of  individuals  who  are  not  affiliated  with  your  health  plan.  Beginning  January  1,   2016,  all  states  will  have  implemented  some  type  of  external  review  process.   This  process  is  extremely  important  in  that  it  is  the  last  process  a  patient  has  once  the   appeal  process  (first  and  second  level)  has  been  exhausted.    This  process  involves  a   request  made  by  the  patient  through  either  the  State  Department  of  Insurance  or  the   Department  of  Health  and  Human  Services  (it  varies  in  each  State).    Once  the  request   has  been  made  and  the  appropriate  documentation  sent,  it  is  reviewed  by  a  non  biased   independent  group.  Physicians  who  perform  independent  medical  reviews  must  be   board  certified  and  in  active  practice  in  that  same  area  of  treatment.    Their  (IRO)   decisions  are  binding  in  most  states.    However,  keep  in  mind  that  the  patient  can  not   request  an  external  review  if  the  physician  has  not  exhausted  the  appeal  process.     Anyone  enrolled  in  a  health  plan  should  be  familiar  with  their  plan’s  internal  review   process  and/or  any  external  review  programs  in  case  problems  later  arise.                 LT-­130  Rev  7      40

 13958 Diplomat DriveFarmers Branch, TX(972) 349-8812 Epidural Lysis of Adhesions Appeal Request Fax (972) 241-6263 Attention: Meredith GeorgePhys. Office Contact _________________________________ Phone # __________________________Status Update E-Mail Address __________________________ Fax # ___________________________Physician Name _____________________________________ Office Zip Code _________ State _____Physician Tax ID ________________________________ Specialty _____________________________Patient’s Name ____________________________________ Hm Phone __________________________Patient’s Address _______________________________ City_______________ State_____ Zip _______Insured’s ID# ___________________________ Insured’s SSN # ___________________ DOB ________Employer _____________________________________ Group # ________________________________Insurance Carrier ___________________________ HMO ___ PPO __ Indemnity ___W/C ___ Auto ___Insurance Address ____________________________________ City_________ State _____ Zip _______Telephone ____________________________________ Precert Phone ___________________________Claim # ______________________________ DOI ___________________ W/C Adj. _______________Facility where procedure will be/was performed _________________________________________________Facility Address: ______________________________________________________________________City ___________________________ State ____ Zip ______________ Phone _____________________Provider ID # _________________________________________________________________________ •   Group insurance carriers by state statute, depending on state, have 30-45 days to respond to formal written requests.The following information must be enclosed; exclusions could cause a delay with your request. H & P (if available) HIPPA FORM Signed by patient Last 30 day Progress Notes Enlarged copy of patient’s insurance card Medical reflecting failure of conservative treatment RX or dictation in the physician notes or reflecting recommendation of Epidural Lysis of Adhesions Copy of denial letter from insurance carrierLT-­130  Rev  7       www.epimed.com 41

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Product Name Catalog Number         Notes: www.epimed.com 43

EQUIPMENTFOREVERYPROCEDURE. Pain Management R-F™ Radiofrequency Cryoanalgesia Specialty Needles Coudé® Blunt Standard Needles R-F™ Cannulas PainBlocker™ BELLA-D™ Tuohy R-F™ Needles Trocar and Hemispherical Probes Day Chiba R-F™ Coudé® Needles Grounding Pad STEALTH™ Quincke R-F™ Blunt Needles Mobile Cart Epidural Introducer Trays & Kits R-F™ Coudé® Blunt Needles Sterilization Tray MiniTrays w/ plastic LOR Probes Exhaust Tubing Needles Tuohy Single Shot R-F™ Electrodes (Thermocouples) RX Coudé® Epidural Prep Tray R-F™ Nitinol Electrodes RX-2® Accessories R.K.™ Flat Filters (Thermocouples) RX Extensions Sets R-F Disposable Electrodes FIC Stingray Connector Catheters Radiation Safety (Thermocouples) Racz® Catheters Aprons and Gloves FETH-R-KATH Glasses Grounding Pads VERSA-KATH Grounding Pad Only Grounding Pad w/ Attached Cablewww.epimed.com Grounding Pad Cable (reusable)

Regional Anesthesia Physician ServicesCatheters and Needles Cadaver TrainingWiley Spinal® Reimbursement SupportFETH-R-KATH™ Fellowship TrainingQuincke Procedure GuidesChiba Physician SupportSPIROL®TuohyTrays, Kits & Minimizing Risk. Accessories Every Procedure. Every Time.™Mini Trays and Prep TraysStingray® ConnectorSingle Shot KitsExtension SetsSimulationGENESIS Epidural-Spinal Injection Simulator

Epimed Customer Service Toll Free: 800.866.3342 Phone: 518.725.0209 [email protected] www.epimed.com Corporate Headquarters 13958 Diplomat Drive Dallas, TX 75324 Phone: 972.373.9090 Fax: 972.373.9095 Manufacturing Plant 141 Sal Landrio Drive Johnstown, NY 12095 Phone: 518.725.0209 Fax: 518.725.0207 www.epimed.comLT-130 Rev. 7 2016 Epimed International, Inc. All rights reserved.