Department  of  Health  and  Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
PRESSURE  REDUCING  SUPPORT 

SURFACES 

JUNE  GIBBS  BROWN 
Inspector  General 
JUNE 1997 
OEI-02-95-00370  OFFICE  OF INSPECTOR  GENERAL 
The mission  of the Office  of Inspector  General  (OIG),  as mandated  by Public  Law 
95-452,  is to protect  the integrity  of the Department  of Health  and Human  Services 
programs  as well as the health  and welfare  of beneficiaries  served by them.  This statutory 
mission  is carried  out through  a nationwide  program  of audits,  investigations,  inspections, 
sanctions,  and fraud alerts.  The Inspector  General  informs  the Secretary  of program  and 
management  problems  and recommends  legislative,  regulatory,  and operational  approaches 
to correct  them. 
Office  of Evaluation  and Inspections 
The Office  of Evaluation  and Inspections  (OEI) is one of several  components  of the Office 
of Inspector  General.  It conducts  short-term  management  and program  evaluations  (called 
inspections)  that focus  on issues of concern  to the Department,  the Congress,  and the 
public.  The inspection  reports  provide  findings  and recommendations  on the efficiency, 
vulnerability,  and effectiveness  of departmental  programs. 
The OEIs New York Regional  Office prepared  this report  under  the direction  of Alan  S. 
Meyer,  Regional  Inspector  General.  Principal  OEI staff included: 
Region  Headauarters 
Demetra  Arapakos,  Project  Leader  Brian  Ritchie 

Jennifer  Caves  Barbara  Tedesco 

Lucille  Cop  Stuart Wright 

Daniel  Ginsberg 

Jane Liss,  intern 

Panayiotis  Beloyeannis,  intern 

To obtain  a copy  of this report,  call the New York Regional  Office  at (212) 264-1998.  Department  of  Health  and  Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
PRESSURE  REDUCING  SUPPORT 

SURFACES 

.o 
2,  JUNE  GIBBS  BROWN 
/ 
Inspector  General  EXECUTIVE  SUMMARY 
PURPOSE 
To determine  the extent of inappropriate  Medicare  payments  for pressure  reducing  support 
surfaces and to assess the effect  of new  1996 Durable  Medical  Equipment  Regional  Carrier 
(DMERC)  medical  policies  and coverage  guidelines. 
BACKGROUND 
Pressure  reducing  support  surfaces  are a kind  of durable  medical  equipment  (DME) used for 
the care of pressure  sores.  These  sores are lesions  caused by unrelieved  pressure  resulting  in 
damage of underlying  tissue.  Support  surfaces  are coded under  one of  16 different  HCFA 
Common  Procedure  Coding  System (HCPCS)  codes and categorized  into three  groups.  A 
major  distinction  between  support  surfaces  is that some are powered  by electricity  and others 
are not. 
In an effort  to clarify  and improve  existing  support  surface  medical  policies,  new Durable 
Medical  Equipment  Regional  Carrier  guidelines  became  effective  January  1, 1996.  These 
changes had the greatest  impact  on alternating  pressure  mattresses  by no longer  allowing 
reimbursement  for these mattresses  if used for preventive  treatment,  as they  had been before 
1996.  The new guidelines  also no longer  require  certificates  of medical  necessity  (CMNs) 
for support surface equipment,  with the exception  of air-fluidized  beds. 
In conducting  this inspection,  we used the following  combination  of methods:  a mail  survey 
to a sample of Medicare  beneficiaries  who had claims paid  for  support  surface  equipment;  a 
medical  record  review  for a subsample of these Medicare  beneficiaries;  an examination  of 
their  support surface billing  histories;  and a review  of Medicare  reimbursement  data for 
support surface codes.  In order  to assess the effect  of new  1996 DMERC  support  surface 
medical  policies,  we selected two beneficiary  samples  for this  inspection  - the first from the 
last quarter  (October,  November,  and December)  of  1995, and the second  from the second 
quarter  (April,  May,  and June) of  1996. 
FINDINGS 
While New 1996 DMERC Guidelines  Appear To Be Having  A Positive  Impact On 
Controlling Medicare  Costs For Support Surfaces,  Inappropriate  Payments  Are Still 
Noted 
Medicare  reimbursement  for alternating  pressure  mattresses  has been decreasing,  dropping 
from $183,358,943  in 1995, to $148,894,337  in 1996.  In  1996, 29 percent  of sample 
beneficiaries  used support  surfaces  that were medically  unnecessary,  fewer than the 47 
percent  of beneficiaries  who used a medically  unnecessary  support  surface  in 1995.  Finally, 
12 percent  of beneficiaries  in  1996, down from  22 percent  in  1995, report  receiving  upcoded 
equipment  or no equipment  at all,  or had duplicate  support  surface  billings.  Because of the 
i  small sample  size, we cannot  demonstrate  that these differences  are statistically  significant. 
However,  these trends  are consistent  with recent  actions  taken by the Health  Care Financing 
Administration  (HCFA). 
A Variety  of Other Problems Continue  To Adversely Affect  Medicare  Support  Surface 
Reimbursement 
These problems  are due to a lack of adherence  to existing  DMERC  guidelines,  and were  not 
impacted  in any way by the establishment  of new 1996 DMERC  policies.  They  include:  the 
use of group  2 equipment  before  a trial  of less expensive  and complex  group  1 equipment; 
the continued  use of support  surface equipment  after sores have healed  completely;  an 
apparent  lack of physician  involvement  in and documentation  for beneficiary  use of support 
surfaces;  and improper  use of support  surfaces by beneficiaries  who do not plug  in their 
electrical  equipment. 
Most Beneficiaries  With Appropriately  Paid Claims Report  Positive Experiences  With 
Their Support  Surface Equipment 
Of the beneficiaries  in 1995 and  1996 who received  electrical  equipment  which  was both 
medically  necessary  and properly  used,  a majority  (79 percent  and 89 percent  respectively) 
report  that their  pressure  sores healed  completely  or improved  because  of their  support 
surface  use. 
RECOMMENDATIONS 
While  the new  1996 DMERC  guidelines  appear to be having  a positive  impact  on controlling 
Medicare  costs for support  surfaces,  inappropriate  payments  are still being  made and other 
problems  continue  to adversely  affect Medicare  reimbursement  for this equipment.  We 
therefore  believe  that additional  steps can be taken to reduce  the extent  of inappropriate 
support  surface  payments.  In particular,  we recommend  that: 
HCFA establish  the requirement  for periodic review and renewal  of the medical 
necessity  for beneficiaries  use of group 2 support surface  equipment. 
We recognize  that establishing  such a requirement  may be cumbersome  to both  the DMERCs 
in processing  claims  and to the suppliers  in obtaining  the necessary  information.  However, 
we believe  that this requirement  should help to eliminate  problems  identified  in this report. 
These  include  beneficiaries  inappropriate  and improper  use of support  surfaces,  provision  of 
upcoded  equipment,  and poor  documentation  of support  surface use.  Periodic  recertifications 
could be done every  3 months  and completed  by a healthcare  practitioner. 
We estimate  that implementing  this requirement  would save as much as $12 million  annually. 
Actual  savings  could be considerably  larger  than this amount. 
ii  COMMENTS 
We received  comments  on the draft report  from  HCFA  and the Assistant  Secretary  for 
Planning  and Evaluation.  We also solicited  and received  comments  from  3 industry  groups, 
the Health  Industry  Manufacturers  Association  (HIMA),  the National  Association  for Medical 
Equipment  Services  (NAMES),  and the Health  Industry  Distributors  Association  (HIDA). 
The HCFA  does not concur  with our recommendation  that  it establish  the requirement  for 
periodic  review  and renewal  of the medical  necessity  for beneficiaries  use of group 2 
support surface  equipment.  It does not believe  such a requirement  is necessary  since group  2 
support surface  claims  must have  a ZX modifier,  which  indicates  the supplier  has 
documentation  that medical  policy  requirements  have been met.  Furthermore,  the HCFA  is 
concerned  about the timeliness  and costs associated  with utilizing  a certificate  of medical 
necessity  (CMN)  for group  2 equipment. 
In response,  we point  out that our recommendation  did not specifically  state that a CMN be 
used for periodic  review  and renewal  of medical  necessity.  In fact,  we deliberately  did not 
recommend  that a CMN be used because  of the same concerns  of timeliness  and costs. 
However,  we feel  strongly  that  some other mechanism  be used to review  and renew medical 
necessity.  We do not believe  the ZX modifier  is sufficient  to do this,  since there  is no 
requirement  for additional  medical  evidence  to support  it beyond  the initial  medical  necessity 
determination.  Currently,  there  is no mandate  for any additional,  ongoing  review  of medical 
necessity.  Furthermore,  the findings  of our report  indicate  inappropriate  utilization  which 
warrants,  in our opinion,  some type of corrective  action. 
We believe  that the Statement  of the Ordering  Physician,  which must be filled  out prior  to 
delivery  of the equipment  and is kept on file with the supplier,  could be used to implement 
our recommendation.  This would  assure that the equipment  continues  to be medically 
necessary.  Such a review  could  also assure that the beneficiary  is using the equipment 
appropriately  and using equipment  that is properly  coded. 
All three  industry  groups  support,  on some level,  our recommendation.  The HIMA  is in 
complete agreement  and states that this is a position  they have held for the past several 
years.  The NAMES  supports  using the Statement of the Ordering  Physician,  but on a 6 
month basis;  HIDA  agrees with the 6 month timeframe.  We believe  a 3 month  time 
requirement  for review  and renewal,  as suggested by HIMA,  is the best option,  and have 
changed the recommendation  accordingly. 
Both HCFA  and ASPE raised  questions  about our cost savings estimate  of $12 million.  We 
have added a further  explanation  as to how we derived  this estimate  in the reports 
methodology.  The ASPE suggests we conduct  a cost-benefit  analysis  for implementing  our 
recommendation.  While  we acknowledge  that certain  costs would be incurred  by 
implementing  this recommendation,  we believe  that these costs are likely  to be minimal, 
particularly  since the Statement  of the Ordering  Physician  is already  kept on file by the 
supplier. 
. . . 
111  The HCFA  also states that it is unaware  of any new support  surface coding  verification 
process by the SADMERC.  During  discussions  with SADMERC  staff,  however,  they 
indicated  that they had improved  their  existing  coding  verification  process  to accommodate 
changes  in support  surface policies  and new support  surface  codes and now send out a sheet 
with guidelines  for suppliers  wanting  written  coding  verification.  As HCFA  notes,  this 
process  is optional  to suppliers  requesting  assistance. 
Finally,  in response  to HCFAs  other  technical  comments,  we have made additional 
clarifications  to the text in both  the background  and findings  sections.  The full text of all 
comments  are included  in Appendix  D. 
iv  TABLE  OF  CONTENTS 
PAGE 
EXECUTJYE SUMMARY 
INTRODUCTION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..I  .  .  .  1 
FINDINGS  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 
 1996 DMERC  Guidelines  Have Positive  Impact on Controlling  Medicare  Costs  . .  7 
 Problems  Continue  to Adversely  Affect  Medicare  Reimbursement  . . . . . . . .  .  10 
 Beneficiaries  Report  Positive  Experiences  with  Support  Surfaces  . . . . . . . . .  . . 12 
RECOMMENDATIONS  . . . . .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . .  13 
APPENDICES 

A:  Sample Selection  . . . . . . .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 
 .  A-l 
I  . 
B:  Confidence  Intervals  ....................................  . B-l 
C:  Non-respondent  Analyses  .................................  . C-l 
D:  Comments  .........................................  .  D-l  INTRODUCTION 
PURPOSE 
To determine  the extent of inappropriate  Medicare  payments  for pressure  reducing  support 
surfaces and to assess the effect  of new  1996 Durable  Medical  Equipment  Regional  Carrier 
(DMERC)  medical  policies  and coverage  guidelines. 
BACKGROUND 
Medicare Program 
Medicare  provides  health  insurance  for approximately  37 million  elderly  and disabled 

beneficiaries  under  two parts.  The first,  Part A,  is hospital  insurance  which covers  services 

furnished  by providers,  such as hospitals,  home  health  agencies,  and skilled  nursing 

facilities.  The second,  Part B, is supplementary  medical  insurance  which  covers physician 

services,  outpatient  hospital  services,  and other  medical  services  and supplies.  The Health 

Care Financing  Administration  (HCFA)  administers  the Medicare  program  and contracts  with 

carriers  and fiscal  intermediaries  to process,  review,  and pay claims  for covered  services. 

DME 
One benefit  covered  under Medicare  Part B is durable  medical  equipment  (DME).  Home 
health  agencies  can also bill for DME under  the Part A home  health  benefit  if such 
equipment  is part of their patients  home  health  plan  of care.  In order  for DME to be 
covered,  it must:  withstand  repeated  use; be used primarily  and customarily  to serve a 
medical purpose;  generally  not be useful  to a person  in the absence  of illness or injury;  and 
be appropriate  for home use. 
In October,  1993, HCFA began processing  DME claims  through  four regional  carriers  called 
the Durable  Medical  Equipment  Regional  Carriers  (DMERCs).  These  four carriers  cover  the 
entire country,  using common  medical  policies  and coverage  guidelines  for DME. 
Support Sur$aces 
Pressure reducing  support surfaces  are a kind  of DME used for the care of decubitus ulcers 
or pressure  sores.  These sores are lesions  caused by unrelieved  pressure  resulting  in damage 
of underlying  tissue.  They  form when patients  are not able to shift their  weight from  one 
part of their body  to the other,  thus resulting  in pressure  being  applied  to only one area 
where the sore then develops.  Individuals  with limited  mobility  who are confined  to a bed or 
wheelchair  for long periods  of time,  as well as those with  impaired  sensation,  are susceptible 
to pressure  sores.  Thus, patients  with conditions  such as multiple  sclerosis  or spinal cord 
injuries,  as well as the frail elderly,  are particularly  vulnerable.  Pressure  sores are classified 
into four stages,  with stage I being  the mildest  and stage IV  the most severe.  Support  surfaces  are coded under  one of  16 different  HCFA  Common  Procedure  Coding 
System (HCPCS)  codes and categorized  into three  groups.  A major  distinction  between 
support  surfaces  is that some are powered  by electricity  and others  are not.  Equipment  in 
group  1 are generally  less expensive  than equipment  in groups  2 and 3. 
Group  1 includes  both powered  and non-powered  mattress  overlays  made of gel,  air,  water 
or foam.  Group 2 includes  two air mattress  overlays,  one powered  and the other not,  both 
of which  were  given their  own codes in April  1996.  It also includes  a powered  air flotation 
bed and an alternating  pressure  mattress.  The only  support  surface  included  in group  3 is the 
air-fluidized  bed,  which uses the circulation  of filtered  air through  silicone  coated ceramic 
beads,  thus simulating  the movement  of fluid. 
Medicare Coverage of Support Surjaces 
In an effort  to clarify  and improve  existing  support  surface  medical  policies  and coverage 
requirements,  new DMERC  guidelines  became  effective  January  1, 1996.  These changes 
had the greatest  impact on alternating  pressure  mattresses  (code EO277), by no longer 
allowing  reimbursement  for these mattresses  if used only  for preventive  treatment,  as they 
had been before  1996.  The new policies  also no longer  require  certificates  of medical 
necessity  (CMN) for support  surface  equipment,  with the exception  of air-fluidized  beds. 
Additionally,  the Statistical  Analysis  DMERC  (SADMERC)  improved  its existing  process  of 
support  surface  coding  verification  for suppliers  with questions  about  which  code to use for 
their  equipment. 
For all three  support surface  groups,  patients  should have a care plan  established  by their 
physician  or home care nurse,  which  is documented  in their  medical  records.  This plan 
generally  should  include,  among  other things,  education  of the patient  and regular  assessment 
by a healthcare  practitioner.  Coverage  for all three groups  continues  until  the patients 
pressure  sore is healed. 
In addition  to the above common  requirements,  coverage  for  specific  groups  of support 
surfaces  varies  as follows: 
GROUP  1.  A group  1 support  surface  is covered  if the patient  is completely  immobile. 
Otherwise,  he or she must be partially  immobile,  or have any  stage pressure  sore,  and 
demonstrate  one of the following  conditions:  impaired  nutritional  status;  incontinence; 
altered  sensory  perception;  or compromised  circulatory  status.  A physician  order  must be 
obtained  prior  to delivery  of the equipment  and should be kept  on file by the supplier. 
GROUP 2.  A group 2 support  surface  is covered  if the patient  has a stage II pressure  sore 
located  on the trunk or pelvis,  has been on a comprehensive  pressure  sore treatment  program 
(which has included  the use of an appropriate  group  1 support  surface  for  at least one 
month),  and has sores which have worsened  or remained  the same over  the past month.  A 
group 2 support  surface is also covered  if the patient  has large  or multiple  stage III or IV 
pressure  sores on the trunk  or pelvis,  or if he or she has had a recent  mycutaneous  flap .or 
skin graft for a pressure  sore on the trunk  or pelvis  and has been on a group  2 or 3 support 
2  surface  immediately  prior  to recent  discharge  from a hospital  or nursing  facility.  A 
physician  order  must be obtained  prior  to delivery  and kept on file by the supplier. 
GROUP  3.  Air-fluidized  beds,  the sole group  3 support  surface,  are covered  if seven 
criteria  are met.  These are stage III or IV pressure  sores;  severely  limited  mobility;  an 
unsuccessful  conservative  treatment  trial;  a trained  adult caregiver  who is available  to assist 
the patient;  physician  direction  of the home treatment  regimen;  and the consideration  and 
ruling  out of alternative  equipment.  For air-fluidized  beds,  an order  and certificate  of 
medical  necessity  (CMN) must be signed and dated by the ordering  physician  prior  to 
delivery.  These beds must have their medical  necessity  recertified  on a monthly  basis. 
OperationRestore Trust 
The Office  of Inspector  General  (OIG) has over the past few years  issued several  reports  on 
durable  medical  equipment  (DME) which have documented  problems  with  inappropriate 
Medicare  payments.  In response  to these and other concerns  with Medicare  fraud  and abuse, 
the Department  of Health  and Human  Services  designed  an anti-fraud  initiative  called 
Operation  Restore  Trust  (ORT) to target fraud,  waste and abuse related  to home  health 
agencies,  nursing  homes  and DME suppliers.  Recent reports  and investigations  by the OIG 
showed that these areas are particularly  vulnerable  to fraud,  waste,  and abuse.  The ORT 
initiative  targets  California,  Florida,  New York,  Illinois,  and Texas.  These  five  States 
account  for 40 percent  of the nations  Medicare  beneficiaries  and program  expenditures. 
METHODOLOGY 
Multiple &fethods 
In conducting  this inspection,  we used the following  combination  of methods:  a mail  survey 
to a sample of Medicare  beneficiaries  who had claims paid for support  surface  equipment;  a 
medical  record  review  for a subsample of these Medicare  beneficiaries;  an examination  of 
their  support  surface billing  histories;  and a review  of Medicare  reimbursement  data for 
support  surface  codes. 
In order  to assess the effect  of new DMERC  support  surface  medical  policies  which  started 
on January  1, 1996, we selected  two beneficiary  samples  for this inspection  - the first  from 
the last quarter  (October,  November,  and December)  of  1995, and the second  from  the 
second quarter  (April,  May,  and June) of  1996.  Both samples  were  selected  from  the HCFA 
National  Claims  History  5 percent  file. 
See Appendix  A for further  discussion  of our sample selection.  Also see Appendix  B for 
confidence  intervals  on key  survey  questions  and medical  record  review  results,  and 
Appendix  C for non-respondent  analyses. 
1995 Sample 
For the  1995 sample,  we selected a stratified  random  sample of 300 Medicare  beneficiaries 
3  who had a support  surface  claim paid during  the last three  months  of  1995.  We selected  50 
beneficiaries  from each of the five  ORT States and the remaining  50 from  the rest of the 
country.  We included  the following  five  codes in this sample:  E0194 (air-fluidized  bed), 
E0193 (powered  air flotation  bed),  E0277  (alternating  pressure  mattress),  EO180 (alternating 
pressure  pad),  and El399  (miscellaneous  durable  medical  equipment).  These five codes 
accounted  for over 90 percent  of all support  surface reimbursement  in the last 3 months  of 
1995. 
After our sample was selected,  we determined  that most of the claims  (110 of  130) for the 
El399  code were for equipment  that was not a support surface.  We therefore  excluded  these 
110 beneficiaries  from  our sample,  leaving  us with a usable  sample  size of 190.  After 
allowing  2 months  for data collection,  during  which time we conducted  a second mailing  to 
non-respondents,  136 beneficiaries  returned  their mail questionnaire,  for a response  rate of 
72 percent. 
We also selected  a subsample  of  150 beneficiaries  for a medical  record  review  - 25 from 
each of the six strata.  From  these,  we had to exclude  58 beneficiaries  with El399  claims, 
leaving  a usable  sample  size of 92.  For each of these 92 beneficiaries,  we requested  medical 
records  from  the physician  listed as the ordering  physician  on the claim.  In some cases,  the 
physician  referred  us to the patients  home  health  agency  for the medical  records.  After  at 
least two efforts  to obtain  accurate  addresses,  we were unable  to locate  five of the 92 
physicians. 
After allowing  2 months  for data collection,  during  which time  non-responding  physicians 
were sent a second follow-up  request,  we received  responses  from  58 physicians.  Of these 
58 physicians,  55 sent us a medical  record  or other patient  specific  response  (such as a 
detailed  letter),  two said they  had never  seen the beneficiary,  and one said he had never 
ordered  the support  surface  equipment. 
Once we obtained  a medical  record  or other patient  specific  response,  we used a medical 
review contractor  to review  the documents  to determine  whether  the support  surface 
equipment  the beneficiary  had a claim  paid for was medically  necessary.  The contractor 
developed  a screening  document,  based on DMERC  medical  guidelines,  Agency  for Health 
Care Policy  and Research  (AHCPR)  pressure  sore guidelines,  and with input from one of the 
DMERC medical  directors.  Nurse reviewers  then used this screening  document  to review 
the records.  Any records  which  failed  this initial  screening  were referred  to a physician 
reviewer  who then made a final  determination  of medical  necessity. 
Due to the big difference  between  weights  used in our analysis  of  1995 sample data,  the 
same number  of responses  may result  in different  percentages,  depending  on the strata from 
which those responses  come. 
1996 Samnle 
Due to revised  DMERC  medical  policy  changes  effective  1996, we stratified  our  1996 
beneficiary  sample differently  than our  1995 sample.  For  1996, we stratified  by HCPCS 
4  code rather  than by ORT State,  in order  to assure a large  enough  number  of the one code 

(E0277) that was most affected  by the new policies.  Additionally,  we determined  that it was 

necessary  to stratify  our sample by codes because  of the wide variance  in frequency  of 

support surface  codes. 

Therefore,  we selected 420 Medicare  beneficiaries  for our  1996 sample:  290 from  stratum  1 

(code EO277), 75 from  stratum 2 (code EOBO), and all 55 from  stratum 3 (E0193 and 

E0194).  These four codes accounted  for over  85 percent  of all Medicare  support  surface 

reimbursement  during  the second 3 months  of  1996.  With  the exception  of E1399,  these 

four codes were the same codes  included  in our  1995 sample.  After  allowing  2 months  for 

data collection,  during  which  time we conducted  a second mailing  to non-respondents,  286 

beneficiaries  returned  their  mail  questionnaire,  for  a response  rate of 68 percent. 

We also selected  a subsample  of 250 of the 420 beneficiaries  for the medical  review  - 145 

from  stratum  1, 50 from  stratum  2, and all 55 from  stratum  3.  Despite at least two efforts  to 

obtain  accurate  addresses,  we were unable  to locate  11 physicians.  After  allowing  2 months 

for data collection,  during  which  time non-responding  physicians  were sent a second follow-

up request,  we received  responses  from  127 physicians  for a response  rate of 51 percent.  Of 

the  127 responding  physicians,  113 sent us a medical  record  or other patient  specific 

response,  10 said they had never  seen the beneficiary,  and four  said they never  ordered  the 

equipment.  The same contractor  and review  procedures  used to conduct  the  1995 medical 

record  review  were also used for the  1996 subsample. 

Determining InappropriateReimbursement 
In determming  inappropriate  Medicare  reimbursement  for support  surface equipment,  we 
looked  at the following  four categories  of beneficiary  use:  equipment  that was not medically 
necessary;  equipment  beneficiaries  report  they  never  received;  equipment  beneficiaries  report 
was less what than Medicare  paid for;  and duplicate  billings  for support surface  equipment. 
While  percentages  are given  for the different  categories  of inappropriate  reimbursement,  we 
report  numbers  when discussing  individual  medically  unnecessary  claims.  Reporting 
percentages  for these claims  would be imprecise,  due to their  relatively  small number. 
EstimatingInappropriateMedicare Reimbursement Costs 
Estimates  for inappropriate  Medicare  payments  were based on allowed Medicare  support 
surface charges  for beneficiaries  falling  into one of the above  four categories.  These 
estimates  are conservative,  however,  since we assumed  Medicare  payments  were appropriate 
for the records  not reviewed  in the medical  record  subsample  and for the beneficiaries  who 
did not respond  to the mail  questionnaire.  Additionally,  due to relatively  small sample  sizes, 
especially  in  1995, the confidence  intervals  for some estimates  are considerably  wide. 
The medically  unnecessary  1996 claims  represent  $3 million  in inappropriate  Medicare 
payments  in the second 3 months  of  1996, or $12 million  if projected  to the entire  year, 
assuming the rest of the year  was comparable  to that quarter.  Of the 33 beneficiaries  who 
5  used medically  unnecessary  support  surfaces  in  1996, a large  majority  (88 percent)  used a 
group 2 surface.  Only four beneficiaries  did not use a group  2 surface:  three used an air-
fluidized  bed and the other  a mattress  overlay.  Furthermore,  costs associated  with the latter 
are minimal,  since monthly  rental  costs for mattress  overlays  are significantly  lower  than 
those for group 2 equipment. 
This inspection  was conducted  in accordance  with the Quality  Standards  for Inspections 
issued by the Presidents  Council  on Integrity  and Efficiency. 
6 
 FINDINGS 
WHILE NEW 1996 DMERC GUIDELINES  APPEAR  TO BE HAVING  A POSITIVE 
IMPACT ON CONTROLLING  MEDICARE  COSTS FOR SUPPORT  SURFACES, 
INAPPROPRIATE  PAYMENTS  ARE STILL NOTED 
Medicare Reimbursementfor Alternating Pressure Mattresses Has Been Decreasing 
Up until  1996, Medicare  reimbursement  for support surfaces  had been  increasing 
significantly,  due specifically  to a dramatic  growth  in reimbursement  for alternating  pressure 
mattresses.  Payment  for these mattresses  climbed  from  $2,777,056  in  1992 to $183,358,943 
in 1995.  The  1996 DMERC  medical  policies,  which  stopped reimbursement  for this 
equipment  if used for prevention,  was an attempt to control  utilization  of these mattresses. 
The support  surface  industry  was well aware before  the new policy  became  effective  that 
such a change  would occur. 
Since the beginning  of 1996, reimbursement  for alternating  pressure  mattresses  has been 
decreasing.  Reimbursement  for these mattresses  dropped  from  $183,358,943  in  1995 to 
$148,894,337  in 1996.  Graph  One below  illustrates  decreases  in quarterly  reimbursement 
amounts,  from the last quarter  of  1995 through  all four quarters  of  1996.  However,  despite 
this decrease,  alternating  pressure  mattresses  still rank highly  in terms  of overall  Medicare 
DME costs.  These mattresses  were the  12th highest  of all DME codes  in terms  of overall 
reimbursement  in the third  quarter  of  1996. 
MEDICARE REIMBURSEMENT  FOR ALTERNATING 
PRESSURE MA-I-I-RESSES DECREASED  IN 1996 
$ MILLION 
8 
60-
Legend 
50- Medicare allowed $ 
30-
20 -
Qtr 41995  Qtr 1:I 996  Qtr 2:1996  Qtr 3:i 996  Qtr 4:1996 
Graph  1 
7  Despite  the new  1996 DMERC  medical  policies  which  no longer  allow  reimbursement  for 
the alternating  pressure  mattress  solely  for the purpose  of prevention,  13 percent  of our 
sample beneficiaries  in that year  report  using their  mattress  for prevention  only. 
Twenty-ninepercent of beneficiaries in 1996 used medically unnecessary support su?face 
equipment, fewer than did so in 1995 
In  1996, 29 percent  of beneficiaries  used medically  unnecessary  support  surface  equipment, 
fewer than the 47 percent  who did so in 1995.  Due to the small  1995 sample  size,  we 
cannot  demonstrate  that this difference  is statistically  significant;  however,  this trend  is 
consistent  with recent  actions  taken by HCFA.  The beneficiaries  used one of four  different 
types of support  surfaces,  ranging  from  an inexpensive  mattress  overlay  to a much more 
costly  alternating  pressure  mattress.  For  113 documents  in the  1996 medical  record  review, 
half  (50 percent)  were medical  records.  The other half  consisted  of physician  letters,  office 
notes,  and other patient  specific responses.  The medical  review  contractor  was able to make 
a final  decision  on the question  of medical  necessity  for 91 of the  113 beneficiaries. 
Insufficient  medical  documentation  prevented  such a decision  from being  made  for the other 
22 beneficiaries. 
The medically  unnecessary  1996 claims  represent  $3 million  in inappropriate  Medicare 
payments  in the second ,3 months  of  1996, or $12 million  if projected  to the entire  year. 
However,  the amount  for the year  is probably  considerably  larger  than  $12 million,  since we 
were only  able to review  approximately  half  of the 250 records  in the medical  review 
subsample.  Since we assumed that all of the other  half we were unable  to review  were 
medically  necessary,  our projection  of $12 million  is a conservative  estimate. 
The 33 beneficiaries  who used a support  surface  that was medically  unnecessary  in  1996 are 
categorized  as follows: 
0 	 12 used an alternating  pressure  mattress  despite having  no pressure  sores.  This 
contradicts  the new  1996 DMERC  medical  policies  for this support  surface,  which 
state that these mattresses  must be used for treatment  only. 
0 	 15 beneficiaries  were using a group 2 support  surface  (mostly  an alternating  pressure 
mattress)  before  first trying  a group  1 mattress  overlay. 
0 	 four beneficiaries  had insufficient  medical  evidence  to warrant  use of their  support 
\ 
surface. 
0  two beneficiaries  used a support  surface  for pressure  sores on their  limbs. 
More  beneficiaries  in  1995 than in  1996 used medically  unnecessary  support  surfaces.  Of 
the 55 beneficiaries  in our  1995 medical  record  review  subsample,  47 percent  (21 
beneficiaries)  had claims  paid for a support  surface  that were determined  to be not medically 
necessary.  This represents  $14 million  in inappropriate  Medicare  payments  in the last 3 
months  of  1995.  Of the 55 physicians,  home health  agencies,  or nursing  homes  which 
8  provided  us with  some medical  documentation,  more  than half  (57 percent)  provided 
complete  medical  records.  The remaining  43 percent  provided  some other patient  specific 
response,  such as a detailed  letter  or office  notes.  Despite poor  documentation  for many 
cases,  however,  the medical  review  contractor  was able to make a determination  on the 
question  of medical  necessity  for all but three  of the 55 beneficiaries.  The contractor  was 
unable  to make  a decision  on medical  necessity  for these three beneficiaries  because  of 
insufficient  medical  documentation. 
The 21 beneficiaries  who used a support surface  that was medically  unnecessary  in  1995 can 
be categorized  as follows: 
13 beneficiaries  used a group 2 support  surface  (almost always  an alternating  pressure 
mattress  for pressure  sore care or prevention)  before  first trying  a group  1 support 
surface  as required.  None of the  13 met the DMERC  medical  policy  criteria  that 
would  have allowed  use of a group 2 support  surface  without  first trying  a group  1 
surface.  Included  in this  1995 group  are beneficiaries  who would  not qualify  for 
support  surface  reimbursement  under  the new  1996 guidelines,  since many  had no 
pressure  sores. 
three  beneficiaries  used a support  surface  for pressure  sores on their  limbs,  not 
allowed  by DMERC  medical  policy. 
three  beneficiaries  had insufficient  medical  evidence  to warrant  use of a support 
surface. 
one beneficiary  was using a support surface  for a diabetic  foot infection,  a noncovered 
medical  condition. 
one beneficiarys  ordering  physician  stated that while  the support  surface  he ordered 
for his patient  was medically  necessary,  it was delivered  after the patient  died and 
therefore  was never  used. 
Twelvepercent of beneficiaries in 1996, downfrom 22 percent in 1995,  report receiving 
upcoded equipment or no equipment at all, or had duplicate billings 
Fewer beneficiaries  in 1996 (12 percent)  than  in 1995 (22 percent)  report  problems  with 
upcoded  or undelivered  equipment,  or had duplicate  billings.  Again,  due to the small  1995 
sample size,  we are unable  to determine  if this difference  is statistically  significant.  While 
the new  1996 DMERC  guidelines  do not directly  address these problems,  the SADMERCs 
improvement  of its existing  coding  verification  process  for suppliers  with questions  about 
which code to use for their  equipment  may be having  some positive  effect  here.  The 
inappropriate  1996 claims  represent  $922,000  in allowed  Medicare  payments  in the second 
quarter  of  1996. 
9 
 The  12 percent  in 1996 are categorized  as follows: 
0 	 7 percent  of 286 beneficiaries  report  receiving  equipment  that was less than  what 
Medicare  paid.  Seven beneficiaries  had claims  paid for alternating  pressure 
mattresses,  and another  seven  for alternating  mattress  overlays.  While  the claims 
paid for these  14 beneficiaries  used codes for electrically  powered  equipment,  they  all 
report  that their  equipment  does not have an electric  plug. 
0 	 4 percent  of beneficiaries  report  never  receiving  support  surface  equipment.  Seven 
claims  were paid  for alternating  pressure  mattresses,  two for alternating  mattress 
overlays,  and another  two for powered  air flotation  beds. 
0 	 1 percent  of beneficiaries  had duplicate  support  surface billings,  two for the same 
equipment  and the third  for two different  types of equipment,  all within  the same 
month. 
In  1995, 22 percent  of  136 Medicare  beneficiaries  report  receiving  either upcoded  equipment 
or no equipment  at all,  or had duplicate  support surface  billings.  These claims  represent 
$6.6 million  in allowed  Medicare  payments  in the fourth  quarter  of  1995. 
The 22 percent  in 1995 are categorized  as follows: 
0 	 13 percent  of beneficiaries  report  receiving  equipment  that was less than what 
Medicare  paid for.  These beneficiaries  report  that the equipment  they are using  for 
the care of their  pressure  sores does not have an electric  plug.  However,  all of the 
claims paid for these  individuals  used codes for electrically  powered  equipment  - eight 
for alternating  pressure  mattresses,  one for a powered  air flotation  bed,  and one for 
an alternating  mattress  overlay. 
0 	 4 percent  of beneficiaries  report  never  receiving  any kind  of support  surface 
equipment.  All of these beneficiaries,  however,  had a Medicare  claim paid  for some 
type of support  surface  equipment.  Four claims  were for alternating  pressure 
mattresses,  and three  were for alternating  mattress  overlays. 
0 	 5 percent  of beneficiaries  had duplicate  billings.  In all of these cases,  more  than one 
support  surface  was billed  and paid for under  Medicare  within  the same month,  which 
Medicare  coverage  policy  does not permit.  Two beneficiaries  had two claims  paid for 
the same equipment,  while  five had claims paid for two different  types of support 
surfaces,  usually  a support  surface  overlay  and a support  surface  mattress,  within  the 
same month. 
A VARIETY OF OTHER  PROBLEMS  CONTINUE  TO ADVERSELY  AFFECT 
MEDICARE  SUPPORT  SURFACE  REIMBURSEMENT 
The following  problems  are due to a lack of adherence  to existing  DMERC  guidelines,  and 
were not impacted  in any way by the establishment  of new  1996 DMERC  policies. 
10  Some Beneficiaries Are Using Group 2 Support Surface Equipment Before First Trying A 
Less Expensive Support Surface From Group 1;9 Out Of 10Have No Documentation Of 
A Comprehensive Pressure Sore Treatment Program 
As noted  in the medical  record  reviews  for both years,  some beneficiaries  are using  a support 
surface  from group 2 without  first trying  equipment  from  group  1.  These beneficiaries 
include  those without  any pressure  sores as well as those  with  stage II pressure  sores,  all of 
whom should have first tried a lesser,  group  1 support  surface  as part of their  comprehensive 
treatment  plan before  moving  to a group  2 support  surface.  Only  10 percent  of beneficiaries 
in the  1996 medical  record  review  had documentation  which  demonstrated  the existence  of a 
comprehensive  pressure  sore treatment  program. 
Other Beneficiaries Report Continuing Use of Their Support Surface After Their Pressure 
Sore Healed 
In both  1995 and  1996, more than one-third  (37 percent  and 38 percent,  respectively)  of 
beneficiaries  report  continuing  to use their  group 2 support  surface  equipment  after their 
pressure  sores healed completely.  While  DMERC  medical  policies  do not allow continued 
coverage  of support surfaces  once the patients  pressure  sore has healed  completely, 
Medicare  continued  to pay rental  for 63 percent  of beneficiaries  with healed  sores in  1995 
and 8 1 percent  in 1996. 
PhysiciansPlayA Limited Role 
Based on the limited  medical  documentation  of beneficiaries  pressure  sore treatment  in both 
years,  physicians  appear to be playing  a limited  role  in their  patients  use of support 
surfaces.  In  1995, plans  of care were  submitted  to us for just  23 percent  of beneficiaries, 
only  four of which  included  a reference  to pressure  sore treatment.  Documentation  showing 
the patient  tried preventative  treatment  prior  to the use of a support  surface was available  for 
only  38 percent  of beneficiaries.  Furthermore,  according  to the medical  record  review,  just 
37 percent  were educated  on the management  of their  pressure  sores,  and only  23 percent 
were regularly  assessed by a healthcare  practitioner;  both  of these practices  are listed  in 
DMERC  medical  policies  as being part of a patients  plan  of care. 
In  1996, we received  plans of care for just  30 percent  of beneficiaries,  only  one-third  of 
which  specifically  addressed pressure  sore treatment.  Furthermore,  documentation  of 
preventive  treatment  tried prior  to use of a support  surface  was available  for only  23 percent 
of beneficiaries.  According  to the medical  record  review,  only  one-third  of beneficiaries 
were educated on the management  of their  pressure  sores,  and just  one-third  were regularly 
assessed by a healthcare  practitioner. 
Finally,  on a related  note,  in 1995, 5 percent  of physicians  report  either  having  no record  of 
the patient  for whom they were listed  as the ordering  physician  or report  never  ordering 
support surface equipment  for their patients.  Even more  physicians  in 1996 - 14 percent  -
report  the same problems. 
11 
 Some Beneficiaries Report Using Their Equipment Improperly 
Five percent  of beneficiaries  in each year  appear not to be using their  electrical  equipment 

properly.  This  improper  use reduces  the medical  efficacy  of their  equipment.  Some of these 

beneficiaries  report  never  plugging  in their  support  surface bed,  mattress  or mattress  overlay, 

despite the fact that their  equipment  has a plug that must be used in order  for it to work. 

Others plug  it in only  occasionally  when using  it. 

Such improper  use of equipment  may suggest a lack of adequate patient  education. 

However,  most of all beneficiaries  in both  1995 and  1996 (72 and 77 percent  respectively) 

report  that the supplier  taught  them how to use their  equipment.  Only  2 percent  in  1995 and 

3 percent  in 1996 report  having  to teach themselves  how to use their  equipment  by reading  a 

manual.  Furthermore,  more than  one-third  of all beneficiaries  in both years  report 

contacting  their  supplier  when they have any questions  about their  support  surface  equipment. 

Place Of Service Coding Is Not AlwaysAccurate 
Twelve  percent  of beneficiaries  in  1995 and 4 percent  in 1996 report  living  in a nursing 
home on their  survey  questionnaire.  However,  more than half of these beneficiaries  in  1995 
and all of them  in  1996 had claims  with  home coded as the place of service.  These  cases 
may not necessarily  be problematic.  However,  a supplier  billing  for the equipment  in this 
way makes a greater  profit:  they  would be paid  15 months  of a high rental  price  by the 
DMERC  and beneficiary,  as opposed  to being  paid a lower purchase  price by the nursing 
home. 
MOST BENEFICIARIES  WITH APPROPRIATELY  PAID CLAIMS REPORT 
POSITIVE EXPERIENCES  WITH THEIR SUPPORT  SURFACE EQUIPMENT 
Beneficiaries Report Benefitting From Their Support Surface  Use 
Of the beneficiaries  in  1995 and  1996 who received  electrical  equipment  which  was both 
medically  necessary  and properly  used,  a majority  report  positive  experiences  with their 
equipment.  More  specifically,  in  1995, 79 percent  of these beneficiaries  report  that their 
pressure  sores healed  completely  or improved  because  of their  support  surface.  Of these,  47 
percent  say it took  1 month  or less for this healing  or improvement  to occur,  while  the 
remaining  53 percent  say it took  longer  than  1 month  (for 20 percent,  more than 6 months). 
One beneficiary  reports  that his equipment  is a very  good product.  I would have trouble 
without  it.   Another  says  my mattress  does wonders.  
In  1996, 89 percent  of beneficiaries  with appropriately  paid claims  report  a complete 
recovery  from  or improvement  of their pressure  sores since using their  support  surface 
equipment.  Almost  half  (46 percent)  say this took  1 month  or less,  while the remaining  54 
percent  say it took  longer  than  1 month  (longer  than 6 months  for 9 percent  of beneficiaries). 
12 
 RECOMMENDATIONS 
While  the new 1996 DMERC  guidelines  appear  to be having  a positive  impact on controlling 
Medicare  costs for support  surfaces,  inappropriate  payments  are still being made and other 
problems  continue  to adversely  affect  Medicare  reimbursement  for this equipment.  We 
therefore  believe  that additional  steps can be taken to reduce  the extent  of inappropriate 
support surface payments.  In particular,  we recommend  that: 
HCFA establish the requirement  for periodic review  and renewal  of the medical 
necessity for beneficiaries  use of group 2 support surface  equipment. 
We recognize  that establishing  such a requirement  may be cumbersome  to both  the DMERCs 
in processing  claims  and to the suppliers  in obtaining  the necessary  information.  However, 
we believe  that this requirement  should  help to eliminate  problems  identified  in this report. 
These  include  beneficiaries  inappropriate  and improper  use of support  surfaces,  provision  of 
upcoded  equipment,  and poor  documentation  of support  surface use.  Periodic  recertifications 
could be done every  3 months  and completed  by a healthcare  practitioner. 
We estimate  that implementing  this requirement  would  save as much as $12 million  annually. 
Actual  savings could be considerably  larger  than this amount. 
COMMENTS 
We received  comments  on the draft  report  from  HCFA  and the Assistant  Secretary  for 
Planning  and Evaluation.  We also solicited  and received  comments  from  3 industry  groups, 
the Health  Industry  Manufacturers  Association  (HIMA),  the National  Association  for Medical 
Equipment  Services  (NAMES),  and the Health  Industry  Distributors  Association  (HIDA). 
The HCFA  does not concur  with our recommendation  that it establish  the requirement  for 
periodic  review  and renewal  of the medical  necessity  for beneficiaries  use of group  2 
support surface equipment.  It does not believe  such a requirement  is necessary  since group 2 
support surface  claims  must have  a ZX modifier,  which  indicates  the supplier has 
documentation  that medical  policy  requirements  have been met.  Furthermore,  the HCFA  is 
concerned  about the timeliness  and costs associated  with utilizing  a certificate  of medical 
necessity  (CMN) for group  2 equipment. 
In response,  we point  out that our recommendation  did not specifically  state that a CMN be 
used for periodic  review  and renewal  of medical  necessity.  In fact,  we deliberately  did not 
recommend  that a CMN be used because  of the same concerns  of timeliness  and costs. 
However,  we feel strongly  that some other  mechanism  be used to review  and renew  medical 
necessity.  We do not believe  the ZX modifier  is sufficient  to do this,  since there  is no 
requirement  for additional  medical  evidence  to support  it beyond  the initial  medical  necessity 
determination.  Currently,  there  is no mandate  for any additional,  ongoing  review  of medical 
necessity.  Furthermore,  the findings  of our report  indicate  inappropriate  utilization  which 
warrants,  in our opinion,  some type of corrective  action. 
13  We believe  that the Statement  of the Ordering  Physician,  which  must be filled  out prior  to 
delivery  and is kept on file with the supplier,  could be used to implement  our 
recommendation.  This would assure that the equipment  continues  to be medically  necessary. 
Such a review  could also assure that the beneficiary  is using  the equipment  appropriately  and 
using equipment  that is properly  coded. 
All three  industry  groups  support,  on some level,  our recommendation.  The HIMA  is in 
complete  agreement  and states that this is a position  they have held for the past several 
years.  The NAMES supports  using  the Statement  of the Ordering  Physician,  but on a 6 
month  basis;  HIDA agrees with the 6 month  timeframe.  We believe  a 3 month  time 
requirement  for review  and renewal,  as suggested  by HIMA,  is the best option,  and have 
changed  the recommendation  accordingly. 
Both HCFA  and ASPE raised  questions  about our cost savings estimate  of $12 million.  We 
have added a further  explanation  as to how we derived  this estimate  in the reports 
methodology.  The ASPE suggests we conduct  a cost-benefit  analysis  for implementing  our 
recommendation.  While  we acknowledge  that certain  costs would be incurred  by 
implementing  this recommendation,  we believe  that these costs are likely  to be minimal, 
particularly  since the Statement  of the Ordering  Physician  is already  kept on file by the 
supplier. 
The HCFA  also states that it is unaware  of any new support  surface coding  verification 
process  by the SADMERC.  During  discussions  with  SADMERC  staff,  however,  they 
indicated  that they had improved  their  existing  coding  verification  process  to accommodate 
changes  in support surface policies  and new support  surface  codes and now sends out a sheet 
with guidelines  for suppliers  wanting  written  coding  verification.  As HCFA  notes,  this 
process  is optional  to suppliers  requesting  assistance. 
Finally,  in response to HCFAs  other  technical  comments,  we have made additional 
clarifications  to the text in both the background  and findings  sections.  The full text of all 
comments  are included  in Appendix  D. 
14 
 APPENDIX  A 
SAMPLE  SELECTION 
I.  Defining  the Universe 
We selected two samples of beneficiaries  for this inspection,  one from  1995 and the other 
from  1996.  We also selected  subsamples  from  each of the two samples.  Using HCFAs 
National  Claims History  (NCH) 5 percent  sample file,  we extracted  all Medicare  Part B line 
items meeting  the following  five criteria: 
1. Processed  by DMERCs 
2. 	HCFA  had received  and posted the claims  as of 
12/31/95  for the  1995 sample and 06/30/96  for the  1996 sample 
3. 	HCPCS code of E0180,  E0193,  E0194,  E0277,  or El399  for 
the  1995 sample and HCPCS  code of EO180, E0193,  E0194,  E0277 for 
the  1996 sample. 
4. Allowed  dollar  amount  greater  than zero 
5. 	An ending  date for line  item services  (TDT) between 
lo/O1195 and 12131195for the  1995 sample, 
and between  04/01/96  and 06/30/96  for the  1996 
sample. 
II. 	 1995 Sample Selection 
: 
The original  universe  consisted  of 7,454  line  items attributable  to 4,178  beneficiaries. 
After  removing  the line items of 648 beneficiaries  whom  HCFAs  Enrollment  Database 
(EDB) show to be deceased,  and by selecting  the most recent  line  item for each 
beneficiary,  we were left with a final universe  of 3,530  line  items,  each attributable  to a 
unique beneficiary. 
We stratified  the universe  by ORT State and an  all other  category  based on 
beneficiaries  zip codes.  We then randomly  selected  50 beneficiaries  from each of the six 
strata,  for a total  original  sample size of 300.  Our original  subsample  was then 
constructed  by randomly  selecting  25 beneficiaries  from  each stratum,  for an initial 
subsample of  150. 
Once it became clear  that only  20 of the  130 beneficiaries  with HCPCS code El399 
claims had used support  surface equipment,  we dropped  them  from  the original  sample. 
This reduced the original  sample size from  300 to a final  sample  size of  190 and the 
original  subsample  size from  150 to a final  sample  size of 92. 
A-l  1995 SAMPLE 

Strata  Universe  Original  Sample  Final  Sample 
1. (FL)  I  285  50  33 
I 
2.  (NY)  125  50  46 
I 
3. (CA)  441  50  15 
I 
4.  (IL)  99  50  I  32  11 
I 
5. (TX)  272  50  31 
6. (Other States)  I  2308  50  33 
I 
TOTAL  3530 
1995 SUBSAMPLE 
Strata  Universe  Oz2F  /  Final  S;rample 
1. (FL)  I  285 
2. (NY)  125  25  23 
3. (CA)  441  25  8 
4.  (IL)  99  25  12 
5. (TX)  272  25  15 
6. (Other States)  2308  25  18 
TOTAL  3530  150  92 

III.  1996 Sample Selection 
The original  universe  consisted  of 3,225  line items attributable  to  1,701 beneficiaries. 
After  removing  the line  items of 228 beneficiaries  whom  HCFAs  Enrollment  Database 
(EDB) show to be deceased,  and by selecting  the most recent  line  item for each 
beneficiary,  we were left with a final universe  of  1,473 line  items,  each attributable  to a 
unique  beneficiary, 
We stratified  the 1996 sample by HCPCS code,  one stratum  for E0277,  one for E0180, 
A-2 
 and one for both  E0193 and E0194.  We then randomly  selected  290 cases from  stratum 
1, 75 from  stratum 2, and 55 from  stratum  3, to form a sample  of 420 beneficiaries.  Our 
subsample  was then constructed  by randomly  selecting  145 cases from  stratum  1, 50 from 
stratum  2 and 55 from  stratum 3, yielding  a subsample of 250 beneficiaries. 
1996 SAMPLE 
Strata  Universe  Sample 
1. (HCPCS E0277)  800  290 
2. (HCPCS  E0180)  618  75 
3. (HCPCS  E0193/E0194)  55  55 
TOTAL  1473  420 
1996 SUBSAMPLE 
Strata  Universe  Subsample 
1. (HCPCS E0277)  800  145 
2.  (HCPCS E0180)  618  50 
-3.  (HCPCS E0193/E0194)  55  55 
TOTAL  1473  250 
A-3  APPENDIX  B 
CONFIDENCE  INTERVALS  FOR KEY QUESTIONS 
We calculated  confidence  intervals  for  14 key questions  (seven from the beneficiary  mail 
questionnaire  and seven from  the medical  record  review).  The response  estimate  and 95 
percent  confidence  interval  are given  for each of the following: 
From  the mail  auestionnaire 
1. 	 Have you ever  received  medical  equipment,  such as a special bed,  mattress  or 
mattress  overlay,  for the care of pressure  sores? 
1995  1996 
Yes response  estimate:  96%  96% 
Lower  interval:  90%  93% 
Upper  interval:  100%  99% 
2. 	 Was the support  surface  paid  inappropriately  (i.e.,  was the support  surface  never 
received,  was the equipment  upcoded,  or were duplicate  billings  paid)? 
1995  1996 
Yes response  estimate:  22%  12% 
Lower  interval:  10%  8% 
Upper  interval:  34%  16% 
3.  Have you ever  had a pressure  sore? 
1995  1996 
No response  estimate:  N/A  13% 
Lower  interval:  N/A  8% 
Upper  interval:  N/A  18% 
4.  Who taught  you how to use your  special bed,  mattress  or mattress  overlay? 
1995  1996 
The company  that supplies  the 
product  response  estimate:  72%  77% 
Lower  interval:  58%  71% 
Upper  interval:  86%  84% 
5. 	 Since using  your  special bed,  mattress  or mattress  overlay,  have your  pressure 
sore(s) healed  completely,  improved,  remained  the same,  or gotten  worse? 
1995  1996 
Healed completely  response  estimate:  37%  38% 
Lower  interval:  21%  31% 
Upper  interval :  54%  45% 
B-l  6. 	 Who do you talk to when you have  questions  about using your  special bed, 
mattress  or mattress  overlay? 
1995  1996 
Someone from the company  that supplies 
the product  response  estimate:  37%  57% 
Lower  interval:  23%  50% 
Upper interval:  52%  64% 
7.  Where  do you live? 
1995  1996 
In a nursing  home  response  estimate:  12%  4% 
Lower  interval:  22%  2% 
Upper interval:  2%  7% 
From  the medical  record  review 
8.  Was support surface medically  indicated? 
1995  1996 
No response  estimate:  47%  29% 
Lower  interval:  24%  20% 
Upper interval:  70%  38% 
9.  Information  source
; 
1995  1996 
Medical record  response  estimate:  56%  50% 
Lower  interval:  34%  39% 
Upper interval :  78%  61% 
10.  Was there  a written  plan  of care that addressed  patient  risk? 
1995  1996 
Yes response  estimate:  33%  30% 
Lower  interval:  12%  20% 
Upper interval :  54%  40% 
11.  Did the plan of care address  pressure  ulcer  treatment? 
1995  1996 
Yes response  estimate:  25%  31% 
Lower  interval:  5%  21% 
Upper interval:  45%  41% 
B-2 
 12.  Was preventative  treatment  initiated  prior  to ordering  surface? 
1995  1996 
Yes response  estimate:  38%  23% 
Lower  interval:  16%  31% 
Upper interval :  54%  15% 
13. 	 Was there  documentation  of education  of the patient  and caregiver  on the 
prevention  and/or  management  of pressure  ulcers? 
1995  1996 
Yes response  estimate:  37%  31% 
Lower  interval:  15%  21% 
Upper interval:  59%  41% 
14. 	 Was there  documentation  of regular  assessment  by a nurse,  physician,  or other 
licensed  healthcare  practitioner  at least weekly? 
1995  1996 
Yes response  estimate:  23%  33% 
Lower  interval:  5%  23% 
Upper  interval:  41%  43% 
B-3 
 APPENDIX  C 
NON-RESPONDENT  ANALYSES 
When  surveys  are used to collect  data,  the results may be biased  if non-respondents  differ 
from  respondents.  For this inspection,  a beneficiary  for whom  a survey  was not received 
is a non-respondent. 
1995 Samrde 
For  the  1995 beneficiary  sample,  due to the relatively  small sample  size and resulting 
small cell sizes in the two-variable  tables,  we were only  able to analyze  one variable. 
To test for the presence  of any non-response  bias in the  1995 survey  data,  we obtained 
information  from HCFAs  National  Claims  History  5 percent  file for all  190 beneficiaries 
who were sent a questionnaire.  A total  of 136 surveys  were returned,  for a response  rate 
of 72 percent.  The following  table  illustrates  the number  of responses  and the response 
rate by strata: 
STRATA  NUMBER  RESPONSE  RATE 
1 (FL)  33  73 
2  WY)  46  61 
3 (CA)  15  67 
4 (IL)  ;  32  75 
5 (TX)  31  84 
6 (U.S.)  33  73 
Total  Respondents  190  72 
The survey  data are analyzed  as a whole  and not by strata.  However,  we did exceed  the 
desired  minimum  60 percent  response  rate for each stratum. 
For the  190 individuals  in our sample,  we looked  at their  sex.  This categorical  variable 
was tested using the Chi-Square  with the appropriate  degrees  of freedom.  The results  are 
presented  in Table A. 
C-l  TABLE A 

SEX 
Respondents  Non-respondents  Total  Response 
Rate 
Male  41  30%  15  28%  56  73% 
Female  95  70%  39  72%  134  71% 
Total  136  54  190  72% 
CHI-SQ  =  .104 
Degree  of Freedom  =  1 
1996 SamDle 
To test for the presence  of any non-response  bias in the  1996 survey  data,  we obtained 
information  from  HCFAs  National  Claims History  5 percent  file for all 420 beneficiaries 
who were sent a questionnaire.  A total  of 287 surveys  were returned,  for a response  rate 
of 68 percent.  The following  table  illustrates  the number  of responses  and the response 
rate by strata: 
STRATA  NUMBER  RESPONSE  RATE 
1 (H&S  E0277)  196  68 
2 (HCPCS EO180)  54  72 
3 (HCPCS E0193/E0194)  37  67 
Total  Respondents  287  68 
The survey  data are analyzed  as a whole and not by strata.  However,  we did exceed  the 
desired  minimum  60 percent  response  rate for each strata. 
To test for the presence  of any non-respondent  bias,  we analyzed  the variables  that might 
influence  whether  an individual  would  respond  to the survey  or that might  affect  his or her 
responses.  For the 420 individuals  in our sample,  we looked  at their  sex, support  surface 
used,  and place  of service.  These  categorical  variables  were tested using the Chi-square 
with the appropriate  degrees  of freedom. 
The results  of this analysis  are presented  in tables A, B and C.  The Chi-square  values 
given  in the tables provide  a test of the difference  between  the distribution  of the 
respondents  and that of the non-respondents  for the variable  of interest.  Also provided  in 
the tables are the response  rates by the different  values  of the variables. 
c-2  These tables  show no statistically  significant  difference  between  respondents  and non-
respondents  for any of the variables  tested.  Given the results  of this analysis,  we believe 
that the original  results  fairly  represent  the opinions  of the sample of beneficiaries  to 
whom the questionnaires  were  sent.  We therefore  believe  that our survey  results  can be 
generalized  to the universe  of Medicare  beneficiaries  who had a support surface  claim 
paid during  the second 3 months  of  1996. 
TABLE A 
SEX 
Respondents  Non-respondents  Total 	 Response 
Rate 
Male  105  37%  46  35%  151  70% 
Female  182  63%  87  65%  269  68% 
Total  287  133  420  68% 
CHI-SQ  =  .158 

Degree  of Freedom  =  1 

TABLE B 
SUPPORT  SURFACE  BILLED 
Respondents  Non-respondents  Total 	 Response 
Rate 
Alternate  196  68%  94  71%  290  68% 
pressure 
mattress 
mO277) 
Other sample  91  32%  39  29%  130  70% 
equipment 
(EO180, 
E0193, 
E0194) 
Total  287  133 
 420  68% 
CHI-SQ  =  .242 

Degree  of Freedom  =  1 

c-3  TABLE C 

PLACE OF SERVICE 

II  I  Respondents  1  Non-respondents  1  Total  1 Response 
Rate 
Home  273  95%  128  96%  401  68% 
Not Home  14  4%  5  5%  19  73% 
Total  287  133  420  68% 

II 

CHI-SQ  =  .263 

Degrees  of Freedom  =  1  II

c-4  APPENDIX  D 
In this appendix,  we present  in full the comments  from  the Health  Care  Financing 
Administration  and the Assistant  Secretary  for Planning  and Evaluation. 
D-l  DEPARTMENT  OF HEALTH  & HUMAN  SERVICES  Health  Care  Financing  Administration 
_ 
The  Administrator 
Washington,  D.C.  20201 
MAY I6 1997 
DATE: 
TO:  June Gibbs Brown 
InsDector General 
I 
FROM:  Bruce C. Vladeck 
Administrator 
SUBJECT:  Office of Inspector  General (OIG) Draft Report: Pressure  Reducing 
Support Surfaces, (OEI-02-95-00370) 
We reviewed the above-referenced  report that describes the extent of inappropriate 
Medicare payments  for pressure reducing support surfaces and assesses the effect of new 
1996 durable medical equipment regional carrier medical policies and coverage 
guidelines. 
Our detailed comments on the reports recommendation  are attached for your 
consideration.  Thank you for the opportunity  to review and comment on this report. 
Attachment  - Comments of the Health Care Financing. Administration  (HCFA) 

on Office of Insuector  General (OIG) Draft Reoort: 

Pressure Reducing  Sunport Surfaces. 

/OEI-02-95-00370) 

OIG Recommendation 
HCFA should re-establish the requirement  for periodic review and renewal of the medical 
necessity for beneficiaries use of group 2 support surface equipment. 
HCFA Resnonse 
We do not concur.  Additionally,  we do not believe such a requirement would save as much as 
$12 million annually.  We believe use of the ZX modifier will continue to decrease the 
inappropriate  utilization  of support  surfaces.  As noted in the report, the new 1996 durable 
medical equipment regional carrier (DMERC) guidelines have had significant impact on 
controlling  medically-unnecessary  Medicare reimbursement for support surfaces.  The downward 
trends in inappropriate  payment for this equipment appear to be continuing. 
In order to perform the type of recertification  suggested by OIG, the DMERCs would need to 
utilize a certificate of medical necessity (CMN).  However,  at this time there is no applicable or 
appropriate  CMN for the DMERCs to use for support surface equipment other than the CMN for 
air-fluidized beds.  CMN changes must be made via the national  standard format system.  These 
changes are iostly  and can only be made once a year.  The earliest we could institute this 
requirement would be July 1998. 
In lieu of using a CMN, the DMERCs require suppliers to use a HCFA common procedure 
coding system ZX modifier for support surface equipment.  The ZX modiier  indicates  the 
supplier has documentation  that medical policy requirements have been met and evidence is 
available in the suppliers records.  The documentation  section of the support surface policy 
requires that an order for a mattress or bed be signed and dated by the ordering physician and 
kept on file by the supplier.  This statement must be supported by information  in the patients 
medical record which would be available to the DMERC on request.  Suppliers are instructed  to 
add the ZX metier  to the code for the equipment only ifall  of the specified medical necessity 
and documentation  requirements  are met.  The use of this modifier will allow the DMERCs to 
monitor and analyze utilization  of the modifier for support surface equipment.  Consequently,  data 
analysis can be performed consistent  with the focused-medical review approach  and actions can be 
taken to correct inappropriate  billing practices.  The policy also states that once the ulcer has 
healed, the ZX modifier should not be used.  If the requirements for use of the modifier are not 
met, the supplier can submit additional  information  with the claim to just@  coverage, but the ZX 
modifier should not be used.  If a supplier uses the ZX modifier despite the applicable 
requirements not being met, the supplier is submitting fraudulent claims to the Medicare program.  Page 2 
At this time, we have no way to control whether or not suppliers submit accurate  and truthful 
medical necessity information  regardless of the mechanism used to collect the information.  This 
type of fraudulent behavior may only be discovered through  a post-payment  review of claims. 
Therefore,  the DMERCs are continuing to require that suppliers substantiate the medical necessity 
of equipment, but have chosen to do so through  the use of the ZX modiier  instead of a CMN. 
The use of the ZX modifier has significantly decreased inappropriate  utilization  of support surface 
equipment.  However,  it should be noted that neither the ZX modifier nor a CMN will solve many 
of the abuses identified in the OIG report.  For example, neither mechanism will be able to 
discover whether beneficiaries are improperly  or inappropriately  using their equipment; i.e., 
beneficiaries never plugging in their equipment.  In addition, neither mechanism will be able to 
determine whether  or not the supplier delivered the same equipment that was billed to Medicare 
or whether the equipment was delivered at all. 
Technical Comments 
We believe there is incorrect information  in the Background  section of the report,  sub-heading 
Medicare Coverage of Support Surfaces.  The first paragraph,  last two sentences state:  The 
new guidelines also no longer require monthly recertification  for support  surface equipment, with 
the exception  of air-fluidized beds.  Additionally,  the Statistical Analysis DMERC (SADMERC) 
initiated a new process of coding verification  for support surface equipment.  These statements 
are incorrect.  Monthly recertification  has never been required for all support  surface equipment. 
Air-fluid&d  beds are the only items that were ever subject to recertification  requirements.  This 
requirement  continues.  Additionally,  we are unaware of any new coding verification  process that 
has been developed by the SADMERC.  The SADMERC coding verification  process is an 
optional  process whereby a supplier may get assistance in identifying the appropriate  code for 
billing.  The SADMERC has always been responsible for responding  to inquiries from suppliers 
regarding the appropriate  codes to use when billing Medicare.  Suppliers are not required to 
contact the SADMERC for coding guidance for support surface products. 
One of the findings states that 13 beneficiaries used a group 2 support surface that was medically 
unnecessary before first trying a group  1 support surface as required.  It should be noted the 
policy allows for a group 2 support surface to be covered under certain circumstances  without 
first trying a group  1 surface; e.g., if the patient has large or multiple stage III or IV pressure 
ulcers on the trunk or pelvis or if the patient had myocutaneous  flap or skin graft surgery within 
the past 60 days for a pressure ulcer on the trunk or pelvis. 
Another  finding states the DMERCs continued to pay the rental of support surface equipment for 
63 percent of beneficiaries with healed ulcers despite the policy not allowing continued  coverage 
of support surfaces once the patients pressure sore has healed completely.  It is not clear 
whether this statement means that coverage  of just the group 2 product would be  Page 3 
discontinued,  or ifall  support surface equipment would not be covered once the ulcer healed. 
Therefore, it should be noted that if a patient qualified for a group 2 support surface, and the 
pressure ulcer healed, the DMERCs would cover a Group 1 support surface to prevent the 
recurrence of the pressure ulcer. 
The study also found that physicians appear to be playing a limited role in their patients use of 
support surfaces and that nine out of ten beneficiaries have no documentation  of a 
comprehensive  pressure sore treatment  program.  Although this may be true, the DMJZRC policy 
requires that patients have a comprehensive  care plan established by the patients physician or 
home care nurse, and documented  in the patients medical records.  In addition, the policy also 
requires the supplier obtain a signed and dated statement from the physician attesting  to the 
medical necessity of the equipment.  Questions pertaining to medical necessity on any form used 
to collect thisinformation  may not be completed by the supplier or anyone in a financial 
relationship with the supplier.  Therefore,  we believe the policy goes as far as it can in requiring 
an active role on the part of the patients physician.  DEPARTMENT  OF HEALTH  & HUMAN  SERVICES  Office  of the Secretary 
Washington,  D.C.  20201 
TO: 	 June Gibbs Brown 
Inspector General 
FROM:  David F. Garrison  d-
Principal Deputy Assistant  Secretary 
for Planning  and Evaluation 
02-+5=  a0370 
SUBJECT:  OIG Draft Report: Pressure Reducing Support Surfaces, m 
CONCUR WITH COMMENT 
The Medicare DME benefit includes coverage of three different types of pressure reducing 
surfaces -- categorized as group 1, group 2, and group 3.  These surfaces (e.g., beds, mattresses, 
and related equipment) are considered  durable medical equipment  and they are used to reduce 
decubitus ulcers.  Groups 1 and 2 surfaces must be ordered by a physician  and the order must be 
kept on file by the supplier.  For group 3 surfaces there is an additional  requirement  for a 
certificate  of medical necessity,  which must be updated monthly.  The OIG inspection  described 
in the report found frequent use of more expensive group 2 equipment  without prior trial of 
simpler group 1 devices. 
The OIG recommends  that HCFA periodically  review the medical necessity  of group 2 support 
surfaces for beneficiaries  who use these surfaces and indicates that such a review process will 
produce $12 million  in annual savings.  However, it was unclear how this amount of savings was 
determined.  The OIG study points out that, in 1996, had &  medically  unnecessary  claims not 
been paid, $12 million  would have been saved.  Given that the scope of the OIGs 
recommendation  seems to address only a subset of these medically  unnecessary  claims,  it was 
unclear how a subset of those claims could also produce $12 million  in savings.  We recommend 
the report clarify how it arrived at the $12 million  in savings. 
In addition, the OIG report does not indicate the costs of implementing  a requirement  to conduct 
periodic reviews and the extent to which any savings would be reduced by these costs.  Such an 
estimate should be fairly straightforward  since monthly recertifications  were previously 
conducted.  We recommend the report estimate the administrative  costs of conducting  the 
recommended  reviews and recertifications,  and emphasize how much the estimated  savings 
would be offset by these added costs.  J 
L  zzz 
iti:  z 
DIG-AS  ,y 
E-E  I& 
D&I 
DIG-MP =  HEALTH  INDUSTRY  MANUFACTURERS  ASSOCIATION 
May 1, 1997 
The Honorable  June Gibbs Brown 

Inspector  General 
 DIGAS 
Department  of Health and Human Services 
 ZiE  V 
330 Independence  Avenue, S.W. 
 DIG-01 
Room 5246 
 !EE 
O&O 
Washington  D.C. 20201 

Extcscc 
DateSen 
Dear Inspector  General Brown: 

The Health Industry Manufacturers  Association  (HIMA) is pleased to be asked by your office to 
respond to the draft report titled  Pressure Reducing  Support Surfaces. The Health Industry 
Manufacturers  Association  (HIMA) is a Washington,  D.C.-based.trade  association  and the 
largest medical technology  association  in the world. HIMA represents more than 700 
manufacturers  of medical devices, diagnostic products,  and medical information  systems. 
HIMAs members manufacture  nearly 90 percent of the $55 biion  of health care technology 
products  purchased  annually in the United States, and more than 50 percent  of the $130 billion 
purchased  annually around the world. 
*First of all, we appreciate that you addressed our concerns when we suggested in our February 
21,1996  letter to Penny Thompson,  Chief, Health Care Branch, that the time period  during 
which you would be collecting the data be changed to take into consideration  proper 
implementation  of the support surfaces medical coverage policy. We believe that your data has 
more validity coming from the second quarter of 1996, rather than retrieving  it from the first 
quarter as you originally intended to do. 
HIMA is in complete agreement with your recommendation  that HCFA re-establish  the 
requirement  for periodic review and renewal of the medical necessity for beneficiaries  use of 
group 2 support surfaces. In fact, this is a position  that we have held throughout  the development 
and implementation  of the Durable Medical Equipment Regional  Carrier (DMERC)  medical 
policy for support surfaces. We would suggest, however, as we did in our October  25, 1995 letter 
to the DMERC medical directors concerning  the support surface policy, that review and renewal 
of medical necessity documentation  should occur every three months. 
We would recommend that the current medical necessity document (i.e., the Statement  of the 
Ordering Physician)  and procedures be utilized to initially establish the medical necessity  and 
to renew. Utilizing this document and procedure  would achieve the goals outlined  in the OIG 
report, while not making the claims fling  and processing tasks more cumbersome.  Based on the 
current DMERC support surface medical coverage  policy, the Statement of the Ordering 
Physician is required before set-up. It is not filed with the claim; but rather it is maintained  inthe 
World Leaders  in Health  Care Innovation 
1200  G  STREET.  N  W  .  SUITE  400 
WASHINGTON.  D  C  20005-3814 
(202)  783.8700  FAX  (202)  783.8750  Inspector  General Brown 

May 1, 1997 

Page 2 

patients chart and provided  upon request. In this way, electronic  claims filing is available if 

requested or as part of a post payment audit. This procedure  and documentation  appears to be 

working well in initially establishing medical necessity. We believe that it should be fairly easy 

for the DMERC medical directors  to add similar language to the current policy to require it for 

renewal. 

In addition, to reinforce the results of your study, we believe that the cascading  coverage 

criteria from overlay to mattress replacement  should be reinstated. Again  in our comments  to the 

DMERC medical directors,  we noted that in the September  1995 support surfaces medical 

coverage policy, the coverage  criteria for all group 2 products is the same. However,  in the 

August 1994 proposed  policy and in the recommendations  of the interested  associations,  a 

coverage criteria cascade existed from overlay, to mattress replacement, to bed system. The 

cascade approach  allowed for a much clearer selection process based not only on therapeutic 

wound care benefit, but on the physical needs of the beneficiary; and on their other clinical 

indicators,  (i.e. need for frequent  adjustment, weight factors, etc.) 

HIMAs recommendation  was (and still is) that, for the most part, industry agreed with the 

cascading coverage  criterion  that was included in the August  1994 proposed  policy. This 

included bottoming  out as an additional  criterion to move from a group 2 overlay to a group  2 

mattress replacement.  Industry  agreed to these parameters. Also, such standards would result in a 

selection process which is more customized to the patient. Based on this, we believe that it 

would be advantageous  for the DMERC medical directors to reinstate the cascading  coverage 

criteria from overlay to mattress  replacement in group 2. 

Finally, we would like to compliment  the staff that were involved in the creation  and 

implementation  of this draft report.  We have worked  closely with your staff in the past and have 

developed an excellent working  relationship.  We were delighted to have the opportunity  to work 

with and serve as an educational  resource to Demetra Arapakos and her stti  concerning  support 

surfaces during the course of the study and at the Medtrade exposition in Atlanta. 

Again  as always, we appreciate  the opportunity  to comment on the draft report. 

Sincerely, 

Marcia Nusgar&  Ph. 

Associate Vice President,  Home Care 
 HEALTH INDUSTRY DISTRIBUTORS ASSOCIATION 
Serving Medical  Products Distributors  & Home Care Companies Since 7902 
April 29, 1997 

June Gibbs Brown 

Inspector General 

Office of the Inspector General 

Department of Health and Human Services 

Washington,  DC  20201 

RE:  Comments on Draft Inspection Report on Pressure Reducing Support  Surfaces 
(pa- uz- czsdm37c, 
Dear Ms. Brown 

Thank you for providing HIDA with a copy of the draft inspection report entitled Pressure 

Reducing Support Surfaces.  HIDA is the national trade association of home care companies  and 

health and medical product distribution  firms.  Created in 1902, I-IIDA now represents 

approximately  800 home care companies and wholesale and retail medical product  distributors 

with over 2,000 locations. 

Subsequent to reviewing the draft report, HIDA recommends that the OIG modify the 

recommendation  that HCFA require periodic recertification of medical necessity for support 

surface equipment on a monthly or bi-monthly basis.  Given that the internal part of a wound often 

needs greater than three months to properly heal, HIDA believes any requirement of recertification 

in less than a three month interval is intrusive, and not in the clinical interests of the Medicare 

beneficiaries.  HIDA maintains that six month intervals are a far more reasonable time fi-ame, and 

should be incorporated in the final version of the report. 

Please feel free to contact myself or Mark Hobratschk at (703)-549-4432 with any question or for 

additional information 

Sincerely, 

Cam C. Bachenheimer 

Executive Director 

Home Care and Long Term Care 

cc: 	 Mark Hobratschk 
S. Wayne Kay  DIG-AS -
CCB:mh  DIG-01  -
66 Canal Center  Plaza, Suite 520, Alexandria.  VA 223 14-159 7  703-549-4432  .  FAX 703-549-6495  NAMES 

National Association  for 
Medical Equipment  Services 
May 2,1997  Via Hand  Delivery 
The Honorable  June Gibbs Brown 

Inspector General 

Department  of Health and Human Services 

Room 5246 Cohen Building 

330 Independence  Avenue, S. W. 

Washington,  D. C. 20201 

Re: 	 Comments  on Draft Renort:  Pressure Reducing Sunnort Surfaces 
&+ag- 9s- 00390 
Dear Inspector  General Brown: 
The National  Association  for Medical Equipment  Services (NAMES) submits the following 
comments  on the Office of Inspector  Generals  (OIG) draft report, Pressure Reducing  Support 
Surfaces.  The draft report, which NAMES received on April  18,1997,  requested comments 
within fourteen (14) days. 
NAMES is a nonprofit  trade association  comprised  of over 1400 home medical  equipment 
(HME) services providers in approximately  4,000 sites across the country.  NAMES members 
furnish a wide variety  of equipment,  supplies,  and services for home use.  These items may range 
from traditional  medical equipment  such as walkers, oxygen and hospital beds, to highly 
sophisticated  items and services such as enteral and parenteral  supplies for complete nutrition 
support  for individuals  who can not digest food normally;  apnea monitors, which allow parents 
to closely monitor  high risk infants breathing;  and specialized wheelchairs  and other 
technologically  advanced equipment  which are custom designed for the needs of rehabilitation 
patients.  A substantial  portion  of HME patients  are Medicare beneficiaries  or Medicaid 
recipients. 
NAMES has had a sustained commitment  to helping  eliminate  fraud and abuse in the home 
625 Slaters  Lane.  Suite  200  Alexandria,  VA 22314-1171  (703)  836-6263  FAX (703)  836-6730 
    medical equipment  (HME) services industry.  For example, the NAMES initiative,  Operation 
Build Trust (OBT), was created in response to requests from state Medicaid programs for 
information  about the HME services industry.  OBT now serves as a vehicle  through which 
NAMES works with the Medicare and Medicaid programs to identify  sources of fraud and abuse 
within the HME services industry.  NAMES also supports anti-fraud  and abuse measures 
proposed by HCFA, such as bonding,  and it is advancing  a legislative  plan that includes 
accreditation  and on site inspections  of HME services providers. 
NAMES is pleased to have the opportunity  to comment on the OIGs draft report.  NAMES 
likewise is pleased to note the favorable trends that the OIG cites in the report, including  the 
following: 
. 	 medically  unnecessary  use of pressure reducing support 
surfaces has declined; 
. 	 fewer beneficiaries  report receiving  up coded or no 
equipment; 
.  fewer beneficiaries  report problems with duplicate  billings; 
. 	 almost all beneficiaries  report receiving  training  in the 
proper use of the equipment from their HME services 
provider;  and 
;  . 	 patient outcomes are favorable  when the support surface is 
used properly. 
Your report also notes that Medicare reimbursement  for alternating  pressure mattresses has been 
declining  since the beginning  of 1996.  These outcomes,  as you point out, demonstrate  the 
effectiveness  of the new guidelines  that the DMERCs implemented  in 1996.  In light of these 
positive trends, NAMES has serious concerns about reestablishing  monthly  or bi-monthly 
certification  of the medical necessity  for group 2 support surfaces. 
As you clearly state in your report, this requirement  would be burdensome  on the DMERCs and 
HME services providers. It is our experience that physicians  would find this requirement 
burdensome  as well. Wound care patients typically  are bedridden  and have a severely 
compromised  health status. The healing process may be lengthy  and will depend on a number of 
variables in addition to the use of a support surface, including  the patients  nutrition,  oxidation, 
and drug therapy. Consequently,  it would be unlikely  to see much improvement  in these patients 
condition  on a monthly  or bi-monthly  recertification  schedule. 
Documentation  of continuing  medical necessity  could be accomplished  in a less burdensome 
manner by requiring that the physician  provide to the HME services provider  an updated 
Statement of Ordering Physician  - Group 2 Support Surfaces every six months.  This information 
would not need to be submitted with a claim, but would be kept on file by the HME services  provider.  The  DMERCs  currently  require  that HME  services  providers  maintain  a Statement  of 
Ordering  Physician  on file for beneficiaries  who  receive  group  2 support  surfaces.  The 
requirement  to update  this  form,  combined  with  HCFAs  bonding  initiative  and NAMES 
legislative  proposal  to require  accreditation  and on site inspections,  would  reduce  the problems 
with  group  2 support  surfaces  cited  in your  report. 
Again,  thank  you  for the opportunity  to comment  on the draft  report.  Please  feel  free to call me 
if you  have  any questions,  or if NAMES  can be of further  assistance  to you. 
Sincerely  yours, 
Asela  M. Cuervo,  Esq. 
Director  of Regulatory  Affairs