Department  of Health  and Hfiman Services 
OFFICE OF 
INSPECTOR GENERAL 
Coverage  of  Enteral  Nutrition  Therapy: 
Medicare  and  Other  Payers  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 sewed 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 Offke of Audit SeMces, 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 Sax&s  (OAS) provides all auditing setices  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 program- and/or its ~antees  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 EVMX.JATION  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 Philadelphia 
Regional Office, under the direction of Robert A. Vito, Acting Regional Inspector General. 
Project staff included: 
PHILADELPHIA  REGION  HEADQUARTERS 
Donna M. Millan, Lead Program AnaZyst  Jennifer AntiCo,Program Spcialist 
Linda M. Ragone, Program Analyst 
Cynthia Hansford, Rogram  Asszkant

Nancy J.W. Lewis, PharmD, MPH, Consultant

% 
.  ..  Department  of  Health  and Hfiman  Services 
OFFICE  OF 
INSPECTOR GENERAL 
Coverage  of  Enteral  Nutrition  Therapy: 
Medicare  and  Other Payers 
.  EXECUTIVE  SUMMARY 
PURPOSE 
This report  describes  and  compares  Medicare  and  non-Medicare  payers  coverage 
policies  for  enteral  nutrition  therapy. 
BACKGROUND 
Enteral  nutrition  therapy  provides  liquid  nourishment  directly  to the  digestive  tract  of 
a patient  who  cannot  ingest  an appropriate  amount  of calories  to maintain  an 
acceptable  nutritional  status. 
Medicare  classifies  enteral  nutrition  therapy  under  the  prosthetic  device  benefit. 
Coverage  is only for therapy  required  due  to the  absence  or malfunctioning  body  part 
which  normally  permits  food  to reach  the  digestive  tract. 
The  Health  Care  Financing  Administration  (HCFA)  administers  the  Medicare 
program.  In an effort  to aid the  Durable  Medical  Equipment  Regional  Carriers 
revision  and  standardization  of Medicare  coverage  policy, HCFA  requested  the  Office 
of Inspector  General  to sulvey  other  payers  to determine  their  coverage  policies  for 
enteral  therapy. 
We  surveyed  Medicare  risk-contracted  and  private  health  maintenance  organizations, 
facilities  from  Department  of Veterans  Affairs,  Medicaid  State  agencies,  commercial 
payers,  and  Blue  Cross/Blue  Shield  associations. 
FINDINGS 
MOST  PAYERS  SURVEYED  ROUTINELY  COVER  ENTERAL  NUTRITION 
THERAPY. 
Twenty  out  of 25 different  payers  routinely  cover  enteral  nutrition  therapy.  The  five 
payers  who  do not  would  only cover  it under  extraordinary  circumstances. 
COMPARED  TO  OTHER  PAYERS,  MEDICARES  COVERAGE 
REQWNWENTS  ARE  SIMILAR  IN SOME  AREAS  AND  MORE 
Restrictive  IN OTHERS. 
Both  Medicare  and  other-payers  routinely  cover  enteral  nutrition  therapy  when  the 
patient  requires  tube  feeding,  when  enteral  nutrition  is the  patients  exclusive  source  of 
nutrition,  and  if the  patient  has  an anatomical  or physiological  malfunction  of the 
gastrointestinal  tract.  Both  types  of payers  also require  a certificate  of medical 
necessity  or a prescription  for coverage.  Like  Medicare,  about  half  of the  other 
payers  do not  routinely  cover  cognitive  disorders  such  as Alzheimers  Disease. 
i  ldedicares  coverage  requirement  is based  on  the  malfunction  of  the  gastrointestinal 
tract.  Medical  documentation  must  then  prove  the  beneficia~s  need  for  enteral 
nutrition  therapy  meets  this  criteria.  Although  some  other  payers  classify  enteral 
therapy  as  a prosthetic  device  as  Medicare  does,  these  other  payers  still  provide 
coverage  for  patients  with  a functioning  gastrointestinal  tract  and  special  nutrient 
needs;  Medicare  does  not.  Medicare  guidelines  require  specific  documentation  for 
category  of nutrient  product  and  caloric  intake,  and  the  use  of pumps,  while  other 
payers  do  not. 
We  hope  the  issues  resulting  from  this  report  answer  HCFAS  request  for  information 
on  other  payers  coverage  policies  for  enteral  nutrition  therapy,  and  aid  HCFA  in their 
effort  to  revise  and  standardize  Medicare  policy. 
Our  work  is continuing.  We  will review  how  other  payers  price  enteral  nutrition 
therapy  products  and  compare  their  units  of pricing,  payment  mechanisms,  and 
supplier  networks  to  Medicares  policy. 
ii  TABLE  OF  CONTENTS 
PAGE 
EXECUTIVE  SUMMARY 
INTRODUCTION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1

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

l
Most  Payers  CoverEnteral  Therapy  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..6

l
Medicares  PolicyIs  Similar  To Other  Payers  . . . . . . . . . . . . . . . . . . . . . . ...7

CONCLUSION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...12
 INTRODUCTION 
PURPOSE 
This  report  describes  and  compares  Medicare  and  other  payers  coverage  policies  for 
enteral  nutrition  therapy  (ENT). 
BACKGROUND 
Me&are  covers ENT underthePartB prostheticdevicebenejit 
Enteral  nutrition  therapy  (ENT)  is a means  to provide  nourishment  directly  to the 
digestive  tract  of a patient  who  cannot,  for a variety  of reasons,  ingest  an appropriate 
amount  of calories  to maintain  an acceptable  nutritional  status.  The  beneficiary 
consumes  a liquid  nutrient  formula  which  can be  administered  one  of three  ways: 
l  nasogastric  tube:  inserted  through  the  nostril, 
.	 jejunostomy  tube:  inserted  through  a surgical  incision  leading  to the  small 
intestine, 
l  gastrostomy  tube:  inserted  through  a surgical  incision  leading  to the  stomach. 
The  Medicare  guidelines  classi~  ENT  under  the  prosthetic  device  benefit  because 
coverage  is only for therapy  required  due  to an absent  or malfunctioning  body  part 
which  normally  permits  food  to reach  the  digestive  tract.l 
Medicare  covers  ENT  for  conditions  based  on the  malfunction  of the  gastrointestinal 
tract.  According  to Medicare  guidelines,  ENT  is reasonable  for: 
l(cid:128) a beneficiary  with  a non-functioning  gastrointestinal  tract,  who  cannot  maintain 
appropriate  weight  due  to disease  or non-function  of the  structures  that 
normally  permit  food  to reach  the  digestive  tract,  or 
l(cid:128) a beneficiary  with  a disease  of the  small bowel  that  precludes  digestion  and 
absorption  of sufficient  nutrients  and  necessitates  tube  feeding  to maintain  the 
appropriate  weight. 
Many  medical  conditions  can  cause  malfunction  of structures  so as to preclude  normal 
ingestion  of food.  Examples  of conditions  that  would  quali&  for coverage  are  head 
and  neck  cancer  with reconstructive  surgery  and  central  nervous  system  disease  which 
lMedicare  Carriers  Manual,  section  2130 and  Medicare  Coverage  Issues  Manual, 
section  65-10. 
1(cid:1) leads  to interference  with the  neuromuscular  mechanisms  of digestion  so severe  as to 
prohibit  oral  feeding.  Medicare  does  notallow  coverage  for beneficiaries  witha 
normally  functioning  gastrointestinal  tract  whose  only need  for ENT  stems  from  lack 
of appetite  or an organic  brain  syndrome2. 
Me&are  nquiies-h  dkummdm  fix  the medical  necessitoyf  ENT
Under  Medicare  guidelines,  all enteral  nutrition  claims  submitted  to the  Durable 
Medical  Equipment  Regional  Carrier  (DMERC)  must  be  approved  on an individual 
case-by-case  basis.  Each  claim  must  have  a certificate  of medical  necessity  (CMN) 
signed  by the  attending  physician  and  sufficient  medical  documentation  (such  as 
medical  records  and  clinical  findings  from  the  attending  physician)  to permit  an 
independent  conclusion  that  the  beneficiary  meets  the  requirements  of the  prosthetic 
device  benefit.  A CMN  must  be  renewed  three,  nine,  and  24 months  after  the  initial 
CMN.  A new CMN  is additionally  required  under  these  circumstances: 
s  when  there  is a change  in the  category  of nutrients  or calories  prescribed,

l  a change  horn  enteral  to parenteral  (intravenous)  therapy,

l  or when  there  is a need  for  a pump.

If a documented  need  exists for ENT,  Medicare  will cover  related  supplies,  equipment, 
and  nutrients.  Additional  documentation  is needed  for the  use  of a pump  to 
administer  ENT.  Only services  rendered  by a physician  or by a non-physician 
professional  whose  services  are  incident  to a physicians  semice  are  covered. 
Mdicare @deli&s&o  requirejusiijicatbraf cucdtzin typeosf   ENTproductr.
Medicare  classifies  ENT  products  into  six categories  based  on the  composition  and 
source  of ingredients  in each  product.  Category  I products  are  the  most  commonly 
used;  they  consist  of natural  intact  protein  or protein  isolates.  The  guidelines  state 
that  if a physician  prescribes  a formula  from  Categories  III through  V, additional 
documents  must justify  the  reason  for prescribing  a higher  category  formula. 
According  to the  policy, if the  request  cannot  be  substantiated,  payment  is based  on 
the  allowance  for the  least  costly alternative.  The  categories  of products,  their 
composition  and  indications  for use  are  listed  in the  table  on the  following  page: 
2Any mental  disorder,  such as senile  dementia  or Alzheimers  disease,  resulting 
from  or associated  with  organic  changes  in brain  tissue. 
2  MEDICARES  CLASSIFICATION  OF  ENTERAL  NUTRITION  PRODUCTS 
BY COMPOSITION  AND  INDICATIONS  FOR  USE 
Category  I  semi-synthetic  intact  protein/protein 
isolates  which  are  standard  products  for 
most  patient  use 
F 
intact  protein/natural  protein  isolates 
that  are  low sodium,  high calorie  products 
Categoxy  III  hydrolyzed  amino  acid formula  used  for 
patients  unable  to  absorb  intact  protein 
isolates 
Category  IV  formulas  designed  to meet  metabolic  needs 
associated  with  specific  disease  conditions 
Category  V  individual  nutrition  components  (fat, 
protein,  carbohydrates)  that  allow the 
making  of customized  formulas 
Category  VI  formulas  with high protein  content 
l'7aeDurablkiUedME@pmentRegionalc  i-wimpnXeSEA7Tcti. 
The  Health  Care  Financing  Administration  (HCFA)  administers  the  Medicare  Part  B 
program.  In October  1993, HCFA  designated  four  DMERCS  to process  claims  for 
durable  medical  equipment,  prosthetics,  orthotics,  and  supplies,  including  ENT.  The 
DMERCS  replace  two previous  carriers  who had  processed  ENT  claims.  Each 
DMERC  is responsible  for its specific  region  of the  country  and  processes  claims 
originating  from  its respective  geographic  region.  The  HCFA  has been  active  in 
aiding  the  DMERCS  in transitioning  to their  new responsibility  for ENT.  The  HCFA 
has  also used  this transition  period  to reexamine  coverage  policies  and  to standardize 
coverage  decisions.  On-going  meetings  led by HCFA  have  included  discussions  among 
DMERC  representatives  and  nutritional  experts. 
To  aid the  DMERCS  in their  evaluation  and  application  of Medicare  coverage  policy, 
HCFA  requested  the  Office  of Inspector  General  to survey  other  payers  about  their 
ENT  coverage  policies.  The  request  included  gathering  information  related  to criteria 
and  documentation  required  for coverage.  The  HCFA  also specifically  expressed 
interest  in information  on the  coverage  of products  designed  for patients  with  special 
metabolic  conditions.  METHODOLOGY 
Using  a standardized  data  collection  instrument,  we obtained  information  on each 
payers  coverage  criteria,  documentation  requirements,  and  product  information.  We 
also asked  respondents  to enclose  a copy of their  medical  review  guidelines  and/or 
coverage  policies  for additional  review. 
Individuals  from  each  HCFA  bureau  reviewed  our  instrument  and  provided  insight  on 
appropriate  questions  and  pertinent  issue  areas.  We  also pre-tested  the  questions  with 
two payers  not  in our  sample.  We  consulted  with DMERC  medical  directors  and  their 
medical  review  staff as well.  Each  offered  input  on the  questions  and  issues we should 
address. 
We  sulveyed  Medicare  contractors  to assess payment  policies  for beneficiaries  under 
fee-for-service  claims  and  services  under  managed  care  arrangements.  Non-Medicare 
payers  include  the  Department  of Veterans  Affairs  (VA),  Medicaid  agencies,  and 
private  payers.  The  largest  payers  were  selected  from  each  group  (with the  exception 
of the  VA facilities  which  are  selected  randomly  in the  Medicaid  States  in the  sample). 
We  surveyed  a total  of 34 payers  and  received  responses  from  28 respondent.  Our 
analysis  is based  on the  information  from  these  payers: 
lfour  Department  of 
Veterans  Affairs  (VA) 
facilities 
five  Medicaid  State 
agencies 
lfour  DMERCS 
lfour  private  HMOs 
l four  Medicare  risk. 
contracted  health  lthree  private 
maintenance  organizations  indemnity/commercial 
(HMos)  insurers 
four  Blue  Cross/Blue 
Shield  Associations 
(BC/13S) 
Although,  not  all payers  responded  to all our  questions,  we grouped  valid  responses 
into  pertinent  coverage  issues  such as benefit  classification,  patient  condition,-and 
documentation.  We  report  how other  payers  policies  differ  or correspond  with 
Medicares  policies  for ENT. 
4
 For  the  purposes  of our  analysis, we designate  the  four  DMERCS  as representing  one 
payer,  Medicare.  Where  the  Medicare  risk-contracted  HMOS coverage  policies  are 
similar  to that  of the  DMERCS,  we also designate  the  Medicare  risk-contracted  HMOS 
as Medicare.  We  also distinguish  any issues where  Medicare  risk-contracted  HMOS 
differ  in their  application  of Medicare  policy.  These  risk-contracted  HMOS  must 
provide,  at minimum,  what  Medicare  guidelines  require  for coverage;  Medicare  risk-
contracted  HMOS  can  also be  more  generous  in benefit  coverage. 
We  gathered  and  analyzed  this information  ffom  August  through  early  November, 
1994.  This  inspection  was conducted  in accordance  with the  Quali~  Standards  for 
Inspections  issued  by the  Presidents  Council  on Integrity  and  Efficiency. 
J  FINDINGS
MOST  PAYERS  SURVEYED  ROUTINELY  COVER  ENTERAL  NUTRITION 
THERAPY  BUT  CLASSIFY  THE  BENEFIT  SEVERAL  DETERENT  WAYS. 
Twenty  out  of 25 different  payers  routinely  cover  enteral  therapy,  while  five payers  do 
not.  Those  five payers  gave  different  reasons  for not  routinely  covering  it.  Two Blue 
Cross/Blue  Shield  (BC/BS)  payers  stated  that  it is not  a standard  benefit  in their  plans. 
One  Medicaid  payer  only covers  ENT  for individuals  under  the  age  of 21 because  the 
cost  of ENT  is seen  as prohibitive.  One  Veterans  Affairs  (VA)  payer  only covers 
persons  on an inpatient  basis.  The  fifth, a private  indemnity  payer,  stated  that  while it 
covers  the  supplies  and  pumps,  it does  not  cover  the  nutritional  product  since  it is 
considered  food. 
These  five payers  would  cover  ENT  under  exceptional  circumstances.  For  example, 
the  private  indemnity  payer  would  cover  the  product  where  it is mandated  by State 
law.  The  BC/BS  payers  provide  coverage  if it were  included  in a specific  group 
contract.  The  inpatient  VA payer  would  provide  ENT  on an outpatient  basis  if the 
individual  were  indigent  and  if ENT  were  the  patientss  sole source  of nutrition. 
According  to Medicare,  ENT  is a prosthetic  device;  however,  other  payers  differ  in 
their  classification  of ENT.  Medicares  classification  of ENT  as a prosthetic  device 
benefit  comes  from  the  basis  that  ENT  serves  the  function  that  an otherwise  normal 
gastrointestinal  structure  would  perform.  Different  classifications  of ENT  may result 
from  other  medical  reasoning.  Table  1 below  illustrates  how payers  classi% the  ENT 
benefit. 
HOW PAYERS CLASSIFYENT ASA BENEFIT
41  18  4/18  5/18  6/18  1/18
%is  term  includes  the  following  classifications:  major  medical  benefit,  under 
the  benefit  plan,  as part  of total  care,  and  expendable  medical  supply. 
6 Three  Medicare  risk-contracted  HMOS  designate  ENT  as a prosthetic  device  benefit. 
Three  other  payers  put  ENTunder  prosthetic  device  aswell.  Five  non-Medicare 
payers  grouped  ENT  as a pharmaceutical  benefit,  while  six place  ENT  in the  durable 
medical  equipment  (DME)  category.  One  Medicare  HMO  also classifies  ENT  under 
general  durable  medical  equipment.  The  remaining  payers  cover  ENT  as a major 
medical/standard  benefit  or as nutrition. 
Note  that  the  18 other  payers  include  the  Medicaid  agency  who  only covers  children, 
the  inpatient  VA facility,  and  the  private  indemnity/commercial  payer  who  only covers 
the  pumps  and  supplies,  not  the  product.  It does  not  contain  the  two BC/13S payers 
who  do not  routinely  cover  ENT.  In addition,  four  other  (non-Medicare)  payers  use 
dual  classifications  for the  ENT  benefit.  These  four  specifically  differentiate  between 
the  actual  ENT  product  and  the  supplies  and  pumps  to administer  the  nutrition.  In 
this case,  typically,  the  ENT  product  is a pharmaceutical  benefit,  while  the  supplies 
and  pumps  are  covered  as DME  or as a prosthetic  device. 
Medicare  and  other  payers  use  similar  strategies  to formulate  their  coverage  policies. 
In defining  their  coverage  policy for ENT,  payers  employed  a combination  of common 
strategies  to compose  their  ENT  policies,  including  consultation  with  nutritional 
experts,  individual  providers  and  manufacturers,  and  review  of scientific  literature. 
COMPARED TO OTHER PAYERS, MEDICARES COVERAGE 
REQUIWMmTS  ARE MORE RESTRICIIV  EINSOMEAREASAND 
SIMILAINRO(cid:1)THERS.(cid:1)
While  almost  all payers  require  their  beneficiaries  to have  specific  health  conditions 
for ENT  coverage,  the  Medicare  guidelines  dictate  that  ENT  must  serve  the  purpose 
of a prosthetic  device,  which  is to replace  a malfunctioning  body  part. 
PatientChditiom  and  ctnwmmwa 
As Table  2 on the  following  page  illustrates,  both  Medicare  and  other  payers  routinely 
cover  ENT  under  three  circumstances:  1) when  the  patient  requires  tube  feedings,  2) 
when  ENT  is the  patients  exclusive  source  of nutrition,  and  3) when  the  patient  has 
an anatomical  or physiological  malfunction  of the  gastrointestinal  tract.  For  these 
three  circumstances,  both  Medicare  and  other  payers  policies  appear  to be  similar. 
7
 clRcuMsrANcEs  WHERE MEDICARE COVERS ENT
AND HOW OTHER PAYERS RESPOND
...! COVERED  16/17 
*.:?..*.:,..  *.:<W.W+/:. 
~-;; ,...... ..................
The  seventeen  other  payers  include  the  inpatient  VA facility and  the  Medicaid  State 
agency  who  serves  only children.  This  figure  does  not  include  the  two BC/BS  payers 
who  do not  routinely  cover  ENT  and  a private  indemnity  payer  who  only covers 
pumps  and  supplies,  not  the  product. 
The  table  below  shows circumstances  where  payers  and  non-Medicare  payers  differ  in 
their  coverage  policies.  Medicare  does  not  cover  ENT  that  is orally ingested,  while 
:@:::: NOT COVERED  0/4  7/17
~;; : 
............. 
:s?  NOTCOVERED  2J4  13/17 
;;.~~~;;,;:,;.~
...... 
For  some  non-Medicare  payers,  patient  diagnosis  is sufficient  to warrant  routine 
coverage  of ENT,  while  other  non-Medicare  payers  will initially  only cover  ENT  for 
specific  diagnoses.  Three  non-Medicare  respondents  require  that  the  patient  have  one 
of a variety  of specific  diagnoses,  such  as Crohns  disease  or enteritis.  For  other 
payers,  another  circumstance  warranting  ENT  coverage  is if a physician  declares  ENT 
medically  necessary  to maintain  the  patients  body weight  and  general  nutritional 
status.  If the  physicians  order  in the  patients  medical  record  states  a need  for ENT 
or if prior  authorization  is issued,  it is covered.  An individual  medical  review  for 
appropriateness  can  also be  required.  In two instances,  State  law mandated  coverage 
of ENT  for specific  diseases.  Often,  for non-Medicare  payers,  physician  evidence  and 
documentation  for the  medical  need  of the  therapy  can repeal  most  coverage 
restrictions. 
8 Non-G@rointminal  ReLz&dDimziem 
In contrast  to Medicare  guidelines,  just  over  two-thirds  of non-Medicare  payers  will 
cover  ENT  for patients  with  a functioning  gastrointestinal  tract,  but  still have  special 
nutritional  needs.  Three  Medicare  risk-contracted  HMOS  classi& ENT  as a prosthetic 
device,  but  do cover  patients  with special  nutritional  needs.  Again,  Medicare  HMOS 
may offer  more  coverage  according  to their  negotiated  contracts.  Also,  even  though 
some  non-Medicare  payers  classified  ENT  as a prosthetic  device,  they would  still cover 
the  therapy  for a person  with  a functioning  gastrointestinal  tract.  Table  4 below 
illustrates  this point. 
I  I I I  II 
1  1 1 1
3  1 1
1 1
1 1  2
According  to the  current  Medicare  definition  of ENT,  unless  the  criteria  for  a 
prosthetic  device  benefit  is met,  patients  with cognitive  disorders  cannot  be  covered. 
Technically,  with  a cognitive  disorder,  the  malfunctioning  body  organ  is the  brain,  not 
a gastrointestinal  structure.  During  this condition,  the  brain  is unable  to transmit  the 
4Again, note  that  some  payers  use  dual  classification  for defining  the  ENT  benefit. 
We  counted  each  classification  separately. 
5This figure  does  include  the  private  indemnity/commercial  payer  who  only covers 
the  pump  and  supplies  for ENT,  not  the  product. 
9 appropriate  neme  impulses  to direct  the  activity  of other  body  organs.  Cognitive 
disorders  such  as Alzheimers  Disease  or pre-senile  dementia  can make  chewing  and 
swallowing  difficult  for a patient  with  an otherwise  functioning  gastrointestinal  tract. 
Defining  the  therapy  under  the  prosthetic  device  benefit  narrows  the  scope  for its 
application  to patients  with cognitive  disorders.  The  table  below  shows the  number  of 
payers  who  routinely  cover  ENT  for patients  with  cognitive  disorders. 
PAYERS WHO ROUTINELY  COVER ENTERAL NUIIUITON
FOR PATIENTS WllH  COONITIVE DISORDERS
Table5.
Medicare  does  not  routinely  cover  patients  with  cognitive  disorders  unless  very specific 
medical  evidence  can  supp&t  the  need  for ENT.  Documentation  for the  patien~s 
functional  inability  to swallow are  necessaly.  Abnormal  results  from  a swallowing 
function  test  and  the  absence  of a gag reflex  (of the  muscular  reflex  contraction  in the 
throat  which  enables  one  to swallow)  and  additional  related  laboratory  and blood  tests 
build  a case  for coverage  under  the  prosthetic  device  benefit. 
The  Medicare  risk-contracted  HMOS  do not  routinely  cover  patients  who  only have  a 
cognitive  disorder  and  no digestive  track  malfunction.  These  respondents  would  make 
exceptions  to this rule  if ENT  were  the  patients  only source  of nutrition.  Additional 
documentation  of abnormal  swallowing function  tests  and  loss of gag reflex  are  also 
necessa~. 
In contrast,  almost  half  of non-Medicare  payers  would  routinely  cover  ElVI for 
persons  with  cognitive  disorders.  Other  additional  payers  would  cover  patients  with 
cognitive  disorders  as long as the  ENT  is the  patients  sole source  of nutrition,  or if 
the  patient  is only able  to obtain  nutrition  through  a tube.  Some  additional 
documentation  for  swallowing tests  and  severity  of the  dysfunction  are  necessary,  but 
as long as the  prima~  physician  or physician  reviewer  deems  therapy  medically 
necessary,  it is covered. 
Enteral  Ni@iion  l%qNand  Sqp@es 
Pumps  may administer  ENT  for patients  whose  medical  conditions  require  a calibrated 
and  timed  flow of nutrients.  As Table  6 on the  following  page  shows, Medicare  policy 
requires  separate  documentation  for the  pump,  while  tw~ M&iicare  risk-contract~d  -
HMOS  automatically  cover  the  pump.  In contrast,  more  than  three-quarters  of non-
Medicare  payers  automatically  cover  the  pump  when  therapy  is needed. 
10(cid:1) PAYERS WHO AU17)MATKAUY  COVER PUMPS
WITH ENTERAL NUITUTION THERAPY
Table6.
NOTCOVEREDWITHOUT  q4  14/186 
SEPARATE 
DOCUMENTATIOFNOR 
NEED 
Supplies  such  as tubing  and  administration  kits are  necessary  for using ENT. 
Medicare  automatically  provides  these  items  with  the  therapy.  Similarly,  three 
Medicare  risk-contracted  HMOS  and  fifteen  other  payers  also follow this  coverage 
practice. 
Cenificatesof  M&al  Nwedy  and Ikmi@om 
Medicare  guidelines  are  explicit  in their  requirements  for documentation  for 
determining  coverage.  Medicare  policy requires  a CMN  for ENT  coverage.  Three 
Medicare  risk-contracted  HMOS  do not  require  a Cm,  instead  they  require  a 
physicians  prescription.  Eleven  out  of seventeen  non-Medicare  payers  require  a letter 
of need  or CMN  for ENT  coverage. 
In addition  to  a CMN,  more  than  half  of the  non-Medicare  payers  also require  a 
prescription  forthecoverage  of ENT.  Those  whodonot  initially  require  aCMN 
either  require  a prescription  or allow the  patients  diagnosis  or the  physicians  order  in 
the  medical  chart  to suffice. 
Medicare  not  only requires  a new CMN  for reassessment,  but  a new CMN  must  be 
revised  whenever  there  is a change  in the  caloric  intake,  a change  in nutrient  products, 
and  also when  there  is a need  for a pump. 
Reassesmenzfw  Th?r&l 
Both  Medicare  and  non-Medicare  payers  require  patient  reassessment  to determine 
whether  the  patient  still needs  ENT.  This reassessment  calls for an update  on the 
beneficiarys  medical  condition  and  a new CMN.  The  Medicare  risk-contracted 
HMOS  also require  periodic  assessment  for ENT  coverage.  Their  intervals  for 
reassessment  range  from  monthly  to every three  months  continually. 
Almost  all non-Medicare  respondents  require  periodic  assessment  to continue  therapy. 
The  intervals  for  continued  assessment  vary from  monthly  to quarterly.  Two payers 
call for yearly  assessments.  Unlike  Medicare,  non-Medicare  payers  require  on-going 
assessment  even  after  24 months.  An update  on the  patients  condition  is the  most 
. 
%is  figure  includes  the  private  indemnity/commercial  payer  who  only covers 
pumps  and  supplies  for ENT,  not  the  product. 
11  common  information  required.  These  payers  require  renewed  letters  of need  or 
CMNS on a continuing  basis ranging  horn  every  30 days to 6 months.  One  non-
Medicare  payer  reported  an interval  of one year. 
Doammwa  fw  Typesof  Rtxlucls
Medicare  also has  special  documentation  provisions  for the  kinds  of products  that 
physicians  prescribe.  The  Medicare  risk-contracted  HMOS  did not  speci&  that  they 
use  categories  of products. 
Only one  non-Medicare  payers  coverage  policy contained  a similar  distinction  for 
groups  of products.  This  payer  reported  that  if a physician  requests  a product  not 
listed  on the  First Line  Usage  Enteral  Nutrition  Product  Table,  additional 
documentation  must  accompany  the  physicians  prior  authorization  request.  The  extra 
information  must  show the  patient  experienced  therapeutic  failure  with  the  First 
Line product  or state  results  of a consultation  between  the  physician  and  a registered 
dietitian.  Other  payers  did not  provide  information  about  product  distinction. 
CWxic  Re@emem 
Medicare  policy requires  documentation  to justi@ any caloric  intake  less than  20 
calories/kilogram  or greater  than  35 calories/kilogram  per  day.  The  Medicare  risk-
contracted  HMOS  do not  have  this requirement,  while  only one  non-Medicare  payer 
requires  a minimum  number  of calories/kilogram  per  day. 
CONCLUSION
We  hope  the  issues resulting  from  this report  answer  HCFAS request  for information 
on other  payers  coverage  policies  for ENT,  and will aid HCFA  in their  effort  to revise 
and  standardize  Medicare  policy. 
Our  work  is continuing.  We will review  how other  payers  price  ENT  products  and 
compare  their  units  of pricing,  payment  mechanisms,  and  supplier  networks  to 
Medicares  policy. 
12