comments, 12/17/09, 6:06 AM
Ms. Charlene Frizzera, Acting Administrator, Centers for Medicare and
RE: CMS-1418-P: Medicare Programs; End-Stage Renal Disease Prospective
Payment System; Proposed Rule
My name is Gary Peterson and I have been in the dialysis field since
1975 in variety of roles, including patient care, technical management,
RN training, and product management. For the last eleven years, I have
been the owner and editor of RenalWEB, a daily updated news and information
web site. As this requires me to read and scan thousands of news and
scientific articles about dialysis care every year, it provides me with
a wide and independent perspective on ESRD care in the US.
As I have
considered possible comments on the ESRD Prospective Payment System
proposal for the last three months, I have become increasingly aware
that what is primarily lacking in it is a mature sense of history. While
it begins with a historical review that is technically correct, it does
not acknowledge or reflect on serious mistakes from the past. Unfortunately,
it builds on many of those past errors.
Back to the future
Imagine that after the federal
ESRD legislation was signed into law in 1972, the people who created it
had been given a glimpse of dialysis care in 2009. It is safe to say that
they would have been shocked by a number of unforeseen developments and
First, they would definitely
be shocked by the epidemic of diabetes and ESRD. They would find the number
of patients and the overall ESRD costs to be staggering. Second, they
would be amazed by the low, inflation-adjusted cost of a dialysis treatment
compared to 1972. They would be very interested in the technological developments
and market dynamics that made this possible. Third, after nearly forty
years of medical advances, they would likely find the continuing high
mortality rate among dialysis patients to be perplexing. They would be
especially confused by recent studies that have shown that daily nocturnal
patients can have survival rates similar to those with transplants from
Lastly, I believe they
would be extremely disappointed by the widespread debilitation and disability
among dialysis patients. Although a high percentage of dialysis patients
were employed in 1972, working dialysis patients are now the exception
and the vast majority of working-age dialysis patients today are disabled.
I believe they would be disheartened and shocked that the moral and spiritual
intentions of the legislation, that as a society we are willing to pay
for medical treatments so that ESRD patients can live and contribute to
society — that the potential and purpose of their lives are deemed
valuable and even sacred — has been lost.
I believe they would
find the failure of renal rehabilitation to be unfathomable. Most working-age
patients were expected to become taxpayers. How would we explain that
to them that instead of regularly celebrating their life successes in
the press and media, most of the publicity is about how debilitating dialysis
is? Or that the long-term dialysis patient who enjoys a normal life is
“one in a million”? If they had known they were going to create
hundreds of thousands of disabled people with this legislation, with all
the additional overall societal costs and losses involved, it is unlikely
the ESRD program would ever have been sponsored, let alone approved and
Putting all these pieces
together, these people from 1972 would be dumbfounded by the contradictions.
How could dialysis treatment costs be so low, yet overall costs be so
high and produce such poor survival and rehabilitation rates? What went
so terribly wrong? How could this be fixed?
In addressing these
questions, it becomes evident that some fundamental errors in the ESRD
program occurred. These errors are mostly unnoticed today as they have
combined, blurred, and evolved over time to become our well-entrenched
medical practices and accepted government policies. Unfortunately, the
proposed PPS builds on many of those fundamental errors.
While it will take a great deal of writing to explain these errors and
their unintended consequences, I believe that many solutions that can
quickly return the ESRD program to its original intent and purpose are
relatively simple — and can be accomplished at no or little extra
costs to CMS. With relatively few changes, CMS can effectively leverage
the financial power and needs of the large dialysis provider organizations
as well as the innovative and creative energies of the smaller providers
to increase rehabilitation — AND improve patient survival and lower
average patient costs.
As most are interested
in the solutions, these are listed here first in order of importance:
- Change the Medicare
Secondary Payer (MSP) period for employed, child-rearing, in-school,
or under-age-25 dialysis patients from 30 months to a continuous period.
This simple change would revolutionize dialysis care by turning dialysis
provider corporations into renal rehabilitation companies overnight.
Home and nocturnal hemodialysis would flourish. At once, the corporations
would have financial incentives to keep working-age patients as healthy
as possible for as long as possible.
require protections, as proposed in the healthcare reform legislation
currently working its way through Congress, from life-time caps on
benefits, termination of insurance coverage, and unfair employment
termination due to excessive healthcare coverage needs. Safeguards
should also be in place to prevent providers from extending the MSP
when patients are no longer significantly employed. Nor should private
payers be allowed to pay Medicare rates during the MSP period.)
- Publicize and
feature in Dialysis Facility Compare, MedPAC reports, and elsewhere
the number of working age (18-67) dialysis patients who are working,
students, and receiving vocational rehabilitation services. The results
should be grouped by provider type (for profit or non-profit), hospital
based or non-hospital based, physician, and/or corporation. With this
publicity, even a small dialysis provider could drive improvements throughout
the entire industry.
- Redefine the federal
ESRD program primarily as a renal rehabilitation program. Require providers
and nephrologists to set appropriate medical and treatment goals to
achieve each patient’s rehabilitation goals.
- Establish a patient-led
ESRD Network organization or establish patient-led working groups in
existing ESRD Network organizations to develop policies that increase
- Create a case-mix
adjuster for employment or consider employment an adequate justification
for extra treatments.
- Encourage more
ESRD patients to work by providing financial and/or tax incentives for
patients, providers, and employers.
- Establish minimum
medical and treatment standards based on biochemical markers AND patient-reported
mental and physical function scores for those not choosing rehabilitation
.... for some
As to the fundamental errors of the ESRD program, the three largest in
order of occurrence are:
- The ESRD program
was created under Medicare, but it was never defined as a renal rehabilitation
program. Under Medicare auspices, it adopted a one-size-fits-all approach
that was appropriate for a typical, non-working, retired, Medicare beneficiary.
No renal rehabilitation expertise, reporting, or effective patient feedback
system was developed. The current proposed PPS does not address this.
- When Medicare
introduced the composite rate payment system in 1983, it chose —
either purposefully or inadvertently — to utilize for-profit corporate
forces in its cost control strategies. Unfortunately, instead of using
balancing financial incentives that lowered costs AND improved outcomes,
it only provided incentives for lowering dialysis treatment costs and,
if effect, shortening hemodialysis treatment times. Without counter-balancing
incentives to improve patient survival and rehabilitation, the composite
rate system has produced a slow, continuous, almost unnoticed decline
in the quality of patient lives (inversely related to cost-of-living
inflation?). The current proposed PPS builds on both the success and
failures of the composite rate system. While it has been very successful
in controlling dialysis treatment costs, it has had an unintended disastrous
effect on patient survival and rehabilitation.
payment system for the ESRD program is a patchwork of fixes and adjustments
from many different sources and perspectives. Today, the MSP period
unintentionally functions to work against long-term patient survival
and rehabilitation. Additionally, the separation between Medicare Part
A and Part B, which does not exist in commercial insurance, makes it
impossible for savings in Part A to offset the higher costs in Part
B that are often necessary to achieve improved outcomes and overall
savings in the ESRD program. Unfortunately, this proposal for a PPS
continues and exacerbates these perverse financial incentives. No top-to-bottom
review has ever been done of the federal ESRD payment system and its
short and long-term effects on patients. After receiving so much feedback
with this proposed PPS, there is likely no better time for a complete
review of ESRD payment policies.
The vast majority
of the proposed PPS focuses on attempting to lower Part B overall costs.
It will likely curtail some wasteful practices, especially excessive use
of ESAs. It also includes some very initial considerations for improving
outcomes for dialysis patients. However, because this proposal is limited
in its scope by the conditions of the MIPPA, it does not include considerations
for Medicare Part A or the MSP period, and by itself cannot address the
all the urgent survival and financial incentive problems patients are
currently facing. It can, however, undertake some of the solutions to
prevent further setbacks to renal rehabilitation in the US.
It is not a chance
occurrence that of all the large dialysis provider organizations today,
the one with the lowest mortality and hospitalization rates is the only
one that is a non-profit corporation, Dialysis Clinics, Inc. (See recent
USRDS yearly reports.) In the long term, despite professional ethics,
CMS and the dialysis providers have efficiently produced the exact results
one would expect from existing financial incentives. For these reasons,
I strongly recommend to the HHS Secretary and the CMS Administrator
that they begin an urgent top-to-bottom review of ESRD payment policies
and the fundamental economic incentives they create in patient care.
In the ESRD
industry today, the most powerful financial incentive is to increase profits
by lowering treatment costs. It would probably distress most patients
to discover that the Medicare payment system has inadvertently created
financial disincentives for them to survive longer than
thirty months on dialysis. This is when, under current MSP policy, they
become eligible for Medicare and the lower Medicare payment rates for
dialysis treatments begin. Under this policy, most working-age patients
actually become a financial liability for the for-profit corporations
if they live and thrive beyond thirty months.
When a government
agency intends to utilize profit-driven corporations to achieve its healthcare
goals, it should recognize that there are no stronger drivers of corporate,
professional, and personal behaviors than the financial incentives it
creates. While it is true that these financial incentives have not driven
heartless decisions concerning individual patient care, these incentives
do influence a thousand little decisions over many years at all levels
of a for-profit corporation. These cumulatively lead to attitudes, beliefs,
and a culture that can increasingly ignore the most important concerns
of the patients.
In the end,
Medicare did what it does best – control medical costs for elderly
and non-working patients. In the end, corporations have done what they
are designed to do – maximize profits from financial opportunities
created by Medicare policies. Clearly, when attempting to achieve healthcare
outcomes through for-profit corporation, we need balanced
financial incentives that reward the desired patient-centered, age-appropriate,
and holistic health outcomes we intend — AND lower costs.
can greatly influence who is promoted into management positions at all
levels in a dialysis provider corporation. As an example, if there are
financial incentives to increase the use of a medication, a physician
who is medically aggressive is likely to be promoted into the chief medical
officer position. If there are instead financial incentives for patients
to continue working, a physician who is specializes in renal rehabilitation
is more likely to become chief medical officer. When forming its policies,
Medicare should always keep in mind in its ability to leverage large changes
in dialysis provider organizations and nephrology — with just a
few well-placed words.
MSP period should allow CMS to remain “budget neutral” in
Part B costs while greatly encouraging renal rehabilitation for the patients
that desire it, as long as discrimination is harshly punished when identified.
As only 21% of prevalent patients age 18-54 were working in 2007 (USRDS
ADR 2009, p. 730), and only 15% of all patients have been estimated to
be working one year after starting dialysis, changing this policy would
have a small effect initially on private insurance companies. If renal
rehabilitation suddenly became widely successful, the political process
could be used to negotiate payment policy changes.
three-times-a week hemodialysis treatment
The biggest medical
mistake that this proposal continues is the overuse of short, three-times-a-week
hemodialysis treatments provided in-center during the workday. The widespread
use of this treatment modality for nearly all patients, young and old,
has been the biggest error made by the dialysis care community. After
decades of pursuing shorter and minimum treatment times, it is becoming
clear that longer and more frequent dialysis treatments provide the best
physical and mental functioning and psychosocial well-being.
was the result of a “perfect storm” of conditions: assessing
“adequate” dialysis by Kt/V, the composite rate, high-flux
dialyzers, volumetric-control machines, the desire to treat more patients
on more shifts in a treatment day, corporate consolidations, and the patients
desire to spend as little time as possible on dialysis. Each provided
its own reasons and logic to shorten dialysis treatment times as much
as possible. As bad as it is for patients, this treatment modality is
now firmly entrenched in our government policies, corporate operations,
clinic architecture, dialysis equipment, medical education, and jobs.
With a perfect
storm of conditions all leading to shorter dialysis treatments, patients
failed to receive enough dialysis therapy to lead full, meaningful lives.
Most live their lives feeling as if they are being continually poisoned
and more frequent dialysis treatments with restorative sleep is the key
to rehabilitation for many. It appears that longer treatments during normal
work hours lead to depression, further disability, and higher mortality
for working-age patients. No able-bodied patient wants to endure longer
treatment times in-center and in chairs with television watching as a
primary life activity.
faced with ESRD, virtually no dialysis care professional would choose
to receive, for themselves or a family member, the treatments that over
92% of their patients receive. Almost no patients in the U.S. receive
the care that most nephrologists would select for themselves. With today's
financial incentives, treatment choices that make sense at the personal
level for professionals can rarely be implemented at the organizational
level for patients.
problem is that the medical practice of nephrology has failed to widen,
evolve, and develop in the correct directions to meet patients’
needs. Most nephrologists have become specialists in managing biochemical
markers, instead of focusing on assisting them in leading meaningful lives.
While nephrologists are rediscovering the benefits of simply talking to
patients, as with new patients in the PEAK program, few understand or
appreciate how much of the traditional “medicine man” role
is needed in a demanding chronic illness.
have a well developed branch called renal rehabilitation medicine. Instead,
renal fellows receive little to no training in renal rehabilitation and
few nephrologists have developed any solid experience, let alone expertise
in the field. Disability and depression have grown common and accepted.
Even the latest “medical home” models developed by leading
nephrologists do not include rehabilitation. Most patients are simply
left on their own, trying to figure out how to feel better and, if possible,
live a meaningful life.
nephrologists should talk to hemodialysis patients who have experienced
both these scenarios:
- Dialyzing for three
hours three-times-a-week during the business day in a crowded, busy,
noisy, sometimes hostile, hemodialysis center environment. Leaving the
facility feeling washed out and exhausted, making work impossible and
normal roles in family life difficult.
- Dialyzing every-other-day
for 6+ hours at night while sleeping in a quiet, supportive environment.
Starting the day feeling rested and restored, making employment possible
and enjoying a near normal family life.
By focusing on biochemical
markers for non-working, in-center HD patients, nephrologists are failing
to consider the most important psychosocial components that determine
so much of a patient's quality of life. We need to remember that the original
intent and purpose of federal ESRD legislation was to create a renal rehabilitation
program. Most nephrologists have forgotten this. The reason why almost
no dialysis care professionals would choose to dialyze in their own facilities
is that they know they could have a much higher quality of life with modalities
other than short, 3-times-per-week hemodialysis.
The PPS proposal continues
the one-size-fits-all approach to dialysis therapy focused on in-center
hemodialysis. CMS should have long ago developed classifications for renal
rehabilitation based on age and life goals. Today, a physician must provide
a monthly medical justification if a patient wishes to receive more than
three hemodialysis treatments per week. Instead, a completely different
mindset is needed. It should be accepted that a patient will need more
than that to stay employed and enjoy successful long-term rehabilitation.
be routinely educated that nearly all dialysis care professionals believe
that rehabilitation will require longer and more frequent dialysis treatments.
Compliance with dialysis dose requirements should become a non-issue when
these patients are targeting and begin enjoying higher levels of rehabilitation.
As a starting point, I would propose these five classifications:
seeks rehabilitation, under age 60 – At least every-other-day
hemodialysis or PD. Yearly medical justification for optimal treatment
required to prove employment, family care, schooling, or community involvement.
Continuous MSP (with harsh penalties for employers who discriminate
against dialysis patients or the worker through whom they have health
insurance). Priority for nocturnal treatment. Specialized “expert
patient” training for optimal therapy. Extra payments for home
seeks rehabilitation, over age 60 – At least every-other-day hemodialysis
or PD. Bi-yearly medical justification for optimal treatment required
to prove employment, family care, or community involvement. MSP period,
if applicable, 48 months (with harsh penalties for employers who discriminate
against dialysis patients or the worker through whom they have health
insurance). “Expert patient” training on request. Extra
payments for home training.
refuses rehabilitation, under age 60 – Three-times-a-week, in-center
or home hemodialysis, or PD. MSP period is 30 months. Monthly justification
for “non-rehabilitation” treatment choice required.
refuses rehabilitation, over age 60 – Three-times-a-week, in-center
hemodialysis, daytime treatment or PD. MSP period, if applicable, is
30 months. Yearly justification for “non-rehabilitation”
treatment choice required.
under age 25 – At least every-other-day in-center or home hemodialysis
or PD. Continuous MSP (with harsh penalties for employers who discriminate
against dialysis patients or the worker through whom they have health
insurance). Priority for nocturnal treatments. Specialized “expert
patient” training for optimal therapy. Extra payments for home
Some patients will choose not to pursue any sort of rehabilitation.
Renal rehabilitation is demanding, requires a high degree of compliance
with prescribed medical care, and is not for everyone. Some patients will
always choose the minimal treatment possible. In those cases, dialysis
providers and caregivers must be non-judgmental, evaluate each patient’s
reasons, and provide education to separate myth from fact about work expectations,
benefits loss, and work incentive programs. Providers should treat physical
and emotional symptoms that limit motivation while providing a level of
care that allows these patients to live as well as possible and for CMS
to avoid excessive care costs.
The proposed PPS continues
current CMS policies of measuring quality of care by using URR and hemoglobin
levels. Again, this carries over long-term mistakes from the past and
ignores the patients’ experiences. Few people realize it, but by
using Kt/V and URR, Medicare is targeting the mortality rates from a model
that was developed over thirty years ago that has also proven no more
predictive of morbidity and mortality than patient self-reported physical
and mental functioning scores. When one considers that, it is not surprising
that there has been so little improvement in survival.
As for hemoglobin,
over $35 billion has been spent on ESAs in the last twenty years to boost
hemoglobin levels, much of it justified by expected improvements in survival
and quality of life. However, survival rates have not significantly improved
and a lower percentage of patients now work than when the ESRD program
was established and before the introduction of ESAs. Without patient-centered,
rehabilitation-focused, financial incentives in place, industry forces
have justified the use of costly (and profitable) medications to improve
biochemical markers that have, unfortunately, resulted in few improvements
in patients’ lives.
Now is the time to finally break the awful practice of measuring quality
care solely by biochemical markers. It is time to establish case mix adjusted
physical and mental functioning scores from patient self-report data and
expect dialysis providers to improve the scores that indicate higher risk
of hospitalization or death. When patients self-report depression, they
have a 48% higher risk of death.
the ESRD program continued as a renal rehabilitation program, we would
likely have discovered that patients need much more time on dialysis than
today’s accepted Kt/V or URR levels provide in order to stay employed
over long periods. We would have also discovered that long treatment hours
in dialysis center chairs during working hours leads to depression. We
likely would have discovered that combining sleep or restorative life
activities with long dialysis treatments greatly reduces depression. We
would have seen many companies providing simple, easy-to-use and maintain
home hemodialysis machines. We would have seen more dialysis providers
specializing in renal rehabilitation and fewer of them overmedicating
patients and providing minimal dialysis treatments. With well-developed
employment and rehabilitation data reporting, the reports by CMS staffers
to MedPAC — and their ensuing discussions — would be very
We would NOT have seen the building of thousands of dialysis facilities
designed for short dialysis treatments with staffing shortages of all
disciplines, the lowering of professional to technical staff, and so many
treatment facilities with stressful — and often hostile and frightening
If there are
no rehabilitation incentives
If Medicare is not going to provide renal rehabilitation incentives, we
should then offer all possible incentives for kidney donations that would
provide transplants for working age patients. With many immunosuppressants
now coming off patent protection, it will be far better — morally
and economically — for the patients, CMS, and our tax-paying society.
We in ESRD care in the US would greatly benefit from the work of a medical
historian and medical economist to sort through the developments, successes,
and failures of the program. If we do not understand the past, it is the
patients who are condemned to pay — with their lives — for
our repeated mistakes.