Department of Health and Human Services 
OFFICE  OF 
INSPECTOR  GENERAL 
OXYGEN  CONCENTRATOR  SERVICES

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 OFFICE  OF  INSPE~OR  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 
stat utory mission is carried out through a nationwide network of audits, investigations, and 
inspections conducted by three OIG operating components:  the Office of Audit Sefices,  the 
Office of Investigations, and the Office of Evaluation and Inspections.  The OIG also informs 
the Secreta~  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 
unjust 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  INSPECTIONS 
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 in the Philadelphia 
regional office under the direction of Joy Quill, Regional Inspector General and Robert A. 
Vito, Deputy Regional Inspector General.  Principal project staffi 
REGION
 HEADQUARTERS

Robert A. Katz, Rroject Leader
 W. Mark Krushat, SC.D.

Donna M. Millan, Lead Ana(yst
 Brian Ritchie

Cynthia R. Hansford
 Tom Noplock

Daniel Brooks

Dianne Griffiths

Leslie Grossman

Craig Feinberg
 Department of Health and Human Services 
OFFICE  OF 
INSPECTOR  GENERAL 
OXYGEN  CONCENTRATOR  SERVICES  EXECUTIVE  SUMMARY 
PURPOSE 
This  report  describes  the  services  provided  to Medicare  beneficiaries  who rented 
oxygen concentrators  in 1991.  We conducted  this study to determine  the  nature  and 
extent  of these  sewices. 
BACKGROUND 
Medicare  coverage  of home  oxygen  care 
Medicare  allowances  exceeded  $660 million  in  1991 for oxygen concentrator  rentals. 
Nationally,  the  average  monthly  allowance  for stationary  equipment  including 
concentrators  was approximately  $273. 
Section  1861(S)(6)  of the  Social Security  Act  prescribes  coverage  of durable  medical 
equipment  (D ME)  including  home  oxygen equipment  and  supplies  under  Medicare. 
Medicare  covers  home  oxygen care  for beneficiaries  who suffer  from  significant 
hypoxemia  (a deficiency  in the  amount  of oxygen in the  blood).  The  Health  Care 
Financing  Administration  (HCFA)  manages  the  Medicare  program. 
@gen  systems 
The  three  primary  oxygen systems  are  (1) oxygen concentrators,  (2) liquid  oxygen, and 
(3) gaseous  systems.  Liquid  and  gaseous  systems  are  administered  directly  to patients 
using conventional  tanks  or cylinders. 
Designed  primarily  for home  use, oxygen concentrators  are  electrically  powered 
devices  which  provide  long-term,  life-sustaining  supplemental  therapy  for patients  with 
inhibited  pulmonary  function,  such as chronic  obstructive  pulmonary  disease.  The 
devices  provide  a richer  concentration  of oxygen to the  patient  by separating 
atmospheric  gases  from  room  air. 
Concentrator  require  maintenance 
The  delivery  of effective  therapy  embodied  in home  oxygen equipment  implies  that 
suppliers  perform  services  on an initial  as well as a continuing  basis  to assure  the 
delivery  of therapeutic  care.  Generally,  patients  using items  such  as wheelchairs  and 
hospital  beds  require  little  monitoring.  In contrast,  oxygen therapy  patients  typically 
require  more  attention  in the  form  of periodic  services  from  the  oxygen supplier. 
Such services  may include  equipment  monitoring  and  maintenance,  emergency  service, 
and  patient  instruction  and  assessment. 
i  The  HCFA  implemented  changes  in the  processing  of DME  claims  (including  claims 
for oxygen concentrator  rentals)  effective  October  1, 1993.  Under  the  new  system, 
suppliers  must  meet  certain  standards  to obtain  a billing number.  However,  the  new 
standards  did not  delineate  minimum  service  requirements  for beneficiaries  receiving 
home  oxygen care. 
Methodology 
Using  a 2-stage  random  sample,  we selected  beneficiaries  in 8 Medicare  carrier  service 
areas.  The  8 service  areas  (referred  to as States  in this report)  were  Arkansas, 
Georgia,  Kentucky,  New Jersey,  North  Carolina,  Oklahoma,  Pennsylvania,  and 
Wisconsin.  Our  beneficiary  sample  represents  the  total  population  of 220,371 
Medicare  beneficiaries  who received  oxygen concentrator  therapy  for at least  3 months 
in  1991. 
FINDINGS 
Home  Ozygen  Concentrator  llerapy  Neceiwitata  Support  Se@es. 
	 Oxygen  concentrator  usage  necessitates  that  suppliers  deliver  services 
periodically. 
	 A number  of national  organizations  have  established  service  standards  for home 
oxygen care. 
	 Standards  implemented  by national  organizations  detail  specific  practices 
suppliers  should  meet,  including  guidelines  for equipment  and  patient  care. 
Some  Benejiczhia  Receive  Extensive  Services  while  Ohm  Receive  Few  Services. 
About  77 percent  of beneficiaries  do not  receive  equipment  monitoring  services 
k	
every  30 days. 
	 Nearly  half of all beneficiaries--47  percent--do  not  receive  any patient  care 
evaluations  or assessments  from  suppliers. 
Many  Benejkiaria  Did  Not  Receive  Services  Endked  @  National  (hganizations. 
	 Many  of the  beneficiaries  did not  receive  the  recommended  selvices  endorsed 
by two national  organizations  involved  in respiratory  treatment--the  Department 
of Veterans  Affairs  and  the  American  Association  for Respiratory  Care. 
Medicare  Poticiix  Contribute  To  The  W&  Variation  In Suppti  Semces. 
	 Current  Medicare  policies  do not  delineate  specific  service  requirements  for 
suppliers  providing  home  oxygen therapy. 
ii  Beneficiaries  may not be  knowledgeable  enough  to select  suppliers  who provide 
b	
appropriate  ongoing  services. 
RECOMMENDATIONS 
We recommend  HCFA  produce  a strategy  to ensure  that  Medicare  beneficiaries 
receive  necessary  care  and  support  in connection  with their  oxygen therapy.  We  offer 
a range  of options  for HCFA  to consider  which include  (1) educating  providers  and 
beneficiaries  about  the  kinds of services  available  and  recommended  by national 
organizations,  (2) promoting  industry  standards  to ensure  better  and  more  consistent 
supplier  practices,  and  (3) setting  minimum  service  standards  by requiring  suppliers  to 
meet  accreditation,  certification,  or licensing  requirements. 
COMMENTS 
We solicited  and  received  comments  on our  draft  report  from  HCFA  and  other 
concerned  organizations,  which  included  the  National  Association  for Medical 
Equipment  Services  (NAMES),  the  Health  Industry  Distributors  Association  (HIDA), 
the  Health  Industry  Manufacturers  Association  (HIMA),  and  the  American 
Association  for Respiratory  Care  (AARC).  The  full text  of their  comments  can be 
found  in Appendix  H. 
The  HCFA  generally  agreed  with our  recommendation,  but  preferred  the  first option 
we presented.  The  NAMES,  HID&  and  AARC  agreed  with our  recommendation 
and  supported  the  establishment  of more  explicit  service  standards. 
We appreciate  the  positive  responses  we received  to our  recommendation.  Of all the 
reviewers  who  commented  on our  recommendation,  HCFA  was the  most  cautious  in 
considering  options  for promotion  of standards  or setting  minimum  requirements. 
The  HCFA  believes  that  supplier  business  standards,  newly in place,  will address  some 
of the  problems  we identified.  While  supplier  standards  can be  used  as a foundation 
for required  services,  they  are  neither  explicit  nor  comprehensive  in adressing  the 
needs  of beneficiaries  on oxygen therapy. 
The  HCFA  also expressed  concerns  about  resources  required  to promote  or set 
standards.  While  we appreciate  these  concerns,  we believe  that  innovative  approaches 
may be  possible  if HCFA  pursues  a productive  partnership  with  concerned 
organizations,  such  as those  which  commented  on our  report.  The  HCFA  may wish to 
explore  these  options  in more  detail  with such organizations  before  committing  to a 
specific  course  of action. 
We also encourage  HCFA  to consider  ideas  beyond  those  which we have  laid  out, 
which  might  also accomplish  the  objective  of ensuring  beneficiaries  receive  needed 
services.  Again,  collaboration  with industry  and  beneficiary  organizations  might 
identifj  some  of those  other  approaches. 
... 
111
 TABLE  OF  CONTENTS 
EXECUTIVE  SUMMARY 
INTRODUCTION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1

FINDINGS  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  6

Home  Oxygen Therapy  Necessitates  Support  Selvices  . . . . . . . . . . . . . . . . . . . . 6

Beneficiaries  Receive  Varying  Levels  of Care  . . . . . . . . . . . . . . . . . . . . . . . ...8

Beneficiaries  Did  Not  Receive  Recommended  Care  . . . . . . . . . . . . . . . . . . . .  12

Medicare  Policies  Contribute  to Variation  in Support  Services  . . . . . . . . . . . .  13

RECOMMENDATIONS  AND  COMMENTS  . . . . . . . . . . . . . . . . . . . . . . . . ...15

APPENDICES 
A  Medicare  Supplier  Standards..  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..A-l 
B:  One  Suppliers  Monthly  Checklist  . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..B-l 
c:	 Examples  of Classification  of Monitoring  Services  . . . . . . . . . . . . . . . . . .  C-1

D:  Calculations  and  Confidence  Intervals  . . . . . . . . . . . . . . . . . . . . . . . . . .  D-1

E:  NAMES  Code  of Ethics  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..E-l

F:  Manufacturers  Maintenance  Procedures  . . . . . . . . . . . . . . . . . . . . . . . . .  F-1

G:  Typical  VA Contract  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..G-l

H:  Comments  from  HCFA  and  Concerned  Organizations  . . . . . . . . . . . . . .  H-1
 INTRODUCTION 
PURPOSE 
This  report  describes  the  services  provided  to Medicare  beneficiaries  who used  oxygen 
concentrators  in 1991.  We conducted  this study to determine  the  nature  and  extent  of 
these  services. 
BACKGROUND 
Section  1861(S)(6)  of the  Social  Security  Act prescribes  coverage  of durable  medical 
equipment  (DME)  including  home  oxygen equipment  and  supplies  under  Medicare. 
Medicare  covers  home  oxygen care  for beneficiaries  who suffer  from  significant 
hypoxemia  (a deficiency  in the  amount  of oxygen in the  blood).  The  Health  Care 
Financing  Administration  (HCFA)  manages  the  Medicare  program. 
The  three  primary  oxygen systems  are  (1) oxygen concentrators,  (2) liquid  oxygen, and 
(3) gaseous  systems.  Liquid  and  gaseous  systems  are  administered  directly  to patients 
using conventional  tanks  or cylinders. 
On  June  1, 1989, HCFA  implemented  a fee  schedule  reimbursement  system  for 
oxygen equipment.  This  replaced  the  customary,  prevailing,  and  reasonable  charge 
methodology  process  which governed  DME  reimbursements  previously.  The  fee 
schedules  set  reimbursement  rates  in four  categories:  stationary  equipment,  oxygen 
contents,  portable  contents,  and  portable  equipment.  Within  a carriers  service  area, 
all items  in each  of the  categories  are  reimbursed  equally.  The  carriers  developed  the 
rates  (subject  to yearly  updates)  based  on  1986 supplier  charge  data.  Medicare 
allowances  exceeded  $660 million  in 1991 for oxygen concentrator  rentals.  Nationally, 
the  average  monthly  allowance  for stationary  equipment  including  concentrators  was 
approximately  $273. 
Designed  primarily  for home  use, oxygen concentrators  are  electrically  powered 
devices  which  provide  long-term,  supplemental  oxygen therapy  for patients  with 
inhibited  pulmonary  function,  such as chronic  obstructive  pulmonary  disease.  The 
devices  provide  a richer  concentration  of oxygen to the  patient  by separating 
atmospheric  gases  from  room  air.  Generally,  patients  qualify  for oxygen concentrator 
therapy  if they  have  reduced  pulmonary  function  measurable  by blood  gas analysis  or 
pulse  oximetry  testing. 
Oxygen  concentrators,  unlike  some  other  types  of DME,  deliver  supplemental  oxygen 
therapy  directly  to the  patient.  Patients  using home  oxygen may be  too  ill to leave 
their  homes;  many  literally  survive from  day to day because  of the  therapy  delivered 
by their  oxygen equipment.  Generally,  patients  using items  such  as wheelchairs, 
walkers,  and  hospital  beds  require  little  monitoring  once  their  equipment  has been 
delivered.  In contrast,  oxygen therapy  patients  typically require  more  attention, 
1  Although  HCFA  states  that  these  services  are  an integral  part  of oxygen and  DME 
suppliers  costs of doing  business,  the  specific  nature  of these  services  is not 
delineated.  The  HCFA  also states,  Such costs are  ordinarily  assumed  to have  been 
taken  into  account  by suppliers  (along  with all other  overhead  expenses)  in setting  the 
prices  they  charge  for covered  items  and  services.l 
Changes  in CZaims I%xrsing  Environment 
There  have  been  concerns  about  past  practices  by some  DME  suppliers  since 
Medicares  inception.  Such  practices  include  (1) carrier  shopping  (essentially,  billing 
the  carrier  which has the  highest  reimbursement  even  though  patients  reside  in a 
different  area),  (2) using multiple  supplier  billing numbers  to disguise  unethical 
billings, and  (3) using telemarketing  techniques  to solicit supplies  and  equipment. 
The  HCFA  implemented  sweeping  changes  in the  processing  of DME  claims 
(including  claims  for oxygen concentrators)  filed  on or after  October  1, 1993.  The 
changes  were  designed  to counter  abusive  practices  and  streamline  claims  processing. 
The  changes  included  the  following: 
All existing  suppliers  had  to reapply  for Medicare  billing numbers  to a new 
b	
entity  known  as the  National  Supplier  Clearinghouse  (NSC).  Among  other 
functions,  the  NSC investigates  to assure  that  suppliers  have  only one  billing 
number. 
	 The  phasing  in of four  DME  regional  carriers  (known  by the  acronym 
DMERCS)  to process  all DME  claims  as well as claims  for orthotics  and  other 
medical  supplies. 
Suppliers  must  meet  specified  standards  to obtain  a billing number,  such as the 
F	
repair  and  maintenance  of rental  items.  (See  Appendix  A for a list of the 
standards.) 
	 Suppliers  found  not  meeting  standards  could  have  their  billing numbers 
revoked. 
At the  end  of 1993, the  supplier  enumeration  process  under  the  new system was 
incomplete.  About  75 percent  of an estimated  120,000 DME  suppliers  had  been 
enumerated,  according  to a HCFA  representative. 
Rewous  Ojjke  of Inspector  General  (OIG)  Work 
In  1987, we conducted  a study comparing  Medicare  reimbursement  for home  oxygen 
and  oxygen equipment  with amounts  paid  by non-Medicare  payers,  We  found  non
]  Medicare  Carriers  Manual,  Section  5105. 
2  Medicare  payers  haddeveloped  cost-effective  reimbursement  methods  for home 
oxygen which  resulted  in monthly  payments  as low as one-quarter  the  amount  paid  by 
Medicare. 
One  of the  non-Medicare  payers  mentioned  in the  report  was the  Department  of 
Veterans  Affairs  (VA).  We contacted  122 VA hospitals  and  found  all paid 
substantially  less than  Medicare  for home  oxygen concentrators. 
We found  that  VA hospitals  have  independent  authority  to decide  which 
reimbursement  options  are  the  most  economical.  About  73 percent  of the  hospitals 
contacted  provided  home  oxygen services  through  a competitive  acquisition  process. 
We completed  a study  in 1990 centered  on the  medical  necessity  of oxygen 
concentrators  for  Medicare  beneficiaries.  Entitled  National  Review  of the  Medical 
Necessity  for Oxygen  Concentrators,  we reported  that  one-third  of the  sample 
beneficiaries  in the  study  either  did not  need  oxygen or did not  need  oxygen to the 
extent  billed.

A follow-up  study completed  in 1991, Oxygen Concentrator  Reimbursement:

Medicare  and  the  Veterans  Administration,  revealed  that  Medicare  pays more  than 
twice as much  for oxygen concentrators  as the  VA. 
In another  1991 study entitled  Trends  in Home  Oxygen  Use, we found  that  oxygen 
concentrators  were  the  most  frequently  used  home  oxygen delivery  system  during  1989. 
Specifically,  concentrators  represented  approximately  80 percent  of Medicare 
payments  for oxygen therapy  semices. 
METHODOLOGY 
Using  a 2-stage  random  sample,  we selected  beneficiaries  in 8 Medicare  carrier  service 
areas.  The  8 service  areas  (referred  to as States  in this report)  were  Arkansas, 
Georgia,  Kentucky,  New Jersey,  North  Carolina,  Oklahoma,  Pennsylvania,  and 
Wisconsin.  Our  original  sample  consisted  of 275 Medicare  beneficiaries  representing 
212 suppliers.  These  beneficiaries  received  oxygen concentrator  therapy  for at least  3 
consecutive  months  in 1991, the  most  recent  year  available.  Due  to lack  of supplier 
documentation,  the  final  sample  includes  183 suppliers  representing  244 beneficiaries. 
This  sample  size allows  us to project  our  results  within  +/- 1.2 percent  to  12.3 percent 
at the  90 percent  confidence  level, with the  great  majority  of estimates  made  within 
+/- 5 percent.  Our  beneficiary  sample  represents  a total  national  population  of 
220,371 Medicare  beneficiaries  who received  oxygen concentrator  therapy  for at least 
3 months  in 1991. 
After  we identified  the  suppliers  who provided  the  oxygen concentrators,  we wrote  to 
them  requesting  copies  of their  records  for the  1991 rental  periods  for the  sample 
beneficiaries.  We  requested  a copy of the  original  physicians  prescription  and  copies 
of any written  instructions  supplied  to the  beneficiaries.  We  also  asked  each  supplier 
3  to complete  -a questionnaire  detailing  their  companys  background,  staff qualifications, 
and  practices  on patient  and  equipment  care. 
Some  beneficiaries  received  services  from  multiple  suppliers  during  1991.  In these 
cases,  we decided  to use the  information  from  the  suppliers  with the  longest  rental 
periods  in our  calculations.  We  did not  attempt  to determine  why these  beneficiaries 
had  more  than  one  supplier. 
We accepted  written  evidence  of home  services  rendered.  When  a supplier  did not 
provide  written  evidence  of services  performed,  we recontacted  them  to ask for such 
documentation.  Twenty-nine  suppliers  representing  31 beneficiaries  were  unable  to 
provide  documentation.  Reasons  for lack of documentation  include  (1) no records 
could  be found,  (2) records  were  lost or destroyed,  and  (3) failure  to document 
services  performed.  Since we were  determined  to use  a conservative  approach,  we 
excluded  these  cases  from  our  sample.  Their  exclusion  reduced  our  sample  size to  183 
suppliers  representing  244 beneficiaries.  Still, our  reliance  on documentation  is a 
limitation  of our  study since  it is possible  in some  cases  that  semices  were  rendered 
but  not  recorded.  Likewise,  semices  which were  documented  may not  have  been 
actually  performed.  Through  follow-up  calls with suppliers,  visits with  suppliers, 
classifications  of services,  and  removal  of suppliers  with no documentation  from  our 
analyses,  we attempted  to minimize  error  in both  directions. 
We analyzed  the  information  to determine  the  nature  as well as the  extent  of services 
rendered  in 1991.  We  classified  the  services  as either  an equipment  or a patient 
monitoring  service.  Where  documentation  existed,  we classified  equipment  set-ups  as 
equipment  monitoring  services.  (An  example  of one  suppliers  monitoring  procedures 
is contained  in Appendix  B.) 
Many suppliers  submitted  documentation  on services  which  did not  involve  equipment 
or  patient  monitoring,  such as disposable  equipment  drop-offs  and  equipment  pick-
ups.  These  services  were  not  included  in our  classifications  of equipment  and  patient 
monitoring  services.  (See  Appendix  C for examples  of monitoring  services.) 
Patient  education  and  training  could  be  classified  as either  an equipment  or a patient 
monitoring  service.  Since we found  this semice  typically  contains  elements  relating  to 
patient  care,  such as assessing  the  patients  capacity  to operate  the  device,  we 
classified  it as a patient  monitoring  service. 
We contacted  the  oxygen supplier  for clarification  when  we had  questions  about  the 
type  of service  rendered.  We gave  suppliers  the  benefit  of the  doubt  by giving them 
credit  for  performing  a service  if unresolved  questions  existed.  A registered  nurse  with 
an extensive  background  in pulmonary  care  acted  as our  consultant  and  assisted  us 
with the  analyses. 
We  initiated  the  data  calculations  with a database  of 244 beneficiaries.  We  divided 
the  beneficiaries  into  two subsets  of data:  (1) those  who had  zero  monitoring  services, 
4  and  (2) those  with one  or more  services.  We then  grouped  beneficiaries  by the 
number  of billing months  during  1991, from  3 to  12 months  of service. 
Some  findings,  such  as the  minimum  and  maximum  number  of days between  sewices, 
are  based  upon  the  number  of days between  monitoring  services.  These  findings  could 
then  be  reported  for those  beneficiaries  who had  two or more  services. 
We  based  our  analyses  on a 30-day standard  of service  provision  because  suppliers  bill 
Medicare  and  receive  reimbursements  on a monthly  cycle.  Therefore,  the  30-day cycle 
with 60 and  90-day  projections  was both  a logical  and  convenient  standard  to use to 
assess  services  provided  to beneficiaries.  (See  Appendix  D for an illustration  of the 
calculations,  statistical  projections,  and  confidence  intervals  for percentages  of 
beneficiaries.) 
We visited  a number  of suppliers  in different  States  to verify the  validity  of 
documentation  and  the  credentials  of supplier  staff.  We  also contacted  22 
beneficiaries  to veri~  the  type  and  frequency  of services  provided. 
We contacted  other  third-party  payers  in the  selected  States,  including  VA hospitals, 
Medicaid  State  agencies,  and  private  payers,  to obtain  their  policies  on setices 
provided  to oxygen patients.  We  also obtained  information  from  the  DMERCS  and 
the  NSC. 
We  met  with a number  of organizations,  including  the  National  Association  for 
Medical  Equipment  Services  (NAMES)2,  the  American  Association  for Respiratory 
Care  (AARC),  the  Health  Industry  Distributors  Association  (HIDA),  the  Health 
Industry  Manufacturers  Association,  the  National  Board  for Respiratory  Care,  ECRI 
(an  organization  which  tests  medical  equipment  and  supplies),  and  the  National 
Association  of Medical  Directors  of Respiratory  Care.  The  Food  and  Drug 
Administration  provided  additional  expertise  on pertinent  pulmonary  equipment  and 
accepted  respiratory  care  protocols. 
our  review  was conducted  in accordance  with the  Quality Standards for Inspections 
issued  by the  Presidents  Council  on Integrity  and  Efficiency. 
2Formerly  known  as the  National  Association  of Medical  Equipment  Suppliers 
5  FINDINGS

HOME  OXYGEN  CONCENTRATOR  THERAPY  NECESSITATES  SUPPORT 
SERVICES. 
Oxygen  concentrator  usage  in the  home  necessitates  that  suppliers  deliver  a wide  array 
of services  on a recurring  basis.  Oxygen  use obligates  suppliers  to perform  these 
services  because  of its relatively  complex,  clinical,  and  life-sustaining  nature  compared 
to most  other  DME  devices. 
The  importance  of support  services,  such  as equipment  and  patient  monitoring,  for 
oxygen concentrator  patients  is critical  for the  proper  functioning  of the  equipment  as 
well as the  effectiveness  of the  therapy  it provides. 
National  accrediting  bodies  eistabhkh serwce standards  for  borne  oxygen  care. 
Accrediting  bodies  such  as the  Joint  Commission  on the  Accreditation  of Healthcare 
Organizations  (JCAHO)  and  the  Community  Health  Accreditation  Program  (CHAP) 
outline  equipment  and  patient  care  standards.  The  JCAHO  has  accredited  oxygen 
suppliers  since  1988.  In its 1993 manual,  JCAHO  requires  oxygen suppliers  to 
perform  ongoing  routine  and  preventive  maintenance  with qualified  staff.  Such 
maintenance  must  be documented.  Approximately  27 percent  of the  responding 
suppliers  maintained  JCAHO  accreditation.  About  50 percent  of the  suppliers  stated 
they were  planning  to seek  accreditation  in the  future. 
The  CHAP  also surveys  and  accredits  home  medical  equipment  companies.  The 
CHAP  stipulates  that  suppliers  must  utilize  qualified  individuals  to provide  patient 
education  and  training  as well as periodic  assessment  of the  equipment. 
I?of&nal  organizations  endcme  senice  standmd  for  home  oxygen care, 
Professional  organizations  such  as the  American  Association  for Respiratory  Care 
(AARC)  advocate  specific  guidelines  in patient  and  equipment  care.  For  example, 
one  patient  care  guideline  recommends  that  credentialed  personnel: 
  visit/monitor  patients  at least  once  a month,  and 
assess  patients,  recommend  changes  in therapy,  and  instruct  caregivers. 
b 
Equipment  care  guidelines  recommend  credentialed  personnel: 
	 reinforce  appropriate  practices  and  performance  by the  patient  and  caregivers, 
and 
6
 assure  that  the  oxygen equipment  is being  maintained  in accordance  with 
F	
manufacturers  recommendations. 
The  National  Association  for Medical  Equipment  Services  (NAMES),  which

represents  more  than  2000 home  medical  equipment  suppliers,  has been  active  in

promoting  service  standards  for the  oxygen therapy  industry.  In a Consensus

Conference  on Home  Medical  Equipment  Services  sponsored  by NAMES  in 1993, the

attendees  stressed  the  desirability  of frequent,  regularly  scheduled  visits for home

oxygen  patients.  The  workgroup  advocated  visits to stabilized  concentrator  patients

every  30 to 60 days.  The  NAMES  Code  of Ethics  relating  to services  is in

Appendix  E.

Equipment  manufacturers  issue service  manuals  containing  recommended

maintenance  activities  for suppliers  to perform  at specified  intervals.  For  example,

DeVilbiss  (model  MC44-90)  advises  suppliers  to check  audible  alarm  systems  and

oxygen concentrations  on a monthly  basis.  (See  Appendix  F for  an example  of

maintenance  recommendations.)  Healthdyne  (models  H-300  and  BX-5000)  prescribes

which  maintenance  functions  should  be  classified  by daily, weekly,  monthly,  and  semi-

annual  time  intervals.

Some  organizations  support  the  use of concentrators  equipped  with indicators  or

monitors.  The  indicators  are  warning  systems  to alert  patients  when  the  purity  of the

concentrator  output  falls below  therapeutic  levels.  These  groups  include  the  American

Society  of Testing  and  Materials,  a voluntary  group  which  evaluates  standards  for

medical  equipment,  and  ECRI,  an organization  which  tests  medical  devices.

Payem  rnunal.zte service  requirements  for  beneficimies. 
Payers,  including  the  Department  of Veterans  Affairs  (VA)  and  Medicaid  State 
agencies,  also delineate  service  requirements.  The  VA hospitals  enter  into  legally 
binding  contracts  with their  suppliers.  The  contracts  set clear  standards  for items  such 
as required  equipment  and  accessories,  patient  education  and  training,  frequency  of 
visits, emergency  care,  documentation  of services,  and  patient  assessment  by qualified 
staff.  A typical  example  of required  services  is contained  in Appendix  G.  (A separate 
report  will compare  Medicare  reimbursements  and  standards  to the  VA as well as 
other  third-party  payers.)  Georgia  State  Medicaid  prescribes  specific  services  which 
suppliers  must  provide  at  no additional  reimbursement.  Georgia  Medicaid 
reimbursement  for rental  of concentrators  includes  disposable  equipment  necessary  for 
operation,  a monthly  trip  for checking  the  equipment,  and  patient  training  and 
instruction. 
Some  third-party  payers  (such  as the  Minnesota  Medicaid  program)  mandate  that 
suppliers  only use concentrators  with an indicator  to monitor  the  concentrator  output. 
Medicare  has no policy on oxygen concentrator  indicators  or monitors. 
7
 SOME  MEDICARE  BENEFICIARIES  RECEIVE  EXTENSIVE  SERVICES 
WHILE  OTHERS  RECEIVE  FEW  SERVICES. 
We found  variation  in the  delivery  of equipment  and  patient  services  to beneficiaries. 
Some  beneficiaries  received  extensive  and  periodic  services,  while  other  beneficiaries 
received  services  on an erratic  basis. 
E@ipment  monitoring  services 
Equipment  monitoring  services  include  checking  concentration  levels,  changing  and 
cleaning  filters,  and  assuring  the  integrity  of alarms  and  back-up  systems. 
Oxygen  equipment  must  be maintained  regularly  to ensure  the  effectiveness  of home 
oxygen therapy.  Unclean  filters,  for example,  can  affect  the  purity  of a concentrators 
output  resulting  in less than  therapeutic  or even  harmful  therapy  for the  patient. 
Moreover,  prolonged  delivery  of less than  therapeutic  levels of concentrator  output 
can  result  in hypoxia  (a reduction  of oxygen in body  tissues  below  normal  levels).  In 
severe  cases,  hypoxia  leads  to death  of tissue  cells.  In less severe  degrees,  hypoxia 
causes  depressed  mental  activity  and  muscle  weakness.  Clinically,  such  a patient 
exhibits  decreased  energy,  shortness  of breath,  and  cyanosis  or a bluish  skin 
discoloration. 
As Table  1 indicates,  8 percent  of the  sample  beneficiaries  did not  receive  any 
equipment  services.  We  projected  this figure  to the  number  of beneficiaries 
nationally.  Of the  18,024 beneficiaries  who did not  get  any equipment  services, 
65 percent  had  been  renting  oxygen concentrators  for 6 months  or longer. 
Percent  of Beneficiaries  Receiving  Equipment  SeMces  in  1991 
Table 1. 
Beneficiaries  Wzth O Services  8% 
18,024 
I 
Beneficiaries  With  One  or More  Services  92% 
202,347
 
Ii Total  Beneficiaries  Nationally  100% 
220,371 
IL 
For  the  remaining  92 percent  of sample  beneficiaries  who got one  or more  equipment 
services,  we conducted  further  analyses.  We  calculated  how often  they  received  one 
service  based  on 30, 60, and  90-day cycles.  These  cycles correspond  with the  30-day 
billing periods  and various  standardized  time  periods  as advocated  by many 
organizations  involved  in respiratory  care. 
8
 As Graph  1 illustrates,  about  25 percent  of these  beneficiaries  received  an equipment 
service  every  30 days.  Almost  47 percent  received  a service  every  31 to 60 days. 
Another  18 percent  got one  service  every  61 to 90 days, while  10 percent  received  an 
equipment  service  every  91 or more  days. 
Graph 1. 
How  Often  Beneficiaries 
Received  One  Equipment  Service* 
A6.9 
24.6 
18.1 
10.3 
I  every 31-60  days  I  every 91 + days 
every 30 days  every 61-90  daYs 
*Benefi-ciariWeahoReceive-Oneor Mo;eServices 
To  display  the  variation  in the  amount  of time  between  equipment  services,  we 
examined  the  number  of days between  services  for beneficiaries  who had  two or more 
services.  We grouped  the  beneficiaries  by the  number  of months  they  had  been  using 
oxygen therapy.  As Table  2 indicates,  a wide  range  in the  number  of days between 
services  exists in each  billing category.  For  example,  one  beneficiary  who used  oxygen 
therapy  for  12 months  waited  223 days between  equipment  services,  while  another 
beneficiary  who also used  oxygen therapy  for  12 months  received  an equipment  service 
2 days following  a previous  service.  This variation  exists in each  of the  billing 
categories. 
9
 Maximum  and  Minimum  Number  of Days  Between  Equipment  Sefices* 
Table 2  u 
Number  of Billing 
Months  for 
Beneficiaries 
Highest  Number  of  58  62  108  84  109  91  237  153  136  223 
Days Between 
Equipment  Servkes 
Lowest  Number  of  5  3  1  10  10 
Days  Between 
IIEquipment  Services 
 lnclu&!OsnlyBeneficiarieWshoReceivedllvoorMoreEquipmenSteMces 
Patient  monitoring  services 
Although  Medicare  does  not  provide  additional  reimbursement  for  clinical  patient 
services  in home  oxygen care,  many  suppliers  provided  these  setices  and  evaluations 
along  with equipment  monitoring  services.  Examples  of patient  monitoring  services 
include  taking  vital signs, testing  pulse  oximetry,  instructing  the  patient  in proper  self-
care  as well as routine  equipment  care,  and  evaluating  symptoms  such  as breath 
sounds,  sputum  production,  and  skin color. 
Nearly  half  (47 percent)  of the  sample  beneficiaries  received  no patient  services,  as 
shown  in Table  3.  This  percentage  represents  102,665 beneficiaries  nationally.  of 
these  beneficiaries,  almost  three-quarters  were  on oxygen therapy  for 6 to  12 months. 
Percent  of Beneficiaries  Receiving  Patient  Services 
Table 3. 
Beneficiaries  With  O Services  47% 
102,665 
Beneficiary=  With  One  or More  Servkes  53% 
[ 
117,706 
Total  Beneficiaries  Nationally  100% 
220,371
Il.... .--,. ___ 
10
 For  the  remaining  beneficiaries  who got one  or more  patient  semices,  we calculated 
the  frequency  of services  based  on 30, 60, and  90-day cycles (refer  to Graph  2). 
About  15 percent  of these  beneficiaries  received  onesemice  eve~30  days.  Forty 
percent  of these  received  one  patient  service  every  31t060  days, while  about19 
percent  had  one  patient  service  every 61t090  days.  Approximately  26 percent 
received  one  patient  service  every91  days or more. 
Graph2 
How  Often  Beneficiaries 
Received  One  Patient  Service* 
~ 
I 
i 
I 
I  every3140 days  I  every91 + days 
every30 days  every61-90days
*ReneficisrieWshoReceiveOneorMoreServices 
As with equipment  services,  the  time  between  patient  services  varied  widely.  We 
ca Iculated  the  amount  of time  between  patient  services  for beneficiaries  who received 
two or  more  services.  We arrayed  these  beneficiaries  according  to the  number  of 
months  they  had  been  using oxygen therapy.  As Table  4 shows, a wide  range  in the 
number  of days between  services  exists within  each  billing  category.  One  beneficiary 
who had  been  on oxygen therapy  for  12 months  waited  334 days between  patient 
services,  while  another  beneficiary,  who had  also used  oxygen for the  entire  year, 
received  a service  one  week  following  the  previous  service. 
11
 Maximum  and  Minimum  Number  of Days Between  Patient  Semkes 
Table4. 
~  3  4  5  6  7  i  9IlU  ~= 
Highest  Number  of Days  49  55  51  82  106  92  190  86  111  334 
I Between  Patient  Services 
~ Lowest  Number  of Days  5  12  1  7  4  2  6  25  22  7 
,1Betsveen  Patient  Semkes 
Includes Only Beneficiaries Who  Receivedl% or More Patient SeMctx 
MANY  BENEFICIARIES  DID  NOT  RECEIVE  SERVICES  ENDORSED  BY 
NATIONAL  ORGANIZATIONS. 
Many  beneficiaries  in our  sample  did not  receive  equipment  or patient  care  as 
specified  in guidelines  advocated  by national  accrediting  bodies,  professional 
organizations,  and  third-party  payers. 
Equipment  service  guidelines  for 77 percent  of the  sample  beneficiaries  did not  meet 
the  standards  set by the  VA and  AARC,  both  of whom  recommend  monthly 
equipment  monitoring  services. 3  We  found  34 percent  of the  sample  beneficiaries  did 
not  receive  services  according  to NAMES  standard,  which  advocates  one  equipment 
service  every  60 days.  As Table  5 indicates,  the  percentages  represent  a projected 
number  of beneficiaries  in the  nation  who did not  receive  equipment  services 
according  to national  standards  set by these  organizations. 
Ninety-two  percent  of the  sample  beneficiaries  did not  receive  the  patient  care 
services  recommended  by the  VA and  AARC,  which  advocate  a patient  monitoring 
service  every  30 days.  About  70 percent  did not  meet  NAMES  guidelines,  which 
recommend  a patient  service  every  60 days. 
3 To  calculate  the  figures  for Table  5, we first added  the  number  of projected 
beneficiaries  who received  zero  services  and  the  projected  number  of beneficiaries 
with one  m-more  services  who fell into  appropriate  30-day cycles.  We  then  divided 
this sum  by the  total  beneficiary  population. 
12  Percent  of Beneficiaries  Whose  Oxygen Therapy  SeMces 
Did  Not  Meet  Recommended  National  Standards* 
Table 5. 
Equipment  Patient  services 
~  mdad  GM-
Department  of Veterans  1 service  every  77.4%  92.1% 
Affairs  30 days  170,535  202,911 
American  Assoeiatkm  for  1 service  every  77.4%  92.1910 
, Respiratory  Care  30 days  170,535  202,911 
lse~~a~34.~3% v  70.5% 
75,602 155,412 
~ ~ 
*Totalpopulation  of Medicarebenefieiarks nationallywho use oxygenconcentratorsin 1991=220s71. 
Many suppliers  cited  various  reasons  for  not  providing  semices.  One  supplier  reported 
that  he occasionally  overlooks  patients.  He  encouraged  patients  to contact  his 
company  if no visits had  been  made  for a couple  of months.  We  contacted  another 
supplier  who had  not  submitted  any documentation  and  asked  if this was an 
inadvertent  omission  on his part.  The  supplier  said the  beneficiary  lived too  far  away 
to visit and  stopped  by occasionally  to pick up filters  and  tubing  to do his own 
maintenance.  These  practices  conflict  with JCAHO  guidelines  which  recommend 
periodic  maintenance  services  conducted  and  documented  by a qualified  person. 
MEDICARE  POLICIES  CONTRIBUTE  TO  THE  WIDE  VARIATION  IN 
SUPPORT  SERVICES. 
We  believe  that  the  lack of standards  or financial  incentives  for support  services  in 
1991 contributed  to the  wide variation  in services  which  our  analysis  found.  Since 
there  were  no mandato~  standards  for suppliers  set by Medicare  and  no payment 
consequences  for different  levels of service,  both  the  quality  and  quantity  of services  to 
Medicare  beneficiaries  differed  from  one  supplier  to another. 
Even  though  HCFA  implemented  business  standards  as part  of its new claims 
processing  system,  they  have  not  detailed  specific  service  requirements  for 
beneficiaries  receiving  home  oxygen therapy.  There  are  no provisions  regarding  type 
or frequency  of services  that  should  be  rendered,  record-keeping  practices,  emergency 
care,  patient  education,  home  safety  assessments,  or infection  control  practices. 
Further,  neither  the  supplier  nor  the  suppliers  staff are  required  to meet  minimum 
licensing,  certification,  training,  educational,  or credentialling  standards. 
The  variation  in levels of services  to beneficiaries  also demonstrates  a payment 
inequity  among  suppliers.  Some  suppliers  provide  regular  ongoing  service,  while 
others  do not.  Although  Medicare  reimburses  fixed payments  to oxygen suppliers 
13
 within  designated  geographic  areas,  the  levels of services  provided  to beneficiaries 
residing  in these  areas  varies  considerably.  Thus  suppliers  providing  necessary 
services,  as delineated  by national  accrediting  bodies,  professional  organizations,  and 
many third-party  payers,  are  placed  at a competitive  disadvantage.  Beneficiaries  may 
not  be  knowledgeable  enough  in many  cases  to distinguish  between  high sexvice 
suppliers  and  low service suppliers,  For  example,  one  DMERC  official reported  that 
some  Medicare  beneficiaries  believe  they  have  to assemble  the  oxygen concentrator  by 
themselves.  The  HCFA  has no recourse  against  a company  providing  minimal  or 
sp{~radic services  because  it has not  adopted  semice  standards  against  which  to 
measure  supplier  practices, 
14
 RECOMMENDATIONS 
We recognize  that  ourdata  represents  thestate  ofcareprotided  by suppliers  to 
Medicare  beneficiariesin  1991, and  concerned  organizations  have  implemented 
improved  standards  of care  since  then.  Nonetheless,  itseems  clear  that  Medicare 
policies  could  better  support  those  efforts. 
WE  RECOMMEND  THAT  HCFA  PRODUCE  A STRATEGY  TO  ENSURE 
THAT  MEDICARE  BENEFICIARIES  RECEIVE  NECESSARY  CARE  AND 
SUPPORT  IN CONNECTION  WITH  THEIR  OXYGEN  THERAPY. 
We  offer  several  options  for HCFA  to  consider  when  developing  this strategy: 
educating  providers  and  beneficiaries,  promoting  standards,  or setting  minimum  service 
requirements  for Medicare  suppliers.  These  options  are  not  meant  to be  exhaustive 
or  prescriptive;  rather,  they  serve  as an indication  of the  range  of possibilities  available 
to  HCFA  in developing  its strategy. 
Educating  l?ovidim  and  Beneficiaries 
The  HCFA  could  initiate  a program  to educate  providers  and beneficiaries  about  the 
kinds of services  available  and  recommended  by national  organizations  for patients 
receiving  oxygen therapy.  Such  an educational  initiative  might  be  most  effective  if 
undertaken  in partnership  with relevant  professional  associations.  This  could  include 
these  options: 
1.	 Educating  health  professionals  (physicians,  hospitals,  etc.)  to question,  seek  out, 
and  refer  patients  to suppliers  providing  recommended  services.  This  could  be 
accomplished  through  articles  in intermediary  and  carrier  newsletters  and 
bulletins  directed  towards  providers. 
2.	 Informing  beneficiaries  of the  kinds  of services  they  should  look  for from  their 
suppliers.  This  could  be  achieved  by including  a section  in HCFAS  Medicare 
Handbook  on oxygen services,  inserting  educational  messages  on the 
Explanation  of Medicare  Benefits  (EOMB)  form,  or using the  expertise  of Peer 
Review  Organizations  or Information  Counseling  and  Assistance  Grants  to 
reach  out  to beneficiaries  receiving  oxygen therapy. 
Educational  initiatives  directed  to providers  and  beneficiaries  would  likely be  the  least 
onerous  option  available  to HCFA.  With  consumer  education,  suppliers  providing 
higher  levels of service  should  receive  more  Medicare  business.  As a result,  more 
beneficiaries  would  receive  higher  levels  of care  and  their  oxygen therapy  would  likely 
be more  effective  and  therapeutic. 
15
 timoting  Standimh 
The  HCFA  could  promote  standards  foro~gen  therapy  setices  which  suppliers 
should  provide  to Medicare  beneficiaries.  For  example: 
1.	 The  HCFA,  perhaps  with the  assistance  of the  DMERCS,  could  take  a 
leadership  role  in promoting  the  standards  endorsed  by JCAHO,  CHAP, 
NAMES  and  other  concerned  organizations  to the  Medicare  supplier 
community. 
2.	 The  HCFA  could  develop  payment  policies  which  provide  financial  incentives 
for suppliers  meeting  specified  standards.  This  could  be  accomplished  in a 
number  of ways.  Suppliers  who are  not  accredited,  for example,  could  receive 
a different  reimbursement  from  Medicare  from  those  which  are  not  accredited. 
Another  option  could  be  to designate  accredited  suppliers  as preferred 
providers  for purposes  of referrals  for Medicare  business. 
Promoting  industry  standards  is just  another  way to encourage  better  and  more 
consistent  practices  among  suppliers.  This  is more  likely to be  effective  if linked  to 
Medicare  reimbursements  or the  flow of referrals  in some  way; however,  this approach 
would  add  a layer  of administrative  responsibility  for the  program. 
Setting Afininuun  Requirements 
The  HCFA  could  establish  a minimum  level of service  requirements  for suppliers. 
This  could  be accomplished  and  enforced  through  a number  of mechanisms.  For 
example,  any one  or a combination  of the  following  strategies  could  be  used: 
1.	 Accreditation  -- The  HCFA  could  require  suppliers  to become  accredited  by a 
nationally  recognized  organization  such as JCAHO  or CHAP. 
2.	 Certification  -- Many  suppliers  meet  accreditation  requirements  but,  for 
financial  or other  reasons,  have  not  undergone  an inspection  process  to become 
officially accredited.  In these  cases,  suppliers  could  certify  (see  below)  that  they 
meet  all such requirements. 
3.	 Licensure  -- We  have  not  surveyed  States  to determine  what  licensing 
requirements  might  be  placed  on DME  suppliers  in certain  States.  We  do 
know, however,  that  in some  States  suppliers  must  be  licensed  by the  agency 
which  regulates  pharmacies.  It may be  that  State  licensure  could  be  a vehicle 
to derive  minimum  standards,  although  a model  licensure  law developed  by the 
Federal  government  might  be necessary  for this approach  to be  effective. 
Suppliers  could  certify  annually  to their  DMERCS  that  they  meet  one  or more  of the 
proposed  alternatives--accreditation,  certification,  or licensure.  Suppliers  found  to be 
misrepresenting  information  in their  certifications  would  have  their  billing  numbers 
16  suspended.  The  HCFAcould  ensure  compliance  through  random  checks,  beneficia~ 
surveys,  and  investigations  of beneficiary  complaints. 
Although  this is the  most  demanding  of the  options  we present,  we believe  it provides 
HCFA  with the  most  assurance  that  standards  are  being  consistently  met  by all 
suppliers.  Additionally,  it gives HCFA  authority  to require  corrective  action  from 
suppliers  found  to be  providing  substandard  or inappropriate  care. 
COMMENTS  ON  OUR  REPORT 
We solicited  and  received  comments  on our  draft  report  from  HCFA  and  other 
concerned  organizations,  which  included  the  National  Association  for Medical 
Equipment  Services  (NAMES),  the  Health  Industry  Distributors  Association  (HIDA), 
the  Health  Industry  Manufacturers  Association  (HIMA),  and  the  American 
Association  for Respiratory  Care  (AARC). 
The  full text  of their  comments  can be  found  in Appendix  H.  A summary  of 
comments  and  our  response  follows. 
HCFA 
The  HCFA  agreed  that  suppliers  should  provide  necessary  services  in connection  with 
the  oxygen equipment  and  supplies  they furnish.  The  HCFA  concurred  with  our  first 
option  to educate  providers  and  beneficiaries  about  the  kinds  of services  available  and 
endorsed  by national  organizations.  They  also provided  examples  as to how the 
education  could  be  implemented.  The  HCFA  felt  our  other  options  would  not  be 
feasible  because  of anticipated  administrative  burdens.  Rather  than  promoting  new 
standards  and  accreditation,  however,  HCFA  indicated  that  the  existing  supplier 
standards  could  be  used  to ensure  improved  setice  to beneficiaries.  As an example, 
HCFA  said  that  a supplier  that  does  not  follow the  equipment  manufacturers 
maintenance  procedures  would  be  in violation  of the  standards.  The  HCFA  will 
continue  to encourage  the  DMERCS  to review  suppliers  for compliance  with Medicare 
requirements  and  standards. 
NAMES 
The  NAMES  supports  our  recommendations  for increased  supplier  and  beneficiary 
education  along  with industry  standards  to enhance  the  level of services.  The  NAMES 
a km stressed  its commitment  to promoting  service  standards  in the  indust~, 
encompassing  minimum  supplier  service  standards  and  supplier  and  beneficiary 
education.  Further,  NAMES  volunteered  to work with HCFA  to develop  specific 
supplier  standards. 
The  NAMES  questioned  some  of the  findings  based  on the  age  of the  data  and  the 
supplier  sample.  They  believe  the  industry  has  moved  consistently  and  aggressively  to 
becoming  more  service  oriented.  According  to NAMES,  JCAHO  accreditation  was in 
17  its infancy  in 1991; relatively  few suppliers  had  been  accredited  at that  time.  Today,

more  than  1400 suppliers  have  received  JCAHO  accreditation.

The  NAMES  also took  the  position  that  our  inclusion  of past  industry  abuses  and

prior  studies  was not  relevant  to the  purpose  and  objectives  of the  current  study.  The

NAMES  also made  a number  of technical  comments.

HIDA

The  HIDA  agreed  with our  conclusions  concerning  inconsistency  among  suppliers  with

respect  to the  level of services  provided  to oxygen patients.  In addition,  HIDA  voiced

support  for our  recommendation  option  to establish  strong  supplier  standards.  The

HIDA  said  that  defining  standards  of service  would  result  in the  provision  of the

highest  levels of service  and  care  for Medicare  beneficiaries.  The  HIDA  advocates

different  levels of standards  based  on the  type  of services  a supplier  provides,  such as

basic  standards  for traditional  DME  or more  stringent  standards  for patients  receiving

ventilator  care  or home  infusion  therapy.  The  National  Supplier  Clearinghouse  could

be the  entity  to develop  and  monitor  stronger  standards,  according  to HIDA.

The  HIDA  felt our  recommendation  option  relating  to different  payment  amounts  tied

to which suppliers  who do or do not  meet  standards  requires  further  analysis.  In

particular,  HIDA  thought  that  we should  consider  levels of service  from  the  patients

needs  in addition  to suppliers  capabilities.  Additionally,  HIDA  made  a number  of

technical  comments.

HIMA

The  HIMA  provided  brief  comments  on the  draft  report.  Oxygen  therapy  should  be

characterized  as supplemental  oxygen rather  than  life supporting,  according  to

HI MA.  The  HIMA  pointed  out  that  FDA  considers  oxygen concentrators  to be  non-

life support  devices  which  provide  supplemental  oxygen.  In our  recommendation

option  on establishing  minimum  requirements,  HIMA  felt that  HCFA  should  also

require  monitors  or indicators  which  are  devices  which  signal concentrator  failure.

Furthermore,  the  absence  of monitors  or indicators  should  result  in less

reimbursement  than  units which  include  such devices.  Some  industry  equipment

standards  require  that  monitors  or indicators  be  included  as part  of concentrator

equipment,  according  to HIMA.

AARc 
The  AARC  agreed  with our  findings  and  recommendations.  The  AARC  stated  that 
support  services,  in particular,  patient  assessment,  is a key element  of home  oxygen 
therapy.  Furthermore,  inconsistencies  in providing  such services  among  suppliers 
cannot  be permitted.  Until  minimum  setice  standards  are  mandated  by HCF~ 
inappropriate  care  will abound,  AARC  added. 
18
 The  AARCexpressed  concern  about  some  aspects  of the  report.  For  example,

AARC  felt the  sample  size was too  small  and  could  affect  the  statistical  validity  of the

report.  Furthermore,  they  said that  broad  comparisons  are  made  between  Medicare

and  the  VA.  They  suggested  that  we emphasize  the  differences  between  the  Medicare

program  and  the  VA program  instead  of broad  comparisons.  The  AARC  also

included  some  technical  comments  in their  response.

OIG  RESPONSE

Recommendation 
We appreciate  the  positive  responses  we received  to our  recommendation.  of  all the 
reviewers  who commented  on our  recommendation,  HCFA  was the  most  cautious  in 
considering  options  for promotion  of standards  or setting  minimum  requirements. 
The  HCFA  believes  that  supplier  business  standards,  newly in place,  will address  some 
of the  problems  we identified.  While  supplier  standards  can be  used  as a foundation 
for required  services,  they  are  neither  explicit  nor  comprehensive  in addressing  the 
needs  of beneficiaries  on oxygen therapy.  The  HCFA  also expressed  concerns  about 
resources  required  to promote  or set standards.  While  we appreciate  these  concerns, 
we believe  that  innovative  approaches  may be possible  if HCFA  pursues  a productive 
partnership  with concerned  organizations,  such as those  which  commented  on our 
report.  The  HCFA  may wish to explore  these  options  in more  detail  with  such 
organizations  before  committing  to a specific  course  of action.  We  also encourage 
HCFA  to consider  ideas  beyond  those  which we have  laid out, which  might  also 
accomplish  the  objective  of ensuring  beneficiaries  receive  needed  services.  Again, 
collaboration  with industry  and  beneficiary  organizations  might  identi@  some  of those 
other  approaches. 
Technical  Comments 
In response  to questions  about  the  size of our  sample,  we have  expanded  on our

explanation  of the  confidence  intervals  for the  sample  and  also refer  readers  to

Appendix  D, which  provides  more  details  on our  projections  and  their  precision.  We

also  have  acknowledged  in this final  report,  as we did in the  draft,  that  the  data  is

based  on  1991 claims  and  services  and  that  our  findings  relate  to Medicare

beneficiaries  experiences  in that  year.  In fact, we have  prominently  acknowledged

that  concerned  organizations  have  worked  to develop  guidelines  and  standards  since

that  time.  Nonetheless,  Medicare  policy could  better  support  these  efforts.

While  we understand  NAMES  comment  that  prior  work  on the  general  topic  of

oxygen therapy  might  not be  of specific  relevance  to these  findings  or

recommendations,  we believe  that  many  readers  will be interested  in the  prior  work  of

the  OIG  on this general  subject.  As a result,  we have  retained  this discussion.

Likewise,  while we understand  AARCS concerns  about  broad  comparisons  between

the  VA and  Medicare  and  agree  that  there  are  certainly  differences  between  the

19  programs,  the  scope  of our  inquiry  is necessarily  at a more  general  level.  In this study, 
the  VA standards  represent  one  of several  points  of comparison  to Medicare 
experience.  Consequently,  we have  also retained  this discussion. 
Finally,  in response  to other  technical  comments  we received,  we have  made  a number 
of changes  in the  report  to clarify or correct  the  use of terms. 
20
 APPENDIX  A

MEDICARE  SUPPMER  ST~ARDS 
1.  In response  to orders  which it receives,  a supplier  must  fill those  orders  from  its 
own inventory  or inventory  of other  companies  with which  it has  contracted  to 
fill such orders  or fabricates  or fits items  for sale from  supplies  it buys under  a 
contract. 
2.  A supplier  is responsible  for delivery  of Medicare  covered  items  to Medicare 
beneficiaries. 
3.  A supplier  honors  all warranties,  express  and  implied,  under  applicable  State 
law. 
4.  A supplier  answers  any questions  or complaints  a beneficiary  has  about  an item 
or use of an  item  that  is sold or rented  to her  or him,  and  refers  beneficiaries 
with Medicare  questions  to the  appropriate  carrier. 
5.  A supplier  maintains  and  repairs  directly,  or through  a service  contract  with 
another  company,  items  it rents  to beneficiaries. 
6.  A supplier  accepts  returns  of substandard  (less than  full quality  for particular 
item)  or unsuitable  items  (inappropriate  for the  beneficiary  at the  time  it was 
fitted  and/or  sold)  from  beneficiaries. 
7.  A supplier  discloses  consumer  information  to each  beneficiary  with whom  it 
does-business,  which  consists  of a copy of these  supplier  standards  to which it 
must  conform. 
8.  A supplier  complies  with the  disclosure  provisions  cited  on the  HCFA-192 
form.* 
*  Refers  to the  disclosure  of ownership  and  control  information  by the  supplier 
business  entity  on the  enrollment  and  application  form  for a Medicare  billing  number. 
A-1
 APPENDIX  B

ONE  SUPPLIERS  MONTHLY  CHECKLIST  FOR  OXYGEN  CONCENTRATORS

J  Clean  exterior of unit 
c1
 Clean  or replace  filters 
-1  Clean  interior of unit 
i-l  Check  for signs of overheating* 
a 
Check  foam for proper  placement  and deterioration 
u 
Check  fan for proper  operation 
c1  Check  unit for leaks 
El  Check  system  pressures 
n 
Check  cycle time 
L1
 Check  outlet pressures  and temperatures 
c1  Check  unit for proper  air flow

rJ  Read  concentration  at maximum  liter flow

id  Read  concentration  at prescribed  liter flow

*  Signs  of overheating  can be heat dots on sieve beds,  changing  color, yellowing  and cracking  of 
finings warpage  of plastic parts, etc. 
B-1
 APPENDIX  C 
EXAMPLES  OF  CLASSIFICATION  OF  MONITORING  SERVICES 
Examples  of Equipment  Monitoring  Services: 
Changing  Filters

Cleaning  Filters

Checking  the  Oxygen  Flow Rate

Checking  the  Back-up  System

Cleaning  the  Cabinet

Checking  the  Concentrator  Purity  (percentage)

Concentrator  Service/Check

Service  Call

Examples  qf Patient Monitoring  Services: 
  Reports  on the  Condition  of the  Patient

.  Pulse,  Blood  Pressure,  etc.

  Patient  Checklist  to Ensure  Understanding  of Equipment  and  Care

  Phone  Calls to the  Patient  Which  Include  In-Depth/Comprehensive  Patient

Care  Questions 
Equipmeru  Set-Ups  Classified as an Equipment  Monitoring  Service: 
Included  When:

Clear  Set-Up  Documentation/Matches  with Billing Start  Date

Not  Included  When:

No Set-Up  Documentation  is Found

Already  Classified  as a Separate  Equipment
 Service 
No Documentation  of Any Sefice,  Despite
 Billing Dates 
Examples  of Equipment  Drop-Ofls: 
  cannulas

  humidifiers

  tubing

  water-traps

  trachea  trays

  E-tanks

  D-tanks

  H-cylinders

  Refills  (liquid)

  Portable  Equipment  Not  Counted

  Nebulizers  and  Drugs  Not  Counted

c-1
 APPENDIX  D 
CALCIZLAITONS  z4ND  CONFIDENCE  lN1ERVXLS 
-tionsofthe  Number  of Sewices  Every  30,  6Q  and90Daysj  andtheM~ 
and Maximuni N&w  of Days  Beiween  Skrvkes: 
Bene  1:

Start  Date
 End  Date 
Jan.  1  Feb.  1  Mar.  1
 Apr.  1 
x  31 dys  X  28 dys  x  31 dys  x 
Total  of 2 Services:  (Feb.  1, Mar.  1) 
Bene  2 
Start  Date  End  Date 
Jan.  1  Feb.  21  Apr.  4  Jun.  1  Aug.  15 
x  51 dys  X  42 dys  X  58 dys  X  75 dys  x 
Total  of 3 Services:  (Feb.  21, Apr.  4, June  1) 
NUMBER  OF SERVICES  EVERY  30 DAYS: 
STEP  1:  Find  the  total  number  of days between  the  start  and  end  dates: 
Bene  1:  90 total  days between  the  start  date  and  end  date 
Bene  2:  226 total  days between  the  start  date  and  end  date 
STEP2	 Calculate  the  number  of 30-day periods  in which  the 
beneficiary  could  have  received  a semice  based  on the 
total  number  of days between  the  start  and  end  dates: 
BENE  1:  90/30=  3 
BENE  2:  226/30=  7.53 
STEP  3:	 To  find the  proportion  of services  every  30 days that  the 
beneficia~  actually  did receive,  divide  the  actual  number 
of semices  by the  number  of services  the  beneficiary  could 
have  received  given the  total  number  of days between  the 
start  and  end  dates  (from  STEP  2): 
BENE  1: 2/3=  .66 services  every  30 days 
BENE  2: 3/7.53=  .39 semices  every  30 days 
D-1
 APPENDIX  E

J!!&
mu
.,.
NAMES 
. . 
CODE  OF  ETHICS 
Ha+ngbeen  aixeptedinto  membership in the NationalAssoUa~  ofM-@-~t 
Suppliets.we do hereby subsonbe whout  resenmnon to the A~  s Code of Ethics. 
7%epurpose of the tie  of Euks  shd  be to set end impfova ~  ~in  tie 
ptztcfice of protding  home medid  equipmmt  anti services.  To maintainthe efhkfil oonduct 
and integrdyofth&AaaooWon. a member pkdges  to abide by the fOff-
1.  To render the highest Ievei of cam pmmpdy  and  competenffy  - ~~  a~  tie 
health and safety of tie  patient. 
2.  To serve a4 pmenta ragacdless  of face,  crwd,  nationaf origin ormm  ofiJ/ness-
3.  TOprotkfe  tviaMyhome medicd  equ$nnent end servioes whkh sss wPW@@  ~r 
the patientnseeds. 
4.  To hsbuct  the patients  antior  care  givers  m the proper use of the we~ 
5.  TO- fWY and acuuately to patients an~or  cam ghws  patiWS  rights and 
ob@stions  mgafdrng  me  ~nw$  sale and sefvice  of home meokzd -enc 
6.  TO ~  me  &d~f&/  na~~  of tie pa~~&  ~~  and not ti  dkdosS  SIKh 
it)hmadm  witho~  p~~r  a~o~,  ~pt  ss  ~iti  by hW. 
7.  To~  to expand  and impnnfeprvfeasiondknowledge and @@ssOas to 
/VOtddePstfentswth
equipment  and  senioes  which  are  ooflfilWSdY  -. 
8.  TO ~  ~  bo~  F@e~/  and  /@  &ws  and  ~@ations  Whti  govern  the  home 
medical equipment industry. 
9.  TO ati  ~sating,  di~  or ~~,  wi~  a sou~  of pati8nt &Olds  /h a 
- mfemtl  arrangement  whereby patien~  are direoted to - a SW@er  of 
~  m- equipment  in derogation of the patients rights to se&ot the sup@e=
of meir choice. 
10. To act in good  faith:@  be  honest.  Wand  far  to  #/  Wnoemd. 
E-1
 APPENDIX  F 
MANUFACTURER%  MAINTENANCE  PROCEDURES 
Every  OeVCVMC44  is  thoroughly  tested  and  8.  Routine Maintenance

burned-in  at the  fa~ory  to make sure that  all 
1,  Humidifier  - The  humidifier  (6  Fig.  3)

of  the  produ~  specifications are being  met,  To 
should  be cleaned  daily  or  as  recom

assure continued  trouble-free  petiormance  vari -
mended  by the  manufacturer.  It should

OUS maintenance  procedures  sbouid  be  per-
be washed  in warm  soapy  water,rinSed

formed  on a regular basis by a qualified  OeVilbiss 
thoroughly,  and refilled. Be CarefUl not to

dealer.  The foll~ing  maintenance  instructions 
overfill.  The  tubing  and  prescribed

are provided  as a guideline. 
canmda or mask should  aiso  be  cleaned

A.  Testing and Calibration  according to $SIanUfaCtUrerercSom
 men
dations.
1. Turn the power  switch to the  ON- posi
thtt  and dowfy  turn the flow  meter  con- 2.  Gr~  particle  Fiiter  - The  gross  particle 
Vd  knob (6 Pig. 2) and note that the flow  filter  (6 Fig. 4) should  be  removed  and 
rate  is  variable  from O to  5 liters  per  cleaned weekly. 
minute. 
To remove and clean: 
2.	 When  the unit is first turned  on (or if not 
used for an   xtended  perid of  time)  it  A.  Turn the  knob  counterclockwise  t/4
may require up  to  30minutesfor the oxy- turn and remwe  the  entire  assembly 
(See fig. 5). 
gti  concentrsnion  to stabilize.  The fiow 
raw  may drift  stightly during  this period  B.  Wash  the  assembly  in  warm  soapy 
of tfme and the Oxygen concers~tion  wiii  water  and  rinse.  Shake  excess water 
9Mdually  increase to a steady value  at a  from the filter. 
specific fiow rate. 
c.  Use a lint-free  cloth or paper  towel  to 
3.	 When  the  oxygen  concentration  has  dry filter.  Be sure Tilter  is completely 
stabilized.  an oxygen analyzer  shotdd be  dry before repiaang. 
attached  to the  oxygen outlet  fitting  (7
fig. 2) to testoxygen concentrations  at  D.  Filter  may  also  be  cleaned  by 
various fiow  rate setdng%  The analyzer  vacuuming. 
thdd  be cdibmted  prior  to  taking  an  NOTE: The gross padcle  filter  shouId  be 
oxygen  percentage  reading  (See  note  monitored  more closely  in enw.ronments 
under 6-6). As the flow rate  is increased.  with  abnormal  amounts  of  particulate
tlw percent of omen  in the delivered  gas  matter  in  the  air.  Operation  of  the 
decreases. though  the actua~  volume  of  DeVO/MC44  without  the  gross  panicle 
oxygen  delivered  per minute  ~s greater.  filter  will  prematurely  occiude  the  felt 
The  range  of  oxygen  delivered  at  the  pre-fdter  and  cause  a decrease  in  unit 
OUthM for various flow  rates IS shown  m  performance.
the graph beiw  for the MC44. 
3.  Felt Pm-filter  - The felt  pm-filter  (2 Fig. 7) 
should be changed  approximately  once a
100 
month under normal  conditions. 
To repiace the pr&ilteC 
OXYGEN 
CONCEN- 90  MC44  A  Rotate  the  filter  housing  (3  Fig.  7)
TR4TION  (llSVdt)  ccruntercfockwise  to  remove  it  from 
(Percent  the intake bacteria  filter  (5 Fig. 7). 
~ 3) 
80 
8.	 RemH  the cap ( 1 fig- 71 on *e  filter 
housing and pull out  and  discard the 
m  used filter pad (2 Fig. 7).
70  ~ 
01234S  c.  Insen a new  felt prefilter  pad  into 
the housing  and  replace  the  cap  on 
FLOW (Liters per Minute)  the housing. 
D.  Place the  filter  housing  on  the  bac-
Oxvoen Production w  Flow Rate  teria  filter  and  turn  clockwise  until 
snug. 
F -1
 4.  Intake  eaaerta  Filter -The Intake bacteria  1	 Final Eacterla  Ftlter  - The  final  bacteria 
filter  (S Fig.  6) should be !nspected at the  filter  [3  Fig.  12) shou~d be  changed  a$ 
same  time  the  felt  pre-fdter  is inspected  needed  (approximately  once  a year  under 
and  changed  when  needed  (approxi normal  condnions). 
mately  every SIXmonlhs). 
To replace  the  final bacteria filter: 
To replace the intake bacteria filtec 
A.  Loosen the  cabinet  fasteners  on  the 
. 
A.	 Pull  the  bacteria  filter  out  of  the  top ana sfdes of zhe umt. 
rubber grommet  (See Ffg. 6). 
8.  Swing the front cover to the right. 
B.  Remove the felt pm-filter assembly  c.	 Remove  hose  clamp  and  hose from 
c	 Place the felt  pre-filter assembly on a   ach  nd of filter  and discard filter. 
new bacteria  filter.  o.	 install  new  bacter]a  filter  and secure 
o.	 The complete  filter assembly can then  with  hose clamps. 
be insemcf  into the rubber grommet. 
E.	 Reptace aver  and secure with  cabinet 
. . 
5.	 Audible  Alarm  - Testing the audible alarm  fasteners. 
system should  be included  in a routine 
2.	 Compr-r  filter.  The comoressar  HEPA 
maintenance  program.  Itshould  be 
filt~  ( 13 Fig. 14) should be changed  at or 
checked on a manthfy basis. 
before 25.000  hours of unit operation. 
A	 To  test  the  audible  alarm  system, 
To replace compressor filtec 
renwve  the line cord from thel 1S voit 
AC outfet  and turn the power switch  A	 Refer to Setvice htruction  8 to Open 
to the  ON- position. If the alarm is  @zinet  covers. The back cover should 
not heard or soundsweak. rep(ace the  be completely  removed. 
9 W  battefy (6 Fig.14)located  on 
the   ccumulator  shelf  next  to  the  B.	 Cut plastic  cable  tie  that  holds HEPA 
fi&mssesntsly.  filter in piece. 
B.  Plugtheunithttoa  115va4t ACoutfet  c	 Loosen hose ciamps and remove  bfack 
a-- turn  the  power  switch  to  the  rubber hose from both ends of filter. 
ON  pti~  The aiarm wiii  sound 
0.	 Install  new  HEPA filter  with  air flow 
munentarily.  If the alarmis not heard  directiort?d arrow  pointing  d~ 
or  sounds  weak  replace  the  9 volt  and secure with  plastic cable tie. 
battery. 
NOTE:  Holes  for  cable  tie  -a-r@- located 
NOTE:  Replacement  batteries  can  be 
directly  behind  left  sieve  bed.  Thumb 
purchased  Iocdly  and should  be alkaline 
screws and  bracke~  that  secure  beds to 
bamecies or equivalent. 
unit must  be removed  so that  cable  tie 
6.	 02  Concentrations - Oxygen  concentra can be ihsemed  into  holes. 
tions  should  be  checked  monthly  in 
E.	 Attach  black rubber  hoses to each  end 
accordance  with  the   stablished  test 
of fifter and secure with hose ClamPS. 
procedures (Section 4, A). 
F.	 Replace  cabinet  covers  and  secure 
NOTE:  Before  checking  concentrations, 
with cabinet  fasteners. 
the  oxygen  analyzer  sftasdd be property 
calibrated using    100%  pure  oxygen  3.	 Compressor  - Inspect  and  change  if 
source.  It  should   lso  be  rtoted  that  neceesaq  the  internal  component  at 
chngee in tempemtwa.  8kitud& or isu.  10,OOQhour  intervals  of unit  operation. 
- -Y  ~  the oxygen  concen Seaservice  ~nstrucdon ~. 
tsdonraedmgasshown  bythea~. 
NOTE:  All  routine  and  periodic 
Tlterebre.  the  analyzer  should  be 
maintenance  should  be  recorded  by 
~  in simi&r  conditions to witera 
listing  the  date  and  hour  re8diftgS  in  a 
theconantnmr  is located. 
maintenance  schedule  iike  the  one 
c  Periodic  Maintenance  shown on the following  page. 
F -2
 ,  1  I  i  I 
.  . 
-
o 
z 
< 
z 
UJ 
VI 
F -3  APPENDIX  G 
TYPICAL  VA CONTRACT 
Oxygen  Concentrator  Requirements 
Contractor  to furnish  all labor  and  equipment  required  to provide  rental  service  of 
oxygen concentrators  for VA beneficiaries  in their  homes  within  geographical 
jurisdiction  of the  VA Medical  Center  (city, state). 
Contractor  will be  responsible  for providing  the  VA beneficiary  with all disposable 
such as nasal  cannulas  or masks,  tubing,  connectors,  nebulizers,  humidifiers  and bottles 
(Aquapak,  or equal  substitute).  Also, the  contractor  will be  required  to furnish 
emergency  back-up  systems:  E size cylinder  or H size cylinder  as appropriate,  cart, 
fk~wmeter/regulator,  wrench,  etc.  and  will also provide  the vendor  service  for the  refills 
of these  cylinders. 
MONTHLY  RENTAL  COST  FOR  HOME  USE  WILL  INCLUDE  THE 
FOLLOWING: 
o	 02  concentrator  and  necessary  disposable  equipment,  i.e., nasal  cannulas  or mask, 
humidifiers,  nebulizers,  extension  tubing,  etc.  Replacement  of disposable  PRN. 
o  Initial  set-up  and  education  of patient  by qualified  respiratory  therapist. 
o	 All equipment  and  supplies  necessary  for back-up  02  to cover  response  time  in 
case  of equipment  or power  failure. 
o  Monthly  equipment  maintenance  and  inspection  visits. 
o	 Monthly  monitoring  visits by a registered  or certified  respiratory  care  practitioner  to 
evaluate  all aspects  of the  services  being  provided  to the  patient. 
o  Equipment  must  be  cleaned  and  semiced  on a regular  basis. 
(~ Delivery  within  the  VA facilitys jurisdiction  service  area  to include  the  counties 
shown  on Page_. 
o  Contractor  will provide  service  7 days a week,  24 hours  a day. 
o	 Concentrators  furnished  under  this rental  agreement  shall be  covered  by U.L. 
Listed  Reference  No. E71727,  grounding  required,  be  double  insulated  with  an 
operating  pressure  of 25 psi - compressor  thermally  protected.  The  concentration 
shall be  9394 to  100% plus or minus  3%,  oxygen at all flows and  flowrate  shall be 
G-1  sufficient  to provide  1, 1.5, 2, 3, or 4 liters/minute.  Unit  shall be  equipped  tith  an 
audible  alarm  and  warning  lights for signaling  concentrator  failure.  The  unit  shall be 
sufficient  to require  only minimum  semice  by VA beneficiary;  i.e., twice weekly 
external  filter  cleaning,  etc. 
o	 Rental  price  indicated  shall include  VA beneficia~  and  family training,  observation 
in use, follow-up  service  on rental  unit  every  6 to 8 weeks  and  24-hour  emergency 
service  coverage  7 days a week.  Contractor  to provide  each  VA beneficiary  with the 
telephone  number  for obtaining  such  service. 
o	 All units  currently  in use as stated  in the  requirements  must  be installed  and 
operating  inthe  VA beneficiarys  home  within  forty-five  (45) calendar  days after 
award  of contract.  The  successful  bidder  will be  required  to coordinate  exchange  with 
the  present  contractor  for the  transition  (in the  event  the  present  contractor  is not  the 
successful  bidder). 
o  Contractor  will be responsible  for providing  patient  with all disposable  and  back-
up systems  as appropriate.  Copy  of all documentation  of service  calls and  routine  and 
emergency  visits to the  VA beneficiarys  home,  and visit assessments  will be  sent  to 
Chief,  Prosthetic  Service. 
o	 Because  of the  age,  condition,  etc.,  of the  VA beneficiary  for whom  the  service  is 
being  provided,  it is recommended,  particularly  in cases where  a unit  is being 
exchanged  due  to equipment  failure,  that  the  exchange  be  accomplished  with a unit  of 
the  same  type  to avoid  unnecessary  confusion. 
()  SPECIAL  NOTE:  Descriptive  literature  must  be  furnished  with offer  on the  unit 
he/she  proposes  to furnish  under  this contract.  Please  indicate  below  nomenclature  of 
this proposed  unit  (Brand,  Model#)  . 
G-2
 APPENDIX  H

Comments  from  the  Health  Care  Financing  Administration

Comments  from  the  National  Association  for Medical  Equipment  Services

Comments  fkom the  Health  Industry  Distriiutom  Association

Comments  from  the  Health  Industry  Manufacturers  Association

Comments  from  the  American  Association  for Respiratory  Care

H-1
 10/25/94  13:42  =410  966  5305  HES OIGOASKCFA  Qloo2/oo5 
  - Health  Care 
13EP.%RT}lEXTOFHE.%LTH& HUMAN  5ERWCES  Flnar:.ac  Adm-.sva:.ofi 
  .      -.  ---- -----
Memorandum  -
,. 
OCT201998 
w
Bruce C. Vladec  @ 
Administrator 
O*  of hspector  General  (OXG) Draft  Report  C)xygen Qmcermator  Sefi- 
(OEI-O3-91-O171O) 
June  Gsbbs &own 
We revimmd  the  above-re~ced  report  which found that some M-c 
benties  who  use  home  qgem  m~n~toy  meqq  remdve  extensive  semkes 
while  others  meek  few. 
We agree  with the  reports reeomrnendatiou that educating  providers  and 
beneficiaries  about standards for necessq  and standard care is impo-~  ~~ever~ 
we  believe  that options  2 and a uy  nd  b  &adble  because  of the ixih~~t 
,.
dmmstrative  burdens 
Our detailed  mmmem  on  the reports  fidings  and recommendation  are  attached 
f=  your cwnsiclcratiom  tile  ym  f~  &  ~~ni~  to  fiew  and  comment  on 
this  draft  repor&  Please  contact  us if you would  like  to disouss  our ~nts  and 
response. 
Attachment 
.  10/25/94  13:42  S41O  966  5305  HES OIG OAS HCFA  5  003/005 
..  ,..  -
~ 
on Office  of ]mmector  General  (OIG)  Draft  ReJOrK 
m
Gxwen  CXmcentrator Services 
PE 1-03-91-01710 
Wcormnendation 
HCFA  should pdum  a strategy to emre  that Mcdicarc kte&iaries  re4w 
necemarycare and support  in eonneotion with their cqgm  therapy. 
We agree  that  suppliers  should puvfde  ~~  services in cmrxxtion  with the 
oxyga  qdprneat  and supplies they fIUIL@Land that HCFA should be doing more 
to ensure that Medicare benefioktrjes -tie  the appropriate level and quali~  of 
qgen  smvices that they require. 
Ra*er  than promoting new standards and accreditation, however,  we belhwe  that  tbe 
existing supplier  ~  could  be used to improve service to beneficiary  FOT 
qlq  if ~ppker  practices  today  are the same as those ~rted  in 1991, itwould 
P  that tbe supplien  are violating the recently irnpiernented Medicare au~lier 
standard% 
-- A suppiier that does not follow the maintenance procedures of the 
equipments manufacturer would be in violation of standard t3vcx A 
supplier mrktains  and repaim.  . . items it has rented to beneficki=. 
- In addition, standard four, Answering any questions  or  complain~  ffOUI 
benefiti  standard tiq  Requiring  suppliers  to be responsible for 
delivery of ~  and standard seve~  Requiring disclosure  of consumer 
tif-ti  to beneficiaries, require ovemll education of the patient end 
family regarding  the use  of the equipment 
HCFA  will conthwe  to eneonragc the tile  ~edicid  equipment (DME) regionai 
carriers to review suppliers for WXOpiiMlcme thMedicare rcquksnents  and 
standards. The DME regional camersare  required to folhw  IIpon beneficiary 
complaints that they or the Nationai Sq@ier  Clearinghouse (NW)  reoeim  In 
additi~  one of the tions  for obtaining a supplier mnzber reqnhes each 
applicant to nti  any liceq  axtifkatio~  Or~tion  required by the State 
where the supplier does business.  The NSC is Imfldinga data base of StitC 
requirements end wiU rendmrdyselect applicants fcx veri6c-ion.  10/2s/94  13:43  =410  066  630S  HES OIG OAS ECFA  ktl004/005 
. 
Page 2 
We will also pursue pruviding further specificatioIM  k  manual instructions to state 
exacdy what is re@rcd  under the cunent  supplier standards for oxygen *N-
For the other patient monitoring services described in the report that am not 
encompassed  in the current standards, H(XA  W  ~mider  whether  it would be 
4T-K  ~  - nppliem  to provide  such semioes 
F~,  weagreewitbthe  rceommendatfon to educate prcwiders and benefkiarie% 
-d  m  inchk  Mdkare  snpplier standards information in our beneficiary ~d 
prcwikr  echmation -~ 
HCFA could initiate a prognnn to educate p~~  and beneficiaries abcmt the 
kinds of services  available and Tecommended by national organization  for patienti 
_  qen  therapy.  Such an educational initiathw might be most effective  if 
Unhtakell  in partnemhip Wthrelew%lntpmkssional  associations 
HCFA Remmse 
We concur with the reeommendation  of an initiative  to eduoa+  providersand 
btIIcficMes  whichvvdlenable Medicare  bin-es  to make  informed  deoisions 
about  their  health care needs and help health ~  pmfcsaionals provide or mange 
for the best possible medkd  care for bend- The i)ME  qional  carriers can 
me  carrier newslettma to advise health professionais and providers about the 
importance  of senkin  g -CD  equipmmt  and meting  the supplier standards 
Additionally,  bene&iarks  should  be eneourag~  by their provider,  to select $upp~e~ 
who are  in the  Participating  SuppIier  Direetory.e 
We further  belkve  that physicians w&o  od~  qgen  for benefiariea  have a 
respomibil.ityto advise them on the  of the quipmcn~ 
uso  ad  be  maintEIUUE 
We do not  believe  that  usc  of  the  Medicare  ~@mok  to educate bcdkhk$  *mt 
theapecifkaervicu  suppliers alwdd  offerwuuld  be  cost-effective  bccanse  I- -
1 perwmt  of bendckriea  use cxygen.  ~,  wu will wnsider  sending out a 
special mailing to Medicare bene~  or drafting a notice for providm  to -d  tO 
their Medicare patiem  who need oqgen  thq  ti~  listing the standards or 
sezvicc requirements for Medkam  auppk  10/25/04  13:43  B41O  966  S305  HES OIG OAS HCFA  Giloo5/oo6 
-----
. . 
. .  -- .  ..- . 
.. 
Page 3 
Qu?i!2d 
HCFA couldpromotestandards  for -en  therapy services which suppliers shouId 
provide to Medicare benefiohies 
We am  withtheiutent ofthe recommcadatkm.  mwcvcra,s mated  abow$ rather 
for
than  promotingn ew standards  accreditatim~
  baeve  that the  -g  supplier
atmuhmk  should  be used to improve  cncygenservicas provided  to beneficiary=

ID*tfOmwbael iCvC 
thti-~hm*timem@mU
m a~ative  for program.
readt  a kavy  burden the Medicare  (Please note  tbai 
making differential payments to - suppliers that arc wxzedhed  would require a 
  IEgishltiveehan~e.) 
HCFA could establish a minimum level  of se*  requirements  for supplie= 
HCFA  Ramonse 
we
do  nut concur.  setting  miainmm requirements for purposes ~  -=di~tio% 
cedficati~  or liccnsure is a process generally resewed  for entities that furnish 
direct patient care and not for suppliers of medical equipmen~  Again, as *X 
befcmawe believe that tbe eximingsupplier standardsshould be nsed to improve 
axygen scMccs  provided to benefidaries.  NAMES

National  Association  fOr 
Medical  Equipment  Services 
September  30,  1994 
IG

HAND DELIVERY 
SAIG

The Honorable June Gibbs Brown  PDIG 
Inspector General  DIG-AS 
Office of Inspector General  DIG-EI 
2

Department of Health and Human Services 
DIG-01

330 Independence Avenue, S.W. 
liiC-CFM

Cohen Building 
Room 5250  AIC-MP

Washington, D.C. 20201  OGC/IG  ~

Re:	 Comments on Draft Report

Oxygen Concentrator Services

OEI-O3-91-O171O 
Dear Ms. Brown:

The National  for Medical Equipment Services 
Association 
(NAMES) appreciates very much the opportunity  to provide

comments on t~e draft Department of Health and Human Services,

Office of Inspector General  (OIG), inspection report entitled,

Oxygen Concentrator Services.  The report discusses  the nature

and extent of services provided to Medicare beneficiaries  who use

oxygen concentrators.

I.  General Comments

NAMES concurs with the  the use of 
OIGS  conclusion  that 
oxygen concentrators  in the home requires a high level of service

for oxygen-dependent  individuals, and it endorses the OIGS

recommendations  for increased education and industry standards to

enhance the level of services.  As the draft report recognizes,

NAMES has been active in promoting service standards to its

members for many years.  NAMES, therefore, supports the OIGS

recommendation to the Health Care Financing Administration

(HCFAI)to consider various strategies, including .supplier and

beneficiary education and establishing minimum supplier service

standards for the provision of oxygen concentrator  services to

Medicare beneficiaries.

As set forth below, however, NAMES believes that some of

the language of the draft report, and the underlying data used by

,.,,  The Honorable  June Gibbs Brown

September  30, 1994

Page 2

the OIG to develop its findings, misrepresent  the current state of

oxygen supplier senices  and care for oxygen patients.  In

particular,  the draft report fails to provide  a complete picture

of the scope and nature of accreditation within  the home medical

equipment  (HME) industry by the Joint Commission  on

Accreditation  of Healthcare Organizations  (JCAHO).  While the

draft report acknowledges  that its findings are based upon 1991

data, and that concerned organizations have implemented improved

standards of care since then  (Report, p. 15), NAMES strongly

believes  that further caveats axe necessary to provide a complete

and accurate picture of the industry.  During  1991, JCAHO

accreditation  -- which mandates specific equipment  service

requirements  -- was still in its infancy.  Few suppliers had been

accredited,  simply because of the newness of the process, the

considerable  cost, and JCAHOS preliminary delays  in scheduling

surveys of those suppliers which had sought accreditation.

Today, 1,420 suppliers have been JCAHO accredited.  Many

of these accreditations  have taken place during the last three to

four years  -- subsequent to the time of the study.  Moreover, the

industry has seen some degree of consolidation during that time

period,  increasing overall the percentage of accredited suppliers.

NAMES, of course, is understandably  concerned with findings of the

draft report chat some of the Medicare beneficiaries  surveyed

received ~  patient care or equipment monitoring  services

whatsoever.  Nonetheless, NAMES believes it is critical to place

these findings in the proper historical context.  NAMES urges that

the report specifically  identify JCAHO accreditation  as a

relatively  new option for suppliers, and also note that the 1991

data sample occurred prior to the accreciitationmovement within

the industry being fully underway.

II.  SPecifiC COmmentS on the Draft 
Rf3DOrt 
Specific comments on the draft report by page number are

detailed below:

Executive Summary, D. i, Report, 
P.  1. 
The draft report states that patients using items such

as wheelchairs  and hospital beds require little monitoring. 

NAMES believes  this sentence to be both unnecessary  and

inadvisable.  For example, severely disabled patients  (especially

children)  utilizing custom wheelchairs, and ventilator-dependent

patients  and others whose health is severely compromised, require

substantial  patient and equipmelltmonitoring.  NAMES certainly
 The Honorable June Gibbs Brown

September 30, 1994

Page 3

concurs that oxygen therapy patients require attention, but would

avoid making sweeping comparisons which may be of limited

applicability.

Executive Summary, D. ii

NAMES recognizes that an Executive  Summary is designed 
to provide a snapshot of a larger document.  At the same time, 
NAMES is concerned that the specific findings which the OIG has 
chosen to include in the Executive Summary paint the HME services 
industry in the worst light possible.  NAMES has worked very hard 
to improve the image of the industry as a whole, and while there 
is no desire to state the results of the study inaccurately, NAMES 
is concerned that  findings  of the Executive  Summary taken out of 
context will undermine NAMES efforts to improve the industry 
image as a whole.  For example, the draft report states on p. ii 
(and on page 10 of the report in substantially  similar language)

that Nearly half of all beneficiaries  -- 47 percent  -- do not

receive any patient care evaluations or assessments  from

suppliers.  Stated another way, over half of all beneficiaries ~

receive such services.  Similarly, one other pertinent  finding

from the report should be included in the Executive Summary:

Ninety-two percent of Medicare beneficiaries

received one or more equipment services and,

of these, 71.5 percent of patients  received

services every 60 days, in accordance with

NAMES standard, which advocates one equipment

service every 60 days.

Executive Summarv, Paqe ii

NAMES does not believe it correct to state that the

Department of Veterans Affairs  (V.A)has endorsed a set of

recommended services.  As discussed below, there are significant

limitations with trying to compare services provided to veterans

under VA contracts and those provided to Medicare beneficiaries,

in part because there is no uniform standard of required services

under VA contracts, nor any review to assess what services are

actually performed.

Re~ort, P. 2

The section entitled Changes in Claims Processing

Environment incorrectly states that these changes were based on

the Omnibus Budget Reconciliation Act of 1990  (OBRA 90).  In
 The Honorable June Gibbs Brown

September 30, 1994

Page 4

fact, these changes were implemented as a result of
 an independent

HCFA initiative permitted by provisions of OBRA  87
 and

subsequently codified into statutory language.

More importantly, the report alleqes that
 there have

been concerns about abusive practi&es by HM~ suppliers  since

Medicares  inception.  The report enumerates carrier shopping,

multiple supplier billing numbers, telemarketing,  and the like.

NAMES believes this introductory provision  to be unduly negative

and irrelevant to the report itself.  There is no need to include

this background  in a discrete study of services provided  for one

type of equipment.  Again, NAMES is very concerned that gratuitous

comments like this will undermine NAMES efforts to improve the

quality of its members, and will serve to frustrate even further

legitimate, ethical suppliers who maintain honest business

practices.

Re~ort, D. 3

Previous Office of Ins~ector General  (OIG) Work

NAMES is concerned about the appropriateness  of

including
 findings from past OIG studies on home oxygen and oxygen

equipment
 in this report.  As discussed below, qiven the serious

methodological-problems  with several of these studies, and the

negative and gratuitous comments about their conclusions, NAMES

recommends that this section be deleted, particularly  because it

does not provide any insight into the objectives,  findings or

recommendations of this report.

The OIG references two studies conducted in 1987 and 
1991, respectively,  in which the OIG attempted to compare oxygen 
concentrator payment levels by Medicare and the VA.  As NAMES has 
commented previously,  this is an Iapples  to  Orangesll  Comparison, 
because Medicare oxygen concentrator payments are not structured 
the same way as VA payments.  For example, most VA contracts have 
separate payments for portable oxygen contents, while the Medicare 
payment includes portable contents.  Even the OIGS own study

indicated that VA disbursements  for oxygen contents may not be

retrievable, thus preventing a meaningful comparison to the

Medicare stationary fee which includes portable contents.

Further, while VA contracts typically enumerate certain service

requirements, the VA has no post-contract  review,  audit, or

similar survey process to determine whether these services are

actually provided.  Thus, cost breakdowns  -- comparing what is

actually provided by a Medicare supplier in a sample study with
 The Honorable  June Gibbs Brown

September  30, 1994

Page 5

what a VA contractor  is required to provide  -- are not 
necessarily 
reliable.  Finally, Medicare suppliers are required to incur 
considerably more  administrative  costs,  such  as  monthly  Clairn.s 
submission,  obtaining  from  physicians  properly  completed 
certificates  of  medical  necessity,  and  the  like.  Thus  ,  NAMES 
believes  there  are  serious  limitations  to  the  usefulness  of  such  a 
comparison,  and  the  reference  to  these  studies  in  this  report. 
The OIG also references a 1990 study entitled  National

Review of the Medical Necessity  for Oxygen Concentrators,  which

reported that one-third of the sampled beneficiaries  in the study

did not need oxygen or did not need oxygen to the extent billed. 

NAMES questions how the OIG could have concluded that these

patients did not need oxygen, since medical necessity  for oxygen

therapy is determined by objective standards for partial pressure

of oxygen  (P02) in arterial blood or oxygen saturation  levels by

ear or pulse oximetry.  These had to have been documented  in order

for Medicare payment to be made.  NAMES also questions  the 1990

reports language with regard to patients not needing oxygen  to

the extent billed,  since there is only one flat monthly fee that

may be billed to the Medicare program.

Methodoloqv

In ~he section entitled  Methodology, the report 
discusses the sample used to conduct this study.  discussed 
AS 
above, data drawn from 1991 is not representative  of the industry 
today.  Accredited organizations  represent an ever increasing 
share of the HME industry.  Further, it is unclear whether 183 
suppliers selected for this study represent distinct corporate 
entities, or whether individual branches of the same company are 
counted as separate suppliers.  This is significant because, to 
the extent this represents individual corporate entities  (rather 
than branches of the same organization) , the data would be skewed 
to representing smaller suppliers which may, in the past, not have 
had the resources to seek JCAHO accreditation or to provide 
enhanced levels of service.  Accordingly,  the size and resources 
available to the suppliers in the study needs to be clarified. 
Also, we understand that one of the suppliers in the sample was 
sold during the period in question.  As a result, the OIG was 
evaluating u  paperwork, while patients were actually being 
served by a w  supplier under new protocols.  Thus, beneficiaries 
may have actually been receivingconsiderably more services than 
were documented by the predecessor supplier.  Finally, we question 
whether a 0.1 percent beneficiary sample size is statistically 
significant .  At the initial meetings on this study, the OIG 
  The Honorable  June Gibbs Brown

September  30, 1994

Page 6

assured  NAMES that  the  groups  chosen  were  statistically  valid. 
That  proof  should  be  appended  to  the  final  report. 
Report, D. 4

Paragraph four on this page indicates  that disposable

equipment drop-offs were not included in the classification  of

equipment and patient monitoring services.  It is likely that

equipment monitoring or clinical visits were made in conjunction

with some disposable drop-offs, particularly  where registered

therapists made these deliveries, even if these services were not

properly documented.  This is because most suppliers attempt to

coordinate  such deliveries with other services  as a means of

achieving higher cost efficiency.  Without JCAHO accreditation,

suppliers may have been less likely to record the services

performed  in a service file or comparable patient  record.  Thus,

the exclusion of these services  (due to lack of documentation) may

have unduly  skewed the results towards a finding of a lower amount

of supplier  services.

Re~ort, D. 5

In paragraph four, the report does not indicate whether

the documentation  requested and credentials of supplier staff were

found to be valid.  In paragraph six, the full names of NAMES is

written  incorrectly.  The correct name of the association  is the

National Association &  Medical Equipment Services.

Report, D. 6

The third full paragraph on this page discusses JC7U+0,

but fails to include the details noted above.  Further, not onlY

has the number of suppliers who are accredited  increased

substantially  since 1991, but the number of beneficiaries

receivinq services from accredited suppliers has increased as

well .  This is due in part to the increased number of accredited

suppliers, as well as other forces resulting  in patients obtaining

services from accredited suppliers, such as consolidation within

the industry, competition and the increased emphasis on standards

by industry associations.

Report, D. 7

In the section entitled Payers mandate  service

requirements  for beneficiaries,  the OIG discusses  contracts which

the VA and state Medicaid agencies enter with suppliers, and goes
 The Honorable June Gibbs Brown

September 30, 1994

Page 7

on to use provisions of some of those contracts as standards

which have been endorsed.  NAMES does not believe this to be an

accurate characterization.  Moreover, as discussed above, NAMES

urges that the report point out an inherent limitation  in its

analysis:  namely, that no survey was undertaken  to determine

whether the requirements  set forth in these contracts  in fact were

being carried out, or whether these requirements achieve

efficiency and cost-effectiveness.  NAMES members provided OIG

representatives with numerous specific examples of instances in

which entities which were awarded VA contracts in fact provided no

services whatsoever,  or provided only some services or different

services.  NAMES believes that this type of anecdotal

information with respect to limitations in the reports

methodology should be included to the extent that the draft report

itself includes anecdotal information with respect to individual

suppliers  (see page 13).

ReDOrt, D. 8 
Table 1 purports to project the findings of the study to

all beneficiaries  nationwide.  Once again, as the sample does not

accurately represent the characteristics of the overall HME

supplier industry, it is not appropriate to project the findings

across the na$ional pool of beneficiaries.  This table, as well as

Tables 3 and 5, should therefore be eliminated  (or at a minimum,

only show the percentages and not the national beneficiary

estimates) .

Report, DD. 9-12

As discussed above, the findings as displayed  in Graph

1, Table 2, Graph 2, and Table 4 may be significantly skewed by

the types of suppliers in the study and the data irregularities

cited earlier.  The level of services provided by suppliers m  the

1991 sample cannot necessarily be extrapolated to a typical

Medicare beneficiary.

Report, D. 13

The draft report includes several anecdotal comments

about suppliers who did not provide services, but includes no

comparable descriptions of the many suppliers who have gone out of

their way -- for example, during Hurricane Andrew and the

devastating floods in the Midwest and Georgia -- to service the+r

patients.  NAMES urges that equal time be given to a description
 The Honorable  June Gibbs Brown

September  30, 1994

Page 8

and equipment monitoring  services,

of suppliers providing patient 
as well as those who did not.

ReDort, w. 14

The draft report states that [suppliers  providing

necessary services.  . .are placed at a competitive  disadvantage. 

NAMES questions  this statement.  At least in some markets,

competitive  forces will drive  (and have clearly driven) some

services out of business.

suppliers not providing the necessary 
The respirator  care industry is driven bv service.

The report goes on to explain that HCFA has no recourse

against a company providing minimal or sporadic services because

it has not adopted service standards against which to measure

While HCFA has

supplier practices.  This is essentially correct. 
adopted minimal standards relating to more generic requirements

for HME  (e.q., responsibility for delivery of items to Med+care

beneficiaries,  honoring warranties, maintaining  and repalrlng

equipment, and the like)  (42 C.F.R. s 424.57(c)),  and,HCFA may

to adhere

revoke a suppliers Medicare supplier nufier for faillng 
to these standards, HCFA, regrettably, has not yet adopted, nor

standards,

endorsed accrediting bodies or other organizations 
As discussed beiow, NmES

for equipment ,andpatient monitoring. 
endorses the recommendations made by the OIG in the final section

of the report to encourage higher levels of service.

Report, D. 15

At the top of the page, the draft states:

We recognize that our data represents the

state of care provided by suppliers to

Medicare beneficiaries  in 1991, and concerned

organizations have implemented improved

(Emphasis

standards of care since then. 
added.)

specifically that

NAMES believes it appropriate to note 
numerous HME suppliers in fact have been accredited since that

time.

ReDort, D. 15

The draft report provides several recommendations under

NAMES

the rubric of Educating Providing and Beneficiaries.   The Honorable June Gibbs Brown

September 30, 1994

Page 9

urges that the report note that NAMES in fact has already

undertaken some of these efforts,  i.e., informing beneficiaries

of the kinds of services they should look for from their

suppliers.   NAMES of course would be happy to work with the OIG

and HCFA to undertake further efforts,  including,  for 
example,  a

section in HCFAS Medicare Handbook.

Re~ort, D. 16

NAMES has been a longstanding  advocate of promoting

standards for the provision of HME services,  including the

requirement for supplies to render the highest  level of care

promptly and competently taking into account the health and safety

of the patient.  See Attachment  E to the draft report.  NAMES is

committed to working with the OIG and HCFA for development and

adoption of such standards.

The OIG has recommended three different  approaches for

setting minimum requirements:  (1) accreditation  by a nationally

recognized organization, such as JCAHO or the Community Health

Accreditation  Program  (CHAP); (2) certification  by suppliers

meeting accreditation requirements  if, for financial or other

reasons, the supplier has not undergone an inspection process to

become officially accredited; or  (3) state licensure.

Because most states do not license HME suppliers, NAMES

does not believe this approach alone is an effective means tO

ensure minimum requirements.  Additionally,  because many suppliers

do not have the resources tobecome  accredited by JCAHO or CHAP,

NAMES endorses the option of allowing suppliers either to become

accredited or to certify annually to their Durable Medical

Equipment Regional Carriers  (DMERCS) that they meet one or more

of the proposed alternatives.

NAMES believes the preferred approach  is for HCFA, in

consultation with NAMES, to develop specific supplier standards

for the provision of equipment monitoring and patient care

services to add to the existing supplier standards.  These

standards should encourage high quality beneficiary outcomes, as

well as efficiency and cost-effectiveness,  in todays marketplace.

Such standards should be reviewed periodically  to ensure that they

reflect current techniques and technological developments.

Suppliers found to be out of compliance with these requirements

would then be subject to having their supplier number revoked or

other appropriate corrective action.
 The Honorable  June Gibbs Brown

September  30, 1994

Page 10

Whatever option is adopted, NAMES strongly urges  that 
consideration  be given to the recommendation  of the Business 
Roundtables  newly published  white paper Toward Smarter 
Recmlation  that paperwork burdens caused by regulatory programs 
should be expressly assessed and substantially  reduced.  While 
NAMES shares the OIGS concerns that Medicare  beneficiaries  --
indeed, all patients  -- receive regular, high quality services, it 
urges caution in mandating any extensive new paperwork 
requirements. 
III.  Conclusion

NAMES supports the OIGS conclusion  that the provision

of home oxygen concentrator services requires an intensive service

component,  and appreciates  the OIGS consideration  of this

important issue.  At the same time, NAMES questions  some of the

findings in this study, based on the age of the data and the

supplier sample.  NAMES believes the industry has moved

consistently  and aggressively to becoming more service oriented,

as evidenced  in the December 1993 Report entitled  NAMES Consensus

Conference on Home Medical Equipment Services.   This is reflected

by the increasing number of suppliers who have obtained JCAHO and

CHAP accreditation.  NAMES requests that the draft report be

revised to ref,lectthe comments provided herein,  including in

particular  avoiding references to the negative  image of the HME

industry which NAMES has fought so hard to dispel.

Should you or your staff have any questions on  these

comments, we would be happy to discuss them with you at your

earliest convenience.

Respectfully  submitted,

2,/--
-\ 
(A+  
- 
Corrine Parver

President
 Ml:!.?

225 Reinekers  Lane, Suite  650 
Alexandria,  VA 22314-2875  703-549-4432  FAX  703-549-6495 
HEALTHINDUSTRY 
IG 
DIS1RIBUTORS 
ASSOCIATION  SAIG

BY HAND DELlVERY  DIG-As 
DIG-E1  I/ 
Se@emberQO,  1994  DIG-01 
AIGCMA  _ 
June Gibbs Brown,InspectorGeneral 
AIGMP
200 Independence Avenue, SW 
OGC/Ic 
Department of Health and Human Semites 
? 
Washington, DC  20201  EXSEC 
DATESENT  q  0 
T

Dear InspectorBrown: 
Thislettercontainsourcommentsonthe Office of InspectorGenerals dralt reportonOxygen

ConcentratorServices (July 19$4, OEI-O3-9I-O171O).  Thank you for the opportunityto

comment, and we look forward to our continued dialogue on this report and other issues that

impact HIDA members.

L  Introduction

HIDA isthe nationaltrade associationofhealth and medicalproductdistributionfirms.

Created in 1902 bya groupofmedicalproductsbusinesspeople, HIDA nowrepresentsmore

than 1000 wholesale and retaildistributorswithapproximately2000 locations. HIDA members

includea broadrangeofhealthand medicalproductdistributors billiondollarmulti-location

nationalcompanies and neighborhoodstores, chains, and independents. HIDA members

providevalue-added distributionservicestovirtuallyevery hospital,physiciansoffice,nursing

home,clinic,andotherhealthcare siteinthe country,andtoa growingnumberofhomecare

patients. We are writingon behalfofourmemberswho provideMedicare Part Bhomeoxygen

sewices to Medicare beneficiaries pursuant to a physicianprescription.

Il.  General Comments

HIDAapplaudsthe IGseffortstostudythe levelofservicessupplierscurrentlyprovideto

Medicarebeneficiariesreceivinghome oxygentherapy. We agree W-ththe IGsfindingsthat

there isa tremendousamountofinconsistencyamongsuppliersintermsofthe levelof

servicestheyprovidetotheirhomeoxygencustomers. We thereforestronglysupportthe IGs

recommendationto establish supplier standards. We believe that defining standards of

semicewillresultinsuppliersprovidingthe highestlevel of serviceand care to Medicare

beneficiaries. We alsostronglysupportextendingthe standardstonon-participatingsuppliers

inadditiontothosewhotake Medicare assignment. The NationalSupplierClearinghouse,

whichreceivesinformationaboutall sup~iierssewices throughthe FormHCFA-192, isan

idealmechanismforestablishingsetvice level requirementsforsuppliers. Attachedare

ConsensusConference recommendationswe developed in 1992 toachieve thisobjective.

Whilewe are verypleased atthe progressivenatureofthe IGsrecommendationtoestablish

separate payment amounts based on service levels, we are unable to fully commit HIDA
 supporttothisrecommendationuntilfurtherpolicyanalysis,and importantly,the administration 
(e.g. DMERC) implicationsare explored. The policyanalysisneedstoconsiderpatient 
outcomesdriven levels of service rather than only  supplier  company  capability.  While 
traditionallycompetitive market forces have caused high service levels balanced by regulatory 
drivenfee schedules,theemergingintegratedmanagedcare marketsare changingthese 
incentivesand restrahts.  Thus, any linkingof reimbursementto service levels needs to 
considerthe emerging operatingenvironmentfor home health delivery. 
[11.  Specific  Comments 
Althoughwe are generallypIeasedwiththe IGsfindingsand recommendations,we have 
several specificcommentswhichwe believewouldimprovethereport. 
On page 4, the lastparagraphsthirdsentencestatesthatthe IGconsultedwitha registered 
nurse with an extensive backgroundin pulmonarycarefor assistance with the reports 
analyses.  We questionwhetheryourregisterednursewitha backgroundinpulmonarycare 
has the necessary qualificationsor experience in home care to evaluate home oxygen 
seivices.  We believe itwouldhave been moreappropriatetohave consultedwitha health 
care professionalwithspecifichomecare expertisefora moreaccurateevaluation.The 
operatingexperience inan institutionalsettingisnotthesame asexperience inthehomeand 
is therefore not intuitivelytransferable. 
on page 5, the sixthparagraph,we questionwhytheorganizationsthe IG metwith  are  not 
listedalphabetically. We alsorequestthatHIDAsacronym- HIDA- please be added after 
the spelling out of the Health IndustryDistributorsAssociationas is done with other 
organizations mentioned in the list. 
On page 6, the thirdparagraphdescribesthe nationalaccreditingbodieswhichestablish 
service standards for home oxygen care.  The last two sentences in the paragraph describe 
the number of supplierswho have maintainedJCAHO accreditationand the number planning 
to seek accreditation in the future. We believe more useful informationwould be the number 
of beneficiaries who were served by those supplierswho maintained accreditation. 
On page 7, the reportneglectstomentionHIDAsrecommendationstothe IG aboutsupplier 
servicestandards.  HIDA hasrecommendeddifferentlevelsofstandardsdependinguponthe 
typeofsewices the supplierprovides,suchas basicstandardsfortraditionalDME, higher 
standards for oxygen (e.g., respiratorycare), and even more stringentstandards for higher 
care patientson ventilatorsorthosereceivinghomeinfusiontherapy.HIDA continuestofully 
supportthese standardsandwouldappreciatementionas suchinthereport. 
On page 12, the repotidescribesthenumberofbeneficiarieswhosesupplierfailedtomeet 
servicestandardssetbytheVA andAARC.  The sectionshouldalsoevaluate whichsuppliers 
whkh are JCAHO accredited failed to meet JCAHO setvice standards. 
On page 16, PromotingStandards,therepofirecommendsHCFApromotingstandards 
endorsed by several organizations,includingNAMES.  To identifystandards, we believe a 
consensusprocesssuchasJCAHO ispreferabletoa narrowerindustrydevelopmentsuchas 
NAMES. 
2
 On page 16, SettingMinimumRequirements,-the report  describes  several mechanisms to 
establisha minimumlevelofservicerequirementsfor suppliers.  HIDA recommends that the IG 
considerthe NationalSupplierClearinghouse(NSQ  as a mechanismthroughwhichto 
establishservice level requirementsforsuppliers.Allsuppliersmustcomplete a Fom  HCFA-
192 andsubmitittothe NSC.  The formcouldincludequestionsaboutservicesprovidedto 
establish sewice level requirementsfor that supplier. Please see our attached 1991 
Consensus Conference recommendationsfor more details on supplier requirements. 
IV. Conclusion 
HIDA supportsmany of the findingsand recommendationsin ttis report. Unlike other items of 
durablemedicalequipment,homeoxygentherapyislife-sustainingand therefore requires 
regularequipmentand patientmonitoringservices. Unfortunately,currentMedicare policies 
have notrecognizedthatservicesshouldbe provided,whichhas resultedinvariationamong 
service levels for beneficiaries. 
Home care dealers would benefit from supplierservice standards for oxygen therapy.  Patients 
who depend on home oxygen therapy to functionwould benefit from a more consistent level of 
serviceratherthantheirrandomselectionofa supplier. HIDA supportshavingMedicare 
educate providersandbeneficiariesaboutthekindsofserviceswhichshouldbe providedto 
home oxygen patients. HIDA suppofis promotingindustryservice standards and recommends 
thatthe NSC be usedas a mechanismforevaluatingwhichsuppliers(dependingontheirlevel 
ofcare patients)shouldbe requiredtomeetwhichstandards. Finally,HIDA supportsrequiring 
suppliersto meet accreditation,certification  or licensing  requirements. 
Thank you for the opportunityto comment. Please contact me or Cara Bachenheimer, HIDAs 
directorof government relations,for further  information. 
Sincerely, 
.
/d
$T
K
. Wayn ay 
CEO a  reside 
Attachment 
cc  Penny Thompson, OIG 
HCMG,  HCGRTF 
Cara Bachenheimer 
Craig Jeffries 
3
 EXECUTIVE  SUMh4ARY 
1991 HIDA  Claim  Efficiency 
Consensus  Conference 
(May  13-14, 1991) 
! 
OVERVIEWO 
As thenation,  and  Congressional  and  Administration  leaders  focus on the  costs of 
the health  care  delivery  system  and  particulatrhle ygrowth of Medicare  expenditures,  it is 
important  to  look  for  areas  of  inefficiency.  One  particularly  inefficient  area  is  the 
administration  of  third  party  claims  by  Medicae  carriers,  home  medical  equipment 
setice  and long term  care  suppliers,  and beneficiaries. 
The  1989  HIDA  Home  Care  Financial  Sumey  reported  that  home medical 
equipment(llME)industrrye sourcewse reincreasin#bye ingdivertetdi ompatienctare

servicetso  the administratioofn
 thirdpaw  clams. Moreover,the hl~hCOS~of

administeritnhgi rdpartyclaimscouldnotbe reducedwithouttheactivea
ndfocused

attentioann dsupportoftheHealthcareFinancinAgd ministrati(oHnC
 FA). Therefore

[he 1990 HIDA  Claim EfficiencCyo nsensusConferenceideniiftekde
y areasfor

improvement.

The  1991  Conferencerecognizetdh eimportanstt ridecsongressandHCFA  made

toaddressthe1990recommendationsa,d dressefdu rtheirm plementatioins suefso
 rold

issuesa,n didentificeedr tainne w issuesI.m portantllye,g islatiinotnr oduceidn
the102nd

Congresswillfurthetrh eimplementatioonf
 many of  the  1991HIDA ClaimEfficien~ 
ConsensusConferencerecommendations.

P~TRPOSE 
HIDA  initiated  the  Claim  Efficiency  Consensus  Conference  to  identify  problem 
areas  in claim  processing  and  to  recommend  specific  changes  that  will allow  HME  and 
long term  care  suppliers  to operate  more  efficiently  and  reduce  their  costs of third  party 
administration.  The  Consensus  Conference  recommendations  also  recognize  benefits  to 
HCFA  and  Medicare  carriers  through  greater  system standardization,  accountability  and 
enhanced  communication. 
Finally  and  most  important,  the  Consensus  Conference  recommendations  highlight 
eme~ging  risks  to  Medicare  beneficiaries  of not  receiving  needed  HME  services  due  to 
barriers  or  inconsistent  interpretations  created  by  the  probiems  in  third  party 
administration. 
The  1991  HIDA  Claim  Efficiency  Consensus  Conference  recommendations  are 
attached  and  reflect  the  discussion  of  the  conference  participants,  recorded  and  drafted 
by workgroup  leaders.  The  recommendations  have been  reviewed  by a broad  sweep  of the 
HME  services  and  long  term  care  supply  industry,  including  participants  in  the  1991 
conference,  state  association  leaders  and  other  industry  representatives,  and  HCFA  and 
General  Accounting  Office  officials.  Final  policy  recommendations  emer~ed  from  this 
review and consensus  process,  and suggest  cooperative  action  involving Medicare  carriers, 
HCF&  and  industry.  Some  recommendations  may be implemented  administratively.  In 
some  cases  recommendations  may  require  Congressional  consideration  and  legislative 
action.  MAIOR  RECOMMENDATIONS: 
Sur)r)lier  Number  Qualification  and  Review 
The  HIDA  Claim  Efficiency  Consensus  Conference  recommends  that  Medicare 
require  SU pliers  (through  an application  process)  to meet  national  standard  criteria  for 
issuance  o Fsupplier  numbers,  and periodically  renew  the supplier  number.  The  standard 
criteria  are  intended  to establish  basic business  standards  that  suppliers  must  meet  (e.g., 
maintain  inventory;  FDA  OS~  DOT  compliance)  and  provide  information  suppliers 
would  disclose  to allow  the  carrier  to monitor  the  supplier  for potential  abusive  activity 
(e.g.  telemarketing  physician  self-referraI).  The  renewal  process  would  allow  HCFA 
carriers  and the Inspector  General  to more  actively monitor  changes  in business  practices. 
Beneficial  Verification  Svstem 
The  HIDA  Claim  Efficiency  Consensus  Conference  recommends  a point  of service 
system  to  allow  a beneficiary  to veri&  his or her  eligibility  for  Medicare  services.  his 
verification  would  include  non-medical  necessity  elements,  e.g.,  Part  B  eligibility,  HIC 
number,  address,  MSP types.  Such a system would be available  to qualified  suppliers  and 
would be s;w~!~-to the verification  svstem currently  in use by hospitals  under  Part  A- . 
.-
ENIC  Standardization  lm~lementation 
HCFA  developed  a  standardized  electronic  media  claim  (EMC)  format  in  part 
based  on the  1990 HIDA  Claim  Efilciency  Consensus  Conference  recommendations.  The 
1991  Conference  recommendations  address  implementation  issues  to  support  I-lCFA 
carrierand suppliergoalsin achievingan EMC  capabili~i,ncludingsyst~rn~

standardizatiaodne quatecarriesru pportsystemsc,r ossovecrl ams processingq,u e~

capabilitsyt,a ndardizatioofn   EOMB  messages,  code  and medicalpollclesm e
recommendationasl soaddrespsr oblemsofaccestsoEMC bysmallvolumesuppliers.

hational  Standard  Coverage  and  Utilization 
The  HIDA  Claim  Efficiency  Consensus  Conference  recommends  the  establishment 
nationaslt andarMde dicarecoveragcer iterainad utilizatgiuoind elinteosc
 urbabusive
of 
carriesrh
opping.

Carrier  Consolidation 
The  HIDA  Claim  Efficiency  Consensus  Conference  reconfirms  the  1990 
recommendation  to  consolidate  the  number  of  carriers  to  achieve  better  carrier 
management  and  carrier  claim  processing  expertise  on HME  and  long term  care  supply 
claims. 
Carrier  Jurisdiction  Rules 
The  I-IIDA Claim  Efficiency  Consensus  Conference  recommends  that  claims  must 
be submitted  to the  carrier  with jurisdiction  where  the patient  resides  except  that  HCFA 
may allow carriers  to exempt  suppliers  that semice  patients  residing within  60 miles of the 
carrier  area,  snowbird beneficiaries,  and for other  reasons with no potential  for abuse. 
I-iIDAHome  Care 
~  225 Reinekers Lane, Suite 650 
Ala,  VA  22314 
(703] 549-4432  HIDA Claim  Efficiency  Consensus  Conference 
Conference  tiaders:  Craig  Jeffnes,  HIDA 
Cullcn  Murphy,  Wasserotts 
Cara  Bachenheimer,  HIDA 
May  13-14,  1991 
WorkwouD  To~ics 
insurance  Verification 
Leaden:  ha  Thomas-Payne,  Medical  Reimbursement  Systems;  Jo~a 
Augst-Johnso~  Redline. 
Participants:  Stephaniel%omto~ ADMEA,  Dawn  Wrigh~  Stein  Medical;Tins 
MorrelhH,CF~  Melanie  Combs,HCFA 
Carrier  Performance;  hfedicare  Carrier  Reform:  Regional  Carriers;  Clean  Claim 
Reforms,  TAG. 
Leuders.-Lynn Snyder,  Epstei~  Becker&Green;Tlm Redmor+NARD 
Participants:  Al  Schnupp,GAO; Ann Berrim~ Ober,Kaler& Grimes;Susan 
Kladiv~GAO; GeraldinWen uk,BuffalHoo spitaSlupply.

EMC/Paper  Processing 
Leaders:  MaureenHanrq  AbbeyHome HealthcareQ;nthiaBendey,Homedco

Participants:  Max  BuffingtoHnC,F A; JimKral,HCFA; CarolynI-Iarr~kl,a
 sIock;
GordonHiltonA,b
 beyHome Hea]thcare.

Supplier  hTumber and  Carrier  Shopping 
Leadem:  Rita  Hill, American  Home  Patient  Centers;  Dan  MoskowiK ASCO. 
Ptiicipants:  JaneHerlockerH,C FA; MikeDeCarlo,N
AMES; CaraBachenheimer,
HID.4.

  KSDA  ~NSENSUS  CO~m 
May  13-14,1991 
TOPIC  SUPPLIER  VERIFICATION 
ISSUE 
In the  r&dst  of ever  evolving  media  reports  portraying  negative  HNfE  sefi=,  brought  on 
in pan  by the  etistence  of  no  bamers  to  entry  to becoming  an  HME  suppbe  r,  the  I-ME 
Industry  clearly  reco-gnizes  the  need  to move  in the  direction  of licensure  and  wrtification 
to  differentiate  qualiiy  and  to  consider  other  barriers  to entry  that  establish  basic  business 
criteria. 
inthecurrentenvironments,u ppLiern umbersareissuedw ithlittlteo
 no scrutiyofthe

applicantbass icbusinessqualificationAsd.d i~ionallIy+,=
  companiesusuallyareRot

subjectto statei icensurlta ws,qualitays surancse! andardosr othersimilacrr iteritay
pically

rtquireodf hta![hor:atizationasn
d professionals.

TRe following  iecomnendations  resulting  from  this  conference  focus  on  a  iron:  e:, d 
screening  program  to  es:ablish  baseline  business  s:zndzrds  as  prerequisites  to  en:r<  Q;< 
involvement  in  the  Sfedicare  program. 
RECDMkZENDATfON: 
Recommended soIutioncsr eatedfromaconsensuosf
 [heworkgroupincludethefollo~in~:

L  Stated  criteria  which  must  be  met  to both  become  and  remain  q-d  as an  I-Lw 
supplier. 
The  criteria,  along  Mti  a  brief  explanation  of  how  the  info~ation  ~  be  uSc~~ 
should  be  available  to  all  suppLier  candidates  prior  to completion  of  an  application 
for  enroUmcnt  in  the  program,  perhaps  in  the  form  of  a  Supplier  Qualification 
packet.  The  supplier  will be asked  to attest  to the  information  in the  application  and 
compliance  with  all  stated  criteria  by  completion  of  the  enrollmcntirenelval 
application.  HIDA  CONSENSUS  CONFEREN= 
May 13-14,  1991 
Page  2 
Suggestedcriterfioar enrollmenatr
 easfollows:

A	 No prior  exclusions  horn the  Medicare/Nfedicaid  program  as a result  of civiI 
or  criminal  actions. 
B.	 CompliancewithaI.aIp plicablset ateand federallicensuraen d regulatory

agencies. 
c.  The supplierm ust maintaina physicalfa
cihy,  With  both  inventory  and
personneoln
 site. 
D.  Proof  of  adequateproducdprofessionhaa]b iliriyn surance.
E.  1~ri[[rt.n~ !ntenancaen dseniceproceduresand protocols.

F.  \tritten  yrsonnel/staffing  standards  and  protocols. 
G.  );ritten  procedures  and  protocols  regarding  record  tmanagement-
H.  Jfritten  szfery  and  ir.fection  control  protocols.  for  both  ernplo:ces  ?fic 
patients. 
IL	 Re@d  disclosure  of  information  that  will  tit  b  carrier  in  mcmitofig  for 
potentially  abusive  pmctia~ 
Suggested  information  disclosure  includes: 
  Physician,  hospital,  nursing  home  owmership  interests. 
  Type  of  producu  and  sewices  offered. 
  Sales/Marketing  inforrnation/practims. 
  Pricing  practices/poliq.  HIDA  CONSENSUS  CONFERENCE 
May  13-14,1991 
Page  3 
IIL	 A  rigorous  appli~tion  to  be  dm.inistered  uniformly  for  both  ncw  supplier 
applications  a.s well  as  on  an  established  renewal  cycle. 
Recommended  content  for  development  of  a  standardized  supplier  application  is 
included  as Attachment  A 
This  application  should  be  administered  uniformly  for  all HME  companies  tha~  w+sh 
to become  or  remain  a  Medicare  supplier. 
The  Workgroup  recommends  that  each  approved  supplier  be  required  to  reapply  on 
acyclicbaalsis  IO remain  qualified  for  participation  in the  program.  A  minimum  r~o 
vear  renewal  term  is recommended  for  all suppliers,  with  the  carrier  maintaining  lh.e 
., 
rl~~iLto  r~auir~  mare  frequentren~wa]sfrom  Se!tCI  sup Dliers  based  on  ~ h]g,n !C<.el 
oi abusive  petiarrnance  or  alleged  problems.  a:  Z[ the  re~uest  of  HCFA  or  the  OIG. 
Signed  at:esta[:cn  as  to  the  accuracy  and  thoroughness  of the  submitted  in formzt:on. 
as  well  as  sier,ed  ameement  with  stated  critetia  and  conditions  for  appro~al.  IS 
xcarnmended  as  an  adjunct  to  the  ,Applica:iori. 
W.	 Required  vefication  procedures  to  be  performed  routinely  and  u.n.i.fo-rrniy prior  to 
approvzd  of  both  initial  and  renewal  applicauons-
Equally  as  imponant  as  expanding  the  deiyee  of  information  requued  to  becornt 
qualified  as  an  I-HIvE  supplier,  verification  of  the  submitted  data  is  absolutely 
imperative.  Therefore,  it is recommended  that  minimum  verification  proc-cdures  and 
protocols  be  established  and  compliance  monitored  to ensure  validiry  of the  screening 
process.  This  proc-ess  could  be  administered  by each  carrier,  by a national  contractor 
or  by HCFA 
IdealIy,  a  system  of  cross  referencing  information  among  all  program  earners  is 
recommended.  A  program  like  LJPIN could  be  used  for  administration  of  Ihe 
application  process  on  a  national  basis. 
Recommended  minimum  verification  procedures  are  also  outlined  in Attachment  A 
These  procedures  are  not  intended  to  be  all inclusive  and  arerecognized(orequire

subjectirveev
 iewinsome cases.
 HIDACO~  CONFERENCE

May  1314,  lm 
Page  4 
It is recommended  that  consideration  be given  to mandatory  on-site  imqxction  based 
on the level of negative  or questionable  responses  which cannot  be ve fied  otherwise, 
or based  on  randorniy  selected  applications. 
Per  the  attestation  section  of the  application,  it is recommended  that  the  applicant 
attest  to their  understanding  that  the  can-ier  (or  other  approval  organization)  has  the 
right  to  require  or  perform  on-site  inspection  at  their  discretion. 
The  above  recommended  barriers  to entry  represent  a first  step  in the  direction  of puri$ing 
the  HME  marketplace  -- both  in  terms  of  legitimizing  competition  and  competitors,  as  well 
as stabilizing  the  reimbursement  en~ironment  adverselv  impacted  bv.  sv. swm  abuse.  Coupled
perhaps  with  additional  standards  of  quality  and  accreditation  oppofiunities,  the  H>lE 
Industry  will  become  postured  among  its  counterparts  within  ~he healthcare  system,  to  pay 
a recognized  si-gtif!carit  role  in  the  future  of  healthcare  delivery  in  this  count~.  :NO1.LV3CYl  (lNV~WVtJ 
.  .. ....... .  .. . ... .. 
LN3WVd03/  NOl.Lv31dll]ll  A  suI1LIEK  VERIFICATION 
I IIDA CONSENSUS  CONFERENCE 
May  13-141,~1

R[;@MMENDED  suppL]~R  APPLl~TJON  CO W1l;Nl 
AND  VERIFICATION  PROCEDURES 
V[;RIFICATION  /COhi  MENT 
................... ......... . 
oTIIER  CARRIERS  BILLED: 
1.	 LA  any o(hcr Mcdicarc  carriers which arc  Inquire  (II C:ICII Iislcd  ~rncr  status of suppiicr  performance  and 
currently billed [or any SCMCC..(include mm  cl;till!  Iypc  I(I  dc(crmincc ornpliancc  with carricr  jurisdiction  rul~$. 
o[arricr,  supplier  number  and primary  i(cms 
for which (hey arc hilled). 
TYPES  OF  PRODUCXWSERvlc=: 
1.	 Which of the following produc[.tiscticcx  Cross rcfcrcncc  cxch inrlicxtd  prcxlucllscmicc  [o: 
do you provide: 
-subnlillcd  hc-Jllh pro[cxional  liccnsurc  information. 
Durable  Medical  Equipmcnl 
  Oaygcn  -c(mlpliancc  will}  sppli~~blc  stale rcgulatoq rquirmcnLs, 
	  Vcntilalors (e.g.  [DA). 
_  Apnea Monitoring 
PEN 
o&P
 
2.	 A(c  Mcdicarc  Ilems  ordered  by Ihc  bcncficinry  If rmptmsc  i(idiCRIC$ bcncflciary  4Jlrcclcd order,  mcxdlor 
prior 10 lhc prescribing physicians prcscrip[imlt  for Irn)ssihlc lclcnmrkcling  abuses. 
If so, arc Ihcsc incxpcnsivc rcluil ilcms 
bought across the txn.mlcr?  sljl1i,llil{  VL!I{II;I(XIION 
111I)A CONSENSUS  CONF13RI?NCE 
May  13-14,  1~1 
I{i.XOMMENDED  SUPPLIER  APPLICATION  CO N1I;NI 
AND  VERIFICATION  PROCEDURES 
v[IRIFIMTION  /COMM~~ 
...................... 
SALES/  MARK~ING: 
1.  Arc ph@ians,  nurm,  IhcrapisLs or  Dcfcrminc  il na(urc  O( rnarkcling  slralcgy  needs [o be 
bcncficiancs used for markcling  purpose..?  m(milorml  for possible abuse. 
If yes, describe. 
2.  If Ihcse individuals provide markcling  1[ rc.slxmsc is Iwrccrilagc  hmis, warranls  a(ldiliorml  invcsligalion 
scMca  under coniract, how arc lbcy  01](1Ill(l(lil(ltllll: 
compensated: 
% of Revenue gcncraid 
  % of Collections on Rcvcnuc  gcncrntcd 
  Flat Fcc (NoI  rciatcd to referrals) 
  Olhcr  (pieasc dwcribc)
 
3.  Do you conduct outgoing solicitation to :  1( bcncfi~iilri~$,  review wriltcn  guide [or inappropriate  ICIC. 
rnarkcling pr:lclica  (Waiver  ofconinsurancc, 
Bcncficiark    n(ln. mcdic:ll  nccwsily,  clc. ) 
~  Physicians 
  Other  Referral  Sources
* If yes, please submil a copy of your wril[cn 
soliciladon guide.  S{ JIILIER  VIWII:l  CA~lON 
I{ IDA  cONSENSUS  CONFERENCE 
May  13-14,  1991 
~p~MMENDED  SUPPLIER  APPLICATJON  CON~l!Nl 
AND  VERIFl~TION  PROCEDURES 
VERIFIGITION  /CO  Mhi  E~ 
........... .-......- 
4.	 For  c-ach salm rcprc..cnlalivc  cmployc-d,  (M;ty  IN IIMJ llurdcnsonlc  10 monilor  IllIS) 
please indicalc: 
-Name  and address. 
-Tclcphonc number where can !hcy can bc 
rcachcd. 
-As.signed branch. 
. States served.  .Scc t)cll)w. 
5,	 Arc orders roccived and proccsscd oulsidc O(  If ym,  review claim  submission  practic~  wilh  mulli@c  Urncm  10 
Ibis carrier jurisdiction?  dc(crminc  compliance  wi[h carriem  jurisdiction  rules. 
6,	 Arc sales made through calalogs to 
. . 
bcncficiarics outside Ibis carrier 
jurisdiction? 
a. Do you dcllver lhc.sc products  from this 
supplier address? 
b. Do you subumtracl  with  another  supplier  1( yrx, w;lrr:lnls  additional  Invdga(lcm  10 dclcrmlnc  valldily  of 
fur delivery  of these  products?  su[lldicr l)illil)~.  SUIII.  I[llL  VERII;IWI  ION

II IDA CONSENSUS  CONFERENCE

Msy  13-14,  1~]

RKOMMENDED  SUPPLIER  APPLICATION  CO NTl~N1 
AND  VERIFICATION  PROCEDURES 
...----- ...........  ....... 
PATllZ~  SET-UP/DELlVERY 
1.	 Indicate  information  given to the bcnctlciary  Ivlwsl h:Ivc WrIllCII  poiiciti. 
prior to or al Ihc lime o{ delivery: 
Teaching  and (raining malcrials. 
  COntracls(adng  [crms of rcn(al or 
	 purchase. 
Patient Bill of Riglus. 
  Emcrgcnq  contact proccdurm. 
   Olhcr  (please specify).
2.  How arc benclkiary  signatures oblaind: 
in person 
  over the phone  W;irr~n{s  [urthcr  invcs(igatbrr  if over [he phone. 
  by mail 
	  olhcr (please explain)
3,  How are products dclivcrcd 10 bencficiarics:  Usc inf[)rnl;lliwl  to idcnlify  p(crrtial earner  jurisdiction 
isslJc.$. 
commercial or U.S. Poslal  scMcc 
~  company delivered. 
_  pickd  Up by bencficia~. 
4,	 Who  u)mplelcs  mcdicai mxxxsity Information 
on the Cxrtificatc  of Mtxlical  Nccmsity: 
  physician or agcnl. The  corrccl  rc.sponsc. 
supplier.  Supplier  II(M acccpInblc,  (Refine  based on currcrrl  earner  instructions) 
  o!hcr (picasc cxpiain), Suspccl  . il}vc.sliga[c, 
5.	 Hmv long arc palienlJlransaclion  spczific 
r.locumcnlsrclaincd?  sIJPPLIIIR  VERIFICATION 
II IDA  CX)NSENSUS  CONFERENCE 
13-14, 1~1 
MJy 
RECOMMENDED  SUPPLIER  APPLICATION  CX)WI{NI 
AND  VERIFICATION  PROCEDURIH 
vI; RI FImTION  /COMMENT 
......-...-............-. 
PRICING: 
Arc Mcdicarc  and non-Mcdicarc  palicnL$  1[ rrspwlsc IS II{), invcsligatc  10 ensure govcrnmcn[ is not charged 
charged [hc same for idcnticd  scrviccs.  more. 
If no, explain 
Do you inform the bcncllciary of his/her  If no, indi(-:llc.s nofl compliance, 
responsibility for coinsurance? 
a, Is this communication  wrillcn  or verbal? 
b. When  dots  Ibis communication  occur? 
Do you have a Wril[en proccdurc 10 review  Require  wrillcn  proccdurc, 
the bcncficiarirx$desire 10 waive coinsurance? 
Pcrcznlagc ofcoinsurancc  waived over lhc pwd  Exccssivc  pcrccnlagc  warrants invcs(igalion. 
IWCIVCmonths (for renewal applications). 
Do yuu have a syslem in place 10 ndjusl  1[nl)l, C:irmt)[ rcccivclmainlain  suppllcr number. 
billed ulillzallon  to actual ulilizz[ion 
for  disposable  supplies?  sl)l11,1~~1  VBRIFICATION 
III1)A CONSENSUS  CONFERENCE 
May  13-14,  1~] 
R~IM~ENDED  SUPPL[ER  ~pL[mT10t4  coffl~~1 
AND  VERIFICATION  PROCEDURES 
vliRIFl(%TION  /COMME~ 
.-- .................. .. ... 
OWNERSHIP: 
1.  ~  0( Business 
Corporation 
  Parmcrshifr 
	  SoIc Propnclorship
2.  Ifincorporaled,  DaIc  and SIatc of Incorporalitm  Verify  wi{h ;IfJl~lIc:IIJlcstn[c. 
3.  Federal Tax  Idcnliflca[ion  Number  Vclify  willl  ;[l]~dic:lblc  govcrnmcn[  agcocy, 
4,  Hosphal based or afliliatcd? 
5,  Was company purchased? If so: 
a.  Were the rweivables  purchased. 
b.  Name of the former  owrrcr(s).  Cross rcfcrcncc  10 OIG  or @her appkablc  databases, 
c.  Former name of company and addr=. 
d,	 Indica{c c8rricrs billed with corresponding  Ir)quirc  M I(I supplier  Pcrformandalanding. 
fwovidcr numbcmo 
6  Please provide a complclc  lisl of company  Cr(tss  rc(crc[~ccwi(h  applicable  gcrwmmcrrl  agcocics,  o(hcr 
OITrccm,with corresponding  .Social!kzuri!y  c;lrlicrs  ;IIId  OIC~, 
Numbcm for each.  SUIII.I13R  VERIFICATION 
III13A  CONSENSUS  CONFERENCE 
May  13-14, 19$J1 
RIIcOMMENDED  SUPPLIER  APPLICATION  CONTII~l 
ANU VERIFICATION  PROCEDURES 
VITRIFICATION  / COMMENT 
...............  ..........- 
7.	 LA  lhc names of each owner, partner or 
olhcr inrlivjclualwho has a financial irrlcrcsl 
in Ihc company. 
a,  SIalc the exact nalurc of Ihc irrlcrc-slcoch 
individual holds (e.g. stock, loan), 
h.	 Idcnlify any oflhcsc  individuals who is 
or has been a provider of Mcdiurc 
Scticcs. 
- Indicalc exact name and address of Ihc  Cross rcfcrcncc  10 OIG  or olhcr applicatrlc source. 
provid~r. 
- Indicate the provider numbers under which 
each operates or has opcralcd. 
8,  Have any of the following individuals been 
the subject of any civil or criminal action 
with rcspxt  10 scmices billed 10 Mrdicarc, 
Medicaid orany othcf  lnsurancc company? 
  any of UIc Ofllc.cm tis{cd above?
any oflhc  Owners,  partners or olhcr 
. 
individuals having a financial irr[crcst 
Iistcxlabove? 
II  any rclalhwa of the Chyncrs, parlncrs or 
olhcr  individuals having a financial 
inlcrc5tlistal-above? 
_  any cmployccs of the comfmny? 
_  any contract thcrapisls, nums  or 
pharmacists? 
I(ycs, provklc cxplanalionl  W;lrr;lnls  invcslign(ion.  sol1[.11~1<  V~Rli71CAl10N 
1I IDA  ~NSENSUS  CQNI:ENENCE 
May  13-14,  191 
RIKOMMENDED  SUPPLIER  APPLICXTION  CONT1lN1 
AND  VERIFJ~TION  PROCEDURES 
vERIFICATION/COMMENT 
...----..-----..------ 
(),(cid:1) l[lhc  company  is rclalc(l (bytmmmon ownership  Crms  rcrcrcncc  10 OIG  or o[hcr  applicable  da[nbascs  used 10 
{lr managcmcnl)  10 any other organ i7~(ior\ (hi)!  ltl~ulilllr  In)(cnli:ll  ahusivc  rc[crrals,

is also a frruvidcr O(Mcdicarc  scrviccis,  (bl I151~l($lilt(  (~II IImr In  owmcrship  (]r  m3nagcrrlcnl).

identify: 
n .  cxacl name and addrms 0( rclwccl 
organi7,alion. 
b,	 relationship 10 lhc company and [trc 
nature of Medicare  scrvicm Ihey provide. 
c.	 name of the Medicare contractors that 
arc billed and the provider numbers used 
for [his purpsc. 
10. USI name, specialty and liccnsc number  Cross rcfcrcncc  to OIG  or other  appl.icablc  dalab-.

of any physician, [hcrapisl or other  Monitor  for po(cnlial  abusive  referrals.

Ikcnscd practitioner  who is an cmploycc, 
o[kcr,  or who has an owrrcrship interest  Sh:irc inf[lrn~a[iorl  ob[aincd  wilh  OIG  as applicable. 
in Ihc company,  S[a[c cxacl function. 
Il.	 M  name, spcdahy and Iiccnsc number  cross rcfcrcnu!  10 OIG  or cxhcr appkablc  da[abiucs. 
of any physician, lherapist or other  M(mil(jr  (I)r  polcnlinl  abuslvc  referrals. 
Iiccnscd  praclilioncr  who  is used on ii 
consultingkxmtract  basis.  Spify  cxacl  Sh;tru  in(or(ll;i[l(m  ob[nincd  wilt]  OIG  M appkablc. 
[unclion,  SUf1Ll13R  VERIFICATION

IIIDA  CONSENSUS  CONFERENCE

May 13-14, !W1

RECOMMENDED  SUPPLIER  APPLICATION  CONTENT 
AND Vf3RlFf~T10N  PROCEDURES 
vI;  I{ IFIcATION  /COlV4MENT 
-. .- ..........  ...... ... 
{) PI?l{ATIONS: 
1.  Is your company accrcdilcd  by:  [( yes,  (I IllI}WIII~  (~uu.$tions  warrfint  Iil[lc  review. 
JCAi-{O? 
  CliAf? 
   01hcr7 (please specify.)
Date of accrcditalion: 
2.	 Do you have writlcn  Quality Assurance  <  Must  how. 
pro!.ods  and proccdurc$? 
-J.  Is Ihc company in compliance with all  Cross rcfcrcncc 10 producls4scrvicm 10 dc[crminc applicable 
applicablestale arid federal rcgulalo~  rcquircmcnts. 
requirements: 
Verify  ~mit)lc  mm-compliance  with  applicable slate or [uleral  agency. 
DOT 
  FDA 
  OSHA 
  O[hcr, as appkablc
4.	 Dots [hc company own producl invcnlory.  If N(I, will  II(JI qunli(y  [or suppllcr  nurnbcr. 
1{no, please dcscribc your arrangements  for 
producI distribution. 
5.	 Are personnel onsi(c at ihc supplier addrms  l(m),  will  II(1I qu:lli(y  [or supplier number. 
ii 
during statal  hours of opcralion? 
1  If no, plasc  explain.  sU11Ll13R  VERIFICA[ION 
tll DA CONSENSUS  CON1713RENC13 
May  13-14,  1~] 
REcOMMENDED  SUPPLIER  APPLIWTION  CO NT[?NI 
AND  VER1FICATION  PROCEDURES 
vllRIFl~TION  /COMMENT 
-..-.-- ---------.-----
6,	 Do you prcwidc(directlyor bycontracl) 24 hour  Required. 
cmcrgcney Iclcphonc  reqmnsc scrvicc? 
7.	 Dots [hccompany  have a wrillcn  policy  Required  ~ilmc  polidcs  do no! gcl reviewed  by Ihe 
regarding patient righls and responsibility?  cxrncr,  as in accrulita{ion,  bul any businas 
requiring  it Mcdicarc  supplier  number  must 
$+.	 Doa  Ihc company have wrillcn  infcclion  I<(qlllttd.  have  Ihc..c wriltcn  policies in place. Such 
conlrol promcols ([or bo[b cmployccs find  wrillcrn  policy could  bc used  in a IaWuil  IO 
pa{icnls)?  c.si;itllish Ihc slnndard  Ihc company  should 
Il;lvc  IllCl). 
9.	 Doe.. Ihc company have wrillcn  main[cnancc  l{cquircd. 
and scticc  protocols, including (raining of 
SCMCCmchnicians. 
10.	 Dm  Ihc company have willcn  personnc~  Required. 
staffing standards and promcols? 
Il.	 Does  Ihc  company  have  Writ(cn  pro{ocds and  Required. 
procedures regarding record marragcmcn$? 
PLIW3E  A7TACH  COPIES  OF: 
1.	 Currenl  Professional Liccnsc for each  Cross rc[crcncc  10 produclshcnices to ensure all appUcable are 
hm]lhcarc  employee or conlrac{or.  in pl:lcc. 
2  Pharmacy ticcnsc,  if applicable.  Vcri(y  Slnndinr  wi(h  slalc  board. 
.3.  Occupational  L.iccnsc, if ilpplkqblc, 
4,	 Certilicalc  of Producl/irofc2ssional  Liabiiily 
Insurance.  S~Jffl.liX  VERIFICAIION 
t{l DA  CONSENSUS  CONll?RilNCU 
May  13-14,  1991 
RE@MMENDED  SUPPLIER  APPLICATION  CO N~[;  N_f 
AND  VER[Fl~TION  PROCEDURES 
vi2Rl  F1(XT10N/  cOMMENT 
- .- .-----------
SIC) NATURES  / A77ESrATION 
1.  Owner/Prcsidcnl  name and signa[urc, 
2.  AllQlalion  sta(cmcn(  10 include: 
a.	 undcrs[and all information  will remain 
confidcn[ial. 
b,	 understand some or all of the information 
provided w11bc verified by lhc umicr, 
both prior 10 issuance of a provider number 
aswell asonanongoingbasisasdccmcd 
appropria(c.This mayincludeonsilc 
inspection. 
c,	 altcmalion that information  provided is 
accurate and complctc. 
d.	 understand Ihal an updated appiica(ion is required 
whhin 60 dap  if change in ownership or for addi!ion 
of products acMcc$ no{ includd  on initial or mos[ 
rcccn[ application. 
c.	 undcrs[and lhc suppiicr number  mny bc suspended 
or rcpealcxi if false information  is provided.  10/04/94  08:39  S41O  966  5305  EES  OIG OAS ECFA  @oo2/oo2 
Se@mber  26, 1994 
. 
Ma. l?enllymmmpson 
-of  Inspector GeLk?nd 
Wallkon  & ImqXctions 
K  of M&  Human sWkcs  . . 
6325 Security Blvd., k- 1-D-MOM  --
Baltimore,Maryland21207 
13e4UM6wTbOmpaorl: 
Thankyoufor sendingus anadvancecopy of the &d  C)IGreporton oxygen services.  We 
sentit to ourmembexswho manufactureoxygen products.  Ourcommmts areasfollows: 
1.	 I%ge  1- Changelibsupporting to su@xnental  oxygen(m  ~W- OXYWI 
comdmtm  ameousidefed  non-l@  support dev-im  bytheFDA  theydo pm* 
-- OXY= 
2.	 Page  16- Under Establishing minimum -ems  section, H(2FA may  want  to 
takeinmaceouot  use of oxygen  c mmenmtbn  status Indieatocs (Osq.  Two 
stsmkds  (ASTM 1464-93 and ISO 8359) will/do  mquke  the use of 4XSIS  on all 
concentrators,  This may be a minimumrequircmcnt, so that absentm  OCSI 
mimhmemcnt foraconcemramr  would  bek3sthan  forth0seuni@  soequippd. 
Plcasecallm  cifytmhavcan  yquestions cmmxnkg  these  comments. 
Sincas.i!. 
Marcia  Nusgart,  R.Ph. 
IM3ct.or,Homo CaIU 
MN/bcj 
Health IIMUSIIY MSIUIfaCMWS ~ 
!200  G  STREET.  N. W,,  SUITE  ~oo 
w66HINGTDN,  o.c.  2aoa5-ta14 
(20Z)  7es-0700 
FAX  (202)  7e3-s750 
., 
t  4P
AMERICAN ASSOCIATION FOR RESPIRATORYCARE 
~1030 Ables Lane, Dallas, TX 75229, 214/243-2272,  Fax 214/484-2720 
October 3, 1994

June Gibbs Brown

Department of Health&  Hiunan Services

OfEce of Inspector General

5250 Cohen Building

330 Independence Awmue S.W.

Washir@q  DC  20201

Dear Inspector General Browm

The  American  Association  for  Respiratory  Care  (AARC),  a  professional  association  representing(cid:1)
37,000 respiratory  care pracl.itioners (RCPS), has reviewed the draft of the Inspector  Generals  (IG)

repoti Oxygen Concentrator Services.

The  AARC  has,  over  the  years,  umsiskntly  stressed the  critical  importance  of providing  support 
services,  in partiouhu  patient  asseasmm  as  a  key  compormt  of  home o- therapy.  We are 
gratifd  that the IGs report  has  reached  the  same  conclusion.  Inoonsistenaes  in providing  support 
services  among  suppliers  can  no longer  be permittd.  The number  of patimts  requising home  oxygen 
therapy  is  increasing  and  will  continue  to  inorease  as  the  population  agea.  l%e  advancements  in 
medical  technol~  coupled  with  the  financial  pressures  on  hospitals  to  discharge  pulmonary-
compromised  patients  earlier  results  in a more fragile patient receiving  oxygen therapy in the home. 
COMMENTS: 
while  the  AARC  supports  the  recommendations  of  the  IGs  repo~  we  are  concerned  about  the 
methodology  used in constructing  this report.  The sample size is very small, i.e.,  only 244 beneficiaries 
out of  220,371  oxygen  therapy  patients  were  surveyed.  Such a small  sample  size  could  affect  the 
statistical validity  of the report. Furthermore,no mentionwas made of the geographicaldistributionor 
the type(i.e.,national&a@ smallindependmtbusiness,respiratoryonly,homeinfbsi~  etc.)ofthe 
183 suppliers used within the report.  l%eae types of variations have an afl?ecton survey outcomes and 
data cokctkm.  We note that the report acknowledgesthat 1991 data was used and stipulates that 
concernedorganizationshave implementedimprovedstandardsof care sincethen.  We believeM 
that point should be fkther  emphasi~  simply for the fact that so much change has mxurred  over the 
last three years in the home health care  arena.  We are also concerned  that broad  comparisons  are made 
betweentheVeteranAdministrationsmethodofprovidinghomeoxygentherapyandthe wayMedicare 
program provides these services.  Perhaps, the differences between the two programs should be 
emphasized. 
IntheExecutiveSummary,respiratorytherapyisincorrectlyreferencedonPagei, paragraph5,theline 
reading ...life smtaking  resoiratorv theraDyfor patient....  The term oxygentherapy  should be 
substituted.  Respiratory therapy  compromises more than just oxygen therapy, and can include, but is 
not limited to, such therapies as chest physiotherapy, mechanical ventilation, and aerosol therapy.  The 
same incorrect reference is made in the introduction on Page 1, paragraph 5.  . 
June Gibbs Brown

Office of Inspector General

Page Two

October 3, 1994

Page 13- Third paragrapk  last line- cred4aUing  is misspelled. 
Page  16- Item  #1  - we  would  urge  you  to  specifically  ackmvvledge  the  AARC,  along  with  the 
references to JCAHO, CHAP, and NAMES.  Much of the standards these organizations developed were 
based on the AARCSstandards. 
A key  elemtmt in the  education  and  clinical  tdng  of  a  respiratory  care  practitioner  is  patient 
assessmeart.  RCPS are the  only profeasiomds trained  in all eiements of respiratory  care diagnosis, 
treatmen~ and therapy.  Patient assessment of the home oxygen patient is an integml component in the 
delivery of proper therapy,  as well as a  safkguard in assuring  only the  appropriate  equipment  and 
services are rendered. 
The  FDA  classifies  home  oxyg=  therapy  equipment  and  related  accessories  as  kgend  devices. 
Aaxdingly,  home medical  equipment (HME)  providers  must have a valid physicians  prescription  prior 
to dispensing  such  equipment.  A device  requiring  a physicians  prescription  would  likewise  require 
consistent  and systematically  planned  follow  up to  redum  the likelihood  of compromising  the  patients 
health and/or life through  misuse  or non-use.  \ 
Perhaps,  another avenue in reaching the goal of enhanced patient  services for home oxygenthqY 
would be to  amend the  curmt  Medicare  certificates  of  medical necessity  (CMN)  for  OXB  by 
requiringmore patient assessment procedures. 
It is apparent  to us that inconsistencies  regarding  appropriate  patient  services  for home oxygm  patients 
will  abound  until minimum  service  standards  are  required  by  Medicare.  It is inherently unfair and 
medically unacceptable for Medicare beneficiaries to be placed in a situaticm where critical  oxygen 
services are left strictly to chance. 
The AARC strongly endorses the recommendations proposed in the K+% repo~  oxygen  Concentrator 
services. 
Sincerely, 
Deborah L. Cullq  EdID,RRT 
Presid~  AARC 
DLC/jr