. 
Department  of  Health  and  Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
THE  BENEFICIARY  COMPLAINT

PROCESS  OF  THE  MEDICARE

PEER  REVIEW  ORGANIZATIONS

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OEI-01-93-00250  OFFICE  OF INSPECTOR  GENERAL 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452,  as 
amended,  is to protect the integrity of the Department of Health and Human Services (HHS) 
programs  as well as the health and welfare of beneficiaries  served by those programs.  This 
statutory mission is carried out through a nationwide network of audits, investigations,  and 
inspections conducted by three OIG operating components:  the Office of Audit 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 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 Boston regional office 
under the direction of Mark R. Yessian, Ph. D.,  Regional Inspector General,  and Martha B. Kvaal, 
Deputy Regional Inspector General.  Project staff included: 
BOSTON  HEADQUARTERS 
Joyce M. Greenleaf,  ProjectLeader  Barbara Tedesco,  TechnicalSupportStaff 
Elizabeth A. Robboy 
To obtain a copy of this report,  call the Boston Regional Office at (617) 565-1050.  Department  of  Health  and  Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
THE  BENEFICIARY  COMPLAINT

PROCESS  OF  THE  MEDICARE

PEER  REVIEW  ORGANIZATIONS 
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OEI-01-93-O0250  EXECUTIVE  SUMMARY 
PURPOSE 
The  purpose  of this  study  is to assess  the beneficiary  complaint  process  of Medicare  Peer 
Review  Organizations. 
BACKGROUND 
In April  1993, the Medicare  Peer Review Organizations  (PROS) altered  the way they 
ensure  the necessity,  quality,  and appropriateness  of care rendered  to Medicare 
beneficiaries.  Previously,  PROS did this by addressing  individual clinical  problems 
identified  primarily  through  reviewing  random  sample medical  records.  Now PROS aim 
to improve  the overall practice  of medicine by analyzing patterns  of care and outcomes 
and by sharing  information  with the medical community.  Under this approach,  the PROS 
random  sample record  reviews--already  reduced  from earlier  levels--are  being completely 
phased  out.  Thus,  the PROS process  for receiving  and investigating  complaints  from 
Medicare  beneficiaries  takes on added significance.  It becomes  a major  vehicle through 
which the PROS can identify and respond to individual  instances of poor medical  care.  It 
is vital,  therefore,  that the complaint process be functioning  well. 
This report  is based primarily  on data from surveys of 22 PROS representing  72 percent 
of the beneficiary  population  in the country  and aggregate  data from the Health  Care 
Financing  Administration  (HCFA)  reflecting  all the PROS record  review  workload, 
including  complaints,  during the fourth contract.  Our findings are based on PROS 
experiences  under  the fourth contract  with HCFA. 
FINDINGS 
Complaints  to PROS can be an important  source for  identifying  quality-of-care 
problems. 
F	 Between  10 and 15 percent  of the complaints  to all 53 PROS led to confirmed 
quality-of-care  problems. 
	 Half the PROS in our sample identified health systems problems  through 
complaints. 
Medicare  beneficiaries  are often unaware of their oppotinities  to complizin to PROS 
about the quality  of their medical  care. 
	 Seventy-seven  percent  of Medicare  beneficiaries  did not even know about the 
PROS, according  to a recent national  OIG survey. 
i  	 Thirteen  of the 22 PROS (59 percent)  in our sample cited difficulties  in making 
beneficiaries  aware of the complaint process. 
As it works now,  the complaint process  has some flaws  that undermine  its effectiveness. 
F	 Lack of Substantive  Responses.  The Federal  confidentiality  regulations  preclude 
PROS from sharing the results of their investigations  with the beneficiaries  without 
physicians  consent. 
	 Few Complaints.  The PROS received  too few complaints  to identify patterns  of 
poor care by individual physicians  and hospitals. 
	 Lengthy  Process.  Beneficiaries  can  wait  a long  time  for  the  results  of the  PROS 
complaint  investigation. 
RECOMMENDATIONS 
The complaint  process  needs to be working  well  in order  for  HCFA  to achieve  its  stated 
mission.  Below  we offer  our  recommendation  in three  parts,  one  part  to address  each 
flaw  we  identified.  It also  addresses  the  lack  of awareness  about  the  PROS  complaint 
process  that  we  found  among  beneficiaries.  If implemented,  our  recommendation  would 
result  in a complaint  process  that  is more  effective  and  more  accountable  to beneficiaries. 
Further,  it would  contribute  to HCFAS  mission  and  to goals  from  its strategic  plan. 
The HCFA should work with PROS to identify  cost-effective  ways to correct the jlaws  in 
the complaint process.  Toward that end, HCFA should: 
F	 Require  PROS to respond substantively  to the complainant.  l%e HCFA should 
give this the highest priority. 
A substantive  response  would require  a PRO to describe:  (1) what it did to investigate  the 
complaint,  (2) what the investigation  revealed,  including whether  a quality-of-care 
problem  was confirmed  and,  if so, the nature of the problem,  and,  (3) if a quality-of-care 
problem  was confirmed,  what action the PRO took based on it. 
	 Identifj  cost-effective  ways to enhance Medicare  beneficiaries  awareness  of 
PROS and the complaint process. 
The HCFA  should allow PROS more flexibility  in conducting  their outreach  activities. 
Such flexibility  could allow PROS to survey local beneficiaries,  target outreach  to family 
members  of beneficiaries  as well as pre-retirement  groups,  and even cultivate  new 
outreach  strategies  in the medical community.  The HCFA  should also identify benchmark 
practices  or promising  approaches  to informing beneficiaries  of the complaint  process. 
The recent  work of HCFAS Beneficiary  Communications  Steering Committee  and others 
could contribute  to this effort. 
ii  F  Streamline  the complaint process. 
The HCFA  should search for ways  in which  the process  of investigating  and  responding  to 
complaints  could  be expedited.  It could  benefit  by examining  ways  in which  other  bodies 
conduct  reviews  for  complaints  about  medical  care.  It could  also  identify  and  share 
promising  approaches  taken by individual PROS to streamline  the complaint  process. 
COMMENTS  ON THE DRAFT REPORT 
We solicited  and received  comments  on the draft report  from the Health  Care  Financing 
Administration  (HCFA),  the American  Medical  Peer Review Association  (AMPRA),  the 
American  Medical  Association  (AMA),  the American  Association  of Retired  Persons 
(AARP),  and the Coalition  for Consumer  Protection  and Quality in Health  Care Reform 
(hereafter  referred  to as the Coalition).  We include the complete  text of the detailed 
comments  in appendix  E.  We also received  a comment  of concurrence  from the Assistant 
Secretary  for Planning  and Evaluation.  Below, we summarize  the major comments  of the 
respondents  on our three  recommendations  and then,  in italics,  summarize  our responses. 
In the report,  we also made a number of minor technical  corrections  in response  to 
respondent  comments. 
The HCFA  took our first recommendation  on substantive responses  to complaints  under 
advisement,  expressing  concerns  about balancing  such responses  with the due process 
rights of providers.  The AMPRA and the AMA expressed  general  support for substantive 
responses  but also stressed the need to balance this with the due process  rights  of 
providers.  The AARP and the Coalition both expressed  strong support for our 
recommendation.  With respect to concerns raised by HCFA, AMPRA,  and the AA4A, we 
understand  the dlficul~  of achieving  a workable balance between  the principles  of the 
Health  Care Quality Improvement  Program and the basics of an e~ective  complaint 
process.  However,  we maintain  our commitment  to the point  made in our report:  that 
without a substantive  response to bene~ciaries,  it is not likely that HCFA can develop  a 
complaint process  that is credible to beneficiaries. 
The HCFA  and the other respondents  all agreed with our recommendation  to enhance 
beneficiary  awareness  of the complaint  process. 
The HCFA  expressed  concern  that our recommendation  to streamline  the complaint 
process  might result  in a less complete  or conscientious  review.  All the other respondents 
agreed  opportunities  exist to streamline  the process.  We recognize oppotiunities  to 
streamline  may be limited but maintain  that such oppotiunities  do exist.  Thus, we suggest 
that HCFA reconsider  this recommendation.  We believe  that some streamlining  of the 
complaint process  is essential  to achieving  a more effective process. 
... 
111  TABLE  OF  CONTENTS 
PAGE

EXECUTIVE  SUMMARY

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

FINDINGS

Complaints  Are an Important  Source for Quality-of-Care  Problems  . . . . . . . . . .  3

Beneficiaries  Often Unaware  of Their  Opportunities  to Complain  to PROS . . . . . .  5

Complaint Process Has Flaws  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...6

RECOMMENDATIONS  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

COMMENTS  ON THE DRAFT REPORT  . . . . . . . . . . . . . . . . . . . . . . ...11

APPENDICES

A:  Sources of Record Reviews  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..  A-l

B:  Summary  of the Fee-For-Service  Complaint  Timeframes  . . . . . . . . . . . . . . . . B-1

c:  Methodology  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. C-1

D:  Random Sample and Complaint Review for all PROS . . . . . . . . . . . . . . . . .  D-1

E:  Complete  Comments  onthe  Draft Report  . . . . . . . . . . . . . . . . . . . . . . . . .E-1

F:  Notes  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. F-l
 INTRODUCTION 
PURPOSE 
The purpose  of this study is to assess the Medicare  Peer Review Organizations 
beneficiary  complaint  process under the fourth contract period. 
BACKGROUND 
Peer Review  Organizations  and the Health Care Quality Improvement  Program 
In April  1993, the Medicare  Peer Review Organization  (PROS) began implementing  their 
fourth contracts  with the Health Care Financing  Administration  (HCFA).  These contracts 
marked  major  changes  in the PROS aims and operations.  Prior  to the fourth contracts, 
PROS had sought to ensure the necessity,  quality,  and appropriateness  of care rendered  to 
Medicare  beneficiaries  by identifying  and addressing  individual  clinical problems.  They 
did this through  reviewing  medical  records,  which at times represented  as much as 
15 percent  of Medicare  hospital discharges. 
Since  1993, PROS have airned to improve the overall practice  of medicine  by analyzing 
patterns  of care  and outcomes  and by sharing information  with the medical  community. 
The HCFA  refers  to this initiative  as the Health Care Quality Improvement  Program 
(HCQIP).  The HCQIP rests heavily on the precepts  of continuous  quality improvement, 
which hold that it is far more important  to improve the overall performance  levels even 
slightly than it is to identify and correct  poor performers  at the margin.  This emphasis 
reflects  the kind of redirection  called for by the Institute of Medicine  in its comprehensive 
assessment  of Medicare  quality assurance  efforts. 1 
Thus,  PROS operational  responsibilities  are much different  than in the past.  They have 
reviewed  far fewer medical  records.  For at least part of the fourth contract  period,  the 
PROS have conducted  record  reviews on a 5 percent  inpatient random  sample,  though by 
October  1995 that sample will be completely  eliminated.2  Appendix  A displays the 
sources of record  reviews  during the early  implementation  of the fourth contract.  The 
HCFA  still requires  the PROS to conduct record  reviews  in certain  instances  under  the 
fourth contract.  These instances include quality-related  beneficiary  complaints.3 
The Complaint  Process 
The Omnibus  Budget Reconciliation  Act of 1986 (Public Law 99-509) requires  PROS to 
review  all written,  quality-related  complaints  received  from Medicare  beneficiaries.4 
Once the PRO receives  a quality-related  beneficiary  complaint  in writing,  it must review 
the appropriate  medical  records.  The PRO manual requires  that each task in investigating 
the complaint  be completed  within certain  timeframes  (see appendix B for a complete 
review  of the timeframes  involved).  Once all reviews  and re-reviews  are completed,  the 
1  PRO invites the provider  and/or  physician  to comment  on the case.  It also seeks consent 
from the physician  to allow information  about the case to be disclosed  back to the 
beneficiary,  as required  in the confidentiality  regulations,5 
The Significance  of the Beneficiary  Complaint Process Under the Fourth Contract 
With less review  under the fourth contract,  the beneficiary  complaint process  has become 
especially  important  to PROS ability to identify questionable  care.  The process  represents 
a key safety valve for beneficiaries,  their families,  and advocates,  who can register 
complaints  against individual physicians  and hospitals.  The HCFA  recognizes  the 
heightened  significance  of the complaint process  and includes it in three  of the four 
elements  it uses to define beneficiary  protections .6 In its vision statement  describing  the 
successful  PRO in 5 years,  HCFA  suggests that  [PROS] will have earned  a position  of 
trust in the eyes of plans,  providers,  and practitioners  and beneficiaries  and that this 
public  trust will be  based on responsive  investigation  of complaints  and protection  of 
consumers.7  Thus,  it is important  that the complaint  process  functions  well. 
METHODOLOGY 
We relied  on three  primary  sources:  (1) surveys of officials from 22 PROS, (2) aggregate 
data from HCFA  reflecting  all PROS record  review workload,  and (3) a national  survey 
of Medicare  beneficiaries.  The 22 PROS represent  72 percent  of the beneficiary 
population  in the country.  We chose those  17 PROS in States with the largest  beneficiary 
populations  and 5 of those with the lowest beneficiary  populations.  (See appendix  C for a 
more detailed  discussion  of our methodology.) 
Our findings  are based on PROS experiences  under their fourth contract  with HCFA. 
Hereafter,  we use the term complaints  to refer to those quality-related  complaints  made to 
PROS by or on behalf  of beneficiaries  that prompted  the PROS to review  medical  records. 
We conducted  our review  in accordance  with the Quality Standards for  Inspections  issued 
by the Presidents  Council  on Integrity  and Efficiency. 
2
 FINDINGS

Complaints  to PROS can be an important  source for  identifying  quality-of-care 
problems. 
b	 Between  10 and 15 percent  of the complaints  to all 53 PROS led to contkmed 
quality-of-care  problems.  In contrast,  less than  1 percent  of the random  sample 
record  reviews  led to such problems.  Proportionally,  then,  complaints  have been a 
richer  source of quality-of-care  problems,  even though the majority  of such 
problems  have emerged  from the random  sample record  reviews. 
Data from our sample of 22 PROS confirm  the value of complaints  as a source of 
information  about quality of care.  Between 8 and 14 percent  of complaints  led those 
PROS to identify  and confirm  quality-of-care  problems.8  All but one PRO in our sample 
confirmed  least one quality-of-care  problem  through  a beneficiary  complaint.9 
The quality-of-care  problems  identified through  complaints  involved both physicians  and 
hospitals.  About two-thirds  of all the quality-of-care  problems  the 53 PROS identified 
involved physicians  and one-third,  hospitals.  In our sample of 22 PROS, we found about 
half the problems  involved physicians  and half,  hospitals. 
The importance  of complaints  as a source of confirmed  quality problems  is magnified 
when we consider just how few record  reviews are triggered  by complaints.  Just 
0.1 percent  of all PRO record  reviews were conducted  due to complaints  (see appendix 
D).  Yet the quality-of-care  problems  stemming from those reviews  accounted  for 
2 percent  of all problems  identified by the PROS under the fourth contract.  As the 
random  sample reviews  continue  to decrease,  however,  complaint  reviews  will constitute  a 
larger  share of the PROS remaining  review  work. 
	 Half the PROS in our sample identified health systems problems  through 
complaints.  These  systemic  issues included  such problems  as beneficiaries  being 
prematurely  discharged  from hospitals and lapses in their treatment  during  transfers 
among different  care settings. 
Identi@ing  systemic causes of quality-of-care  problems  is clearly  a focus of the PROS 
under their  fourth contract.  In our sample,  11 PROS (10 from the high-population  and 
1 from the low-population  stratum) reported  having identified  17 instances of health 
systems problems  through  their investigations  of complaints.  The systems problems 
included:  four systems related  to discharge  planning;  three to communications;  two to 
transfers;  and eight to issues such as patient restraints,  protocols  for pressure  ulcer 
prevention,  and lack of timely reporting  of test results,  among others. 10 
A health  systems problem  identified by one PRO,  for example,  concerned  the proper 
placement  of feeding tubes.  Based on a complaint,  this PRO learned  that a beneficiary 
suffered  complications  due,  at least in part,  to being fed through  a feeding tube inserted 
3  into a lung.  No protocol  existed to confh-m the tubes proper  placement  through  x-ray or 
other imaging.  The PRO alerted  facilities  in its area and its own reviewers  to the 
potentially  catastrophic  consequences  of improper  tube placement. 
F	 Sixteen of the 22 PROS (73 percent)  in our sample rated the complaint  process  as 
critical  to their ability to protect beneficiaries  from individual  instances  of poor 
care. 
Officials from one PRO with whom we spoke pointed out that the opportunity  to complain 
is an important  safeguard  to identifying problems  that will no longer be caught through  the 
random  sample review.  Officials from another PRO noted that identifying  even one 
quality-of-care  problem  through  a complaint can protect  many other beneficiaries  from 
facing the same problem.  Others pointed out that the experience  of complaining,  could, 
in fact, be cathartic  for beneficiaries. 
The HCFA  also recognizes  the importance  of the complaint  process,  as reflected  in an 
internal  memorandum  on beneficiary  protection: 
The purpose  of the beneficiary  protection  program  is to reduce  the likelihood  of 
harm,  from both systemic causes and from individual  incompetent  or impaired 
providers  and practitioners.  Additional protection  will be afforded  by addressing 
specific  instances  of poor care identified through beneficiary  complaints. 11 
The extent to which PROS have referred  complaints  to other parts of the medical 
community,  known as joint  referrals,  underscores  the importance  of their roles within 
those communities.  The PROS make referrals  when complaints  raise concerns  beyond  the 
PROS authority,  such as concerns  about the cleanliness  of a facility or the qualifications 
of its staff.  In our sample,  19 of the 22 PROS referred  some of the complaints  they 
investigated  to others  in the medical community.  Overall,  these PROS referred  at least 
17 percent  and possibly  as many as 29 percent  of all the complaints  they received.12  As 
shown in figure  1, PROS referred  the majority  of complaints  to fiscal intermediaries 
(33 percent),  followed by HCFA project  officers  (25 percent),  and survey and certification 
agencies  (13 percent). 13 
4
 Figure 1 
Complaints  Jointly  Referred by PROS Under the Fourth Contract 
HCFA Proj 
F1/Carrier(33%) 
HMO(2%) 
spital (i%) 
Survey & Certifkation Agency (13%) 
Note  N=560 complaints. These represent joint referrals for 19 of the 22 PROS in our sampie. 
Complaints may be jointly raked  to more than one entity. 
Sourcw  HHS Offiea of inspeetor Generai Survey of 22 PROS, January 1995 
In addition to making joint  referrals  to others,  the PROS in our sample reported 
occasionally  receiving  referrals  from members  of the medical  community.  Most often, 
these referrals  came from physicians,  but some also came from hospitals  and State 
medical  boards.  Not one PRO in our sample,  however,  had explicit policies  to encourage 
referrals  from either physicians,  hospitals,  or medical boards.  While these referrals  were 
few in number,  the PRO officials described  them as solid and often including  specific 
details. 14 
Medicare  beneficiaries  are often unaware of their oppo~nities  to complain  to PROS 
about the quality of their medical  care. 
F	 Seventy-seven  percent  of Medicare  beneficiaries  did not even know about the 
PROS, according  to a recent national  OIG survey. 
F	 Thirteen  of the 22 PROS (59 percent)  in our sample cited difficulties  in making 
beneficiaries  aware of the complaint process. 
In accord  with their contracts,  the PROS in our sample have conducted  outreach  activities 
aimed at increasing  beneficiaries  awareness  of their rights under Medicare  and of their 
opportunities  to complain  about quality to the PROS. They reported  undertaking  roughly 
the same range of outreach  activities  (see the box on the next page). 
5
 Twenty  of the 22 PROS judged  their 
outreach  activities  critical.  When asked 
which outreach  activities  lead to the most 
complaints,  PROS identified  local 
presentations  more often than any other 
activity. 15 Yet reaching  beneficiaries 
through  such presentations  has presented 
some difficulties.  In many large States, 
the beneficiaries  are dispersed  and thus 
difficult  to reach. 16 Many beneficiaries 
are unable  to attend local presentations  due 
to frailty,  weather  conditions, 
inconvenience,  or lack of knowledge  about 
the presentations. 
Successfully  reaching  beneficiaries  not 
involved  in local senior centers presents 
challenges  to the PROS.  Although many 
PROS rely in part on direct mailings to 
beneficiaries,  some questioned  their value, 
because  beneficiaries  are often inundated 
with reading  materials.  And while 
indications  from HCFA  suggest that PRO 
outreach  activities  have become  an 
increasingly  important  part of the work 
that PROS do,  resources  for those 
activities  remain  limited. 
As it works now,  the complaint process  has ,some jlaws  that undermine  its effectiveness. 
	 Lack of Substantive Responses.  The Federal  confidentiality  regulations  preclude 
PROS from sharing the results of their investigations  with the beneficiaries  without 
physicians  consent.  Thirteen  of the 22 PROS (59 percent)  in our sample judged 
these regulations  to be a major barrier  to a more effective  complaint  process. 
The confidentiality  regulations  hinder the PROS ability to be responsive  to beneficiaries 
who complain.  These regulations  require  the PROS to gain the consent of physicians 
before  disclosing  information  to the beneficiary.  Without that consent,  PROS cannot 
reveal  the results  of the record  reviews  and must therefore  respond  in generalities.  The 
box on the next page presents  one PROs response to a beneficiary  complaint  in which the 
PRO did in fact confirm  a physician problem,  but the physician  failed to consent to 
disclosure.  These restrictions  frustrate  the PROS, and,  in the words of one PRO official, 
leave beneficiaries  feeling cheated.  
6
 When the physician  does consent to 
disclosure,  theinformation  released by the 
PRO is still limited  in some important 
ways.  The response  would likely exclude 
any PRO actions directed  to the physician, 
such as education  or referral  to the 
hospital  quality assurance  committee.  The 
box below presents  part of such a 
response. 
According  to the complaint  data for the 
22 PROS in our sample,  physicians 
consented  to disclose  information  to the 
beneficiary  45 percent  of the time.17 
However,  when the complaint  involved a 
contlrmed  physician  quality-of-care 
problem,  physicians  consented  13 percent 
of the time.  Some PROS appear more 
successful than others  in gaining physician 
consent for disclosure.  For example,  one 
PRO in our sample gained physicians 
consent  for 90 percent  of all complaints 
for which  it requested  consent and for 
50 percent  of the complaints  involving 
confirmed  physician  problems.  Thirteen 
of the 22 PROS in our sample reported 
that they had yet to gain consent for any 
complaint  involving  a confirmed  physician 
quality-of-care  problem. 18 
	 Few Complaints.  The PROS received  too few complaints  to identify patterns  of 
poor care by individual physicians  and hospitals.  In fact,  9 of the PROS 
(41 percent) judged  lack of beneficiary  complaints  to be a major barrier  to their 
ability to identify quality-of-care  concerns. 
During  our telephone  interviews,  PRO officials often noted that while they judge  the 
complaint  process  as critical  to their ability to protect beneficiaries,  they lack the volume 
of complaints  to identify patterns  emerging  from them.  Under the HCQIP,  identifying 
patterns  is an important  prerequisite  to taking any action directed  toward  a physician  or a 
hospital  based on quality-of-care  problems.  With PROS receiving  so few complaints,  the 
likelihood  of identifying  such patterns  is small.  The PROS in our sample received 
between  8 and  164 complaints  per million beneficiaries.  Even when we accounted  for the 
length of time these PROS have operated  under the fourth contract,  the number  of 
complaints  remained  low. 19 
7
 Overall,  complaints  have accounted  forabout  O.lpercent  oftie  PROs'  review  caseload. 
The bulk of their review  caseload comes from the 5 percent  random  sample (about 
72 percent) .20 And the low volume of complaints  coupled with the reduction  in record 
review  overall  weakens the PROS ability to identify quality-of-care  problems,  and thus 
patterns. 
We noted previously  that beneficiaries  are often unaware  of the PROS and that PROS 
acknowledge  difficulties  in reaching  beneficiaries.  The low volume of complaints  may 
also be related  to other factors  as well.  For example,  half the PRO officials with whom 
we spoke identified beneficiaries  reluctance  to file a complaint  as a major barrier  and 
nearly half as a minor barrier.  These officials noted that beneficiaries  fear reprisals  from 
the medical  community  on which they rely and also respect.  This reluctance  can be 
exacerbated  in rural  areas where beneficiaries  have fewer choices of where to receive  their 
care.  Another  factor that may account for the low volume of complaints  is that 
beneficiaries  can complain  to others,  such as State medical  licensure  boards,  ombudsmen, 
hospitals,  or their  own physicians,  rather than the PROS.  But how often they complain  to 
these other entities  is unknown.  Nothing in the PRO manual,  however,  directs  the PROS 
to encourage  beneficiaries  to lodge their complaints  with all the possible entities. 
	 Lengthy Process.  Beneficiaries  can wait a long time for the results of the PROS 
complaint  investigation.  Fifteen of the PROS (68 percent) judged  the length of the 
process  to be a major barrier  to a more effective beneficiary  complaint  process. 
The complaint  process  involves multiple  steps, ending with the PROS final responses  to 
the beneficiaries  who complained.  Each step has a specific timeframe  for completion,  and 
these make  it difficult  for PROS to respond quickly  (see appendix B for the complaint 
timeframes).  If a complaint  involves no confirmed  quality-of-care  problem,  the process 
should last a maximum  of 110 days.  However,  when the PRO identifies  a quality-of-care 
problem,  the process  can take up to 220 days--25O if a re-review  is requested.  In one 
complaint  we reviewed,  which involved both a confirmed  quality-of-care  problem  and a 
re-review,  the beneficiary  received  the PROs final response 266 days after the PRO 
received  the complaint. 
The PRO officials  who cited length of the process  as a major barrier  reported  being 
constrained  by it.  They identified with the beneficiaries  frustrations  and suggested  that 
the length could discourage  beneficiaries  from complaining  to the PRO. 
Many PRO officials with whom we spoke are trying,  where possible,  to streamline  the 
process,  or at least to better prepare  beneficiaries  for the long wait.  For example,  one 
PRO routinely  combines  its request  for consent to disclosure  with the physicians 
opportunity  to request  a re-review,  thereby  shaving as many as 60 days.  Another  PRO 
employs  a case management  approach,  so that beneficiaries  have a single contact person 
throughout  the process.  Other PROS inform the beneficiaries  about the timeframes  when 
they complain.  Some correspond  routinely  with beneficiaries  throughout  the process. 
8
 RECOMMENDATIONS 
The complaint  process  needs to be working  well in order  for HCFA  to achieve  its stated 
mission of serving  beneficiaries  effectively. 21 Below we offer our recommendation  in 
three parts,  one part to address each flaw we identified.  It also addresses  the lack of 
awareness  about the PROS complaint process that we found among beneficiaries.  If 
implemented,  our recommendation  would result in a complaint  process  that is more 
effective  and more accountable  to beneficiaries.  Further,  it would contribute  to HCFAs 
mission  and to goals from the strategic plan that call for HCFA  to act on [program] 
weaknesses  to assure they respond to beneficiaries  needs. 22 
The HCFA should work with PROS to identijj  cost-effective  ways to correct the flaws  in 
the complaint process.  Toward that end, HCFA should: 
F	 Require PROS to respond substantively  to the complainant.  The HCFA should 
give  this the highest priority. 
A substantive  response  would require  a PRO to describe:  (1) what it did to investigate  the 
complaint,  (2) what the investigation  revealed,  including whether  a quality-of-care 
problem  was confirmed  and,  if so, the nature of the problem,  and,  (3) if a quality-of-care 
problem  was confirmed,  what action the PRO took based on it. 
Many physicians  and hospitals  are likely to have concerns  about providing  such feedback 
to those who have complained  to the PROS.  But at a time of increasing  consumer 
involvement  in patient-care  decisions,  beneficiaries  (and their families)  are unlikely  to 
have confidence  in a process  that fails to afford them substantive  feedback  on how the 
PROS responded  to their complaints. 
To facilitate  substantive  responses,  HCFA could amend the PRO regulations  to eliminate 
the requirement  that physicians  consent to disclosure  before providing  feedback  to 
complainants.  It has been considering  such a revision  for some time.  Another,  more 
expeditious  approach  would be for HCFA to issue contract  modifications  or manual 
instructions  calling  for substantive  responses to complainants.  This approach  would 
require  an interpretation  that a regulatory  amendment  is unnecessary  because  of HCFAS 
existing  statutory  authority  that allows disclosure  to the extent that may be necessary  to 
carry  out the purposes  of the PRO program. 
F	 Identi!  cost-effective  ways to enhance Medicare  beneficiaries  awareness  of 
PROS and the complaint process. 
The  HCFA  should  allow  PROS  more  flexibility  in conducting  their  outreach  activities. 
Such  flexibility  could  allow  PROS  to survey  local  beneficiaries,  target  outreach  to family 
members  of beneficiaries  as well  as pre-retirement  groups,  and  even  cultivate  new 
outreach  strategies  in the  medical  community.  Any  efforts  in this  realm  could  tie  in 
closely  with  HCFAs  consumer  information  strategy. 
9  The HCFA  should also identify benchmark  practices  or promising  approaches  to

informing  beneficiaries  of the complaint process.  The recent  work of HCFAS Beneficiary

Communications  Steering  Committee,  the Communications  Network  sponsored  by the

American  Medical  Peer Review Association,  and the Citizen Advocacy  Center  could all

contribute  to this effort.

  Streamline  the complaint process. 
The HCFA  should search for ways in which the process of investigating  and responding  to 
complaints  could be expedited.  It could benefit by examining  ways in which other bodies 
conduct  reviews  for complaints  about medical care.  It could also identify and share 
promising  approaches  taken by individual PROS to streamline  the complaint  process.  A 
benchmarking  effort  of this kind would be in concert  with the PROS overall  emphasis  on 
continuous  quality  improvement. 
10
 COMMENTS  ON  THE  DRAFT  REPORT 
We solicited  and received  comments  on the draft report  from the Health  Care Financing 
Administration  (HCFA),  the American  Medical Peer Review Association  (AMPRA),  the 
American  Medical  Association  (AMA), the American  Association  of Retired  Persons 
(AARP),  and the Coalition  for Consumer  Protection  and Quality in Health  Care Reform 
(hereafter  referred  to as the Coalition).  We include the complete  text of the detailed 
comments  in appendix  E.  We also received  a comment  of concurrence  from the Assistant 
Secretary  for Planning  and Evaluation.  Below, we summarize  the major  comments  of the 
respondents  on our three recommendations  and then,  in italics,  offer our responses.  In the 
report,  we made a number  of minor technical  corrections  in response  to respondent 
comments. 
RECOMMENDATIONS  FROM THE DRAFT REPORT 
The HCI?A should work with the PROS to identify  cost-effective  ways to correct the jlaws 
in the complaint process.  Toward that end, HCFA should: 
F	 Require  the PROS to respond substantively  to the complainant.  This is the 
standard to which the Joint  Commission  on the Accreditation  of Health  Care 
O~ani@ons  holds hospitals accountable.  The HCFA should give this the 
highest priori~. 
The HCFA  took this recommendation  under  advisement,  expressing  concerns  about 
balancing  such responses  with the due process rights of providers.  The AMPRA  and the 
AMA expressed  general  support for substantive responses but also stressed the need to 
balance  this with the due process rights of providers.  The AMA specified  in detail the 
due process  elements  that it favors and expressed  a preference  for a regulatory  approach 
to any changes  in the physician  disclosure  process.  The AMPRA questioned  the accuracy 
of our reference  to a standard  from the Joint Commission  on the Accreditation  of Health 
Care  Organizations.  The AARP and the Coalition both expressed  strong support for our 
recommendation.  The AARP favored  implementing  the recommendation  through  contract 
modifications  rather  than through  regulation.  The Coalition  expressed  frustration  with the 
lack of meaningful  responses  and questioned the PROS ability to represent  Medicare 
beneficiaries  without a much improved complaint process. 
With respect to concerns raised by HCFA, AA4PRA, and the AMA,  we understand  the 
difficulty  of achieving  a workable  balance between the principles  of the Health  Care 
Quali~  Improvement  Program and the basics of an e~ective  complaint process.  However, 
we maintain  our commitment  to the point  made in our report:  that without a substantive 
response to beneficiaries,  it is not likely that HCFA can develop a complaint process  that 
is credible  to beneficiaries. 
We appreciate  AMPRA pointing  out the out-of-date  standard from  the Joint  Commission, 
and we dropped  the reference j70m the recommendation.  The Commissions  1996 manual 
11  calls for  the resolution  of complaints and recognizes the rights of patients  to include 
unrestricted access to communication.   
F	 Identifl  cost-effective  ways to enhance Medicare  beneficiaries  awareness  of 
PROS and the complaint process. 
The HCFA  and the other respondents  all agreed with this recommendation. 
While we welcome  the widespread  support for  this recommendation,  we stress that 
increased  beneficiary  outreach sends a mixed message if it is not accompanied  by refom 
that lead to more substantive  responses to complaints.  Increased  outreach  is likely to 
raise beneficiaries  expectations  regarding  complaint  resolution.  Those expectations  could 
be largely  unmet without addressing  ourjirst  recommendation. 
F  Streamline  the complaint process. 
The HCFA  expressed  concern  that streamlining  the complaint  process  might result  in a 
less complete  or conscientious  review.  It suggested that beneficiaries  be made aware  of 
the timeframes  involved rather  than streamlining  the process.  All the other respondents 
agreed  opportunities  exist to streamline  the process.  The AMPRA and the AMA 
suggested  some steps of the review process can be performed  concurrently,  thereby 
streamlining  the process. 
We recognize  opportunities  to streamline  may be limited but maintain  that such 
opportunities  do exist.  Thus, we suggest that HCFA reconsider this recommendation.  We 
believe  that some streamlining  of the complaint process  is essential  to achieving  a more 
efiective process. 
12
 APPENDIX  A 
SOURCESOFRECORDREVIEWSDURINGTHEEARLY IMPLEMENTATION 
OF THE FOURTHCONTRACT 
(FORREVIEWSCOMPLETEDTHROUGHJUNE 30,  1994) 
Number 
Source of Record Being Reviewed  (Percent) of 
Inpatient Record 
Reviews 
Random Sample Record Reviews  381,875  (72.3%) 
Mandatory Reviews,  including 
;omplaints  44,575  (8.4%) 
Vliscellaneous Reviews~  101,681 (19.2%) 
rOTAL  528,541  (100%) 
~OIXS:
N=53  PROS. 
PRO mandated reviews include beneficiary complaints and records flagged for the following 
tasons:  assistmrt at cataract surgery, Medicare code editor, hospital adjustment, referral from tfre 
iserd intermediary or regional office, and hospital-issued notices of noncoverage. 
Includes records selected for the following reasons:  specialty hospital, DRG 468, day and cost 
mtliers, unifnrm clinical data set and cooperative cardiovascular project, focussed review selection, 
ntcrvening we,  fiscal intermediary prepayment rejcet,  intensified review, ventilator-dependent 
mit, deemed admission, and nther. 
Frequency missing =410. 
IOURCE:  HCFA PROD3 database. 
!NALYSIS:  HHS Ofticc of Inspector General. 
A-1
 APPENDIX  B 
SWmY  OF THE FEE-FOR-SERVICECOMPLAINTRmmw  Tmmmmms 
Number  of  Cumulative 
Days  Days 
Acknowledge  complaint  15  15 
30* 
Receive  medical  records  45 
Complete  Review  30  75 
If no quality concern: 
Seek physician  consent and  30  105 
provider/physician  comments;  and 
provide  notice required  by 476.132(a)(2) 
Respond  to complainant  5  110 
If potential  quality concern: 
Provide  opportunity  for discussion  30  105 
Confirm/resolve  quality concern  20  125 
Provide  opportunity  for re-review  60  185 
If re-review  not requested: 
Seek physician  consent and  30  215 
provider/physician  comments;  and 
provide  notice required  by 476.132(a)(2) 
Respond to complainant  5  220 
If re-review  requested: 
Resolve/confirm  quality concern  30  215 
Seek physician  consent and  30  245 
provider/physician  comments;  and 
provide  notice required  by 476.132(a)(2) 
Respond  to complainant  5  250 
x 
If documentation is incomplete or illegible, allow an additional 15 days for submission of requested information. 
Source  HCFA, Peer Review Organization Manual, p, 537, 
B-1
 APPENDIX  C 
METHODOLOGY 
We collected  the data presented  in this report primarily  through  telephone  interviews  and 
mail surveys  of 22 PROS.  We chose these PROS through  a stratified  sample in which we 
arrayed  PROS according  to the number  of Medicare  beneficiaries  in each State (high and 
low beneficiary  population).  We chose all 17 of the PROS for States in the high-
population  stratuml  and a random  sample of 5 PROS for States in the low-population 
stratum.z  The PROS in our sample represent  72 percent  of the Medicare  beneficiary 
population  in the country.  The response rate for both the telephone  interviews  and the 
mail survey  was  100 percent. 
We sent out a mail survey in which we asked PROS for specific data under the fourth 
contract.  The data included how many complaints  triggered  a record  review,  how often 
physicians  consented  to disclosure  for both confirmed  and non-confirmed  problems,  cases 
that were referred  elsewhere,  and sources for confirmed  quality-of-care  problems. 
We supplemented  the mail survey with more in-depth telephone  interviews.  For the 
interviews,  we designed  and pretested  a discussion guide with questions  about identifying 
quality-of-care  problems,  the complaint  process,  outreach  activities,  barriers  to identifying 
individual  quality-of-care  problems,  and barriers  to establishing  a more effective 
beneficiary  complaint  process,  among others. 
We also drew on data from HCFAS PROD3 data base (which includes the results  of all 
inpatient  record  reviews)  and PROD5 data base (which includes the results  of all physician 
reviews).  Through  these we obtained data on the number  and sources of confhrned 
physician  and hospital  quality-of-care  problems  for all PROS for reviews  completed  under 
the fourth contract  through  June 30,  1994.3  Our tests of the data revealed  that  10 PROS 
reported  no beneficiary  complaints  when,  in fact, they had received  such complaints. 
1 These  included the following  States (listed in descending  order  of beneficiary 
population):  California,  New York,  Florida,  Pennsylvania,  Texas,  Ohio, Illinois, 
Michigan,  New Jersey,  North Carolina,  Massachusetts,  Missouri,  Indiana,  Georgia, 
Virginia,  Wisconsin,  and Tennessee. 
2 These  included the following  States (listed in descending  order  of beneficiary 
population):  New Mexico,  Utah,  Montana,  South Dakota,  and Delaware. 
3 In analyzing  our data on complaints  and confirmed  quality-of-care  problems,  we 
report  the most conservative  interpretations.  We chose this approach  to avoid double 
counting  complaints  that resulted  in confirmed  problems  with both a physician  and a 
hospital. 
c-1  Nevertheless,  when these data are viewed in the context of our telephone  interviews  and 
survey data,  we believe the findings and recommendations  in this report  are valid. 
We also relied  on data from a beneficiary  survey conducted by the Office of Inspector 
General  (OIG) in the summer of 1994.  The question relevant  to our study sought to 
determine  the level of beneficiaries  awareness  of PROS.  The OIG mailed  this survey to a 
randomly  selected national  sample of 1,299 Medicare  beneficiaries,  of which 20 were 
either  nondeliverable  or mailed to beneficiaries  who had died.  A total of 
1,002 beneficiaries  returned  completed  surveys,  a response rate of 78 percent.  The 
survey results presented  in this report  have a margin  of error  of 3.5 percent  at the 
95 percent  confidence  level. 
To strengthen  our  understanding  of the  complaint  process,  we reviewed  the  PRO  manual 
and  statutory  and  regulatory  requirements  concerning  the  complaint  authority, 
confidentiality,  and  disclosure. 
c-2  APPENDIX  D 
RANDOM SAMPLEm  COMPLAINTREVIEW FOR ALL PROS 
UNDERm-m Fomm  Comwx 
FOR INPATIENTIWcow  Rmmws  COMPLETEDTHROUGHJum  30,  1994 
Number  of Records  Percentage  of 
with a Confirmed  Records  with a 
Source of Records  Number  of Record  Quality Problem  Confirmed 
Reviews  Involving  a  Problem 
Being Reviewed  Physician  and/or  Concern 
Hospital 
Random  Sample

Record  Review  381,875  (72.3%)
 4,255  (70.9%)  0.7%  to 1.1% 
Beneficiary

Complaints  737  (o. 1%)
 108  (1.8%)  9.8%  to 14.7% 
NOTE:  N =53 PROS.  The number of beneficiary complaints represented here should be considered conservative because of reporthrg flaws. 
Ten PROS reported no beneficiary complaints when in fact they received such eomplairrts under the fourth contract. 
SOIJHCE  HCFA PROD3 and PROD5 data bases. 
ANALYSIS:  HHS Office of Inspector General. 
D-1
 APPENDIX  E

In this appendix,  we present  in full the comments  from the Health  Care Financing 
Administration,  the berican  Medical Peer Review Association,  the American  Medical 
Association,  the American  Association  for Retired  Persons,  andthe  Coalition  for 
Consumer  Protection  and Quality in Health  Care Reform.  Inaddition  to receiving 
comments  from the groups listed,  we also received  a comment  of concurrence  from the 
Assistant  Secretary  for Planning  and Evaluation. 
E-1
  
. ,,.
l,,  , 
:, +* Jg
. DEP.\RT.MENT OF HEALTH  & HU,IIANSERVICES  Health  Care  Financing  Admlnlstratlc 
. 
-, 
.,
*[>w ,,.
The  Administrator 
Washington,  D.C.  20201 
SEP  11995 
DATE: 
TO:	 June  Gibbs  Brown 
+ 
Inspector  General 
&u!!! 
FROM:  Bruce  C. Vladec  &L 
Administrator 
% 
SUBJECT:	 Office  of Inspector  General  Draft  Report:  Beneficiary  Complaint  Process 
of the  Medicare  Peer  Review  Organizations  (PROS)  (OEI-O 1-93-00250) 
We reviewed  the  above-referenced  report  which  assesses  the  beneficiary  compkint 
process  of Medicare  PROS.  Attached  are our comments  on the report  findings. 
Thank  you  for the  opportunity  to review  and comment  on this report. 
-Attachment  Comments  of the Health  Care  Financing  Administration  (HCFA\

on OffIce  of Insuector  General  (OIG)  Draft  Reuort:

Beneficiary  Comnlaint  Process  of the Medicare  Peer Review  Orm.nizations  (PROS)

(OEI-01-93-00250)

OIG Recommendation  1 
HCFA  should  work  with  PROS to identi&  cost-effective  ways  to correct  the flaws  in the 
complaint  process.  Toward  that  en~  HCFA  should:  require  PROS to respond 
substantively  to the  complainant.  This  is the  standard  to which  the Joint  Commission  on 
the Accreditation  of Health  Care  Organizations  holds  hospitals  accountable.  HCFA 
should  give  this the  highest  priority. 
HCFA  Response 
HCFA  will  take  this  recommendation  under  advisement  and  tier  analyze  its  options. 
Physician  consent  is  a complex  and  sensitive  issue,  entailing  the balancing  of physician 
due process  and privacy  interests  with  the need  for meaningful  feedback  to beneficiaries.. 
We  are also  sensitive  to the  issue  of fll  disclosure  to the  beneficiaries  as it may  impede 
the  cooperative  exchange  of information  between  physician  and PRO  which  enhances  the 
peer  review  process.  A provider  and/or  practitioner  might  be far willing  to less  volunteer 
of information  which  might  directly  or indirectly  place  them  in jeopardy  of civil 
malpractice  actions. 
OIG Recommendation  2 
HCFA  should  identify  coj.t-effective  ways  to enhance  Medicare  beneficiaries  awareness 
of PROS and  the complaint  process. 
HCFA  Resuonse 
HCFA  concurs.  Our  OffIce  of Beneficiary  Services  and Health  Standards  and  Quality 
Bureau  will  work  together  on beneficiary  outreach  activities  which  will  enhance 
beneficiary  awareness  of the complaint  process.  The  beneficiary  complaint  process  is an 
important  and complex  issue,  affecting  beneficiaries,  providers,  physicians,  and  managed 
care  plans.  We intend  to meet  with  representatives  of beneficiary,  provider,  physiciw 
and managed  care  organizations  in developing  a regulation  that  will improve  this  process.  Page 2

In addition  to regulatory  changes,  it wilI be necessary  for our outreach  program  to help

beneficiaries  understand  that  an effective  peer  review  process  may  limit  fid.1disclosure.

We will  consider  the  complainants  right  to have  information  about  hirnseWherseK  and

the plans,  providers,  and practitioners  rights  to accurate  informatio~  while  maintaining

personal  privacy,  to ensure  a balanced  approach.

Recommendation  3

HCFA  should  streamline  the complaint  process.

HCFA  Resnonse

We are concerned  that  attempts  to expedite  the process  may  actually  result  in less than

complete  or conscientious  review.  The timefiarnes  were  established  to allow  adequate

time for all parties  to consider  and  take  appropriate  action  including,  where  necess~,

dialogue.  We,  therefore,  are concerned  about  shortening  the process,  particularly  in the

way cited  in the report.

Rather  than  shortening  the process,  we would  suggest  making  the beneficial  aware  of

the timeframes  and  the necessity  of the length  of the process  as part  of an improved

information  process.

In revising  the PRO  process,  HCFA  and the  OIG could  examine  the  End Stage  Renal

Disease  Network  Grievance/Complaint  policy  which  apparently  works  well.

Additional  Comments

We are concerned  about  another  aspect  of the complaint  process  which  has not  been

addressed  in the  OIG  report.  We  are  concerned  that  current  policy  may  not eliminate

barriers  for minority  and  disabled  beneficiaries.  There  should  be studies  to determine

whether  complaints  filed  with  PROS are submitted  at at least  the same  rate from  minority

and disabled  beneficiaries  as from  the  general  Medicare  population.  The HCFA  strategic

plan requires  us to focus  attention  on eliminating  barriers  to special  needs  populations.

Revised:ES  :PLB :PSirnons  for Meta  Thomas

Typist: CCook:x65225

Disk: WPThomas2:complain.  wpd
 Nil??A 
AMERICAN  MEDICAL  PEER  REVIEW  ASSOCIATION 
1140 Connecticut Avenue, NW   Suite 1050   Washington, D.C. 20036.  202/331-5790 .  FAX: (202) 833-2047 
September  8,  1995

June  Gibbs Brown

Inspector  General

Department  of Health  & Human  Services

Office  of Inspector  General

330 Independence  Avenue,  S.W.

Washington,  D.C.  20201

Dar  Ms.  Brown: 
On  behalf  of  the  American  Medical  Peer  Review  Organization  (AMPRA)  -- the  trade 
association  representing  the nations  network  of peer review  organizations  -- I appreciate  the 
opportunity  to review  the draft  inspection  report,  The Beneficiary  Complaint  Process  of the 
Medicare  Peer  Review  Organizations.. 
While AMPRA  generally  agrees with the philosophy  of the report,  we offer specific  comments 
and suggestions  on the matters  described  below 
Require  PROS to respond  substantively  to the complainant.  This is the standard  to which  the 
Joint  Commission  on  the  Accreditation  of  Healthcare  Organizations  holds  hospitals 
accountable.  2%e HCFA  should  give  this the highest priori~. 
Responding  substantively  to a complaint  has always  been  a delicate  and complex  issue 
for the PRO community  and indeed  all who engage  in medical  peer review.  While we 
ail sympathize  with the beneficiary  who wants to be fully  informed  about the results  of 
the  investigation  of  his  complaint,  such  disclosure  has  serious  ramifications  for  the 
conduct  of peer  review.  Any  new  approach  needs  to be considered  thoughtfully  and 
carefully  before  a decision  is made.  Therefore.  we recommend  that  changes  be made 
thorough  the reguia~ory process. 
First,  AMPRA  supports  the  need  to  provide  beneficiaries  and  their  families  with 
substantive  feedback  while  maintaining  the  due process  provisions  currently  in place 
for handling  quality  concerns,  i.e., an appeals  process.  In addition,  the response  from 
the physician  on the PRO findings  could  be forwarded  to the beneficiary  concurrently 
with the PROs report.  Finally,  if fill  disclosure  is implemented,  AMPR4  recommends 
expansion  of existing  immunity  protection  for PROS from  civil  suits. 
While  full  disclosure  is advocated  for the  beneficiary,  such  a decision  could  harm  the 
provider  relationships  which  PROS have  formed  as  part  of  the  Health  Care  Quality 
Improvement  Program  (HCQIP).  A concerted  effort would have to be made to increase 
the  awareness  and  support  of  the  providers,  physicians,  and  plans  in  regard  to  this   
matter.  AMPRA  would  welcome  the  opportunity  to participate  in any  discussions  to 
seek  an  improved  process. 
Finally,  to our knowledge,  the Joint  Commission  does ~  have a standard  which  holds 
hospitals  accountable  to respond substantively  to complaints  about quality of care issues 
in the manner  which  this report  recommends. 
Identlfi  cost-e~ective  ways to enhance  beneficiaries  awareness  of PROS and  the  complaint 
process. 
As  has  been  pointed  out  in  previous  studies  conducted  by  the  Office  of  the  Inspector 
General  (OIG),  there  exists  a lot of room  for improvement  in the  ways  beneficiaries  are 
made  aware  of their  rights.  HCFA  is currently  working  with  the  PROS  on  this  topic, 
and  PRCS  would  welcome  additional  opportunities  for  iiexibiiity  in  their  outreach 
activities.  AMPIL4  would  be pleased  to be to be part  of such  efforts. 
Streamline  the complaint  process. 
AMPRA  agrees  that  there  are  many  efficiencies  and  economies  which  can  be built  into 
the  complaint  process  to afford  a speedy  response  to the  beneficiary.  Potential  change 
could  simply  be  the  by-product  of  a  revised  disclosure  policy.  For  example,  if 
physicians  were  made  aware  of  the  fill  disclosure  requirement  in  the  initial 
correspondence  to them,  the  response  time  fiarnes  to  the  beneficiary  could  effectively 
be shortened  by  30 days. 
AMPRA  would  also  like  to  point  out  that,  while  the  random  sample  review  has  been 
eliminated,  the improvement  efforts  initiated  through  HCQIP  projects  have  the potential 
for  greater  impact  by  improving  care  and  protecting  beneficiaries  on  a  broader  scale 
than  does  review  of an  individual  case. 
AMPRA  recommends  that  the  Health  Care  Financing  Administration  (HCFA)  form  an 
improvement  team  to  address  the  aforementioned  issues  and  increase  the  effectiveness  of the 
beneficiary  complaint  process.  The  improvement  team  -- at  a minimum  -- should  consist  of 
the  follow@  iC~itXtxlt~tiVt3S:  .LUWW;  FRO  leadership  and  applicable  personnel; 
malpractice/legal  expert;  members  of  applicable  trade  associations  (i.e.,  AMA,  AHA.  AARP, 
JCAHO.  GHAA/AMCR.A,  etc.).  HCFA,  and  OIG. 
Again.  we  thank  you  for allowing  us  the  opportunity  to comment.  Please  feel  free  to contact 
me  at 202/331-5790  should  you  have  any  questions. 
Sincerely, 
A4?iliif? 
Executive  Vice  President  AmericanMedicalAssociation 
Physicians  dedicated  to the health  ot Mer]ca 
JamesS.Todd..M
 D  515NorthStateStreet  312464-5000 
ExecutivVe icePresident  ChicagoI,llinois60610  312464-418F4ax 
September  11,  1995 
June Gibbs Brown

Inspector General

Department of Health and Human Services

330 Independence Avenue,  S.W.,  Rrn. 5250

Washington,  D.C.  20201

I 
Dear Ms. Brown:

The American  Medical  Association  (AMA) greatly appreciates the opportunity  to respond to the 
recommendations  contained  in  the Office of Inspector  General  (OIG) reporr. The Benefrciarv 
Comcdaim Process  of the Medicare Peer Review Organizations.  We believe that it is essential for 
patlen[s to have an opportunity  to express  their concerns about the quality of care they receive 
from any provider  of health care services,  and that when problems  of quality are identified they 
are addressed  and corrected.  However,  just  as the rights of patients must be observed  and 
protected,  so must we protect the rights of physicians and other providers  of medical care. 
The resolution  of concerns  raised by patients should be done in a fair and equitable reamer  that 
protects the rights  of privacy and confidentiality  of those being investigated.  While the ALMA 
agrees that, if possible,  the complaim  process should be streamlined,  it must not be at [he expense 
of denying full due process to the provider  whose services are being examined.  Only after 
affording the physician  his or her full due process rights should the patient be provided  a 
substantive response  to his or her complaint. 
The PRO Fourth  Scope of Work correctly  and appropriately  attempts to improve the overalI 
practice of medicine  by analyzing patterns  of care and outcomes and by sharing information  with 
the medical community  while moving  away from the prior punitive approach.  We are pleased 
that the new Fifth Scope of Work,  which will provide the future direction  for the PRO program, 
continues to emphasize  cooperation  and education for those providing  medical care.  It would be a 
serious mistake  for the PRO program  [o revert to a more punitive approach (as suggested  by the 
OIG) in an attempt  to change behavior  by setting aside the rights of the individual  physician 
through eliminating  the physicians  consent to disclosure. 
The A!hl.Ahas no objections  [o a PRO describing  what it did to investigate a complaint,  what the 
investlgacion revealed  (including whether a quality-of-care problem  was confirmed),  and what 
action [he PRO  took based on the complaint,  but  not until the provider  of services has been 
afforded a full opportunity  for due  process.  We believe, however,  that any change in current 
physician disclosure  regulations  must  be accomplished through the usual no[ice and comment 
process rather than by way of contract  changes or manual instruction  changes.  Moreover,  as it 
considers changes,  HHS must take great care not to undercut the educational,  non-puni[ive 
approach of the current  PRO program.  as well as the improving cooperative  relationship  between 
PROS and the medical  community.  Page 2- June Gibbs Brown 
The AMA believes that prior to notifying  the patient of the ou[come of a PRO investigation  following 
a complaint about quality,  the physicians  due process  rights should be exhausted.  EIements of that 
process should  include: 
a written statement  of the charges/complaint  against him or her; 
adequate notice of the right to a hearing,  his or her rights in the hearing,  and a reasonable 
opportunity  to prepare for the hearing; 
detailed  disclosure  of the evidence and witnesses against him or her sufficiently  in advance of 
the hearing  to enable preparation  of the defense; 
a fair, objective,  and independent  hearing,, with the right to ask questions  of the panei 
members  and of any hearing officer designed to reveal bias or prejudice,  and the right to 
challenge the impartiality  of any member or hearing officer; 
the right to be represented by an attorney or other person of the physicians  choice; 
the opportunity  to be.present at the hearing and to hear all of the evidence against him or her; 
the opportunity  to present a defense to the charges,  including,  but not limited to, the right to 
call, examine and cross-examine  witnesses; 
a presumption  of imocence  and an assurance that the hearing  body shall not render a decision 
against the physician  unless the evidence produced  at the hearing  clearly supports  that adverse 
determination: 
a hearing within a reasonable proximity  of the location of the physicians  practice;  and 
a hearing which protects the imeres[s of the physicians  patients,  and the public in quaiity 
pauem care. 
The ALMA isalso concerned  about the possibility  of well-meaning  but erroneous  referrals to [he PRO 
& & L~~~~l&lin\.$JYISXYJ &-L
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constitute  poor quality  care, there is a significant  possibility  that a patients  genuine concerns may 
lead to a referral  to the PRO for care which does not reflect a quality problem  at all, and which in 
fact is entireiy  appropriate.  Adhering to proper due process provisions  assures that no information  is 
communicated  to the patient until the physician  has had the opportunity  for a full and open hearing on 
the nature of the complaint. 
We believe [hat HCFA  should be as interested  in protecting  [he due process  rights of individual 
physicians  as they are in providing  substantive  follow-up  to individual  patients.  The AMA would 
welcome the opportunity  to work with HCFA  and the patient community  in reviewing and 
commenting  i:. advance on the proposed  contents of any letter sent to the patient by the PRO about 
the quality of a physicians  services.  It is important that all communications  with the patient 
regarding  the complaint  be handled in a nonbiased and nonprejudicial  reamer  to protect the rights of 
the physician while the case is being investigated.  Page 3 - June  Gibbs  Brown 
We  concur with the OIG that a lack of a timely  response to a patients complaint may serve as a 
deterrent  to a patients  willingness  to refer complaints  to the PRO program.  We believe that it may 
be possible  to find more  efficiency in the review process by performing  some s~eps of the review 
process concurrently,  but the program  must not compromise  the physicians  opportunity  for due 
process in pursuit  of more timely reviews. 
Physicians  have had,  in large part,  a positive  reaction to quality  review process enumerated in the 
PRO Fourth  Scope of Work.  The AMA is pleased that HCFA  incorporated  many of our 
recommendations  for improving  the quality  review mechanisms  of the PRO program.  As I indicated 
earlier,  we believe the Fifth Scope of Work builds on the positive  changes of the Fourth  by increasing 
the level of collaboration  among PROS, hospitals,  and physicians on quality  improvement  efforts. 
The emphasis  on internal  quality improvement  which uses pattern analysis  is to be commended,  rather 
than a punitive  approach  that addressed  individual  clinical errors. 
The AMA strongly  believes that physicians  must continue to play an active role in any public or 
~irate sector effort to develop national medical quality and performance  standards.  And that when 
individual problems  of quality are identified,  they mus[ and will be addressed  bu[, it must be done in 
a way that respects and enforces patient and physician confident iali[y and without abridging the due 
process rights ot individuals. 
Once again.  I want to express my appreciation  for the opportunity  we have had to comment on this 
process.  The AMA wants [o continue to play an active role to ensure that physicians perspectives 
are part of the PRO process. 
Sincerely, 
J.  y~  , %@ 
ames S. Todd,  MD  September  27,  1995  ,.

June Gibbs Brown

Inspector  General

Dep@nent  of Health  & Human Services

OffIce of the Inspector  General

330 Independence  Ave.,  S.W.

Washington,  D.C.  20201

Dear Inspector  General Bro~:

Horace Deets has asked me to respond  to your request for comments  on the draft report,

The Beneficiary  Complaint  Process  of the Meclicare Peer Review  Organizations.  We

appreciate  the opportunity  to comment.  AARP has long supported  the effective

implementation  of the PROS complaint  authori~y, and believes that yow report is a great

service to the beneficiary  community.  It is useiiul to be reminded  of the Congressional

mandate  regarding  PRO consideration  of beneficial  complaints:

The  organization  shall conduct  an appropriate  review of all written complaints

about the qutdity of services  ..... not meeting professionally  recognized  standards

of health  care.... The organization  shall itiorm  the individual  of the

orgtizations  final disposition  of the complaint.

In light of the elimination  of random  sample record review by the PROS, the process  of 
investigating  and responding  to beneficiary  complaints  assumes  even greater importance 
as a means  of protecting  beneficiaries  from poor quality care. 
Our specific  comments  follow.  We welcome the reports recommendations,  and offer 
suggestions  for some additional  ones.  We also raise a few questions  of clarification 
about the reports  findings. 
Comments  on the Recommendations 
  Require  PROS  to respond  substantively  to the complainant 
The OIG recommends that HCFA  either: (1)amend the PRO regulations  to eliminate  the 
requirement  that physicians  consent  to disclosure  before providing  feedback to 
complianants;  or (2) issue contract modifications  or manual instructions  calling for 
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Page 2 
substantive  responses  to complainants.  We support  both recommendations,  both of 
which are consistent  with N  policy,  but feel that the latter approach  would be most 
expeditious. 
We have long believed that the confidentiality  regulations  have a chilling  eff6ct on the 
beneficiary  complaint  process: The fact that beneficiaries  have no assurance  that they will 
ever receive a substantive  response to their complaint  cannot help but serve as a deterrent 
to ~gistering  one.  Those beneficiaries  who do voice complaints,  and whose physicians 
thti  refhse to consent to disclosure  -- which happens  in 87 percent  of cases when there is 
a confirmed  quality problem  -- likely feel frustrated or even an~  at the lack of 
meaningfid  response.  Such a situation  serves to undermine  overall  beneficiary 
confidence  in the PRO program. 
While we recognize  that many physicians  and hospitaIs  have serious  concerns  about 
changing  the coti]dentiality  regulations,  the finding that over half (59 percent) of the 
PROS smeyed  viewed these regulations  as a major barrier to a more effective complaint 
process is compelling  evidence that the regdations  bear revision.  In addition,  the report 
notes that at least one PRO has been successful  in gaining physicians  consent in a 
majority  of cases, even when the complaint  involved  a conilrmed  quality problem.  It 
would be a valuable addition to your final draft to indicate  any specific  methods  used by 
that PRO.  This finding suggests that, if regulations  are revised,  PROS will be able to 
respond  substantively  (e.g., according to the OIGS definition  of what constitutes  a 
substantive  response) without  alienating  the physician  community. 
In order to help allay f=s  among the provider  community  that these responses  will be 
used unfidrly against them  we suggest: 
	 permitting  physician  responses  to PRO findings  to be attached  as part of the PRO 
response  to the beneficiary.  This practice would parallel  that used by HCFA  in 
attaching voluntary  hospital comments  when it released  the hospital  mortality  data. 
.	 developing  a recommended  response  letter that informs the beneficiary  of the final 
disposition  of the complaint  without  becoming  tantamount  to a verdict in malpractice 
litigation. 
We also urge thatproven quality of care findings  be referred to other oversight  entities  as 
required by Memoranda  of Understanding  entered  into by PROS in the Fifth Scope of 
Work.  Inspector General Brown 
Page 3 
	 IdentifJ cost-effective ways to enhance.hfedicarebeneficiaries awareness  of 
PROS and  the complaint  process. 
We strongly  support  this recommendation,  which is consonant  with AARP  policy calling 
upon HCFA  and the PROS to actively  encourage  beneficiaries  to use the PROSauthority 
to investigate quality of care complaints. The extremely low volume of complaints 
(beWeen 8 and 164 per one million  beneficiaries),  coupied with the elimination  of 
random case review, jeopardizes  the PROS ability to identi~  quality  of care problems. 
We agree that HCFA  should give PROS more flexibility  in conducting  their outreach 
activities,  including  permitting  them to survey  local beneficiaries  and targeting  outreach 
to family members of beneficiaries as well & pre-retirees.  We would  like to offer any 
assistance  that AARP  may be able to provide  in this effort. We finther  believe that the 
PROS budgets  should  be increased  to permit  concerted  outreach  efforts. 
The fact that only 23 percent of beneficiaries  surveyed were aware of the existence  of 
PROS is, of course, a major barrier to the complaint  process.  We are curious if the 
beneficiary  smey  reveaIed any other barriers.  Were respondents  asked if they would be 
tiling  to lodge a complaint,  or if they would  he reluctant to do so, and the like?  Any 
data bearing  on this issue from the beneficiary  sumey should be reported. 
  Streamline  the complaint  process. 
The current timeline  for PRO review and response  to beneficiaries,  as outlined  in the 
PRO manual,  is fa  too long. For example,  the process can take up to 250 days to respond 
to identified  quality  concerns in cases requiring  a re-retiew.  Over two-thrids  of the 
PROS surveyed  (68 percent) felt constrained  by this lengthy process.  Moreover,  it is 
quite feasibte  that  beneficiaries  who are seriously  ill may no longer  be alive by the time 
the review  is completed. 
We support the OIGS recommendation  to HCFA to find ways to expedit the process, 
e.g., by examining  ways other bo~les conduct complaint  reviews  and identifying  and 
sharing promising  approaches  taken by individual  PROS.  For example,  ail PROS should 
be encouraged  to use a case management  approach  as is being used with one PRO, and to 
regularly  communicate  with beneficiaries  throughout  the process.  Inspector  General Brown 
Page 4 
Comments on Findings 
Page 1. The text states that OBRA-86 requires PROS to review all writte~  quality-related 
complaints  received  from Medicare beneficiaries.  However, the footnote  to which this 
statement  refers  (#4  in Appendix  E) does not list physician  offices  as one of the settings 
for which PRO review  is mandatory.  This should be clarified. 
Page 3.  We suggest  adding an Appendix  which lists the total number  of beneficiary 
complaints  received,  and gives more descriptive  information  about the nature of the 
complaints  reviewed,  especially those that resulted in confirmed  quality  probIems.  For 
example,  the report states that about two-thirds  of these problems  invoived  physicians, 
and about one-third hospitals.  Were quality of care problems found in any other settings, 
e.g., in home health or HMOS? Such information would provide more context for 
interpreting the reports fmiings. 
Page 5.  Based on the discussion  here, the OIG may wish to state that PROS should 
establish  explicit  poIicies to encourage complaint referrals from physicians, hospitals, or 
medical boards. 
Page 6.  The majority  (59 percent) of  PROS cited difficulties  in making  beneficiaries 
aware of the complaint  process,  It wouid be helpful to know whatspecific difficulties 
they encountered. If this was asked on the PRO survey, it would .usefid to report the 
responses here. 
Thank you again for the opportunity  to comment.  If you should have any questions, 
please contact Mary Jo Gibson in AARPs  Public Policy Institute  at (202) 434-3896  or 
Cheryl Matheis  in Federal Affairs at 434-3774. 
Sincerely.
* 
.W 
Uohn  Rother 
Director,  Legislation 
and PubIic Policy  . 
Coalition  for  Consumer  Protection  and  QuaIity  in Heakh  Care Reform 
1275  K Street N.W., Suk?9W  Wa$hiniww  DC 20005 
(202)789-3606  Fax (202) 842-1  1S0 
September 15, 1995 
Ms, June Gibbs Brown

Inspector General

Department of Health and Human Servictx

Cohen Buiiding, Room 5250

330 Independence Ave., S,W.

Washington, D.C.  20201

Dear Ms. Brown: 
Thank you  for the opportunity  to review and comment  on your draft  inspection 
report,  The Beneficiary  Complaint  Process  of the Medicare  Peer  Review 
Organizations.    I am pieased  to provide  to you the comments  of four of the Consumer 
Coalitions members, and I know that others in the Consumer Coalition have provided 
their comments to you indepcndcntiy. 
Piease keep our Coalition in mind coreview and comment on other reports that 
you produce in the areas of health care consumer protection and quaiity,  We would 
aiso be wiiiing to assist with your studies in any other ways that you consider 
appropriate, 
Thank you again for inciuding  us and for your efforts to improve  these 
important  heaith  care programs. 
Sincerely, 
/&  bJ#=L$z_ 
Brian W. Llndberg 
Executive Director  Center  fbr 
Health  Care Rights 
/  A  step  ttt  tbe  rdgbts  dfrect  ion 
TO:  Brian IJndberg

FROM:  Geraldine Dallek, Center for Health Care Rights

RE:  The OIG Drafl Report on The BeneficiaryComplaintProcess of the Medicare

Peer Review Organizations 
DATE:  September 5,  1995 
The OIG repofi provides a thoughtful critique of the PRO complaint system and otlkrs some 
criticallyimportant suggestions  for reform of the system.  Given the likelihood of some basic 
reform in the Medicare pmyam  and the potential fcwsubstantialincreased Medicare enrollment in 
manased care, the repon is especially timely, 
What follows are some specific comments  on the report and additional  suggestions  for improving 
the PRO complaint process. 
NEED FOR A PRO PROCESS RESPONSIVE TO BENEFICIARY COMPLAINTS 
The Center for Health Care Rights (CHCR) provides education+counseling and legal services to 
over 15,000Medicare bencficimiesannually. Withthe exceptionofhospitaldischargecases,we 
refix few Medicare beneficiariesto our PRO (CMRI), The reasons are two-fold: 
(1)	 The inability of PROs to Provide Comdainants with Information on the 
Disposition of Their Comdaints 
Asthe OIG notes, the lackofa meaningfidPRO responseto beneficiariescomplaintsis

incredibly  fimstrating,  Indeed, it is such an impedimentto the review process, that I believe unless

it is ~hanged,  MK)s  will  never be able ?Qdlkcthdy  represent Medicare beneficiaries, Nor wi]l

PROS,regardless of outreach efforts, be sent more than a trickle of complaints. 
(2)	 The Lemzthof the Review Process and Inabilitvof PROSto Respond in a Time& 
Manner to Emer~encv Cases 
As the OIG also noted, the review process is too lengthy. I am especially concerned about the 
lackof formal procedures fur the PRO to investigate  emergency cases where deIays could result 
in serious harm to a beneficiary.  Agai~  with the exception of hospital discharge  cases, CHCR 
does not view a complaint  to the PRO as an effective way to obtain redress for our client 
concerns, especially those relating to denials of care by HMOS. 
520 S. Lafayette  Park Place,  Suite214  a  Los Angeles,  CA 90057 
213/383-45  19    800/824-0780  m Fax: 2 13/383-4598  Lindberg 
page 2 
NEED FOR GREATER SPECIFICITYON THE COMPIx41NTPROCESS 
TheOIGreport contains anumberofrecommendationsforchangesinthe PRO complaintSyst% 
inoludingspecific requirements detailingto the complainantwhat it didto investigatethe 
complaint,the outcome oftheinvestigationandanyactiontalmnbythePRO. 
In addition, I  believe the 010s  repoti should hiclude recommendations to HCFA on substantive 
additional changes in the complaintsystemincluding:recommendedtimeties  for handling 
complaints,protocolsforwhoinvestigatescomphdnts;standardsforwhattypesofcomplaints 
shou~dbe handled by the PROS;standards on how comphdnts should be investigated; ant  as 
discussed below, reporting of outcomes of complaint investigations to the public. 
Currently, the PROS do not seem to investigate cases when care is denied, focusing instead on the 
deliveryofpoor qualityofcare. Webelieve[hatdenialsofappropriate care are, bydefinition, 
poor quality care and should be investigated  by 
LACK OF COORDINATION BETWEEN THE PROS, HCFA AND STATE 
REGULATORY AGENCIES 
The CaIifomiaDepartment ofCorporations (DOC),whichregulatesHMOSinthe state, willsoon 
inaugurate a hot line for HMO consumer complaints. DOC has told CHCR that it plans to refer 
allMedicareHMO complaintsto HCFARegion9 
We do not know how HCFA will handle the large number of expected calls. HCFA and CMRI 
need to establish protocols for handling these complaints and sharing complaint information. 
OIG should include in its report specific recommendations  for ways that the PROS,  HCFA  and 
state agencies should coordinate the handlingof beneficiarycomplaints and share complaint 
information. 
LACK OF PUBLISHED PRO COMPLAINT DATA 
In addition to informing Mividual complainants of the outcome of the PROs investigation of 
their complaints,PROSshouldbegivenauthorityto publishcomplaintdata onan annualbasis, 
including; 
+	 The number of complaints by provider type (FFS, Physician, Hospital, HMO, 
Home Health Agency) and types of complahts (e.g., denials of care, poor quality 
care, etc.),  Lindberg 
page 3 
+  Outcome of complaints by providertypq 
+  The names of institutional providers ( HMOSand when applicable, contracting 
providergroups, hospitela, home health agencies, etc.) for whom complaints were 
found to be, following an investigatio~ justi.tlable. 
OUTREACH THROUGH GROUPS REPRESENTING MEDICARE BENEFICIARIES 
All states have fderally  finded ICA programs which could be a potential source of beneficiary 
complaints. A number of other organizations also represent the interest of Medicare beneficiaries. 
However, for the reasons stated above and a sense among some beneficiary groups 
that PROShavenot, inthe past, beenresponsiveto beneficiaryconcerns, PROSwilfhaveto make 
a special effort to gain the trust of some of these organizations. 
I believe that complaints from bem%ciariescan bean effective source of monitoring quality of 
care. However, heavy relianceon complaints will not produce an effi?ctivequality monitoring 
system unless the entire PRO complaint system is changed to meet beneficiary needs. 
Thank you for the opportuni& to comment on the OIGS drafl report.   
NATIONAL SENIOR  CITIZENS  LAW  CENTER 
1815 H STREET,N.W.,  SUITE  700 
WA5HIffiTON,  D.c.  20006 
TELEPHONE  (202) 887-5280  FACStMILE  (202) 78S-6792 
WA!WINCTON, o c 
DUR70N D, mm 
EXECUmTmIWc-roa 
September  14,  1995

Brian  Lindberg

Executive  Director

Coalition  on Consumer  Protection

and  Quality  in Health  Care  Reform 
1275  K Street,  N.W.  , Suite  900 
Washington,  DC  20005 
Re:	 Comments  on OIG  Report  on Beneficiary  Complaint  Process  of the 
.Medicare  Peer Review Organizations 
Dear  Brian: 
Thank  you  for the  opportunity  to submit  comments  on behalf  of the  National 
Senior  Citizens  Law Center  (NSCLC).  Over  the years,  NSC.ZC has been  involved  in 
nuxnerw+s matters  involving  quality  of care issues  and Peer  Review Organization 
(PRO)  review,  particularly  issues of premature  hospital  discharges,  For the  most 
part,  we have  found  the  l?RO review  process  to be unsympathetic  to beneficiaries  and 
theprocesosf obtaininrge view
cumbersome,  even when  working  through  an 
experienced  advocate.  111addition,  the  Iack of a detailed  and  substantive  response  to 
beneficiaries  complaints  has impeded  our ability  to advocate  on behalf  of our  clients. 
1.  &  a general  matter,  there  is still a question  among  beneficial  advocates 
about  whether  the  PRO process should  be maintained  as it. relates  to bene-ficiary 
coverage  and  quality  issues.  Some  advocates  are of the  opinion  that  the  process 
delays  meaningful  review before  a hearing  officer,  und administrative  law judge 
review,  etc, as appropriate. 
2.  Hospital  notices  explaining  PRO review procedures  have  improved  over the 
years,  Nonctheiess,  beneficiaries  do  not  always receive these  notices  in a timely 
fashion,  nor  do they  always receive  sufficient  instruction  from  hospital  staff  about  the 
importance  of these  notices. 
3.  We  applaud  the notion  of expanding  PRO outreach  efforts  in terms  of 
publicity  about  the  PRO review process.  We  wotdd  be happy  to work with  the 
La  ANGELE2~.  S1.RTE4230, 777 SO~  ffilJER~  STREET,102 ANGELES,(XLIFORNL4 9W17   (213) 23&3890 
s  NATIONAL SENIOR CITIZENS lAW CENTER 
Brian Lindbcrg 
Page2 
September14, 1995 
Health  Care Financing  Administration  (HCFA),  the  PRO community,  and  others  in 
exploring ways of reaching Medicare  beneficiaries to tell them  about the role and 
function and vaIuc  of the  PRO process  as it is improved. 
4.  We  agree  that  the  low number  of beneficiary  complaints  being  filed with  the 
PRO is a problem.  The  problem  is a function  of poor  outreach,  bad beneficiwy 
experiences  with  the  PRO  system,  and ineffective  notice  systems  within  hospitals. 
We have  long  sugg~stcd  that  ho~pilalsbe  reqt.drcd to play  a larger  role in the  patient 
education  and  outreach  efforts  about  the  PRO process,  Wc  suggest  theuseof notice 
boards  in hospitak,  presenting  information  about  the PRO process  at several points 
during a patients  stay  in the  hospital,  and the  use of patient  advocates  or a hospital 
educatioann doutreacehf forts.
ombudsman  to  augment 
5,  Hospital  utilization  review committees  should  involve  Medicare  beneficiaries 
in all upects of utilization  questions.  This  would  given benefiaaries  greater  access 
to the  PRO process  and  increase  beneficiary  comfort  lcvels in using  the  PRO  review 
process. 
6.  It would  also be useful  if PROS were required  to publish  and  make  available  to 
the beneficiary  community  statistical  information  about  the  number,  nature,  and 
disposition  of complaints  received.  7%1sinformation  could  be made  available  in 
hospitals,  at senior  centers,  and  to individuals  upon  request. 
Again,  thank  you  for the  opportunity  to comment. 
Sincerely, 
Alfred  J. Chipiin,  Jr. 
Staff  Attorney  clWTERFORMEDIOAM  ADVOCACY,  lNC-
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Brian  Lindberg

Executive  Director

Coalition  far  Consumer  Protection

and  Quality  for  Health  Care  Refo~

1275  K  Streett  N.W.

Washington,  D.C.  20005

Dear  Brian:

Thank you  for giving  me.the  opportunity  to  comment  on  the  OIG 
draft  inspection  report,  The  Beneficiary  Complaint  Process  of  the 
Z4edicare  Peer  Review  OrganlzatiozsX!  MY commentson  the  draft 
report, in  no particular  order,  ure,as follows: 
1.  The  OIG  and  PROS  are,correct  in  concluding  that  randont 
reviews  of  sample  medical  records  were  an  ineffective  way  to 
improve  quality  of  care,  and  that  responding  to  beneficiary 
complaints  is  a  far  better  way  to uncover  problem  areas,  (Why did 
it take them  so long  to  figure  this  out?) 
2.  We should  urge the PROS  to  devote  much  more attention  to 
investigating  instances  of  underservice  by  HMOs~  as this  is the 
area  in  which  Medicare  beneficiary  advocates  find  the  greatest 
pzoblexcs. 
3.  Closer  links  should  be  developed  between  PROS  and 
Medicare  beneficiary  advocates.  Until  now,  many  PROS  have  been 
quite  unresponsive  to  beneficiary  advocates  in  their  regions. 
Greater  contact  would  help  increase  the  number  of  complaht~  they 
receive  and  sensitj.ze  them  to  beneficiary  interests. 
4.  PROS  should  not  rely  only  on  medical  records  i.n 
investigating  beneficiary  complaints.  Medical  Tecords  do  not 
reliably  document  instances  of  poor  quality  medical  care  (after 
all,  .who;:creates  the~zecazds?)  ,..Me.dical  :rec,ords  are  even  less 
likely  to  document  si,tu,ations  where  the  problem  was.that  not  enough 
medical  care was  provided,  which  is the most  common  problem  where

HMOS  are involved, 
(mmI?ALoFFIclE?:o .mxsswolu
 mwvmc,cToez2a  (209)456-7WI Brian  Lindberg

September  7, 199S

Page  2

5.  The  reports  statistic  that  PROS  have  found  confirmed 
quality  of care problems  in 10 to 15 % of complaints  is shockingly 
low.  Beneficiaries  rarely  go to the trouble  of lodging  complaints  ~ 
that  are  not justified.  This low confirmation  rate may result  from 
a  number  of  factors:  PROS  are  gOnerally  too  solicitous  of 
providers;  PROS  can  not  obtain  all  of  the  relevant  facts  from 
suedical  records;  PRO quality  of  care protocols  in many case?  simply 
do not measure  underservice.  Beneficiaries  will not bother  lodging

complaints  unless  the resulting  investigations  are more  balanced.

,.

6.  Many observers  have noted that PROS do not seem to be the 
appropriate  agencies  to monitor  qqality  of  caref  since  they  are 
also  entrusted  by  HCFA  with  the  job  of  performing  hospital 
utilization  review.  This inconsistency  in  their  two  hats  should  be 
removed. 
7.  HCFA  should  work  on  developing  a  penalty  System  that 
gives  beneficiaries  anincentive  for  ,referring  their  problems  to 
the PROs--e.g.,  monetary  fines  levied  in  response  to deficiencies 
that  are  found  in  health  care. 
8.  PROS  should work with other agencies  that review  medical 
quality	 such  as  licensing  boards  and  HMO regulatory  agencies  to 
create  stronger  incentives  for  providers  to  provide  adequate, 
quality  care.

I am  sorry  to  have  been  slow  in  getting  these  comments  to  you. 
Please  let  me  know  If  I  can be of further  assistance. 
Very  truly yours,

< > 
Sally H  t Wilson

~AFt
torne  at Law

SHW:md
 Citizen Advm~  Center 
A tiining,  R~  and SWport  Network for Public 
Membem of Hbalth Clzre Regulatory and Gove?ningBou@s 
September  14, 1995

Mr,  Brian  Lindberg,  Executive  Director 
coalition  for Consumer  protection  and 
Quality  for Health  Care  Reform 
1275 K Street,  NW, Suite  900 
Washington,  DC  20005

Dear  Brian:

Thank  for  asking  CAC  to  comment  on  the  OIG  draft 
you 
inspection  repoxt  entitled,  The Beneficiary  Complai.n. t. pro-- of
the-Medicare  Peer  Review  0r9an~zationa  (PRO=)  -  A?  .You  now  c 
is a unique  support  program  for the thousands  of public  members  who

serve  on  healtih care -regulatory  boards  and  governing bodies as

representatives  of  the  consumer  interest.  Whether  appointed  by 
governors  to serve  on regulatory  or  other health policy boards  or 
selected by private sector institutions and agencies to serve on 
boards or advisory panels, public members are  typically  in-the 
minority  and  are  usually  without  the  resources  and  ,technlcal 
support  available  to  their  counterparts  from  professional  and 
business  communities.  CAC  is  a  not-for-profit  501(C) (3) 
organization  created  to  serve  the  public  interest  by  providing 
research,  training,  technical  support, and networking  opportunities 
to  help  public  members  make  their  contributions  Informed, 
effective,  and significant.

One of our networks  under  the CAC umbrella  is PRONET,  made up

of  the  Medicare  beneficiary  members  who  serve  on  the  boards  of

directors  of  all  PROS.  At  PRONETS  annual  meeting in Salt Lake

City,  Utah,  on  September  28,  1995,  these  beneficiary  members  will 
be  discussing  the  draft  report  and  most  likely  issuing  their  own 
comments  on  it.  However,  because  of  the  deadline  you  told  us  you 
were  operating  under,  we  wanted  to give you the comments of CAC. 
Please  understand  that  the  CAC  comments  may  or  may  not  be  similar 
to  those  that  PRONET  will  make  later  this  month.  I  will  send  you 
a  copy of whatever  results  from the PRONET  meeting. 
We appreciate  your asking our views.  AS one of the members  of

your coalition,  we are pleased  to respond,  since we closely  observe

the PRO program.

The  OIG  makes  three  findings,  and  offers  three 
recommendations.  we would  like to comment  briefly  on  each. 
1424Six&enthStreNeW~.  Suke106.Waahi-n@On,D
C20036

PHONIU(202)462-1174N
AX(202)2654Y564
 PIG  Findirau  #l.	 Complaints  to PROS can be en important source 
for  identifying  quality-of-car. problems. 
commeJ&.  We agree.  AS you know, we also are deeply  involved  with 
the operation  of state  health  licensing  boards,  Both the PROS and 
the  licensing  boards  can  do a much  better  job  of  protecting the 
public health and safety if they have direct access to the users of 
health services,  while PROS can  and  do  have  the  authority  to 
review medical  records  of patlenta,  that is not the same as hearing 
from patients  who  have  had  an adverse experience.  Granted, some 
complaints are frivolous, and some do not  really  fall  within  the 
PROs authority,  Neverthelessr enough of them do allege  actions or 
inactions  that should  be investigated  and, if substantiated,  dealt 
with  in an appropriate manner. 
019 Findina #2s	 Modicaze  baneficiarie- are  often  unaware  02 
tlmir  opportuuitiem  to complain  to PROS  about 
the quality  of  tlaoir medical  ca=e. 
Comment.  The  01(3  finding  does  not  surprise  US.  Most  studies  Show 
that  the  public  is  uninformed  as  to  the  existence  of  PROS and 
licensing  board  and  the  authorities  uizder  which  they  operate.  ThiH 
lack of awareness  is a problem  that cannot  be corrected  overnigh~, 
but the effort  should be made.  If one examines  the budgets  of most 
PROS,  one will  find precious  few dollars  allocated  to beneficiary 
education  and  outreach.  CAC  did  a  study  a  while  back  (copy 
enclosed)  that  examined  PRO outreach  programs.  As you  will  see, 
some  PROS  spend  as little  as $5,00 0 a vear  on outreach  (Table 25, 
page  72).  Almost  half  the  PROS  (24)  had  outreach  budgets  of 
between  $5,OOO  and  $50,000.  Not  a  single  PRO  had  an  outreach 
budget  of  over  $100,000.  Some  PROS  have  developed  imaginative 
outreach  programs  to  do  a better  job  of  beneficiary  education. 
Furthermore, the Fifth Scope of Work  in  HCFAS  contracts  with  PROS 
elevates  outreach  to  a  higher  priority  than  it  has  had in the past, 
But ,  until  there  is  a  much  larger  financial  commitment,  these 
programs  are  unlikely  to  overcome  the  lack  of  knowledge  found  by 
the  OIG  and  others. 
OIG F- ixuf#~.	 As  it  works  now,  the  complaint  process  has 
some  flaws  that undermine  its  effectivezxessg 
o  Laak  of substantive  response

0  Faw  complaints

0  Langthy  process

Comment.  Again,  the  OIG  finding  is  disturbing  but  not  surprising.

If  few  beneficiaries  know  that  they  have  a  right  to  complain

(Finding  #2),  then  of  course  there  wont  be  very  many  complaints

registered.  If  those  who  do  complain  get  a  non-substantive

response,  and if chat  non-substantive  response  takes  an  unduly  long

2  time  to arrive,  then the complainant  is unlikely  to ever  complain 
again,  and  is  likely  to  discourage  friends  and  relatives  from 
registering  complaints  of  their own, 
In  eummary,  the  01(3  finds  that  complaints  can  bai  an  important 
source  of  information  to  help  PROS  identify  quality  of  care 
problems,  but  very  few  beneficiaries know  about  the  complaint  . 
process,  and  those  few  who  do  use  the  system  find  it  seriously 
flawed and non responsive.

The  OIG  offers  three  solutions,  in  the  form  of

recommendations,  namely;

b	 !rheHCFA  should work with PROS to  identify  cost-affective  waym 
to correat  the  flawe  in the complaint  proceos.  Toward  that 
end, FICFA  shoulds 
o	 Requ3x=  PROS  to  respond  substantively  to  the 
complainant.  TMsim  the  standard  to  which  the 
Joint  CommissioA on  the Mcredltation  of  Health 
Care  Organizations  holds  hoepitals  accountable. 
The  HCFA  should  give  this the highest  priority. 
o	 Identify cost-effeotive  ways  to  enhanca  Medicare

beneficiaries  awareness  of PROIYand the complaint

process.

o  Streamline  the mxmplaint  process.

We  support  eaah  of  these  recommendations,  and  find  them  on 
target.  In  addition,  we  would  add  a  recommendation  that  PROS  not 
only  be  allowed  more  flexibility  in  conducting  outreach  activities, 
but  that  these  activities  be  allocated  higher  levels  of  funding. 
We  would  also recommend that as part of  streamlining the 
complaint process,  PROS be given  specific  deadlines  for each phase 
of  complaint  handling  -- fox  example,  14  days  to  acknowledge 
receipt  of  the  complaint;  30  days  to  complete  a  preliminary 
investigation;  60  additional  days  to  complete  a  fuller 
investigation  -- and  be  required  to  justify  each  instance  where  the 
time  limits  were  exceeded. 
Finally,  we  believe  that  14CFA  should  regularly  compile 
complaint  handling  statistics  from  all  PROS  and  issue  an  annual 
report  describing  their  substance  and  their  resolution.  A good 
model  would  be  the California  Board  of Medicines  Annual  Report. 
CAC  is aware that PROS have  moved  away  from  case-by-case 
review  and  toward  pattern  analysis.  However,  PROS  still  retain 
authority  to  receive,  investigate,  and  act  upon  complaints.  so 
long  as  they  have  this  authority,  PROS  should  be  expected  to 
exercise  it  responsibly.  Otherwise,  PROS leave  complainants  with 
3
 . 
a  false  confidence  that  their  complaints  are  being  handled 
appropriately. 
There  are  really  only  two  viable  choj.ce~;  either  correct  the 
deficiencies  documented  in  the  OIG  report,  or  remove  from  PROS  the 
responsibility  for  handling  complaints,  reduce  their  budgets 
accordingly,  and  direct the funds to organizations better equipped 
or more willing to  handle complaints effectively, promptly, and 
appropriately. 
Again, we appreciate this opportunity to comment.

Sincerely,

4  APPENDIX  F 
NoTEs 
1.  The Institute  of Medicine,  Medicare:  A Strategy for  Quality Assurance  (Washington, 
D. C.:  National  Academy  Press,  1990). 
2.  Hebbeland  McMullan  to Executive  Directors,  Peer Review Organizations, 
20 December  1994, Health Care Financing  Administration,  Baltimore,  MD. 
3.  Other instances  in which HCFA requires  the PROS to conduct case reviews  include 
hospital-issued  notices of noncoverage,  referrals  from HCFA  or the fiscal intermediary, 
adjustments  to higher-weighted  DRGs,  and other limited instances. 
4.	 The PROS must review  complaints  about the quality of care in the following  settings: 
fee-for-service  inpatient hospitals;  fee-for-service  freestanding  ambulatory  surgical  centers; 
fee-for-service  home health agencies,  skilled nursing facilities,  hospital  outpatient  areas, 
and emergency  rooms;  risk-sharing  health maintenance  organizations;  and services 
received  through  cost-based  health maintenance  organizations.  The PRO review  is 
mandatory  for written,  quality-related  complaints  about services received  in a physicians 
office when the physician  is a part of a health maintenance  organization  in which the 
beneficiary  is enrolled. 
5.  See 42 CFR 476. 
6.	 The Health  Care  Financing  Administration  defines beneficiary  protection  under  HCQIP 
as comprising  four key elements: 
1. A quality surveillance  system.  The HCFA  defines surveillance  as an 
ongoing epidemiologic  strategy to identify quality problems,  structured  by 
hypotheses  about what the problems  are.   The HCFA  further  defines the aims of 
the quality  surveillance  system as targeting  and supporting  quality improvement 
projects  by finding and fixing unacceptable  patterns  as diverse  as high rates of 
medication  errors,  high rates of unnecessary  right heart catheterization,  and 
systematic  delays in providing  antibiotics  to patients  with infections,  
2.  Strategies  to identify and intervene  in instances of incompetent  and 
impaired  physicians  and providers.  According  to HCFA,  the HCQIP  employs 
two methods to effectively  identify and root out incompetence.  First,  physicians 
and hospitals  who fail to participate  in and improve  as a result of projects  will 
become  increasingly  isolated and obvious.   It states that  data collected  in 
projects  and shared on a confidential  basis will become persuasive  evidence  for 
implicit peer pressure  and for exclusion  if that becomes  necessary.   Second,  PROS 
will become  more  aggressive  in soliciting and investigating  complaints,  including 
F-1
 strengthened  liaison with licensing and certifying  agencies  and existing  local 
consumer  protection  and advocacy programs.  
3.  A more comprehensive  and informative  approach toward resolving 
beneficiary  complaints  concerning  quality issues.  The HCFA  states that 
traditional  peer review  of individual cases will remain  a key tool for investigating 
complaints.   In addition,  HCFA  is revising  its regulations  to  provide more 
thorough  and sensitive follow-up to beneficiary  complaints.   According  to HCFA, 
the new rules and procedures  for complaints  will permit  (and HCFA  will require) 
PROS to explain health care events to beneficiaries  to promote  understanding  and 
encourage  conflict resolution.  
4. Enhanced  beneficiary  information  activities.  The HCFA  is currently 
exploring  ways to improve educational  and informational  activities  to ensure that 
beneficiaries  are filly  aware of their rights and opportunities  under  Medicare, 
including  the right to have complaints  about poor quality medical  care  investigated 
by the PROS.  
(Gagel to Vladeck,  3 May  1994,  Beneficiary Protection  Under the Health  Care  Quality 
Improvement  Program  (HCQIP)--DECISION,   Health  Standards  and Quality Bureau  of 
the Health  Care  Financing  Administration,  Baltimore,  MD.) 
7. Health  Care  Financing  Administration,  The Successful PRO in 5 Years,  Baltimore,

MD,  November  8,  1994.

8.  This is based  on our analysis of data representing  11 PROS beneficiary  complaints

and the number  of cases with at least 1 confirmed  quality-of-care  problem.  Each case can

have multiple  quality-of-care  problems.  For 20 PROS in our sample,  we had number  of

individual  problems.  When we calculate  the rate for those 20 PROS, the result  is within

the range  of the case results presented:  at least 10.5 percent  to as many as

17.3 percent.

9.  This PRO,  from the low-population  stratum,  reported  having received  13 complaints

under  the fourth  contract  at the time of our survey.

10.  The PROS responses  to these systems issues also varied,  and included  action plans,

HCQIP projects,  and consideration  of sanction,  among others.

11.  Gagel to Vladeck,  3 May  1994. 
12.  We asked the PROS how many complaints  that triggered  a case review  were also 
referred  elsewhere  and listed the following choices:  FI/carrier,  managed  care  institution, 
hospital,  HCFA  project  officer,  survey and certification  agency,  and other.  Because a 
PRO could have referred  a single complaint more than once,  we present  both the most 
conservative  interpretation  of joint referrals  (16.7 percent)  and the most liberal 
(28.9 percent). 
F-2
 13.  Because the HCFAproject  officer  islkely  torefer  the complaint  again,  for example 
to the appropriate  survey and certification  agency,  the percentages  shown may be under-
reported. 
14.  Thirteen  of the 22 PROS reported  having received  referrals  from physicians  during 
the fourth  contract  period.  Nine of these PROS reported  having received  either  a small 
number  or between  1 and 4 such referrals;  1 reported  having received  6; and 2,  10 or 
more.  One PRO did not offer an estimate. 
Eight PROS reported  having received  referrals  from hospitals.  Those who offered  an 
estimate  reported  having received  between  one and four referrals. 
Six PROS reported  having received  referrals  from State medical  licensure  boards.  Those 
who offered  an estimate  reported  having received  one or two,  or a few. 
15.  When we asked the PROS to identify two outreach  activities  leading to the most 
complaints,  half the PROS identified  local presentations. 
16.  Of the  13 PROS that judged  reaching  beneficiaries  a major barrier  to a more effective 
complaint  process,  4 were from the low-population  stratum. 
17.  Five of the 22 PROS in our sample noted that,  in some cases,  the response  to the 
request  for consent was pending. 
18.  The 5 PROS in the low-population  stratum gained consent 84 percent  overall 
compared  to 43 percent  for the  17 PROS in the high-population  stratum.  The PROS in the 
low-population  stratum gained consent in 25 percent  of the complaints  involving  confirmed 
physician  quality-of-care  problems  (3 of 12 such complaints)  compared  with  13 percent 
for the high-population  PROS (22 of 176 such complaints). 
19.  The 7 cycle-1  PROS in our sample received  between  31 and 141 complaints  per 
million beneficiaries,  a spread of 110 per million;  the 7 cycle-2 PROS, between  50 and 
164, a spread  of 114 per million;  and the 8 cycle-3 PROS, between  8 and 125, a spread of 
117 per million. 
20.Miscellaneous  reviews  account for 19.2 percent  of the review caseload.  Other 
mandatory  reviews,  such as hospital-issued  notices of noncoverage,  account for 8.4 
percent.  After  October  1995, the PROS review caseloads  will include complaints  and 
other mandatory  reviews. 
21.  Health  Care Financing  Administration,  Strategic Plan,  Baltimore,  MD,  1994, p.3. 
22. Ibid,  p.  17. 
F-3