Department  of Health  and Human  Semites 
OFFICE  OF 
INSPECTOR  GENERAL 
NAPPROPRIATE  PAYMENTS  FOR  TOTAL 
PARENTERAL  NUTRITION  (TPN)  OFFICE OF INSPECIOR GENERAL 
The  mission of the  Office of Inspector  General  (OIG),  as mandated  by Public  Law 95-452, as 
amended,  is to protect  the  integrity  of the Department  of Health  and Human  Services (HHS) 
programs  as well as the  health  and welfare  of beneficiaries  served  by those  programs.  This 
statutory  mission  is carried  out  through  a nationwide  network  of audits,  investigations,  and 
inspections  conducted  by three  OIG  operating  components:  the  Office of Audit  Services,  the 
Office of Investigations,  and the  Office of Evaluation  and Inspections.  The  OIG  also informs 
the  Secretary  of HHS  of program  and management  problems  and recommends  courses  to 
correct  them. 
OFFICE OF AUDIT  SERVICES 
The  OIGS Office of Audit  Services  (OAS)  provides  all auditing  services for HHS,  either  by 
conducting  audits with its own audit  resources  or by overseeing  audit work done  by others. 
Audits  examine  the performance  of HHS  programs  and/or  its grantees  and contractors  in 
carrying out  their  respective  responsibilities  and are intended  to provide  independent 
assessments  of HHS  programs  and operations  in order  to reduce  waste,  abuse,  and 
mismanagement  and to promote  economy  and efficiency throughout  the Department. 
OFFICE OF INVESTIGATIONS 
The  OIGS Office of Investigations  (01)  conducts  criminal,  civil, and administrative 
investigations  of allegations  of wrongdoing  in HHS  programs  or to HHS  beneficiaries  and of 
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  INSPECHONS 
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  Health  Care 
Branch  under  the  direction  of Penny  R. Thompson,  Chief. 
Cathaleen  A. Ahern,  Project  Leader 
Computer  and statistical  assistance  provided  by Wm. Mark  Krushat,  Sc. D., Linda  M. Moscoe, 
and Brian  P. Ritchie,  of the Technical  Support  Staff, OEI. 
For  additional  copies  of this report,  please  contact  the Health  Care  Branch  at (410) 966-3148.  Department  of Health  and Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
INAPPROPRIATE  PAYMENTS  FOR  TOTA  . 
PARENTERAL  NUTRITION  (TPN) 
MAY  1993  OEI-12-92-O0460  EXECUTIVE  SUMMARY

PURPOSE

Thepurpose  of this  report  istoexamine  Medicare  coverage  of  total  parenteral

nutrition,  a high  tech  means  of feeding  patients  who  do  not  have  a functioning

intestinal  tract.

BACKGROUND

Total  parenteral  nutrition  is lifesaving  for  the  small  number  of  patients  who  lack  a

functioning  intestinal  tract,  usually  because  of severe  bowel  disease  or  a surgical

shortening  of the  bowel,  so  that  insufficient  length  remains  to  absorb  nutrients.

Medicare  covers  this  very  expensive  therapy  as  long  as  strict  coverage  guidelines  are

met.  Prior  to  the  advent  of the  common  working  file,  inconsistent  carrier  reporting  of

payments  hampered  analysis  of  payment  data.  Claims  paid  in  1991  represent  the  first

reliable  source  of  data  for  analysis  and  are  available  at  a time  when  the  infusion

therapies,  of which  parenteral  nutrition  is one,  are  undergoing  rapid  expansion.  This

is the  first  in a series  of  reports  examining  infusion  therapy.

METHODS

We  based  this  inspection  on  three  data  sources:  a  l-percent  sample  of  paid  claims  for

parenteral  setwices;  a telephone  survey  of 93 randomly-selected  dialysis  facilities;  and

intewiews  with  experts  in the  field.  We  examined  the  claims  data  to  determine  for

whom  and  for  what  conditions  parenteral  nutrition  is being  used,  and  the  survey

information  supplements  the  claims  data  for  a subset  of  patients,  those  with  end-stage

renal  disease  (ESRD).

FINDINGS

	 Medicare  overpaid  $69  million  for  total  parenteral  nutrition  in  1991,  43  percent 
of the  total  of $162  million  paid  for  this  service. 
	 More  than  half  the  patients  in the  sample  (53  percent)  had  ESRD,  and 
received  parenteral  nutrition  as  a supplement,  three  times  a week.  The  benefit 
of supplemental  parenteral  nutrition  for  these  patients  is unproven,  and  the 
charges  are  disproportionately  high  for  the  nutrients  supplied. 
	 Review  of  total  parenteral  nutrition  use  in the  non-ESRD  population  reveals 
inappropriate  patient  selection  and  over- and  under-feeding. 
i  RECOMMENDATIONS 
The  Health  Care  Financing  Administration  (HCFA)  should: 
	 instruct  carriers  to  adhere  to  a strict  interpretation  of  the  coverage  guidelines. 
We  estimate  this  will  result  in savings  of $69  million  a year. 
	 require  the  carriers  to  intensifY  review  of certificates  of medical  necessity, 
discuss  therapeutic  options  with  physicians,  and  monitor  the  use  of  nutrients 
over  time.  One  approach  might  be  the  use  of case  managers,  to  interact  with 
suppliers  and  physicians. 
	 review  research  into  the  clinical  appropriateness  of and  payment  methodologies 
for  intra-dialytic  parenteral  nutrition. 
AGENCY  COMMENTS 
We  received  comments  on  the  draft  report  from  HCFA  and  the  Assistant  Secretary  of

Management  and  Budget  (ASMB),  both  of whom  concurred  with  these

recommendations;  HCFA  has  taken  steps  to  implement  them.  The  HCFA  will defer

responding  to  the  question  of  appropriate  payment  methods  for  intra-dialytic

parenteral  nutrition  until  a coverage  decision  has  been  made.  The  HCFAS  comments

are  appended  in full.

ii  TABLE  OF  CONTENTS

INTRODUCTION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1

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

  Overpayments  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  6

  ESRD  Patients  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  7

  Non-ESRD  Patients  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  9

RECOMMENDATIONS  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  11

APPENDICES

A  1991  payments  for  Total  Parenteral  Nutrition  . . . . . . . . . . . . . . . . . . . . . . . .  A-1

B:  Distribution  of  claims  by carrier  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  B-1

C:	 Survey  of  dialysis  facilities.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  c-1

D:  Agency  comments  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  D-1
 INTRODUCTION

PURPOSE

The  purpose  of this  inspection  was  to  examine  Medicare  coverage  of total  parenteral

nutrition  (TPN),  a high  tech  means  of feeding  patients  who  do  not  have  a

functioning  intestinal  tract.

BACKGROUND

Clinical:  Total  parenteral  nutrition  (TPN)  is a therapy  designed  to  maintain  adequate

nutrition  in those  patients  who  cannot  eat  normally.  Early  attempts  at  enriched,  easy-

to-digest  formulas  included  carbohydrate-rich  joy juice,  taken  by mouth,  and  vitamin-

enriched  intravenous  (IV)  feedings.  Generically  called  hyperalimentation,  both

enteral  and  parenteral  nutrition  have  become  treatments  of choice  for  nutritionally-

impaired  patients.

Oral  or  tube  feedings  meet  the  needs  of those  patients  with  a functioning

gastrointestinal  tract.  Enteral  formulas,  which  can  be  milk-based  or  milk-free,  are

available  in drugstores.  The  formulas  can  be  merely  protein  or  calorie  supplements,

or  nutritionally  complete.  These  are  administered  by mouth  for  debilitated  patients;

through  naso-gastric  tubes  for  patients  who  cannot  swallow  or  who  have  a damaged

alimentary  tract;  and  directly  into  the  stomach  or  intestines  via  surgically-implanted

tubes  for  patients  requiring  long-term  maintenance.  A  simple  pump  can  be  used  to

maintain  a steady  flow,  although  gravity  will  suffice  for  all  but  those  patients  fed  into

the  jejunum.  These  are  comparatively  low tech  therapies,  easily  managed  in terms  of

the  patients  nutritional  status,  cleanliness  and  patency  of  the  tubes,  and  ease  of

administration.  Many  patients  on  tube  feedings  are  residents  of  nursing  homes,

although  the  technique  can  be  used  in the  patients  own  home,  managed  by the

patient  or  a family  member,  with  the  help  of a visiting  nurse.

An  intermediate  nutritional  supplement,  used  mainly  in conjunction  with  surgery,  is

enriched  IV  feedings.  Normally,  IVS hydrate  patients  who  should  not  take  liquids

orally,  for  fear  of vomiting  and  aspirating  the  tluid  into  the  lungs  during  or  following

surgery.  They  can  be  glucose  solutions,  to  provide  some  calories,  or  other  chemical

solutions  to  maintain  the  patients  electrolyte  balance.  If a patient  cannot  tolerate

solid  food,  he  or  she  can  be  maintained  on  IVS with  additives,  such  as vitamins,

purified  fats,  and  amino  acids,  for  about  10 days.  These  solutions  cannot  be  used  for

longer  than  that  since  the  patients  peripheral  veins  cannot  tolerate  the  enriched

solutions,  and  because  these  solutions  may  not  be  not  sufficient  to  meet  a patients

nutritional  needs  over  time,

When  a patient  lacks  a functioning  gastrointestinal  tract,  nutrition  must  be  supplied

directly  into  the  blood  stream,  from  which  it can  be  absorbed  by the  tissues.  This  is

known  as TPN.  A  catheter  is advanced  into  a  large  vein,  usually  the  superior  vena

1
 cava,  through  the  chest  wall.  The  catheter  can  be  tunnelled  through  the  fatty  tissue  of

the  chest,  both  to  anchor  it and  to  prevent  air  from  entering  during  dressing  changes.

All  stages  of this  therapy  require  the  use  of sterile  technique  - during  surgery  to  insert

the  tube,  during  dressing  changes,  during  the  preparation  of  the  nutritional  tluid,  and

during  the  attachment  of the  fluid  containers  to  the  catheter.

Manufacturers  sell  standard  nutrient  solutions  in quantity;  these  solutions  are  then

modified  by prescription,  depending  on  the  patients  condition,  blood  counts,  organ

function,  weight,  etc.  In the  hospital,  a pharmacist  would  add  trace  minerals,

additional  amino  acids,  vitamins,  etc.,  based  on  the  physicians  order.  The  solutions

composition  might  change  daily,  depending  on  the  results  of frequent  blood  tests,

urinalyses,  and  monitoring  of fluid  balance.  A  nurse  attending  the  patient  would  add

medications  such  as  insulin  just  before  administering  the  solution.  A  pump  maintains

a steady  rate  of flow,  and  a filter  inserted  in the  line  filters  out  bacteria  or  any  other

particulate  matter.

Although  the  TPN  technique  is more  complex  than  other  feeding  regimens,  patients

can  learn  to  administer  their  own  feedings.  Teaching  begins  in the  hospital,  and  can

be  reinforced  at  home  by visiting  nurses.  By the  time  the  patient  goes  home,  he  or

she  would  not  require  such  frequent  adjustments  of the  formula,  and  would  add

medication,  vitamins,  etc.,  by injecting  them  through  the  sterile  rubber  diaphragm  over

the  neck  of the  bottle  or  bag  before  hanging  it.  To  successfully  administer  their  own

TPN,  patients  (or  family  members)  must  be  able  to  understand  and  maintain  sterile

technique,  monitor  their  weight  and  physical  condition,  and  be  alert  for  complications.

Patients  who  are  otherwise  healthy  can  infuse  overnight,  and  go  to  work  during  the

day,  plugging  the  catheter  when  not  in use.  Other  patients  are  too  debilitated  by their

underlying  disorder  to  lead  a normal  life.

Complications  of TPN  can  be  life-threatening.  Among  the  metabolic  complications  of

the  therapy  are  electrolyte  imbalances,  which  can  lead  to  irregularities  of the

heartbeat,  diabetic  coma,  fainting,  etc.,  and  fluid  imbalances.  Other  complications  of

long-term  TPN  are  bone  pain  and  liver  dysfunction.  Among  other  risks  are

pneumothorax  [lung  collapse)  caused  by the  catheter,  and  thrombosis  or  air  embolism,

caused  by a clots  breaking  loose  or  air  entering  the  superior  vena  cava,  usually

associated  with  a dressing  or  tube  change.  Another  serious  complication  is septicemia

(blood  poisoning)  associated  with  use  of the  indwelling  catheter.  Some  patients

cannot  be  maintained  on  TPN  because  of recurrent  infection,  intolerable  diarrhea,  or

an  inability  to  manage  their  own  care.

Among  the  conditions  for  which  TPN  is indicated  are  short-bowel  syndromes,  in which

the  intestines  have  been  removed  due  to  cancer  or  necrosis  of the  tissues.  In other

conditions  such  as  Crohns  disease,  TPN  may  be  used  during  acute  phases  of the

disease,  and  normal  food  may  be  tolerated  during  remissions.  (Patients  with  Crohns

disease  can  use  enteral  nutrients  during  some  stages  of their  disease.)  Hospitalized

patients  who  have  extensive  burns  can  be  given  TPN,  as  can  patients  with  multiple

organ  failure.  Surgeons  will  sometimes  want  to  prepare  poorly-nourished  patients  for

2
 the  demands  of extensive  surgery  by putting  them  on  TPN  pre-operatively.  Healing

can  be  delayed  when  nutrition  needs  are  unmet,  so TPN  is sometimes  used  on  a short-

term  basis  for  patients  who  have  functioning  gastrointestinal  tracts,  but  fail  to  take  in

enough  food  to  nourish  themselves.

Other  patients  for  whom  TPN  may  be  ordered  are  those  who  are  cachectic,  i.e.,  in a

disease-related  state  of  profound  ill health  and  malnutrition.  Two  conditions  in which

cachexia  is common  are  terminal  cancer  and  renal  failure.  Acquired

immunodeficiency  syndrome  (AIDS)  is associated  with  a wasting  syndrome,  in which

weight  loss,  fever,  night  sweats,  oral  thrush,  and  diarrhea  are  common.

Medicare  coverage:  Medicare  covers  TPN  both  at  home  and  in the  hospital.  When

TPN  is administered  in the  hospital,  payment  for  it is included  in the  diagnosis-related

group  (DRG)  payment.  No  justification  for  using  it is needed.  In  the  home  setting,

however,  Medicare  covers  TPN  as  a prosthetic  device,  which  replaces  an  inoperative

body  organ  or  function.  Most  prostheses  replace  a missing  body  part,  so  they  are  by

definition  permanent  conditions.  As  discussed  above,  however,  some  patients  use

TPN  only  intermittently.  The  Coverage  Issues  Manual  addresses  this,  by providing  for

a presumption  of  permanence  if the  impairment,  in the  judgment  of  the  attending

physician,  will  be  of  long  and  indefinite  duration.

A  physician  must  certify  the  medical  necessity  of the  therapy,  the  pump,  and  pre-

mixed  (as  opposed  to  patient-mixed)  compounds.  Only  a one-month  supply  of

nutrients  will  be  paid  for  at  one  time.

Medicare  requires  that  the  certifying  physician  describe  the  functional  impairment

which  necessitates  the  use  of TPN.  A  diagnosis  of colon  cancer  or  colostomy,  for

example,  does  not  describe  a functional  impairment,  since  most  patients  with  either  or

both  conditions  could  ingest  and  digest  food  normally.  Generalized  debility  and  weight

loss,  as  in cachexia,  would  similarly  not  meet  the  coverage  guidelines,  since  no

functional  impairment  is identified.  Thus,  for  example,  a patient  terminally  ill with

cancer  of the  throat  would  be  eligible  for  treatment  with  enteral  therapy,  most  likely

through  a tube  into  the  stomach  or  intestines;  while  another  very  ill cancer  patient,

with  severe  weight  loss  but  no  functional  impairment,  would  not  qualify  at  all;  and  yet

another  patient,  whose  treatment  included  radiation  treatment  which  scarred  the

intestines  so  that  they  no  longer  function,  would  be  eligible  for  parenteral  therapy.

While  such  coverage  guidelines  may  appear  to  restrict  access  for  patients  who  would

benefit  from  nutritional  therapy,  such  restriction  can  be justified  by the  invasive  nature

of the  treatment,  the  risk  of  complications,  and  the  lack  of  proven  benefit.  A review

of the  limited  medical  literature  discussing  parenteral  therapy  (in  The  New  England

Journal  of Medicine,  Vol.  325,  No.  8, August  22,  1991,  pp  573-5)  refers  to  the  few,

largely  inadequate  clinical  trials,  mixed  results  of therapy,  and  the  need  to  balance  the

theoretical  benefit  with  the  risk  of serious  complications.

3
 Both  the  Covera~e  Issues  Manual  andthe  Carriers  Manual  specifically  exclude 
coverage  of nutritional  supplements.  While  the  manual  pages  do  not  address  the 
question  of oral  food  intake  (except  in excluding  nutritional  supplements),  the 
certification  form  does  ask  if TPN  is the  patients  only  form  of  intake. 
Beginning  in  1985,  the  Health  Care  Financing  Administration  (HCFA)  established  two 
carriers  for  all  hyperalimentation  claims.  Transamerica  Occidental  Life  Insurance 
Company,  Los  Angeles,  handles  claims  west  of the  Mississippi,  and  Blue  Cross/Blue 
Shield  of South  Carolina  processes  those  in the  East,  with  the  geographic  determinant 
the  location  of the  suppliers  head  office.  The  Eastern  carrier,  South  Carolina  Blue 
Shield,  processes  the  majority  of all  parenteral  claims.  The  carriers  have  established 
special  units  to  certify  and  process  claims  for  enteral  and  parenteral  patients.  (Claims 
for  Railroad  Retirement  beneficiaries  are  processed  by the  Travelers  Insurance 
Company.)  A  Final  Rule  with  comment  period  published  in June  1992  outlined  a 
change  in the  way  durable  medical  equipment  claims,  including  those  for  prosthetic 
devices  and  thus  TPN,  will be  processed.  Four  specialty  carriers  with  responsibility  for 
segments  of the  nation  will  process  these  claims  based  on  the  beneficiarys  residence. 
METHODS 
We  relied  on  three  data  sources  developed  for  this  inspection.  The  first  involved  a 
l-percent,  random  sample  of al] patients  who  had  claims  paid  on  their  behalf  by 
Medicare  for  a parenteral  pump  or  parenteral  nutrients  in  1991.  A  total  of 58 
patients  were  identified  in June  1992.  We  selected  this  sample  from  the  common 
working  file  (CWF),  and  it is the  source  of the  summary  payment  data  presented  in 
this  report.  Patients  whose  first  claims  were  submitted  later  than  May  1992,  even  if 
the  semices  were  rendered  in  1991,  may  not  be  represented  in this  sample.  These 
data  represent  patients  with  claims  paid  as  of December,  1991,  updated  for  the  final 
report  with  claims  paid  through  March  1993.  We  further  identified  the  patients 
appearing  in the  sample  in the  enrollment  data  base,  for  information  on  their  age, 
date  of death  (when  applicable),  and  basis  of eligibility. 
We  also  asked  the  three  carriers  for  copies  of a certification  of need  for  TPN  for  each 
sample  patient.  We  did  not  examine  medical  records,  but  rather  obtained  diagnostic 
information  from  the  Part  A payment  records  and  from  the  certification  of the  need 
for  TPN. 
The  second  data  set  was  information  received  from  a randomly-selected  sample  of 93 
outpatient  dialysis  facilities.  We  sumeyed  the  facilities  by telephone,  asking  for  the 
number  of patients  currently  receiving  intra-dialytic  parenteral  nutrition  (IDPN)  (that 
is, parenteral  nutrition  given  to  a patient  who  is being  dialyzed),  whether  any  of  these 
patients  were  on  TPN  at  home,  whether  they  received  the  nutrients  through  a central 
line,  and  how  many  days  a week  they  were  given  IDPN,  among  other  questions. 
We  also  interviewed  a number  of experts  in the  field.  Among  those  to  whom  we 
spoke  were  a physician  who  prescribes  TPN,  a home  health  agency  nurse,  a hospital 
4
 pharmacist,  hospital  discharge  planners,  a hospital  nurse  specializing  in infusion 
therapy,  a dietitian,  supplier  representatives,  infusion  therapy  and  nutritional  therapy 
association  staff  members,  dialysis  facility  staff,  and  HCFA  and  carrier  staff. 
We  conducted  this  review  in accordance  with  the  Qua&y  Standards for  Inspections 
issued  by the  Presidents  Council  on  Integrity  and  Efficiency. 
5
 FINDINGS

Medicare  overpaid  $69  million  for  TPN  in  1991 
	 Qf $162  mllwn  paid  in claims  for  ZPN  in  1991,  43 pe~ent  or $69  million  was 
impropedy  paid  for patients  who  did  not  meet  Medicares  coverage  guidelines. 
Most  of thae  were  end-stage  renal  dkease  (ESRD)  patients 
Based  on  our  sample  results,  we  estimate  that  $68,862,240  (90  percent  confidence 
interval:  $53,910,825  to  $83,813,654)  could  be  saved.  Appendix  A  provides 
information  about  the  classes  of patients  for  whom  Medicare  made  payments.  The 
following  discussion  centers  around  their  status  as  ESRD  enrollees  or  not  ESRD-
eligible,  since  the  two  groups  are  very  different  in their  use  of parenteral  nutrition. 
.	 i%e ESRD  pahents  in the sample  (53 percent)  do  not  meet  coverage  guidelinm. 
Zlze entire  $545,000  spent for parentera[  numtion on  their  behalf  is an 
oveqnynen~  projected  to $54.5  million  nationally  in  1991. 
As  discussed  earlier,  coverage  guidelines  prohibit  payment  for  supplemental  feedings,

and  require  that  patients  have  a functional  impairment  of the  gastrointestinal  tract.

None  of the  31  ESRD  patients  in the  sample  was  totally  dependent  on  parenteral

feedings.  Generally,  documentation  of functional  impairments  of the  gastrointestinal

tract  was  not  found  in our  review  of certificates  of  medical  necessity  (CMNS)  and

hospital  admission  data.  Only  one  patient  in the  sample  had  a diagnosis  code

associated  with  a hospital  admission  that  indicated  any  failure  of the  gastrointestinal

tract.

The  CMNS  for  these  patients  were  incomplete,  non-specific,  and  misleading.  Ten  of

the  31 certificates  did  not  indicate  how  many  days  a week  the  patient  received

nutrients.  This  was  not  merely  a failure  to  document  the  number  of times  the  patients

were  fed,  since  payment  amounts  and  the  sumey  of dialysis  facilities  discussed  in

appendix  C indicate  that  these  patients  are  given  nutrients  three  times  a week,  as  are

the  ESRD  patients  whose  CMNS  were  completed.  The  average  number  of grams  of

protein  ordered  per  day  was  42, which  is suboptimal  for  most  patients.  The  average

@  equivalent  (i.e.,  the  grams  given  per  day  times  the  three  days  given,  divided  by

the  7 days  a week  most  TPN  patients  are  fed)  is less  than  17 grams  of  protein  a day,

which  is clearly  supplemental,  since  it is not  enough  protein  to  sustain  life  in infants,

much  less  in adults.  Non-ESRD  patients  were  given  an  average  daily  equivalent  of 74

grams  of protein  per  day,  every  day  in most  cases.

The  diagnoses  entered  on  the  CMNS  were  non-specific,  referring  to,  for  example,

malnutrition  syndrome  with  weight  loss  and  visceral  protein  depletion.

Malabsorption  is mentioned  for  many  patients.  However,  the  medical  literature  uses

the  term  malabsorption  to  describe  the  impaired  absorption  of  nutrients  due  to

specific  disorders  of  the  digestive  tract,  not  to  episodes  of  nausea,  vomiting  and

6
 diarrhea  in the  absence  of digestive  disease.  The  most  specific  term  used  in the

CMNS  was  diabetic  gastroparesis,  or  paralysis  of the  stomach.  This  evidently  refers

to  delayed  gastric  emptying  seen  in some  patients  with  diabetes.  Regardless  of the

presence  or  absence  of a functional  impairment  of the gastrointestinal  tract,  these

patients  used  parenteral  nutrition  to  supplement  their  oral  intake.  Thus  it is not  a

covered  service.

We  also  saw  misrepresentations  in the  Ch4NS.  For  example,  6 CMNS  indicated

incorrectly  that  parenteral  nutrition  was  the  patients  only  form  of  intake;  and  all

indicated  the  reason  pre-mixed  formula  was  required  was  sterility  or  patient  unable

to  learn,  when  in fact  the  patient  need  not  touch  the  nutrients  or  equipment,  since

nurses  in the  dialysis  facility  administer  the  nutrients.  The  Beneficiary  is in . . .  field

was  shown  as home  or  SNF  in al] instances  in which  it was  filled  in,  although  in fact

the  nutrients  were  administered  in a dialysis  facility.  Additional  information

concerning  carriers  and  the  number  of  ESRD  beneficiaries  they  cover  is in appendix

B.

.	 Non-ESRD  patients  who  are not  dependent  upon  TPN  had  $144,000  overpa@ 
which projects  LO$14.4  million  national&  in  1991. 
Of  the  27  non-ESRD  patients  in the  sample,  11 received  too  few  grams  [~f protein  to

sustain  life;  or  received  TPN  for  only  a short  while  (less  than  3 months)  and  did  not

die;  m- both.  This  indicates  that  the  therapy  was  not  necessary  to  sustain  life and/or

not  required  as  a result  of  a functional  impairment,  in violation  of coverage  guidelines.

We  calculated  the  overpayment  for  non-ESRD  patients  as follows:

One  patient  who  received  too  little  protein  to  survive,

on  TPN  for  a year  $41,407.2(1

Eight  patients  who  were  on  TPN  for  less  than  3 months,

averaging  37 days  $91,644.43

Two  patients  who  received  too  little  protein  to  sumive,

for  an  average  of 42 clays  $10,584.61

Total  overpayment  $143,636.24

The  benefits  of parenteral  nutrition  for  ESRD  patients  are  unproven,  its  use  is

associated  with  a high  rate  of  complication,  and  the  cost  of care  is disproportionate  to

the  resources  expended.

The  basis  for  giving  dialysis  patients  nutrients  appears  to  rest  on  the  perceived

connection  between  raising  serum  albumin  levels  and  reducing  mortality  in ESRD

patients,  rather  than  on  gastrointestinal  impairments.  This  connection  does  not

appear  to  have  been  rigorously  tested,  with  few  clinical  trials  and  mixed  results.  The

7
 current  strict  requirements  for  Medicare  payment  make  it unlikely  that  such  trials 
would  be  conducted  within  dialysis  facilities  largely  supported  by  Medicare  (since  trials 
would  include  patients  who  do  not  meet  the  coverage  guidelines),  unless  a separate 
grant  were  to  support  such  research. 
The  high  rate  of complications  may  be  related  to  using  dialysis  patients  access  ports 
for  both  IDPN  and  the  returning  flow  of dialyzed  blood.  (In  contrast,  indwelling 
central  catheters  used  by TPN  patients  are  not  to  be  used  for  any  other  purpose.) 
The  31 ESRD  patients  had  30  readmission  with  mechanical  complications  of their 
shunts,  and  12 readmission  with  other  complications  of treatment  (many  related  to 
tluid  overload).  Eleven  of these  42  readmission  were  also  for  septicemia.  These 
admissions  may  have  been  for  complications  of their  dialysis  treatments,  their  IDPN 
treatments,  or  both.  Only  six patients  had  no  readmission.  We  do  not  know  how  this 
compares  to  the  rate  of readmission  for  dialysis  patients  not  receiving  IDPN. 
The  Medicare  Carriers  Manual,  Part  3, Chapter  III,  section  3329,  refers  to  1 to  1.5 
grams  of protein  per  day  per  kilogram  of body  weight  as  a guideline  for  adult  TPN 
patients.  Using  a rough  measure  of  ideal  body  weight  (100  pounds  plus  or  minus  5 
pounds  for  each  inch  over  or  under  five  feet  in height),  we  calculated  the  range  of 
grams  of protein  required  and  received  by  those  patients  whose  CMNS  contained 
adequate  information  to  perform  the  analysis.  We  considered  patients  over- clr under-
weight  if they  deviated  from  their  ideal  weight  by  10 percent  or  more.  Note  that  for 
ESRD  patients,  the  prescribed  grams  per  day were  actually  administered  only  three 
days  a week.  We  found  that  only  six of 29  patients  were  underweight  and  two 
overweight.  Taking  the  CMNS  at  face  value,  only  5 were  fed  within  the  range  of  1 to 
1.5 grams  of  protein  per  day  per  kilogram  of body  weight,  and  none  were  overfed. 
,- .. 
ESRD  patients  fed  too  little	 ~fed  within  correct  I fed  too  much  ~ 
i range  I 
~ Within  10 Yoof  I  16  5  01 
~ ideal  weight  I 
I

1~Totals  I  24  I  51  () II 
The  costs  associated  with  delivering  nutrients  to  ESRD  patients  should  be  less  per 
infusion  than  for  non-ESRD  patients  for  the  following  reasons:  The  nutrients  can  be 
stored  in bulk  in the  facility,  with  less  wastage  than  at  home  (particularly  when 
patients  are  hospitalized);  the  facilitys  nurses  should  be  expert  at  handling  the 
equipment,  resulting  in less  contamination  and  thus  waste;  no  catheter  is involved,  as 
the  solution  goes  into  the  patients  blood  stream  with  the  cleansed  blood;  pumps  and 
IV  poles  could  be  shared  between  patients  infused  on  different  schedules.  The  daily 
cost  per  gram  of  protein  delivered,  however,  for  the  25  non-disabled  ESRD  patients 
8  ($5.96)  does  not  reflect  such  savings,  since  the  equivalent  cost  per  gram  per  day  for 
the  9 disabled,  non-ESRD  patients  is $3.72.  A  representative  of one  major  supplier  of 
both  dialysis  and  nutritional  therapy  indicated  that  savings  should  not  be  expected, 
because  suppliers  cannot  become  simply  shippers;  rather,  according  to  the 
representative,  the  demands  on  the  clinical  expertise  of  the  supplier  remain  the  same, 
including  training  of the  facilitys  nurses  (rather  than  the  patients  and  families).  This 
does  not,  however,  explain  why  the  costs  for  ESRD  patients  are  higher  than  for  non-
ESRD  patients. 
The  payments  for  nutrients  and  supplies  associated  with  the  328  days  that  ESRD 
patients  spent  in the  hospital  were  $29,257.  We  cannot  be  sure  of the  days  on  which 
ESRD  patients  would  have  received  dialysis  and  nutrients  if they  had  not  been 
hospitalized,  or  if they  received  nutrients  in the  hospital  (in  contrast  to  TPN  patients, 
who  are  infused  every  day). 
The  use  of TPN  in the  non-ESRD  population,  while  adhering  more  closely  to  the 
coverage  requirements  for  a demonstrable  functional  impairment  is not  closely 
monitored  by the  carriers,  resulting  in  inappropriate  patient  selection  and  over- and 
under-feeding. 
We  saw  patterns  of stopping  TPN  - a  life-saving  therapy  - which  raise  questions. 
Seven  of the  27  patients  stopped  using  TPN  following  an  admissicm  due  to 
complications  of the  therapy  (although  one  of those  patients  spent  212  days  in the 
hospital,  and  may  have  been  on  TPN  then).  Only  five  patients  who  used  TPN 
intensively  did  not  cease  its  use  even  when  serious  complications  ensued. 
Some  of the  high-intensity,  longer-term  patients  who  stopped  therapy  (and  who  are 
not  included  in the  overpayment  calculation)  may  have  gone  into  remission,  although 
this  cannot  be  determined  from  the  available  data.  We  believe  that  the  pattern  of 
stopping  what  is supposed  to  be  a life-saving  therapy  on  which  the  patient  is 
dependent  may  indicate  poor  patient  selection  by prescribing  physicians,  or 
exaggerated  claims  on  CMNS,  or  both.  In  only  two  cases  of the  six who  were  on  TPN 
for  very  short  periods  of time  were  the  CMNS  completed  in such  a way  that  the 
carrier  reviewer  could  reasonably  have  thought  the  patient  qualified  for  TPN.  In one 
of the  cases,  the  patient  appeared  to  qualify  for  enteral  rather  than  parenteral 
therapy,  based  on  the  diagnosis  and  functional  impairment. 
Again  using  the  Medicare  Carriers  Manual  guidelines  and  a rough  measure  of  ideal 
body  weight,  we  calculated  the  grams  of protein  required  and  received  by those 
patients  whose  CMNS  contained  adequate  information  to  perform  the  analysis.  We 
considered  patients  over- or  under-weight  if they  deviated  from  their  ideal  weight  by 
10 percent  or  more.  The  results  are  displayed  on  the  next  page. 
9
 I Non-ESRD  fed  too  little  ~fed  within  correct  ~fed  too  much  I 
1 patients  , range 
I 
I
1Totals  I  4!  81  6! 
Patients  who  are  on  TPN  for  only  short  periods  (less  than  a month)  have  higher-than-
average  monthly  bills  (in  one  instance  $17,470  for  a 30-day  period).  This  is probably 
due  to  (1)  high  contamination  rates  when  patients  are  not  familiar  with  the  therapy, 
(2)  intense  efforts  to  overcome  nutritional  deficits,  and  (3)  the  delivery  of a months 
supply  when  the  patient  only  uses  the  therapy  for  a short  time.  Conversely,  some 
long-term,  stable  patients  can  (and  should,  according  to  a physician  who  sees  many 
overfed  TPN  patients)  reduce  their  intake,  and  thus  achieve  economies  that  short-
term  patients  do  not.  This  is not  true  of all  long-term  patients,  some  of whom  excrete 
large  quantities  of  fluid  through  fistulae,  for  example.  One  such  patient  had  payments 
for  12 months  in  1991  of $122,130,  for  145 grams  of  protein  a day.  The  other  long-
term,  relatively-stable  patients  in whom  economies  might  be  achieved  do  not  appear  to 
bear  out  this  possibility.  One  who  received  85 grams  of  protein  a day  for  $73,781  (for 
12 months)  was  hospitalized  7 times  for  a total  of  70 days,  so  the  low  total  payment 
could  reflect  failure  to  bill while  the  patient  was  hospitalized  (i.e.,  the  $73,781  actually 
covered  services  for  fewer  than  10 months.)  Another  long-term  patient  had  payments 
of $105,098  for  11 months,  for  85 grams  of protein  a day,  but  was  able  to  maintain  a 
weight  of only  100 pounds. 
Non-ESRD  patients  in the  sample  spent  a total  of 252  days  in the  hospital  while  TPN 
was  being  billed.  Using  average  daily  costs,  we  estimate  Medicare  paid  $5S, 195 for 
TPN  that  was  not  used  because  the  patient  was  hospitalized,  although,  as  mentioned 
above,  some  suppliers  may  reduce  charges  when  patients  are  hospitalized.  Because 
suppliers  ship  a months  supply  at  a time  (unless  the  patient  or  a care  giver  asks  for  a 
smaller  shipment  because  of  a planned  admission  or  likely  prescription  change),  and 
because  nutrients  have  a limited  shelf  life,  this  wastage  is largely  unavoidable  as  cases 
are  currently  managed.  Patients  cannot  take  their  prescription  nutrients  into  the 
hospital  when  they  are  admitted,  because  the  hospital  will  not  accept  the  liability  for 
infusing  solutions  their  pharmacy  did  not  prepare  and  store.  Neither  nutrients  nor 
sterile  supplies  can  be  returned  to  stock,  because  of the  chance  that  they  may  have 
been  stored  at  an  improper  temperature  or  have  been  contaminated.  Close 
communication  between  the  supplier  and  patient  (directly  or  through  an  agent)  can 
help  to  reduce  the  provision  of  unnecessary  supplies,  as  can  proper  training  and 
supervision  of  patients,  particularly  in the  early  stages  of  therapy. 
10
 RECOMMENDATIONS

F	 The  HCFA  should  instruct  carriers  to  adhere  to  the  coverage  guidelines. 
Failure  to  do  so  puts  patients  at  risk  of developing  severe  complications,  and 
wastes  resources.  We  estimate  that  a strict  application  of coverage  guidelines 
would  result  in $69  million  in savings  yearly. 
	 Carriers  should  intensify  their  review  of CMNs,  discuss  therapeutic  options  with 
physicians,  and  monitor  the  use  of  nutrients  over  time.  One  approach  to 
carrying  out  these  responsibilities  would  be  the  use  of case  managers  to  interact 
with  physicians  and  suppliers,  and  to  monitor  patients  on  TPN.  Case  managers 
should  have  clinical  backgrounds  and  extensive  training  in the  use  of TPN  and 
Medicares  requirements.  They  should  have  the  authority  to  approve  hydration 
therapy,  brief  home  health  agency  coverage,  and  other  benefits  for  TPN 
patients.  They  should  give  prior  approval  to  TPN,  and  monitor  weaning  of 
patients  with  some  functioning  intestinal  tract.  They  should  monitor  as well 
those  patients  who  use  excessive  TPN  (more  than  100 grams  of  protein  per  day, 
for  example)  or  who  are  not  given  enough  protein  to  sustain  life.  Case 
managers  should  pay  particular  attention  to  ESRD  patients  for  whom  IDPN  is 
proposed. 
b	 The  HCF~  as  the  major  payer,  should  review  research  concerning  the  use  of 
IDPN.  Among  the  questions  to  be  answered  are  the  relationship  of  low  serum 
albumin  levels  to  mortality,  whether  blood  samples  drawn  within  days  of 
infusing  amino  acids  can  give  an  accurate  reading  of  albumin  levels,  whether  a 
history  of  complications  with  the  venous  shunt  should  be  a contraindication  t[~ 
the  infusing  of  IDPN  through  the  shunt,  whether  IDPN  results  in better 
nutritional  status  than  enteral  supplements,  whether  the  low  level  of  treatment 
(an  average  of 42 grams  of  protein  three  times  a week)  can  be  expected  to 
improve  nutritional  status,  whether  the  fluid  used  in  lDPN  is excessive  for 
ESRD  patients,  whether  albumin  levels  (or  nutritional  status)  can  be  raised  in 
some  less-invasive  way,  whether  it is necessary  to  use  pumps  to  deliver  the 
nutrients.  Until  these  and  related  questions  are  answered,  parenteral  nutrition 
should  be  used  only  in those  ESRD  patients  who  would  qualify  for  it based  on 
a documented,  life-threatening,  functional  impairment  of the  gastrointestinal 
tract,  and  in whom  it is not  a supplement  to  oral  intake. 
	 If IDPN  is considered  reasonable  and  necessa~  for  the  treatment  of a subset  of 
~RD  patients,  it should  be  paid  for  on  a per-capita  basis,  with  discounts 
negotiated  by each  facility  or  the  networks,  or  by using  some  other  method  that 
takes  into  account  the  efficiencies  associated  with  facility  administration  of the 
nutrients. 
11
 AGENCY  COMMENTS

We  received  comments  on  the  draft  report  from  HCFA  and  the  Assistant  Secretary  of

Management  and  Budget  (ASMB),  both  of whom  concurred  with  these

recommendations;  HCFA  has  taken  steps  to  implement  them.  The  HCFA  will  defer

responding  to  the  question  of appropriate  payment  methods  for  intra-dialytic

parenteral  nutrition  until  a coverage  decision  has  been  made.  The  HCFAS  comments

are  appended  in full.

12
 APPENDIX  A

MEDICARE  PAYMENTS  FOR  TPN 
Medicare  made  paymena  of approxirnate~  $162  million  in  1991 for  TPN for  5,800 
patients,  projecting  jiom  a random~-selected  one-percent  jile  of patienfi  who  received 
TPN. 
These  patients  fell  into  four  classes: 
Class  (number)  1991 TPN  average  average  age  average 
from  enrollment  payments  from  daily  TPN  number  of 
data  one-percent  payments  days  with 
samp]e,  CWF  A  TPN  bills 
disabled,  not  $653,255.83  $255.28  49.9  284# 
ESRD  (9) 
 
I 
not  disabled,  not  $420,176.11  $232.27  ~  74.9  101 
ESRD  ( 18) 
disabled,  ESRD  $122,910.58  $97.70  49.8  210 
(6) 
I 
not  disabled,  $422,075.67  $99.29*  !  70.9  170# 
ESRD  (25) 
$1,618,418.19 
* f3SRD patientsdo not receive nutrientsdaily; they are given nutrients  three  times a week during  their outpatient 
cfi~ilysistreatments.  These  daily payments  are  calculated  from the tot~ll ~:lid for the patients  and the number  of days 
(inclusivef)orwhichpaymentsweremade.Theyreceive so few grams o~ protein,  however, that their costs per gram 
are twice that of patients  fed more  and daily. 
#  These  represent  the number  of days billed in 1991.  Including  the days billed in 1990, the first class of patients 
had an average  time of use of 397 days, and the last class, 173 days. 
A See a discussion of the limitations of the data  in the footnotes,  appendix  B. 
A-1
 PATIENT  CHARACIT3RISTICS 
These  patients  varied  in intensity  of therapy,  and  in the  length  of time  they  received 
TPN,  as the  table  on  the  previous  page  shows.  They  also  varied  in their  underlying 
conditions  and  in their  outcomes: 
; 
[  I 
: Class  Most  frequent  diagnoses  admitted  with  I stopped  ~died  in  ~ 
, (number)  (from  hospital  claims)  complication  of  ,~TPN,  did  ~ 1991
1  therapy  ~not  die  !  ;1
I
i 
disabled,  not  Crohns  disease,  short- 67  %  admitted,  1  22  %  11%1 
~ ESRD  (9)  bowel  syndrome,  to  7 times 
septicemia 
~ not  disabled,  Ii   metastatic  cancer,  ~42  %  admitted,  1  56  %  44%1 
I  not  ESRD  ~septicemia,  dehydration,  ~to  3 times 
~ (18)  ~intestinal  obstruction  ~: 
I  I 
 disabled,  chronic  renal  failure,  ~50  admitted,  1 I  100 %  ~  17 %  ~ 
$ZO 
I 
ESRD  (6)  ~ diabetes  I to  3 times 
 .  .~.....   
: not  disabled,  chronic  renal  failure,  40  %  admitted,  1 1  44%  52  % 
ESRD  (25)  , hYPertens~  renal  to  4 times 
1 disease,  diabetes,  -] 
l! 
~congestive  heart  failure, 
I fluid  overload.  semis  I  11 
A -2
 APPENDIX  B

CARRIER  DETERMINATIONS 
Cam-em varied  widely  in their  coverage  determinations 
I  1  I 
Carrier  ~ Patients  in  ~Sample  patients  Number  of 
~ sample  ~with  ESRD:  CMNS  missing  1 
1 
I  ~ number  (percent)  critical  data  1 
~~South  Carolina  Blue  Shield  ~!  48  (83  %)  ~  27  (56  %)  I 
II 
~~Transamerica  Occidental  ,1  7 (12  %)  I  2 (29  %)  I 
~ Travelers  for  Railroad  i  3(5%)~  2 (66  %)  ~  1 I 
i Retirement  Board  (RRB)  ~ 
I  z;! 
I,_ T__o_ta ls  I  58  (100  %)  31  (53  %)  I 
South  Carolina  Blue  Shiekl  pays for  (he majority  OJ TPN/IDPN  clairru;  inconsklenl  and 
incomplete  reporting  make  it impossible  to determine  payment  trends 
,[
I  I1 
~South  Carolina  ~Transamerica  Travelers  for  ,i 
~1
I Blue  Shield  I Occidental  RRB  I 
,11991  ~ 
$125,535,876  ~  $32,061,953  I  $4,243,990  II  $161,841,8190  ~~ 
7896  20  %  2%1  100 Yo*  ~ 
Il   I 
1 
1990  $122,911,719  I  $32,285,943:  $2,492,626  ~  $156,690,280  ~ 
, 1989  ~  $69,289,206A  I  $28,474.910  I  $2.260,578  I  $1 OO,024,695A  1~ 
I  69 %  28 %  2%  100 5ZO*~ 
!l__ 
  This amount  is projected  from the cases in the sample discussed  in this report.  The  1990 and  1989 figures tire 
from summary  Part  B files maintained  by HCFA. 
* These totals understate  total TPN  payments  slightly, since other  carriers  made  minimal, spor~idic payments  for 
TPN  nutrients  and supplies  in all three years. 
A This probably underst:ites  payments  made by south Carolina Blue shield, which has a history of inconsistent  and 
incomplete  reporting  of TPN  payments.  Thus,  these figures should  not be used to attempt  to determine  trends  in 
TPN  use and payment. 
B-1
 APPENDIX  C

ESRD  PATIENTS  RECEIVING  NUTRIENTS  IN  DIALYSIS  FACILITIES 
An  average  of 2.4 percent  of patients  in aiaiyti  facilities  receive  intra-dia~hc  parenteral 
nutntion  (IDPN),  in all cases  only  3 times  a week  through  their shunt. 
Facility  size*;  Facilities  Have  used  Currently  have  ~ Number  of  ~ 
number  in  which  have  IDPN  in the 
sample  never  used  past 
IDPN 
Small;  27  12  5 
Medium;  44  13  11 
Large;  22  4  3 
Total  29  19 
* Small =  1-9 stationy  medium  =  10-19; klrge = 20 or more. 
[  I  , 
Status;  number  ~ Do  not  use  ~ Past  use  Now  use  Patients  on  ~~ 
~ IDPN  ,  IDPN  IDPN  ! 
11 
For-profit;  53  I  12  ~  gi  32  I  109 I 
+---  .,.,.
Not  for-profit;  40  17 i  10 ~  13  51  II 
Total  29  191  45  160 !: 
All  patients  in the  45 sample  facilities  currently  using  IDPN  are  fed  3 times  a week,  in 
all  cases  through  their  access  ports  or  venous  shunts  (rather  than  a central  line). 
None  of them  are  on  TPN  at  home. 
We  asked  respondents  (usually  the  nursing  supervisor,  but  in some  cases  a staff  nurse 
or  staff  dietitian)  to  discuss  their  facilitys  use  of  IDPN.  We  did  not  speak  to  patients. 
These  responses  are  all  anecdotal,  since  few  facilities  had  any  historic  information 
about  patients  use  of  IDPN  and  their  outcomes. 
The  changes  in patients  health  and  quality  of  life  most  often  cited  by the  respondents 
(in  descending  order)  were  improved  laborato~  values  (particularly  serum  albumin); 
weight  gain;  the  patients  feeling  better,  more  energetic,  or  stronger;  or  the  patients 
having  a better  outlook.  The  responses  ranged  from  saying  that  IDPN  maintains  life 
and  decreases  mortality,  to  saying  that  improvements  are-not  dramatic  or  patients 
had  negative  reactions.  Two  patients  were  cited  who  improved  enough  to  qualify  for 
c-1  transplants,  and  indeed  were  transplanted.  Another  respondent  noted  that  in  her

experience,  only  10 percent  of patients  improve,  50-60  percent  maintain  their  status,

and  the  rest  are  too  late  in the  course  of  their  disease  to  be  helped.

Fifty-one  of the  facilities  outlined  their  criteria  for  putting  patients  on  IDPN.  The

criteria  mentioned  most  frequently  were  low  serum  albumin  levels  and  weight  loss.

Five  mentioned  Medicares  requirements,  one  cited  guidance  from  their  network,  and

18 mentioned  gastrointestinal  disorders.  Among  the  reasons  for  using  IDPN  were  that

enteral  fills  them  up  and  they  dont  want  to  eat  and  that  enteral  products  dont

work  because  of fluid  retention  and  no  reimbursement  for  them.  Other  respondents

noted,  however,  that  oral  supplements  work  if patients  will take  them  and  that  IDPN

is used  infrequently  in children,  because  children  cant  refuse  NG  (naso-gastric)

tubes.

Among  the  reasons  given  for  stopping  IDPN  were  dramatic  improvements,  reaching

a target  goal,  elevated  blood  glucose  levels,  chest  pain  (from  tluid  retention),

diarrhea,  the  treatments  not  helping,  and  the  patients  death.  When  IDPN  is stopped

because  of improvements,  respondents  noted  that  some  patients  maintain  their

improved  status,  but  many  do  not.  Those  patients  who  use  IDPN  to  recover  from  the

demands  of surgery  reportedly  tend  to  maintain  their  status.  Most  respondents  noted

that  patients  are  reevaluated,  usually  every  three  months,  with  one  respondent  noting

no  patient  has  ever  needed  to  go  off  treatment.

c-2  APPENDIX  D 
COMMENTS  OF  THE  HEALTH  CARE  FINANCING  ADMINISTRATION 
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Date 
F~om 
Acting  Administrator 
Sublect	 Office  of  Inspector  General  (OIG)  Draft  Report:  Inappropriate  Payments  for 
Total  Parenteral  Nutrition  (TPN)  (OEI-12-92-00460) 
To 
Bryan  B. Mitchell

Principal  Deputy  Inspector  General

We  reviewed  the  above-referenced  draft  report  which  examined 
Medicare  coverage  of total  parenteral  nutrition  (TPN),  a high tech  means  of 
feeding  patients  who do  not  have  a functioning  intestinal  tract. 
Our  detailed  comments  on the  report  findings  and  recommendations  are 
attached  for your  consideration.  Thank  you for the  opportunity  to review  and 
comment  on  this draft  report.  Please  advise  us if you agree  with our  position 
at your  earliest  convenience. 
Attachment