Department  of Health  and Human  Sefices   
OFFICE  OF 
  INSPECTOR  GENERAL 
MEDICARE  CARRIERS  POLICIES  FOR 
TRANSCWNIAL  DOPPLERS: 
A NEW  TECHNOLOGY 
MARCH  1993  oEI-03-91-m951  EXECUTIVE  SUMMARY 
PUIiiOSE 
This  report  reviews  Medicare  carriers  coverage  policies  for transcranial  dopplers,  a 
new  technology. 
BACKGROUND 
Transcranial  doppler  (TCD)  is a noninvasive  ultrasound  technique  that  measures 
blood  flow velocities  in the  major  arteries  in the  skull.  The  TCD  technology  was 
introduced  in  1982. 
The  Health  Care  Financing  Administration  (HCFA)  contracts  with  private  insurance 
organizations,  called  carriers,  to make  Medicare  coverage  determinations  and  disburse 
payments.  When  HCFA  issues  policy guidance  on a new technology,  carriers  are 
required  to follow it.  When  no guidance  is provided,  each  carrier  establishes  its own 
coverage  policies. 
Carriers  use  the  HCFA  Common  Procedure  Coding  System  (HCPCS)  to  reimburse 
Medicare  Part  B services,  including  physician  services.  The  HCPCS is based  on the 
Current  Procedural  Terminolo~  (CPT)  coding  system,  which was developed  by the 
American  Medical  Association  (AMA)  in  1966 and  updated  annually.  Effective 
January  1, 1992, two new  CPT  codes  were  established  for TCD  services.  Physicians 
use  the  new  codes  to  claim  Medicare  reimbursement  for TCD  tests  performed  on or 
after  that  date. 
In a related  study  (Medicare  Carrier  Assessment  of New Technologies,  0EI-Ol-88-
00010),  we found  inconsistencies  in carrier  coverage  and  pricing  decisions  and  a 
significant  need  for  HCFA  guidance  involving  new technologies.  We  recommended 
HCFA  improve  its ability  to identi~  emerging  technologies  and  make  more  consistent 
coverage  decisions  for  new  technologies. 
METHODOLOGY 
In late  1991, we reviewed  earners  coverage  policies  and  guidelines  for  TCDS.  In early 
1992, we recontacted  those  carriers  that  did  not  cover  TCDS in  1991 to determine  if 
they  had  changed  their  policies,  and,  if SO,what  had  influenced  their  decisions.  We 
also  obtained  payment  information  for  the  two TCD  procedure  codes  for the  first 
quarter  of  1992 from  the  Part  B Extract  Summary  System  (BESS)  file.  We  obtained 
technical  and  clinical  information  on TCDS from  medical  literature,  professional 
provider  organizations,  and  individual  physician  experts. 
i  TABLE  OF  CONTENTS 
EX&UTIVE  SUMMARY 
INTRODUCIION  . . . . . . . . . . . . . . . . . . ..-.....--...-...=...====..===- 1 
Carrier Coverage Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..-00.0-003 
Carrier Payments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..0000003 
Influence ofCPTCodes  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..=- ==..4 
HCFAEfforts  . . . . . . . . . . . . . . . . . . . .- . . . . . . . . . . . . . . ..=.  ======--==5 
RECOMMENDA~ON  . . . . . . . . . . . . . ..-..............-...=--=-==-- -=7 
COMMENT S. . . . . . . . . . . . . . . . . . . . . * * . . =- . * -- * =* - * . ==- * * - **=-*-.*- 8 
APPENDIXA  AmerkanAcademyofNeurologyEWitbkhed  andliwestigational 
Uses ofTranscranial  Dopplers  . . . . . . . . . . . . . . . . . . . . . . . ..A-1  INTRODUCTION 
P~OSE 
This  report  reviews  Medicare  carriers  coverage  policies  for transcranial  dopplers,  a 
new technology. 
BACKGROUND 
Transcranial  doppler  (TCD)  is a noninvasive  ultrasound  technique  which  measures 
circulation  in the  major  arteries  inside  the  skull.  First  introduced  in  1982, the  TCD  is 
used  to determine  changes  in blood  flow velocity.  Increased  velocity  generally 
indicates  a narrowed  blood  vessel. 
The  test  is done  with  a hand-held  instrument  which  transmits  ultrasonic  energy  from  a 
probe  to a point  inside  an  artery  in the  brain.  Some  of the  energy  is reflected  back  to 
the  probe.  It is then  analyzed,  displayed  on a monitor,  and  recorded  graphically. 
According  to  the  American  Academy  of Neurologys  Repoti  of the Z?zerapeutics and 
Technology Assessment  Committee,  TCD  has  a number  of established  and 
investigational  uses.  Their  March  1990 report  lists five conditions  for which  TCD  is of 
established  value,  including  detecting  severe  stenosis  in the  intracranial  arteries.  See 
Appendix  A for  a complete  list of uses. 
The  Health  Care  Financing  Administration  (HCFA)  contracts  with  private  insurance 
organizations,  called  carriers,  to make  Medicare  coverage  determinations  and  disburse 
payments  in a local  service  area.  When  HCFA  issues  policy  guidance  on a new 
technology,  carriers  are  required  to follow  it.  When  such  guidance  is not  offered,  each 
carrier  makes  its own  coverage  determinations.  Claims  for  new  or unusual  devices, 
tests,  procedures,  or treatment  modalities  can  present  serious  coverage  issues. 
Carriers  use  the  HCFA  Common  Procedure  Coding  System  (HCPCS)  to reimburse 
for Medicare  Part  B selvices,  which  includes  physician  and  outpatient  semices.  The 
HCPCS  is based  on  a coding  system  maintained  in the  Physicians Current IYocedural 
Te~ino20gy  (CPT)  Manual.  The  American  Medical  Association  (AMA)  developed 
CPT  codes  in  1966 and  publishes  annual  updates. 
Effective  January  1, 1992, the  AMA  established  two new  codes  to  represent  TCD 
semices.  Physicians  and  other  providers  of semices  use  the  new  codes  to claim 
Medicare  reimbursement  for  TCD  tests  performed  on  or after  that  date.  First  quarter 
1992 allowances  nationally  for  the  two  codes  approached  $580,000. 
The  Medicare  Carriers  Medical  Directors  New Technology  Workgroup  and  HCFAS 
Coverage  and  Payment  Technical  Advisory  Group  are  two entities  which  evahate  new 
technologies  for the  Medicare  program.  Composed  of medical  directors  from  six 
1  carriers,  the  New Technology  Workgroup  meets  periodically  to research  new 
technologies  and  make  recommendations  to HCFA  as well as other  carriers.  The 
HCFAS Coverage  and  Payment  Technical  Advisory  Group  consists  of 10 carrier 
medieal  directors  who  recommend  policy decisions  on various  issues,  including  new 
technologies,  to HCFAS  Bureau  of Policy Development. 
In a related  study  (Medicare  Carrier  Assessment  of New Technologies,  0E1-01-88-
00010), we found  (1)  a significant  need  for HCFA  guidance  to carriers  on new 
technologies,  and  (2)  earner  inconsistencies  in coverage  and  pricing  decisions  involving 
new technologies.  We  recommended  that  HCFA  improve  its own capability  and  that 
of the  carriers  to identi~  emerging  technologies  and  to make  more  informed,  explicit, 
and  consistent  coverage  decisions  concerning  new  technologies. 
In its comments  on the  earlier  report,  HCFA  recognized  that  problems  exist with 
carriers  assessment  of new  technologies  and  noted  that  it had  taken  several  initiatives 
to improve  technology  assessment.  The  HCFA  was concerned  that  our  findings,  at 
least  in part,  were  no  longer  valid because  of its efforts.  It asked  the  Office  of 
Inspector  General  to  conduct  another  study to  assess  the  effectiveness  of its initiatives. 
We  plan  to  conduct  such  a study in the  fiture.  The  current  report  sheds  light  on the 
larger  picture  by providing  a case  study  of how  coverage  and  payment policies  are 
made  for new technologies. 
METHODOLOGY 
In late  1991, we contacted  36 Medicare  carriers  representing  58 geographical 
jurisdictions  to  obtain  their  coverage  guidelines  and  policies  for TCDS.  (Some  carriers 
service  more  than  one  jurisdiction.)  Responses  were  received  from  carriers 
representing  56 jurisdictions.  In this  report,  we refer  to  the jurisdictions  as carriers. 
During  the  first  quarter  of  1992, we recontacted  the  carriers  that  did not  cover  TCDS 
in  1991 to  determine  if they  had  changed  their  policies.  If the  carriers  had  changed 
their  coverage  policies,  we asked  what  influenced  their  decisions.  We  also  obtained 
payment  information  for  the  two TCD  procedure  codes  for the  first  quarter  of 1992 
from  the  Part  B Extract  Summary  System  (BESS)  file. 
We  obtained  technical  and  clinical  information  from  medical  literature,  physician 
experts,  and  professional  organizations,  including  the  Medicare  Carriers  Medical 
Directors  New Technology  Workgroup,  HCFAS  Coverage  and  Payment  Technical 
Advisory  Group,  the  American  Academy  of Neurology,  the  American  Society  of 
Neuroimaging,  the  Intersocietal  Commission  for  Accreditation  of Vascular 
Laboratories,  and  the  American  Institute  of Ultrasound  in Medicine. 
C)ur review  was conducted  in accordance  with  the  Interim Standards for hspections 
issued  by the  Presidents  Council  on  Integrity  and  Efficiency. 
2  FINDINGS 
Carriers coverage policies for transcrankd dopplers are inconsistent. 
Carriers  coverage  decisions  are  not  uniform,  despite  the  fact  that  some  carriers  have 
provided  for  payment  since  1988.  Currently,  40 of 56 carriers  cover  TCD  tests. 
Several  carriers  not  covering  TCD  tests  consider  their  use  investigationaL 
The  40 earners  which  cover  TCDS  differ  on the  conditions  required  for  payment.  Half 
(19 of 40) have  no specific  coverage  criteria.  Essentially,  payment  is made  for  any 
TCD  claim  submitted.  The  19 carriers  with  no specific  guidelines  allowed  $188,200 
while  the  21 carriers  with  specific  coverage  criteria  allowed  $157,278. 
Twenty-one  of 40 carriers  covering  TCDS  make  payment  decisions  based  on certain 
conditions  or criteria.  Fifteen  (of 21) carriers  base  their  criteria  on the  American 
Academy  of Neurology  (/lAN)  position  paper,  which  identifies  5 conditions  for which 
TCDS have  established  value  (see  Appendix  A).  The  remaining  six carriers  make 
determinations  on an individual  basis. 
This  lack  of consistency  among  the  carriers  exists even  though  TCD  technology  has 
been  on  the  market  for  several  years.  At  least  two carriers  have  covered  TCDS since 
1988, and  four  others  began  coverage  in  1989.  Five  of the  six carriers  still have  no 
specific  criteria.  In fact,  nearly  half  of the  25 earners  that  covered  TCDS  as of 1991 
did not  have  any specific  criteria  for  coverage.  This  inconsistency  corroborates  our 
previous  study  in which  one-third  of the  carriers  stated  that,  as a group,  they  are 
minimally  consistent  in making  coverage  decisions  about  new  technologies. 
As we stated  in our  earlier  report  entitled  Medicare  Carrier  Assessment  of New 
Technologies: 
Since  each  of the  earners  interprets  the  meaning  of demonstrated  value 
and  general  use within  its service  area,  coverage  decisions  can  and  do 
vary,  reflecting  differences  in local  practice  patterns.  These  variations 
are  of concern  to some  carrier  representatives  who  feel  that  health  care 
has  become  a much  more  uniform  process  nationally  than  it was in  1965 
when  Medicare  was enacted.  One  of the  medical  directors  obsemes, 
the  idea  of local  practice  patterns  that  was accurate  20 to  30 years  ago 
no  longer  applies  today.  The  carriers  are  looking  for  more  coordination 
--some  even  say uniformity--in  coverage  decisions. 
Some carriers pay for transcranial dopplers despite noncoverage policies. 
Although  16 carriers  advised  us that  they  do not  cover  TCD  tests,  BESS  statistics  for 
the  first  quarter  of  1992 disclosed  a total  of more  than  $200,000  in allowances  for  10 
of the  16 carriers.  Total  carrier  allowances  ranged  from  $254 (Nevada)  to $100,000 
3  (Washington).  We  contacted  these  carriers  during  the  first quarter  of  1992, with  all of 
the  contacts  occurring  in late  February  or later.  At that  time,  carrier  representatives 
informed  us that  their  policies  prohibited  payment  for TCDS.  Since  the  BESS  data 
was unavailable  at the  time  we spoke  to  these  carriers,  we were  unable  to verig  the 
BESS  data  with  the  carriers. 
New CPT codes influenced carriers coverage decisions for transcrankl  dopplers. 
Prior  to January  1, 1992, 31 (of 56) carriers  did not  cover  TCDS.  Half  (15 of 31) 
reversed  their  noncoverage  determinations  on or after  January  1, 1992, following  the 
introduction  of CPT  codes  representing  TCD  tests.  Twelve  of the  15 carriers-
according  to  contacts  with  8 medical  directors  and  7 personnel  at  a supervisory  or 
managerial  level--cited  the  new CPT  procedure  codes  as an influence  in changing  their 
coverage  decisions.  Seven  carriers  based  the  reversals  solely on the  new  codes. 
The  creation  of a CPT  code  does  not  mean  a procedure  is automatically  covered 
under  Medicare,  although  it could  signi~  a growing  acceptance  of the  service.  It is 
HCFAS responsibility  to determine  if a procedure  will be  covered.  However,  when 
HCFA  does  not  make  a determination,  carriers  establish  coverage  policies 
independently.  For  TCDS, carriers  were  clearly  influenced  in their  coverage  decisions 
by the  creation  of the  new  CPT  codes.  Physicians  increase  the  pressure  on us to 
cover  a service  when  new  codes  are  established,  one  medical  director  said. 
A few carriers  also mentioned  provider  requests,  new in-house  coverage  policies, 
relative  value  unitsl  (even  though  this  payment  system  is designed  to  correct 
reimbursement  inequities  rather  than  influence  coverage  policies),  and  the  Medicare 
Carriers  Medical  Directors  New Technology  Workgroup  as influencing  their  decisions 
to  provide  coverage. 
Despite  the  fact  that  the  Workgroup  concurred  with  the  recommended  uses  outlined 
by the  AAN  in December  1991, carriers  mentioned  the  new CPT  codes  as the  reason 
for  changing  TCD  coverage  decisions  more  often  than  the  Workgroup.  (The 
Workgroups  recommendations  are  advisory  only.  Carriers  still have  the  option  to 
grant  or deny  coverage.) 
Prior  to the  creation  of the  new  CPT  codes,  the  25 carriers  who  covered  TCDS  used 
existing  codes  to process  claims.  While  codes  varied  by carrier,  over  half  used  CPT-4 
codes  93850 and  93860 (noninvasive  studies  of cerebral  arteries  other  than  carotid)  or 
code  93799  (other  procedures  unlisted)  for  claims  processing.  Because  these  codes 
encompassed  studies  other  than  TCDS, we were  not  able  to identi~  the  frequency  of 
TCD  services. 
1 The  relative  value  unit  (RVU)  represents  the  value  of a unit  of physician  work  to 
deliver  a specific  medical  semice  in relation  to the  value  of other  medical  services. 
Medicare  uses  the  RVU  to  calculate  reimbursement. 
4  Our  previous  study  on new  technologies  revealed  carrier  vulnerabilities  in identifying 
claims  involving  such  techniques,  especially  when  billed  under  existing  codes.  A new 
technology  billed  under  an  established  procedure  code  would  not  be  recognized  as 
new but  would  be  paid  as submitted. 
A carriers  failure  to recognize  a new  technology  can  lead  to problems  for 
beneficiaries,  physicians,  the  health  care  indust~,  and  program  administrators.  Any 
Medicare  payments,  of course,  are  subject  to recovery.  However,  if not  corrected 
promptly, such incorrect  payments  create  an erroneous  impression  that  Medicare  now 
pays for  the  new  technology. 
The  HCFA  efforts to update the coverage process and improve communications with 
carriers do not appear to have resolved problems with carriers coverage of this 
technology. 
Our  review  of TCD  policies  indicates  HCFAS efforts  to update  the  coverage  process 
and  improve  communications  with carriers  do not  appear  to have  solved  the  problems 
with  carriers  assessment  of this new technology.  We  found  that  carriers  still have 
conflicting  or non-existent  coverage  policies  for TCDS  even  though  some  carriers  have 
been  paying  for it since  1988. 
The  inconsistent  coverage  policies  may  prevent  Medicare  payments  for  appropriate 
tests  and  allow  payments  for inappropriate  tests.  According  to some  experts,  carriers 
may be  paying  for inaccurate,  unnecessary,  or inappropriate  TCD  tests.  Concerns 
about  the  accuracy  of TCD  tests  were  raised  by experts,  providers,  and  professional 
organizations,  and  supported  by pertinent  literature. 
In response  to  our  earlier  report,  HCFA  mentioned  several  initiatives  they  had 
undertaken  to improve  communications  with  earners.  These  include: 
b  Publishing  a proposed  rule  in the  Federal Register which  describes  the  coverage 
process  in detail  and  which  makes  explicit  the  criteria  that  are  to be  applied 
when  making  coverage  decisions. 
E  Requiring  carriers  to submit  a copy  of all medical  coverage  policies  to identify 
carriers  with widely  variant  policies. 
P  Requiring  carriers  to have  licensed  physicians  as medical  directors, 
b  Holding  annual  Medical  Directors  Conferences  with  time  devoted  to new 
technology  assessments. 
5  Discussing  both  emerging  technology  and  coverage  issues with  HCFAS 
Coverage  and  Payment  Technical  Advisory  Group,  which  includes  selected 
physicians  from  earners  and  HCFA. 
Providing  significant  pricing  guidelines  to  carriers  on new technology. 
The  TCD  experience  suggests  that  these  initiatives  have  not  been  successful  in 
eliminating  problems  with  assessment  and  coverage  for  this  new technology.  The 
proposed  rule  has yet  to be  finalized. 
6  RECOMMENDATION 
In our  earlier  study  entitled,  Medicare  Carrier  Assessment  of New  Technologies,  we 
identified  two primary  problem  areas:  (1)  a need  for HCFA  to  provide  guidance  on 
new technologies,  and  (2) inconsistent  carrier  policies.  Our  findings  regarding  TCD 
technology  mirror  our  conclusions  in the  earlier  study. 
We  therefore  recommend  that  HCFA  continue  its efforts  to  review,  coordinate,  and 
guide  earner  coverage  policies  of this  and  other  new technologies. 
7  COMMENTS 
The-Assistant  Secretaxy  for  Planning  and  Evaluation  concumed  with the  report.  we 
recehed  no  comments  from  HCFA. 
8  APPENDIX  A

* 
AMERICAN  ACADEMY  OF NEUROLOGY  POSITION ON TCD 
In March  1990, the  Therapeutics  and  Technology  Assessment  Subcommittee  of the 
American  Academy  of Neurology  (AAN)  released  a position  paper  delineating  the 
established  and  investigational  uses  of TCD. 
Established uses of TCD: 
1.	 Detecting  severe  stenosis  (greater  than  65 percent)  in the  major  basal 
intracranial  arteries. 
2.	 Assessing  patterns  and  extent  of collateral  circulation  in patients  with  known 
regions  of severe  stenosis  or  occlusion. 
any cause  especially 
3.	 Evaluating  and  following  patients  with vasoconstriction  of 
after  subarachnoid  hemorrhage. 
4.	 Detecting  arteriovenous  malformations  and  studying  their  supply  arteries  and 
flow patterns. 
5.	 Assessing  patients  with  suspected  brain  death. 
hvestigational uses of TCD: 
1.  Assessing  patients  with  migraine. 
2.  Monitoring  during  cerebral  endarterectomy,  cardiopulmonary  bypass  and  other 
cerebrovascular  and  cardiovascular  interventions,  and  surgical  procedures. 
3.  Evaluating  patients  with  dilated  vasculopathies  such  as fusiform  aneurysms. 
4.  Assessing  autoregulation,  physiologic,  and  pharmacologic  responses  of cerebral 
arteries. 
5.  Evaluating  children  with various  vasculopathies  such  as sickle  cell disease,  moya 
moya,  and  neurofibromatosis. 
A -1
 Department  of Health  and Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
MEDICARE  CARRIERS  POLICIES  FOR 
TRANSCRANIAL  DOPPLERS: 
A  NEW  TECHNOLOGY  OFFICE OF INSPECTOR GENERAL 
The mission of the  Office of Inspector  General  (OIG),  as mandated  by Public  Law 95-452, as 
amended,  is to protect  the  integrity  of the  Department  of Health  and Human  Services  (HHS) 
programs as well as the  health  and welfare  of beneficiaries  served  by those  programs.  This 
statutory  mission  is carried  out  through  a nationwide  network  of audits,  investigations,  and 
inspections  conducted  by three  OIG  operating  components:  the  Office of Audit  Sewices,  the 
Office  of Investigations,  and the  Office of Evaluation  and Inspections.  The  OIG  also informs 
the  Secretary  of HHS  of program,  and management  problems,  and recommends  courses  to 
correct  them. 
OFFICE OF AUDIT  SERVICES 
The  OIGS Office  of Audit  Services  (OAS)  provides  all auditing  services  for HHS,  either  by 
conducting  audits  with its own audit  resources  or by overseeing  audit work  done  by others. 
Audits  examine  the  performance  of HHS  programs  and/or  its grantees  and contractors  in 
carrying  out  their  respective  responsibilities  and are intended  to provide  independent 
assessments  of HHS  programs  and operations  in order  to reduce  waste,  abuse,  and 
mismanagement  and to promote  economy  and efficiency throughout  the  Department. 
OFFICE OF INVESTIGATIONS 
The  OIGS Office  of Investigations  (01)  conducts  criminal,  civil, and administrative 
investigations  of allegations  of wrongdoing  in HHS  programs  or to HHS  beneficiaries  and of 
un@st enrichment by providers.  The investigative efforts of 01 lead to criminal convictions, 
administrative sanctions, or civil money penalties.  The 01 also oversees State Medicaid fraud 
control units which investigate and prosecute fraud and patient abuse in the Medicaid program. 
OFFICE OF EVALUATION  AND  INSPECIIONS 
The  OIGS Office  of Evaluation  and Inspections  (OEI)  conducts  short-term  management  and 
program evaluations (called inspections) that focus on issues of concern to the Department, 
the Congress, and the public.  The findings and recommendations contained in these inspection 
reports generate  rapid, accurate, and up-to-date information on the efficiency, vulnerability, 
and effectiveness of departmental  programs. 
This report  was prepared  under  the direction  of Joy Quill, the  Regional  Inspector  General  for 
the  Office  of Evaluation  and Inspections,  and Robert  A. Vito,  Deputy  Regional  Inspector 
General,  Office  of Evaluation  and Inspections,  Region  III.  Participating  in this project  were 
the  following  people: 
REGION  HEADQUARTERS 
Robert  A. Katz, Project Leader  Wayne  Powell 
Eileen  E. Silk  Brian  Ritchie 
Cynthia  R. Hansford 
To obtain a copy of this report, call the I?hiladelPhia llegional Office at (215) 596-0607.