It is not often that an organization like McKinsey,
high-priced heavy duty business consultants, would look to the
non-profit world as a model for business innovation. In “The
ergonomics of innovation
”
two McKinsey consultants analyze what made the IHI 100,000 Lives
Campaign so successful. The point is not that the campaign worked,
but the techniques which made it work. To read their analysis
offers a different way of thinking about innovation in any setting.
Making the right thing to do the easy thing to do is key to having
a real impact. Blending new ideas with old, limiting the burden
of thought and action, specificity of goals, naming the problem,
using a hard count, applying “affordances” are all
highlighted as techniques that foster the spread of innovation.
This is a really interesting look at how pure business consultants
see what we talk about in terms of “using engaging methods” to
engage with physicians. Highly recommended to stimulate thinking
about how to proceed to implement the principles of UFT-A and
more.
The costs associated with ‘never events’ will
no longer be paid by Medicare and many other
payors. What will the impact of no payment
for never events
actually look like? In a case study approach to the reality of
these issues, and the clinical complexities they present, Caroline
Blankenship, in a recent issue of the Health
Lawyer,
not only factualizes clinical circumstances, but calculates the
financial
impact on the hospital and offers practical suggestions to avoid
trouble in the first place. Interesting reading. Please note
the following with regard to the PDF: Copyright 2008 American
Health Lawyers Association, Washington, D.C.Reprint permission
granted.
Further reprint requests should be directed to
American Health Lawyers Association
1025 Connecticut Avenue, NW, Suite 600
Washington, DC 20036
(202) 833-1100
For more information on Health Lawyers content, visit us at
www.healthlawyers.org
The organized medical staff has a unique role in
assuring the quality of care in hospitals. Yet the volunteer
medical staff members are under unprecedented pressures which
inhibit their willingness to take on tasks they traditionally
have performed for free – whether medical staff leadership,
service on committees, or on-call and indigent care coverage.
Now, there is some data showing that throughout the country,
there is an emerging bifurcation into alternate models of medical
staff-hospital relationships. (See, Casalino et al, “Hospital-Physician
Relations: Two Tracks And The Decline of the Voluntary Medical
Staff”, Health Affairs (Sept 2008).
Where in the era of post-failed Clinton health reform, hospitals
bought primary care practices and then had to unload them, more
and more hospitals today are acquiring specialist practices and
employing specialist physicians. Equally present are the settings
in which members of the medical staff go into competition with
the hospital and cease to attend there as much as they used to,
while they own and develop ambulatory surgery centers, imaging
facilities and even whole specialty hospitals. What is the significance
of this for medical staff governance and quality surveillance?
These changes in organizational arrangements really ought to
have little meaning to the functioning of the organized medical
staff in relationship to the hospital board and administration
with regard to its principal responsibilities for quality. The
medical staff members, whether employed or independent or more
typically a mix, still have a unique role in the hospital.
Some commentators have taken the position that
the organized
medical staff is obsolete if not moribund.
We believe they may be wrong; although it is becoming increasingly
important to consider carefully just what the function of the
medical staff ought to be in the highest quality environments.
If 20% of the medical staff is responsible for 80% of the hospital
admissions, then who should be considered Active Staff with governance
authority to make the rules for the interrelationships among
all physicians? Who should define the quality culture for physicians?
If the hospital employs the physicians and mandates their participation
in activities that fundamentally do not interest them, what will
be the outcome for patients? If the medical executive committee
is focused on internecine warfare, endovascular food-fights and
not how many hearses leave the hospital and why, what will the
hospital do without a medical staff on whom it can rely to create
a high quality environment? We think these are essential questions
which merit the attention of hospitals, their boards and medical
staff members. We do not believe that employment of medical staff
members ensures an engaged medical staff which will work well
on quality issues. We think that the current moment in quality
policy and demand for demonstrated hospital quality performance
offers an unprecedented opportunity to reinvigorate the role
of the medical staff around issues that really matter.
Since the inception of this website we have highlighted
the inexorable movement of fraud enforcers to direct targeting
of quality problems as fraud. (See, link to (5) #5, #8, #13,
#27) When the AHLA and the OIG published joint guidance to hospital
boards on their fiduciary responsibilities
for quality it was clearly game on! We have highlighted
the quality-compliance nexus
in the past as well. The rules of the game have so intensified,
however, that we now believe that it can
be said that a major goal for all health care providers in the
21st century will be “Avoiding
Quality Fraud”.
Our article in Trustee magazine is directed to hospital
boards, but has meaning to everyone in health care. The increasing
volume of quality data reporting, implied statements about quality
in claims filed, and flat out false claims liability lurk. It
is significant that hospital quality data reporting has been
targeted by the OIG in the 2009
Work Plan as
a topic of attention.
In her first participation in the teleconference series offered
by The Reinertsen Group, Alice elucidates the varieties of these
frauds and their pitfalls. In this 90 minute presentation she
offers practical tips for avoiding quality fraud in a dialogue
with Jim and Jamie Orlikoff. The teleconference is available
for
sale and download.
The search for a new payment model to propel and
support better quality of care continues with even greater fervor,
given the economic crisis and rising health care costs. Meredith
Rosenthal, a member of the PROMETHEUS Payment® Design Team, but
also one of the premier scholars on pay-for-performance, looks
at efforts to move beyond P4P in her article “Beyond Pay
for Performance – Emerging Models of Provider-Payment Reform.” NEJM
359:12 (September 18, 2008) 1197-1200. She offers a nice chart
which compares the general approaches of incremental reform (no
pay for “never events”), primary care payment reform
(medical home), episode-based payment (PROMETHEUS and Geisinger)
and shared savings models (Medicare Group Practice Demo). She
concludes that there are fundamentally no “new” payment
methods, and that economic theory (and she is an economist) holds
that mixed payment models will work better than any one approach.
This leaves the door open to new variants to emerge. It is fair,
however, to observe, based on this review, that the PROMETHEUS
Payment® Model offers the most robust new payment vehicle
available, today.
The Medical Home, sometimes
referred to as the “Patient-centered Medical
Home”, despite
sounding like a website or new kind of residential facility,
is gaining traction as a route to reorganizing the delivery of
care to certain populations. Finding its foundation 40 years
ago in pediatrics, it is now touted as the answer for primary
chronic care improvement as well as payment. A recent search
for those who are very successful with these programs has led
Arnold Milstein MD, to draw some interesting conclusions about
what makes for a “Medical
Home Run”. Unwavering commitment
to keeping patients out of the hospital
is key. By the same token, though, a recent issue of Health Affairs
has looked at a variety of controversies and claims regarding
the medical home, from differences in its definition
and components,
to whether those who might be most interested in offering the
medical home model in fact have the infrastructure to do so.
Rittenhouse, Casalino, et al, found that large
medical groups were better prepared
with elements of infrastructure alone (e.g., patient reminders,
physician feedback, electronic
records
and more) to offer this approach to organizing care delivery,
but even they were not routinely ready to do all that the medical
home model promises.
In reviewing the claims for this model, it appears there are
two movies currently playing in local theaters: Medical
Home: The Clinical Movie --- which is about organizing care delivery
to be sure patients can rely on a single practice to be accountable
for and responsive to their needs across the continuum of care
delivery; and then there is Medical Home: The Payment
Movie.
Here the story is yet another transitional approach to curing
the dissymmetry between high quality, patient-centric clinical
processes and current payment models. Medical Home: The Payment
Movie seeks additional dollars to pay for the infrastructure
which makes coordination of care possible. In fact, were additional
payment to be made for intrastructure alone, there is no guarantee
any change in quality would result. Still, it is indisputable
that it costs money to implement infrastructure that makes a
medical home possible --- to use non-physicians to help engage
patients in their own care, maintain registries and other electronic
data to foster clinically important interactions with patients
and to keep tabs on the care they are getting.
The PROMETHEUS Payment® Model is highly consistent
with the Clinical Movie script and is even better than the transitional,
small-additions-to-current-payments storyboard of the Payment
Movie. Also intriguing is the application of the medical home
clinical approach to other types of care, like hematology-oncology.
Those physicians are losing their business model based on drug
payments and ought be paid for the care and coordination that
are the core of what they do. Infectious disease physicians have
similar issues, as do rheumatologists treating arthritics. The
basic premise of the Clinical Movie is not only viable for primary
care. It deserves consideration elsewhere. Elements of it are
consistent with UFT-A principles as well.
The Institute for Healthcare Improvement (IHI)
offered the first program on Engaging Physicians in A
Shared Quality Agenda in February, 2007. IHI has offered the program
four times; and the next time will be April 21-23, 2009, in Chicago.
This program has consistently sold out six weeks in advance.
Under the leadership of Jim, we are joined by two other faculty
members for what has been a two day program. Now, because of
the intense interest and burgeoning need for more tools to engage
physicians, IHI is adding an optional additional half day, led
by Alice and Jim, that will focus on the role of medical staff
bylaws in advancing quality and associated controversies with
hospital payment to physicians around quality including Stark
and gainsharing, as well as compensating physicians for quality
within their own groups. Folks who have attended the earlier
IHI programs can register for the half day as a stand alone as
well.
If you look
at the agenda, you will see how unique it is, interweaving
principles of clinical process standardization, with the physician
business case for quality, the use of compacts to change culture,
with an understanding of permissible boundaries for financial
relationships between hospitals and physicians under fraud and
abuse, stories of what works…and more. We have revised
the session in multiple ways to make it even better based on
attendee comments. Jim and Alice are also available
to present their parts of this program outside
of the IHI context, customized for specific organizations in
shorter sessions. The driving principle
here is that hospitals will fare far better if they organize
more around engaging effectively in the physicians’ quality
agenda. The principals, methods, and framework are applicable
to other kinds of health care providers and in other settings.
The background for the program is now available in a formal IHI
Innovation Series White Paper which
provides the framework and the reasoning behind its six components,
along with resources
and tools to make physician engagement real.
Gainsharing ---- where hospitals give to cooperating
physicians some of the savings from cost reduction steps ---
has been cited as a potential quality enhancing technique which
also can bond physicians with hospitals. Gainsharing was the
basis for a fraud and abuse settlement with the Paracelsus Hospital
Company back in 1983 when DRGs were first implemented. The OIG
has now approved about a dozen of these programs, focused
around procedurally based services. Labeled
as efforts to standardize care, the approved programs have multiple
bell-and-whistle safeguards against reducing services to patients,
but all of approved programs are short-lived (one year in length).
While gainsharing may serve some purposes in the short-run, it
has limited applicability and is not at its essence about quality.
By contrast, as part of the 2009 Medicare Fee Schedule, CMS has
proposed regulations to govern both gainsharing (“shared
savings”) programs and quality incentive payment programs
under the Stark statute. Protection will be available only to
programs between hospitals and physicians. You can read Alice’s
comments to CMS on the proposed quality
incentive payment regulations,
in which she distinguishes the risks in these types of programs
and calls for greater flexibility in the context of incentive
payments.
Under the auspices of the Office of the Governor,
North Carolina has launched a statewide program to implement
evidence-based care guidelines for five chronic conditions. Health
plans and providers have agreed to provide consistent services
to patients regardless of their health insurance coverage. The
initiative was
apparently a year in its development. Involving collaborative
efforts among
physicians, quality experts and insurers, it is part of an
effort “to
fundamentally restructure the delivery of health care in North
Carolina” in accordance with best practices. Interestingly,
none of the press stories reveal the chronic, traditional anxiety-driven
provider arguments with respect to potential malpractice liability
which could emerge from the adoption of these guidelines. Perhaps
we are finally getting to the enlightened understanding that
doing the right thing will actually potentially prevent both
malpractice claims and exacerbated illnesses --- the point
of standardizing care in the first place.
The fundamental principle of UFT-A is that if all
the members of the care team collaborate in accordance with the
same iterations of the best science available, the whole system
will work better. In an interesting survey of The
Role of Nurses in Hospital Quality Improvement,
the Center for Health System Change elucidates the tensions in
the accreting volume of quality improvement work expected of
hospitals, as well as the need for nurse engagement while care
at the bedside is also a critical challenge in light of staffing
shortages. The role of culture and leadership in supporting nurse
involvement was cited, along with the results that came when
nurses were supported in their engagement. As Jim says on his
website, “If
you really want it done right, regularly, get a nurse involved.”
For UFT-A principles to work, the whole care team should be engaged
at their highest and best uses, in accordance with the clinical
guidelines that drive the enterprise.
Pay for performance is sweeping the country. Despite
equivocal data as to success and impact, most payors regard it
as inevitable, and most physicians are resigned to its arrival
soon at a theater near them, if they are not already confronting
it. Medicare’s ‘pay for quality reporting’ initiative
really is “pay for whatever I did” because it is
the completion of the form, not the quality of the care, which
gets the payment bonus. CMS was met with a tepid enrollment of
17% of potential participants. And that program is not
limited to physicians, but includes other non-physician practitioners
as well. While these initiatives continue to be touted as ‘payment
reform,’ on the other side of the ledger, both CMS and
many health insurance programs are adopting no pay for no performance
programs by denying payment for never events -- mishaps of such
an egregious nature that they never should have occurred in the
first place, in essence no pay for no performance. Hospital associations
have stepped forward to say their members will not bill for such
events including wrong site surgeries, retention of foreign objects
after surgery, death or disability associated with wrong type
blood transfusions. First promulgated by the National
Quality Forum in 2002, the list of the initial 27 “never events” is
not without controversy, since a range of the conditions cited
include matters which may have been present on admission (decubitus
ulcers). Medicare has proposed to add conditions to those it
already requires to be reported and on which it will not pay
for the care devoted to treatment of the event or complication.
There is some question as to whether this approach will be applied
to physicians. In the PROMETHEUS Payment® model, a readmission
for something related to myocardial infarction within thirty
days of discharge is considered a potentially avoidable complication
for both the physician and hospital.
The challenge of engaging physicians in quality
initiatives at the hospital often falls most heavily on the shoulders
of the medical leadership in the C-suite, whether the chief medical
officer or the VPMA or the chief of staff. In our article directed
to these folks, “Finding
Common Cause in Quality: Confronting The Physician Engagement
Challenge”, we dispute
the metaphor offered by Jeff
Goldsmith of the hospital-physician engagement continuum as a
coral reef of predators and prey. From our continuing work with
IHI and medical staffs and hospitals around the country, we continue
to hold the firm belief that enormous strides can be made for
better patient care and more activated physicians, when physicians
are seen as the hospital’s true partners and not mere customers.
With her study of the current identified effects
of P4P, traditional compensation models within physician groups,
survey of groups
which do compensate on quality and consideration
of the legal issues in doing so, Alice opened the door to focusing
on this aspect of motivating quality improvement. In her article, “Compensation
for Quality: The Next Inevitable Step”, she not only makes
the point that quality will never reach optimal levels if physicians
do not have consistent payment incentives within their groups,
but she affirmatively calls for more information about organizations
which do pay their physicians for quality. It is hard to believe
that only 14 groups around the country, and most of them very
large multi-specialty organizations, are experimenting with these
efforts. Since the article was published she has received information
from 5 more groups whose data tracks directly to her earlier
findings. The phenomenon is increasing. But some have been toiling
quietly at this work for longer than any published reports would
reveal. If your physician group or system compensates your physicians
in any measure for their quality performance or based on their
quality performance, please contact us at info@uft-a.com with
your story.
First convened in December
2004 as a disparate group of experts intending to design a new
payment model, PROMETHEUS
Payment® Inc., has now been awarded a $6.4
million grant from the Robert Wood Johnson
Foundation, to develop a scorecard, refine the concepts and most
importantly test the program in
four pilot sites across the country. Having modeled its first
Evidence-informed Case Rates® for actual implementation
beginning in 2009, the results are quite stunning. In her plain
language article, “Making
PROMETHEUS Payment® Rates
Real: Ya’Gotta’ Start Somewhere” Alice
explains the methodology of constructing the rates. First, she
elucidates
how the Design Team took into account its clear understanding
that physicians would be suspicious of rates built on claims
data. There are five specific financial cushions built into the
rates. The result is that the care for a controlled non-insulin
dependent diabetic, whose care comes primarily from a physician
office, would be paid based just on the claims data at $311 a
year; but, under the PROMETHEUS system, the same patient’s
care would be eligible for $2329 to the physician!!! At the same
time, what is most remarkable is that this approach to the broad
problem of delivering science based diabetes care would save
the system represented in just the database we are using and
this one condition, more than $340 million. This is a very powerful
reason to move to the PROMETHEUS Payment® model. Similar
results are emerging for the other conditions we will address
initially as well. The more important hidden message in the article,
though, is whether our specific program is implemented is not
the issue. Throughout the American healthcare system, we are
spending extraordinary amounts of money on potentially avoidable
complications, while we are not paying providers enough to do
what needs to be done to prevent those complications in the first
place. Thinking about which services the PROMETHEUS model considers
to be potentially avoidable, and then analyzing how to avoid
them, is a good way to approach how to organize clinical service
delivery for better results with greater efficiency. PROMETHEUS
Payment® Inc. is looking for provider-plan combos who want
to step up and try implementing some of the ECRs® without
being a formal pilot site (which requires a three year commitment
to use all the ECRs® and participate in evaluation. If you
would like to explore that possibility, please contact us at PROMETHEUS@uft-a.com.
Be careful
what you measure and reward is a longstanding truism
in quality measurement, because the subjects of the reports
will work to get good scores. As
a result, the risk that other problems will be ignored increases.
This phenomenon has recently produced potential over-diagnosis
and consequent over-prescribing in response to CMS
measures.
When payment is linked to specific activities, those activities
will
be done to be assured of achieving the payment. That is the point
of incentives. UFT-A takes a different approach. While one of
the tenets is to fix accountability at the locus of control,
linking specific accountable behaviors to specific additional
payments or reductions, is like fee-for-service in drag – it
simply motivates the measured behavior in isolation and nothing
more, unless composite scores are used, UFT-A, and now the PROMETHEUS
Payment® model, both stand for the proposition that paying
the right amount for the right services at the right time, with
no single behavior generating additional or reduced payment is
a far better way to go.
For well more than thirty
years, the literature has confirmed that the single most powerful
risk management technique is a good doctor-patient relationship.
Patients do not sue the doctors whom they love. In the current
world of quality performance and measurement, patient satisfaction
is an important metric, given the weight of patient-centeredness
since Crossing The Quality Chasm. "Engage the patient" is
one of the five tenets of UFT-A. In an interesting discussion
of patient satisfaction, and specific steps to improve scores,
Goodman and Ward have demonstrated that "Satisfied
Patients Lower Risk and Improve the Bottom Line." Besides
the very practical guidance they offer, though, their article
speaks to
the need to aggressively seek out patient complaints. This approach
to patient-centeredness offers a potential bellwether for clinical
quality problems. And the most advanced organizations are engaging
patients and families much more pro-actively—as partners
in the actual design and delivery of care—rather than asking
patients to report on their experiences after the fact. This
process, which has been labeled “Putting
the patient in the room”, is exemplified by the work
of Cincinnati Children’s (family
are considered essential members of the ‘rounding team,’)
Dana Farber (patients and family members are prominent members
of virtually every committee and task force) and perhaps most
aggressively at PeaceHealth St. Joseph’s, Bellingham WA
(where a patient is a full member of the Medical Executive Committee!)
When we launched this website almost five years ago, we proposed a range of activities for
which evidence-based
medicine, clinical practice guidelines and standardized care
could be brought to bear in far broader ways than simply with
regard to a payment model. While PROMETHEUS
Payment®, Inc., will now be given
an opportunity to demonstrate its potential with the award of
a more than $6,000,000
grant from the Robert Wood Johnson Foundation to test the model
in four pilot sites, other attempts at payment reform are surfacing.
The Geisinger Health System has launched its ProvenCare
methodology which is not really a payment
system but a warranty for the quality of the care they produce.
Limited initially to CABG surgery, tested in their own health
plan, for
a single case rate
payment the hospital and physicians agree to provide care for
all complications. Obviously this creates an incentive to prevent
those complications. In a similar vein to prevent errors, increasingly
health plans are refusing to pay for, and in Massachusetts, Pennsylvania,
Minnesota and Vermont, hospitals are agreeing not to seek payment
for “never
events.” While these new disincentives
may improve patient safety, none qualifies as actual payment
reform.
On a different note, the Blue Cross Blue Shield
plan in Massachusetts has launched a program which appears to
be a new
form of capitation with a quality bonus added
on top. The press reports they are using to launch their voluntary
program
tout the fact that the capitation rate will be severity adjusted
on an unspecified basis. They expect a very slow roll out and
acknowledge that most of the takers will be primary care physicians
who might appreciate a 10% bonus on their capitation rates. This
is pay-for-performance on a capitation platform and not true
payment reform. In fact, besides the PROMETHEUS Payment®,
model, there are essentially no other true provider payments
reform
models being proposed. Presumably the complexity in designing
something comprehensive is daunting. In her article “Physician
Compensation: Behind the Green Door,”Alice reviews
the current major payment reform proposals, including the advanced
medical home and some other ideas for primary care, and elucidates
their limitations. Only the PROMETHEUS Payment®, Inc.,
model conforms with the fundamental UFT-A principle of defining
the
payment amount from a clinical evidence-informed base making
it clinically relevant by removing actuarial risk from payment,
but also aims at engaging patients through transparency and fixing
provider accountability at the locus of control.
The battles over physician
views of quality rankings
based on efficiency
continues. In a measured analytical piece on “Comparing
Physicians on Efficiency” Arnold Milstein, M.D.
and Tom Lee, M.D., parse out nicely the differing perspectives
of customers – both patients
and subscribers, as well as employers and insurers – versus
the views of physicians regarding efficiency measurement. To
the extent that efficiency is “who is cheapest,” neither
customers, nor physicians can take comfort in the quality of
the care that is fostered in such an environment. Challenges
to the way health plans manage these programs will continue among
stakeholders until common values can be brought to bear in this
arena. Milstein and Lee rightfully challenge physicians to step
up and embrace the need for such measuring tools in the struggle
for improved quality of care in a context of limited, that is,
not infinite, resources.
From our first exposition of the principles of
UFT-A, one of the simple values at the core has always been physician
engagement, not just through medical staff structures. We have
emphasized a far more expansive view of the potential contributions
of physicians in implementation of corollary, quality-supportive
initiatives. “Guiding
Force” tells the story of the successful design and
implementation of an electronic medical record and computerized
physician order
entry system at a hospital in California where the entire project
was turned over to the physicians to make it happen. This was
not a closed medical staff, but a medical staff of volunteer
community-based physicians in a fiercely competitive market.
The article speaks very directly to the real potential in and
the positive impacts from broader physician engagement with hospitals
than simply around the implementation of clinical practice guidelines.
It also supports the proposition that with the proper attention
to governance in the development of such initiatives along with
clear principles of engagement, truly effective programs can
be crafted.
As the spotlight is focusing
more intensely on hospital quality performance, the roles of
trustees are increasingly
under government scrutiny. In addition to our suggestions regarding
how trustees can more effectively facilitate improved
physician engagement around
quality, the new publication jointly authored by the American
Health Lawyers Association
and the OIG “Corporate
Responsibility and Healthcare Quality: A Resource for Healthcare
Boards of Directors” reinforces
the intense interest of the government’s enforcers
on the critical accountability of hospital boards for effective
quality initiatives and sound quality performance. This unique
monograph elucidates the Board’s fiduciary duty for quality
and its accountability for the implementation of quality initiatives,
but, most significantly, it also presents an explicit exposition
of the government’s role in enforcing healthcare quality.
The monograph suggests ten critical questions all boards should
be asking to be sure that they are effectively fulfilling their
obligations.
The ability to get proper on call coverage for
the hospital emergency department is a growing challenge for
community hospitals as documented by the Center
for Health System Change. Specialist
physicians have become increasingly fearful of serving on the
on-call rotation given increased liability and larger numbers
of indigent and uninsured patients. Medical staffs around the
country have reduced the requirements for physicians on the medical
staff to perform this function, which long was seen as the physician’s
professional responsibility, which in earlier times they fulfilled
without much complaint. To cope with this problem, hospitals
have developed a range of strategies which the Center identifies
in their report. Now, for the first time, the OIG has issued
an advisory
opinion
explicitly approving an on-call and indigent coverage program
to pay members of the medical staff for performing these services.
Some have declaimed the safeguards this hospital established
as unwieldy and impractical, but the good news is that the OIG
has acknowledged this critical dilemma. They are still confused,
in some ways, though, over the role of the medical staff in that
most bylaws no longer require most categories of the staff to
provide coverage. And, the EMTALA liabilities to make sure coverage
is available are the hospital’s and not the medical staff
members’ unless they are on the on call schedule. This
is one of many ways in which hospitals can pay physicians to
do work on their behalf to the ultimate benefit of their patients.
Clinical integration is a technique by which independent
physicians and group practices can relate to one another for
quality and still bargain collectively over price with managed
care plans. Although cited by the FTC in virtually every settlement
with IPAs and combinations that bargained collusively over fees,
the indicia of proper clinical integration have not been well
defined. Some settlements and one Advisory
Opinion,
now almost six years old, have staked out some of the tur;, but
most of what the behavior the government has reviewed, it has
always seemed, were motivated more by price aspirations than
quality improvement. The lack of clear guidance has led the American
Hospital Association to call
on the FTC and DOJ for
greater specificity
in describing what would qualify as good
clinical integration.
Now, in their advisory opinion to the Greater
Rochester IPA,
the
FTC has described a program which seems far more to emanate from
a quality impetus. Because GRIPA was well integrated clinically
for the work it did in connection with HMO products, it had a
relatively easier time orienting its activities to the PPO, fee
for service, business where the antitrust risks are far greater.
The opinion is a useful statement of one modern model of clinical
integration.
The recent change in the JCAHO
Medical Staff Standard 1.20
to require that the medical staff bylaws be an integrated document
has created a firestorm of controversy that should be less than
a tempest in a teapot. Prediction of expensive disasters in redrafting
bylaws, and arguing over what is process versus what is procedure,
is absurd and fomented by a cadre of law firms who have made
significant income from advising medical staffs and hospitals
that the bylaws should be divided up into five different sections
so that they may be more easily amended. The Medical Staff Bylaws
are the Constitution of the Medical Staff and should be amended
about as easily as the US Constitution is amended. Alice has
written and advised on medical staff bylaws for more than 100
medical staffs all around the country over the last 30 years,
and this is not all she does, as it is for some law firms. She
has never advised a medical staff to disaggregate their bylaws.
The other noteworthy change adopted by the JCAHO for 2009 is
that the medical staff should have the right to propose medical
staff bylaws changes directly to the board. This should be non-threatening
unless you have a renegade medical staff or a renegade medical
executive committee where the representative function of the
MEC has broken down. It would be the board’s responsibility
to sort this out if the medical staff asked for changes, not
recommended by the MEC, that were not in the best interests of
the hospital. Everyone should calm down about these feared power
struggles and focus on the real purpose of the medical staff,
which is to be responsible for quality in the institution. When
organizations do that effectively the medical staff can become
more galvanized for a far better purpose than internal turf and
power struggles.
For years, we have been working on techniques to
help physicians and hospitals collaborate more effectively to
improve quality. In our white paper for IHI
and the two
day programs we do for IHI which routinely sell out weeks
in advance
as well as other
offerings,
we describe a six step plan to accomplish improved engagement
around quality. Now, in “Sharing
the Quality Agenda with Physicians”,
we focus explicitly on the unique responsibility of lay
trustees to create
more effective physician engagement with hospitals. We explain how the board can ask the right questions
and seek the right data to make engagement and quality strides
effective and real. We emphasize the importance of meeting the
varying needs of different segments of the medical staff and
describe Stark compliant initiatives that should be considered.
Pay for performance programs
show no signs of abating in popularity, yet their impact remains
equivocal. Whether quality
would be better if physicians within groups also paid themselves
based on quality performance is unknown. If the incentives of
P4P are to have impact, how are those monies distributed to the
individual physicians once the group gets paid? There is virtually
nothing in the literature on point. In “Physician
Compensation for Quality: Behind The Group’s Green Door,” Alice
looks at the data on P4P programs, the basics of traditional
compensation within groups and then presents the findings from
a unique survey which was sent out on her behalf by the AMGA
producing responses from 14 groups around the country who are
variably paying for quality as part of physician compensation.
Some report significant improvement in quality performance, too.
Alice then looks at the payment reform models on the horizon
and concludes that traditional notions of productivity, on which
most current group compensation models turn, will not reward
what the new systems, and most particularly the PROMETHEUS Payment® model
(www.prometheuspayment.org) is designed to generate. She examines
whether the Stark rules on compensation will be a barrier
to changed, creative approaches, concludes that it will not,
and then looks at what employment contracts will have to accommodate
to make physician compensation for quality within groups real
and of value to both patients and physicians.
On December 5, 2006, Health Affairs published a
web
exclusive series of articles offering some fascinating
perspectives on hospital-physician relationships which
are particularly relevant to physician engagement
with hospitals around quality. Berenson, Ginsburg and May
observe that physicians have increasingly become competitors
of the
hospitals which were formerly their most valued "significant others".
Fisher, et al. argue that hospital quality results should be
measured to include the "extended hospital medical
staff" which
would take in physicians who refer to the facility but never
set foot in it. Wilensky, Wolter, and Fischer present a new spin
on gainsharing as a way to meet the ever elusive goal of "aligned
incentives". Smithson and Baker contend that the medical
staff organization itself is a moribund anomaly and not
worth accommodating at all. Goldsmith offers a view of
the medical
staff as a Darwinian coral reef with predators and prey;
while Cortese and Smoldt claim that legally integrated
hospital-physician entities are the only hope for the future.
The provocative juxtaposition of these articles reflects the
intensity of interest in the intersection of physicians’ economic
behavior with the hospital’s status as an institution where
most of the activities are driven by physician orders. All acknowledge
that improved medical staff-hospital relationships are indispensable
in today’s world.
We make no argument for a one-solution-fits-all
approach. We have seen circumstances in which employed physicians
are just
as restive and disengaged as independent physicians and, by contrast
hospitals where the independent medical staff has taken significant
responsibility for enhancing quality of services rendered within
institutions’ four walls. In our programs
for IHI,
the IHI
white paper, and other work with clients, we take
the position that most physicians have a profound interest in
quality, particularly in terms of outcomes for their patients
and efficiency in the use of their time. The holy grail of “aligned
incentives” and structure-driven solutions can only offer
short-lived hope unless these efforts recognize that physicians
themselves are increasingly reported on for their quality results,
risk fraud and abuse enforcement for quality failures, and have
a strong cultural concern for excellence and professionalism.
All combine to define their business case for quality which must
be the fulcrum to better relationships with hospitals if they
are to be sustainable.
Among the many strategies for closer alignment
between hospitals and their physicians are the proliferating
joint ventures and financially driven exercises, including gainsharing,
that are intended to capture with more revenues the loyalty of
the medical staff members who are involved. In her editorial
in a recent issue of the Journal of Oncology, "Physician-Hospital
Partnerships: What Really Counts?",
Alice argues that unless the quality implications of hospital-physician
ventures
are their driving purpose, these transactions may generate short-term
revenues, but they will not feed the core needs of their participants.
Still, they may have an important role within the context of
a well-thought out physician engagement strategy.
What qualifies as excellent care is the core of
any quality discussion. When the issue is who are “the
very best doctors”, there are new questions worth asking.
Jim has raised these in an incisive PowerPoint
presentation
which
supported a program he conducted for a large physician group.
He articulates commonly cited attributes of good doctors – reputation,
technical skill, pedigree and bedside manner--- and distinguishes
them from uncommonly cited attributes of good doctors such as
reliability and accessibility. What physicians have traditionally
valued in their assessment of what makes the best physicians
is more and more at variance with views of high quality expressed
by regulators and payers, and is rarely based on data. How to
marry both views and improve quality of care is a persistent
challenge which we believe can be met through the kind of organized
analysis which we present in our framework for physician engagement
in the IHI
white paper.
The increasing emphasis on quality as a basis for
fraud and abuse enforcement is now clear. Yet many compliance
officers are not integrated into the quality activities of the
organizations they serve. In her viewpoint on “Doing
What Really Matters: The Compliance Connection to Healthcare
Quality” in the Journal of Health Care Compliance, Alice presents three
activities through which compliance officers can work more effectively
on quality issues in addition to the fundamental challenge of
raising the consciousness of the board and administration of
any healthcare entity to these new quality mandates.
UFT-A principles call for using clinical practice
guidelines at the center of a wide array of administrative and
clinical processes, and most particularly with respect to payment.
A fascinating report on one organization’s response to
a managed care plan’s creation of a high performance network
(a far narrower network for more efficient providers) can be
found in the story of how the Virginia-Mason
Medical Center (VM) redesigned care delivery to achieve better
payment
. Aetna had been planning to exclude VM from its Aexcel program,
but four major employers agreed to reconsider including VM if
they would work toward specific cost reductions. The report of
the steps that were taken is especially interesting coming from
a health care system that was revamping many of its clinical
processes to achieve stellar results. VM is widely regarded as
a principal avatar for implementing the Toyota production model
in American health care. This story is particularly intriguing
since Aetna represented only 10% of the Seattle market.
The innovations relied significantly on the use of guidelines-based
care. For the relatively limited services on which they focused
--- pharmaceuticals, emergency department visits, diagnostic
testing, some physician services in treatment of migraines, use
of magnetic resonance imaging, and treatment of GERD – there
were some limits to the exercise. There was no formal program
evaluation and therefore no comprehensive data corresponding
to the major cost centers that had been initially identified
as meriting change. The impact of VM’s interventions was
difficult to assess because relative data remained proprietary.
The impact on VM’s margins was also entirely unclear.
Despite these limitations, the elements of success
in the program reflect many of the UFT-A principles and some
that mirror PROMETHEUS
Payment® principles. The collaboration among purchasers, health
plan and provider was critical, as was access to detailed cost
data. This issue raises, yet again, a fundamental problem – namely,
even very sophisticated and highly integrated provider networks
have virtually no data available with respect to what it costs
them to treat a patient for a condition. Providers ought to begin
to develop this data whether PROMETHEUS Payment® comes
to their local movie theater soon or not.
Improved clinical collaboration,
which is at the core of the PROMETHEUS Payment® program, also
is relevant to
the five UFT-A principles – (1) standardize; (2) simplify;
(3) make clinically relevant; (4) engage the patients; and (5)
fix accountability at the locus of control. These principles,
combined with highest and best use of all clinicians, administrative
burden reduction and reinvigorated time and touch with patients,
will be keys to PROMETHEUS Payment® success too. In fact, much
of what the new payment model rewards, providers should be doing
anyway, whether anyone pays them differently or not. Quality
driven efficiencies – not in the “who is cheapest” sense,
but in the “how can we be more resourceful and use our
time and resources better” sense --- ought to compel providers
today. UFT-A calls for the methodical elimination of self-imposedinefficiences
which steal time and touch from care. In her editorial "A
New Payment Model for Quality: Why Care Now?" Alice
articulates some of the tenets of PROMETHEUS Payment® that all
providers should be working to make real without a new payment
model.
Clinical practice guidelines (CPGs) are the foundation
for UFT-A principles and also the predicate for PROMETHEUS Payment® Evidence-informed
Case Rates®? (ECRs®). In their article “Integrating
Clinical Practice Guidelines Into The Routine of Everyday Practice”,
cardiologists John Brush, Martha Radford and Harlan Krumholz
confront the complexity of many CPGs – and particularly
the spectacularly well documented ones of the American College
of Cardiology/American Heart Association – and how that
impedes their implementation on a day to day basis by practicing
physicians. Published in 2005, their propositions have not been
widely discussed, but the issues presented will have to be addressed
if CPGs are to be used more widely than they have been. The application
of the ‘heuristics’ they cite as endemic in the practice
of medicine --- unwritten rules of thumb, practical short-cuts,
and other work-arounds – must be explicitly acknowledged
and taken into account to get to more standardized and evidence-based
care. Fortunately they offer specific solutions for professional
organizations creating CPGs and physicians who would seek to
apply them. All will lead toward more reliable standardization
to the science.
The creation of ‘high
performance networks,’ which
tier and exclude some providers with the stated purpose of incentivizing
patients to go to the ‘better’ physicians has met
with considerable alarm from physicians.
Decried as purely networks of the cheapest, the debates today
include direct challenges
to the quality of the data used to exclude some in favor of the
preferred status of others. The tensions are only escalating.
In “Doctors
Rated But Can’t Get Second Opinion”
the Washington Post reports on tiering programs with report cards
in Massachusetts, the District of Columbia, Seattle, New Jersey,
New York and Connecticut which have met enormous resistance,
including a threat by the New York Attorney General to enjoin
United Healthcare’s implementation there of the program
it launched in St. Louis. Lawsuits abound and the struggles over
the intersection of cost and quality continue.
With the announcement of an initiative to launch
September 2007, CMS will seek information from 500 hospitals
nationwide about physician investment in them. Of broader significance,
however, they will also be asking hospitals for disclosure of
hospital-physician compensation relationships under Stark. Half
of the hospitals are those who did not respond to a voluntary
request for data. The others will be chosen at random. In the
announcement of the now mandatory
reporting,
the government makes it clear that the information can be used
by them for any legitimate purposes including enforcement. While
this announcement is a good reason for hospitals and physicians
throughout the country to review all such relationships for compliance,
it is not well understood that the Stark regulations offer both
flexibility and some opportunities for hospitals to pay physicians
directly for work they do for the hospital’s benefit. The
Phase II regulations made it clear that compensation for physician
personal services provided to the hospital has safe harbors which
are specified in the definition of ‘fair market value’.
At the same time the preface to the regulations explicitly states
that paying outside of the 50th percentile of MGMA does not necessarily
violate the law, although safety is not guaranteed there.
Paying physicians for their time in helping the
institution improve its quality performance is increasingly important
as
physicians struggle against lowering reimbursement and higher
overhead expenses. As the activities for which hospitals pay
physicians expand, the fundamental problem is that they can be
paid primarily for their time --- the one dear commodity they
have little to spare. There are, however, a host of things hospitals
can provide which benefit physicians and enhance their business
case, while improving quality --- all without making cash payments
to them. These are issues we have addressed in our articles in
Hospitals and Health Networks Online (Part1, Part
2), the
Journal of Oncology Practice,
the IHI
White paper and more.
Some of
our clients are also looking more closely at rewarding the “good
citizenship” of their active medical staff members ---
the ones who attend meetings, and work on quality initiatives
and help the organization meet quality targets. Without paying
for achievement of good results (which patients expect of their
hospitals and physicians anyway), some hospitals are considering
more innovative approaches: when departments are working hard
and achieving good quality scores, they get departmental perquisities
from flat screen TVs, to free internet access in the departmental
doctors’ lounge, to a preferred line for transcription
or lab results, to concierge-type support for their offices in
the admission process. None of these implicate the Stark statute
because they are not about providing physicians with a financial
benefit or service they would otherwise pay for themselves. These
are services specifically valuable to the hospital, but they
give the physicians back time. Using the compliance education
regulatory exception under Stark has become even more popular
as the legal issues associated with quality, including antitrust
and P4P, have multiplied.
David Eddy has long been regarded as one of the
most prominent and elegant thinkers regarding evidence-based
medicine. His 1998 article on performance measurement in Health
Affairs presaged many of the issues, including attribution,
now being decried in the context of pay for performance. In 2005
he wrote about the confounding by most users of the term ‘evidence-based
medicine’ to apply to both the evaluation of the quality
of the science supporting clinical processes as well as a separate
and distinct concept of the application of that valuation to
other societal choices related to payment
and benefit coverage. Now, in a provocative dialogue with
Sean Tunis, who formerly managed technology coverage policy for
CMS, David elucidates further the boundaries of true
'evidence-based' medicine,
and its applications. Without cost and value judgments introduced
in the application of the evidence to the policies for which
it will be used (e.g., coverage and payment policy), though,
he argues that the application of the first part of the analysis
(what is the quality of the evidence on which clinical activities
should unfold) is not enough. “What people need to realize
is that by pretending to ignore costs, we are not only wasting
money, we are also spoiling quality. If one cannot consider costs,
then there is no way to address efficiency or set priorities.” “…[A]fter
you have analyzed the evidence for a performance measure, you
still have to make a value judgment about whether the benefits
of increasing performance outweigh any harms and justify any
costs.”
UFT-A principles would say that if you start with
CPGs based on the best evidence available, which often includes
reasoned
consensus, and evaluate the resource costs associated with providing
that continuum of care for a condition, there is a better chance
that much of equivocal value would be excluded. The PROMETHEUS
Payment® program is beginning with Evidence-informed Case
Rates™ calculated from claims data, which everyone recognizes
is not
ideal. Starting with calculating payments made in large, national
claims databases for core services required by guidelines, adding
dollars for discretionary services recommended by guidelines
but not for all patients, augmenting that with an explicit additional
financial margin for providers, plus a “warranty” corridor
for expected appropriate clinical variation, combined with risk
adjustment, the Design Team believe the major drawbacks to using
claims data to construct rates has been confronted. We think
this represents a far better accounting for the kinds of decisions
David calls for than what has existed in any other payment models
of which we are aware.The longer range view of PROMETHEUS Payment®,
would expect providers to be developing far more explicit evidence
of what it costs them to treat their patients in accordance with
science.
The interest of federal prosecutors
in quality has never been as intense as it is today. As a
dramatic manifestation
of prosecutorial focus on board responsibility for hospital
quality generally and “the quality we are paying for,” attached
is a PowerPoint
presentation created by James G. Sheehan, Associate
Attorney in the U.S. Attorney’s Office of Philadelphia.
He is particularly interested in how boards remain indifferent
to quality while cheerfully accepting the financial rewards
of less than optimal care. You will note that, as in
many prior instances, he is identifying both specific
cases
that will
be
models for future prosecutions as well as upcoming new
approaches to prosecution. He has always followed through
on such public
statements. All hospitals should take heed.
For those not familiar with the role of the Office
of the Inspector General as distinct from the Department of Justice,
recent testimony
by Daniel Levinson, on the occasion of the 30th anniversary of
the OIG, the 20th anniversary of the False Claims Act, and the
10th anniversary of HIPAA, provides a focused look at the breadth
of their activities.
With the crisis regarding
the Sustainable Growth Rate (SGR) creating a significant reduction
in physician reimbursement
under Medicare for 2007, Congress enacted the Tax Relief and
Healthcare Act of 2006. While Congress froze payment rates to
2006 levels, they also created a program to provide bonuses for
physicians to report on consensus based quality measures. The
first measures would be those used in the Physician
Voluntary Reporting Program until the end
of 2007. After that the measures will be specialty focused and
consensus based, meaning endorsed by a national organization
such as the Ambulatory Quality Alliance or the National Quality
Forum. The standards apply to physicians, non-physician practitioners,
and physical and occupational therapists. The bonus of 1.5% of
allowed charges for satisfactory professional service reporting
will give physicians more of a reason to pay attention to what
their specialty acknowledges as legitimate measures of quality
but the total payment is capped. New data specifications make
it clear there will be added administrative burden to get the
payments. There are no appeals of the determinations that the
Secretary makes on this payment and there will be sampling to
validate the reporting. The system need not be implemented by
regulation but may be implemented through program memoranda.
These are easily accessed through the CMS
website (when it is
working).
When Congress appropriates $1.35 billion dollars
for physician quality improvement initiatives, the federal government
is getting serious about quality. Section
204 of the Medicare
Improvements and Expansion Act of 2006
created a demonstration project to evaluate the viability of
the “medical
home”
concept sponsored by the American College of Physicians and the
American Academy of Family Physicians for primary care physicians
to coordinate care on quality
issues.
At the same time, under Section 203, the OIG was called on to
report in two years on “never events” (e.g. amputating
the wrong leg, operating on the wrong patient) which the National
Quality Forum
has identified as errors that should never happen. The issue
for the government is how to avoid paying for these events and
to what extent payment is denied. For example, if the wrong leg
is amputated, should only the hospital not be paid or also the
anesthesiologist and the surgeon who participated? These questions
have no answers yet, but the Congressional focus on these issues
brings Medicare far more in line with the direction private industry
has been moving, and rather faster than has typically been the
case.
Implementation of the PROMETHEUS Payment® model
is progressing. With sponsorship from the Commonwealth Fund to
model Evidence-informed Case Rates™, the program expects
to launch in the latter part of 2007. To make it real, there
are contractual issues that must be addressed including what
is appealable and what is not. In her 2007 Health Law Handbook
chapter Alice provides “The
PROMETHEUS Payment® Program:
A Legal Blueprint” which outlines not only contractual terms but also potential
liability and data issues associated with PROMETHEUS Payment® implementation.
Quality is increasingly becoming part of the basis
on which providers compete. While advertising about quality really
began with managed care organizations, it has now spread to many
hospitals and increasingly will be of interest to physicians.
The issues associated with physician advertising, including trademark,
liability and branding concerns, are addressed by Daniel Shay
in his 2007 Health Law Handbook chapter “Four
Out of Five Doctors Need to Know: Legalities of Physician Advertising.”
These matters are of increasing concern to our clients, beginning
with the plethora of generic names which they use to describe
themselves. Diagnostic testing services all over the country
call themselves “Cardiac Diagnostic Services”, “Diagnostic
Cardiology Services”, and the like. Similarly “Cardiovascular
Associates”, “Cardiovascular Consultants” and “Cardiology
Consultants” can be found in every state. This is not smart
marketing. There is no question that consumers get confused and
contact the wrong providers. Savvy physician groups will look
at Daniel’s article.
The Ventura County California hospital-medical
staff case generated a firestorm of controversy regarding board
involvement in medical staff governance before it was eventually
settled. The parties had very intense views regarding the matters
at hand. (See
the views expressed by the the attorneys representing
the physicians.)
Subject to significant physician advocacy, the California legislature
enacted a law establishing the medical staff’s right of
self-governance in the most explicit terms ever . Specific topics
statutorily reserved to the medical staff include selection of
clinical criteria and standards to oversee and manage quality
assurance and other medical staff activities, selection and removal
of medical staff officers, and the right to retain and be represented
by independent legal counsel. In case of any dispute on these
issues, the medical staff and hospital governing board are obligated
to meet and confer in good faith to resolve the dispute. Astonishingly,
though, the statute says that when any person or entity is even
about to engage in acts or practices that hinder or restrict
or obstruct the ability of the medical staff to exercise its
rights, the superior court “on application of the medical
staff” may issue an injunction. (West’s Ann. Cal.
Bus. & Prof Code §2282.5). While acknowledging the ultimate
authority of the hospital board to protect the quality of medical
care and competency of its medical staff, the legislature explicitly
stated that their final authority may only be exercised with
a reasonable and good faith belief that the medical staff has
failed to fulfill a substantive duty pertaining to quality of
patient care.
Many commentators have characterized this legislation as establishing
that the medical staff must be considered an independent legal
entity. If that were true, for many reasons it would be a disaster,
although there are physician advocates that have long called
for this approach in the form of incorporating the medical staff.
Certainly the medical staff counsel in the Ventura case makes
that argument. We do not read the statute as requiring that the
medical staff be seen as an independent entity and will be keenly
interested in how it is interpreted by the courts.
The new possibilities for liability where a medical
staff is separately incorporated are significant: It will then
be able
to conspire with the hospital board under antitrust principles
pertaining to credentialing. It will have its own separate malpractice
liability for negligent credentialing. It would not be protected
under the hospital’s own director and officer’s liability
insurance but rather would have to obtain its own. The full interpretation
of the statutory provision is not yet known; but for medical
staffs which act responsibly to surveil the quality of care in
the organizations to which they direct their attention, the decision
to incorporate should not be lightly taken. While ‘bad
cases make bad law’, the essence of this law is not bad.
It’s interpretation in already difficult circumstances
could create serious consequences. In the last analysis, the
extremely critical role of the organized medical staff for quality
assurance and particularly among their peers, is strongly supported
here. How to change the way medical staffs and hospitals interact
around quality is the key challenge for hospitals of the future
and a substantial theme in our work. (See “In
Common Cause for Quality”, “Engaging
Physicians in a Shared Quality Agenda”, “W(h)ither
Medical Staffs?”
and more throughout Latest Issues and in Publications
Many physicians have long been suspicious of public
quality reporting efforts because they fear the data is wrong,
it really only reports who is cheapest and not who is good, and
the accumulated data will be used for nefarious purposes. As
payors have moved more into the arena of efficiency measurement
with Episode Treatment Groups (ETGs) and the like to evaluate
physicians, the tensions have continued to escalate. In “Doctors
Dispute Quality Rankings” the Pittsburgh-Post Gazette
reports very recent scuffles over the same issues which have
been in contention since the earliest
days of report cards and quality reporting. Achieving a balance
between measuring efficiency and quality in report cards is a
major challenge for the current quality-driven environment. Fixing
accountability at the locus of control is a cardinal principle
of UFT-A that would ameliorate some of these problems; but the
primary concerns are both transparency of the metrics and equitable
application of them in a way that users of the data can apply
appropriately and subjects of the data need not fear will distort
their circumstances.
At our recent participation
in the IHI Program on “Engaging Physicians in The Shared
Quality Agenda”,
one of the participants approached us to report on the explicit
application of the principles of UFT-A in organizing his group
of physicians in New Hampshire to participate in pay-for-performance.
We are delighted to have this report from the field “Harnessing
the EHR to Accelerate Improvement in Diabetes Care” to
share with you about how this group of physicians, using electronic
health records embedded with CPGs, were able
to standardize their care, putting themselves in a position to
work effectively, particularly on diabetes care, within a pay-for-performance
program. While their initial efforts were focused on office-based
care, the Concord Hospital Physicians Group is now working to
apply similar principles to integrate physicians more effectively
with the hospital to accomplish similar purposes. We look forward
to hearing of their further efforts which we will share with
you. We welcome other similar reports.
Hospitals and physicians have
tried to collaborate more effectively through bonding, purchasing,
owning and managing.
Virtually none of these initiatives has improved quality
of care. In addition, the rise in economic credentialing, conflicts
of
interest policies and disclosure of ‘competing investments’ further
entrenches the parties as disparate stakeholders. In their
work with hospitals and physicians in common cause
for quality,
Jim
and Alice have focused on the negative effect of these initiatives.
Frequently, overly conservative attorneys contribute to mythologies
pertaining to the impact of Stark and the anti-kickback statute
on these issues. In an article we wrote jointly written for Hospitals & Health
Networks Online appearing October 10th, 2006,
they debunk these myths and offer strategies for more collaborative,
quality-enhancing relationships. The second part of the
presentation on October 17th, 2006, describes how PROMETHEUS
Payment® can
further these relationships by supporting with a different
payment system efforts that hospitals and physicians ought
to be involved
in any way.
The challenges of the current payment system have been enumerated
and addressed in many quarters. The limited sustainability of
Pay For Performance is well established. PROMETHEUS Payment® is
emerging as another option that will offer opportunities to providers
and payers to lower their administrative burdens, improve transparency,
enhance quality of care and generate fair payment for appropriate
procedures. In order to succeed under PROMETHEUS Payment®,
physicians, hospitals and other providers will want to collaborate
in far more explicit terms than they have until now. There will
be management challenges. In the first published article from
the design team, “PROMETHEUS
Payment®:
Better for Patients; Better for Physicians”, Alice
illuminates the challenges for physician practices and the two ways that
PROMETHEUS Payment® can be made to them. The website at
www.prometheuspayment.org offers additional resources and information.
Pay for performance programs
as currently configured, while a positive development in terms
of focusing attention on
the relationship between quality results
and payment systems, have inherent limitations, as we have described in various
publications. How PROMETHEUS Payment® addresses the shortcomings of
P4P is important to understand. In addition, group practices are ideally
suited
to take on PROMETHEUS Payment®, but only if they also change their
systems to be more efficient with measurable quality. In "Getting
Beyond P4P: PROMETHEUS Payment® and Group Practice", Alice elucidates the potential positive nexus between the new payment model
and group configurations.
The need for broader implementation of electronic
health records (EHR) and electronic prescribing has been decried
far and wide in healthcare policy,
including by the appointment of a healthcare technology czar within DHHS.
The long awaited regulations under Stark and the antikickback statute
permit plans
and hospitals to provide EHR and e-prescribing software programs and
assistance to physicians. This is a profound and important
development which merits
close attention because, while the regulations have improved the environment
immeasurably,
they are not without ambiguities. In these PowerPoint
slides the
basics of the distinctions in what is permissible under each
law is summarized.
But issues associated with the prohibition on providing physicians with
a program
when they have substantially the same software in place already presents
some significant challenges. What is substantially the same or similar?
Requiring physicians to pay 15% of the cost of the software can
present a problem when
the hospital has a single license. In addition, because this exception
to the
prohibitions on hospitals providing tangible goods of real value to physicians
who refer to them, was adopted as part of the Medicare prescription drug
benefit enacted by Congress, there are mandates that e-prescribing be
part of the software.
The real point is that if quality is really to advance more quickly than
following its glacial pace of the last thirty years, widespread movement
to electronic
record support is critical. These regulations are a major step on that
pathway and should be examined carefully by physicians, hospitals
and plans.
P4P programs are being adopted far and wide in
this country, despite the general acknowledgement that they are
transitional.
In a fascinating interview
with one of the managers of the British pay for performance
program which was adopted nationally, Bob Galvin has elicited
some real insights into the limitations in the design
and implementation of P4P programs. Among the problems
the British faced was a vastly increased payout over what had
been budgeted and expected,
in part because they were paying more for what was already
being provided. This issue has been raised by Meredith Rosenthal
and her colleagues at the Harvard School of Public Health even
in the early years of American P4P.
In
considering the potential impact of quality-based payment incentives,
a usually overlooked problem is how P4P
incentives are used and/or distributed
within the systems and physician groups to which
they are paid. Without paying attention to those effects, it is not possible
to
evaluate how the incentives
actually influence behavior. In "Incentive Implementation in Physician
Practices: A Qualitative Study of Practice Executives Perspectives on Pay
for Performance (Medical Care Research and Review,Vol 63, No 1,
Supp. To Feb.2006,
pp 73S-95S) Barbara Bokhour and colleagues surveyed executives of physician
group recipients of P4P payments in Massachusetts regarding how they used
the incentives within their groups. There were some differences which turned
in
part on the style of practice (e.g., within an IDS, free-standing, hospital-affiliated)
but the evidence showed there was little systematic study of this problem.
In a blog interview conducted
by a surgeon who has been a client,
Alice is questioned about how she became a health lawyer, her views on
P4P, why she didn't become a physician and more. For a real change of
pace go to http://insidesurgery.com/.
In pursuing its new initiatives
to link board certification activities to dynamic, active quality
work, the American Board
of Internal Medicine through its Foundation, commissioned
and is now making available a compelling video program "Putting
Quality Into Practice -- Physicians in Their Own Voices",
which simply presents exactly that -- physicians who have
come to understand what it has taken them in their practices
to
implement serious quality improvement projects describing
their experiences.
No voice-overs, no didactic presentations, the power of the
story comes from the practical experiences of internists
from disparate
practice settings speaking to the joy that quality work has
added to their professional lives. An excerpt of the video
can be found
at www.abimfoundation.org. We recommend it for anyone seeking
to encourage physician engagement in quality.
In the May 11, 2006
issue of the NEJM, George Annas, a lawyer who teaches in the
Boston University School of Public
Health,
had published an article calling for the creation
of a
patient's right to safety through litigation against hospitals.
His ideas are consistent with ours presented in "The
100,000 Lives Campaign: Crystallizing Standards of Care for Hospitals".
But, while we share the view that litigation is to be expected
when
hospitals fail to implement the six planks of the campaign, we
believe that the enrollment of 3100 hospitals nationwide has
created that change already. IHI has announced that more than
122,000 lives have been saved as a result of the campaign, but
also that even enrolled hospitals have been very variable in
the extent of their implementation. That variability will also
raise the liability stakes even higher than they were in November,
2005 when our piece was published. The focus of litigators on
patient safety and quality is taking very different turns. Erin
Brockovich has become the plaintiff in a false
claims whistleblower case against at least three health care
systems, based on medical errors.
We have heard rumors, on legal listserves, of pending class actions
with regard to these issues. The legal tide is turning regarding
hospital liability for patient safety.
PROMETHEUS Payment® Inc. is a new not for profit corporation which has been
established
to steward the further development and implementation of a
new provider payment model. PROMETHEUS payments is specifically
designed to improve quality, pay the right amount for the best
science we know, and lower administrative burden, both to providers
and plans. Provider payment Reform for Outcomes, Margins, Evidence,
Transparency, Hassle-reduction, Excellence, Understandability,
and Sustainability, is intended to address the limitations
of pay for performance with a program that is relatively easy
for plans to implement, and has as one of its bedrock principles,
transparency of all aspects of the mechanism. Alice Gosfield
has been intimately involved in the design process since its
inception in December 2004. Jim Reinertsen served as an expert
resource. Alice is the Chairman of the Board of PROMETHEUS Payment® Inc. PROMETHEUS Payment® is not intended to supplant
fee for service and capitation. It is intended to substitute
for it in those instances where it makes sense to do so. The
model is voluntary, collaborative, and expects negotiation
between plans and providers. To learn more read "PROMETHEUS:
Provider Payment for High Quality Care."
A vendor has been selected to develop the core of the "Engine" --
the critical software to manage the data needs to track which
providers are delivering what care, how money is to be allocated
among them, and how they are doing in rendering the care they
have bargained to deliver. Five clinical topic areas have been
chosen for the first implementation of PROMETHEUS: interventional
cardiology; chronic and preventive care, orthopedics and cancer.
Pilot markets are being selected. Working groups which include
practicing clinicians have been selected and will convene to
select the CPGs for payment, consider which providers most often
render which pieces of the CPGs, consider appropriate measures
of whether the CPG has been provided, and determine appropriate
clinical risk adjustments. The work is on target for implementation
in early 2007.
The impetus for quality comes
in many forms. We have authored an article in the November/December
2005 issue
of Health Affairs, "The
100,000 Lives Campaign: Crystallizing Standards of Care for Hospitals",
which makes the case that IHI's 100,000 Lives Campaign
has changed overnight the legal
standard of care for hospitals throughout
this country --- whether they enrolled in the campaign or
not. We elucidate why. We speculate on the kinds of cases
which
failure to implement the six planks of the campaign will
generate. We
look at the top ten reasons hospitals get sued and place
the planks in that context. Risk avoidance certainly adds
to the
business case for quality. And then we say why fear of malpractice
liability is not the
principal reason to implement the six planks, but it might
serve to “bring up the rear” in implementation
of these lifesaving measures. Vanguard hospitals have already
implemented
these planks for the most powerful of reasons: if patients
are dying in our care, and we know how to prevent many of
these deaths,
leaders have a moral, professional, and mission-driven duty
to act.
As health plans and health systems have consolidated
and fraud and abuse enforcement has intensified throughout healthcare,
the natural tendencies in any other industry for business partners
to find ways to benefit each other economically in win-win strategies
has been stifled in health care. Anxiety over fraud and abuse
and antitrust risks, has gotten in the way of hospitals and physicians
on one hand and health plans and physicians on the other working
together for their mutual economic benefit with the purpose
of improving quality. In a new chapter in the Health Law Handbook,
Alice makes the argument that until the three principal drivers
of the care that patients receive in this country take common
ownership of the quality mission and stop thinking of themselves
as disparate, adversarial stakeholders, quality will never advance
to the levels we would like. In "In Common Cause
for Quality" she articulates a perspective on how to consider a business case
for quality, sets forth the quality demands on hospitals and
health plans which cannot be met without the full cooperation
of physicians and debunks the myths that the law impedes collaboration
which benefits any party economically. She then enumerates 10
specific strategies by which hospitals and health plans can advance
the physician's business case for quality through activities
with direct beneficial financial impact on those physicians.
She also presents 6 additional strategies through which physicians
can and will have to help hospitals to optimize their quality
efforts.
In "Enhancing
Oncology's Business Case: How the Hospital Can Help" she presents a crisper version of these arguments in terms of
how oncologists can safely look to their
hospitals to help them with their own quality demands.
The role of clinical practice
guidelines has been criticized as problematic as applied to older
patients with co-morbid
diseases -- likely to increase costs if used for payment
and to harm patients
if CPGs developed for single conditions were merely cumulated
and applied to frail elderly with complex conditions. (See
Boyd et al, "Clinical Practice Guidelines and Quality
of Care for Older Patients with Multiple Co-Morbid Disease",
JAMA 2005; 294: 716-724). Similarly, others have decried
the difficulties
of using CPGs on the ground in every day practice. (See, Brush
et al, "Integrating Clinical Practice Guidelines Into
the Routine of Everyday Practice," Critical Pathways in
Cardiology 2005; 4: 161-167). There is no question that most
CPGs have
not been developed with either application in mind. And the
need
for better CPGs, developed with a clear eye toward their eventual
applications, would improve this set of circumstances. Yet,
as we have argued in our White Paper, the use of CPGs
as the basis
for payment, initially for simple conditions and eventually
for those more complex, would profoundly advance the business
case
for quality, make life easier for those delivering care and
improve the quality of care itself. Now this fundamental concept
is coming
to life in a multi-stakeholder project in which Alice is participating
in the principal working group, and Jim has acted as a resource
and reactor. As set forth in a recent letter
to the editor of JAMA, this payment
model, which is soon to go public, is
intended to incorporate appropriate clinical flexibility, combined
with a comprehensive scorecard with the goal of higher patient
and physician satisfaction along with improved quality. Stay
tuned for its formal announcement and publication of a substantive
White Paper describing how it will work. We are available
to present on this payment model.
The project is targeted for pilot projects in the first quarter
of 2007.
For quality to advance
in this country, it is becoming increasingly clear that universal
electronical medical records
will necessary.
Proposed regulations to permit hospitals to provide record
systems to their physicians have been published
under Stark. Many physician practices
are looking to obtain these programs. Whatever the source
of an electronic health record system,
it is certain there will have to be a license agreement by which
the practice obtains access to the software, unless they build
their own. In "A
Primer on Electronic Health Records License Agreements", Daniel
Shay reviews the context for these contracts, elucidates their
common features, based on
reviews
of real-life documents, and points out pitfalls that physician
practices should avoid in obtaining access to these vital practice
accessories.
As pointed out in our original
White Paper, P4P programs are designed to deal primarily with
under-use, and to some extent
with mis-use. Up to now, P4P programs have been very reluctant
to address the quality problem known as “overuse:” i.e.
services that can not help the patient, add cost, and add risk.
But the overuse problem won’t go away. Overused
services have been extensively and persistently
documented by Wennberg, Fischer, and their colleagues, but to
date hospitals have been able to ignore this issue because the
focus has been
on metropolitan statistical
areas rather than individual hospitals. However, recent advances
in methodology allow overuse levels to be attributed to individual
hospitals, and public reports on overuse have generated a great
deal of concern from prestigious institutions whose margins would
appear to be generated, at least in part, from procedures and
services that add no value for patients. It is our belief that
the next versions of P4P will include designs to deal with overuse
and other inefficiencies as quality problems, and Jim has made
this one of his four major predictions for quality and safety
in his chapter in FutureScan: Healthcare Trends and Implications,
2006-2011 (Health
Administration Press)
Continuing its demonstration
that quality is a fraud and abuse concern, the Department of
Justice entered into a settlement agreement with a small hospital
over
its use of physical restraints.
Of major significance is the Department’s own assertion
that the "First Fraud and Abuse
Settlement Based on Failure of Care Claims" is
the first of its kind in the nation addressing
failure of care claims based on alleged violation of regulatory
requirements. In this instance, the requirements pertained to physical
and chemical restraints at the medical center that ended with the
death of a restrained elderly patient in 2002.
While quality performance
measurement initiatives have received
considerable attention and are rising to the fore as a significant
force in the healthcare market place, less appreciated is the sub-rosa
use of “efficiency measures” by health plans to evaluate
resource consumption (i.e., costliness) by providers. While health
plans have been using these proprietary software measurement programs
for some time, there is now an increasing appreciation that making
efficiency information available can serve a variety of useful
purposes other than simply excluding providers from networks. In California
and Washington new
programs to inform physicians as to their relative efficiency evaluations
are being touted as important developments to facilitate
delivery of appropriate quality care. In Tennessee,
the hospital association has joined with a local Blue Cross/Blue
Shield
plan to publish report cards on efficiency performance. Bridges
to Excellence has issued a white paper addressing principles associated
with equitable
efficiency measurement.
The rise of quality performance measurement and public
reporting, controversies associated with these activities, and
potential legal
liabilities are addressed in the new AGG Note, “Performance
and Efficiency Measurement: Implications for Provider Positioning” This
phenomenon further underscores the value in physicians, in particular,
coming together in clinically
integrated networks to improve their
performance, learn from each other, develop data that can be shared
with payors in a meaningful way, and potentially collectively bargain
over fees. This AGG Note offers practical steps to begin
integrating.
Congress has stepped into the debate regarding protection of potentially
negative quality information in the interest of improving quality
with the Patient Safety and
Quality Improvement Act of 2005.
Providers who come together to engage in patient safety activities
and report their “patient safety work product” to “patient
safety organizations”(“PSOs”) can be assured
that the data they are reporting will be protected from discovery
and will be treated confidentially, at least as the law reads.
Judicial interpretation may produce different results. Courts have
undermined many state peer review protection acts; but to be fair,
most were enacted in the mid-1970’s and their drafting did
not anticipate the very different context today in which plaintiffs
seek to use them.
“Patient safety activities” are broadly inclusive
and go well beyond strict patient safety. Any organization seeking
to be recognized as a patient safety organization must be involved
in: efforts to improve patient safety and quality of healthcare
delivery; collection and analysis of patient safety work product;
development and dissemination of information to improve patient
safety such as recommendations, protocols, or information regarding
best practices; utilization of patient safety work product for
the purpose of encouraging a culture of safety and providing feedback
and assistance to minimize patient risk; maintaining procedures
to preserve confidentiality with respect to the work product; providing
appropriate security measures for the work product; using qualified
staff and engaging in other activities related to the operating
of a patient safety evaluation system to provide feedback to the
participants. A “patient safety evaluation system” means
collection, management or analysis of information for reporting
to or by a patient safety organization. The data protected includes
written materials, reports, records, memoranda, and analyses as
well as oral statements. The statute provides for the creation
of a network of patient safety databases. Moreover, patient safety
organizations self-nominate and attest to their certification that
they qualify.
The statute is self-executing and effective upon enactment. Obviously
some administrative mechanisms will be necessary for PSOs to list
themselves. And the Secretary does have authority to issue regulations,
which may clarify the import of this statute. Nonetheless, this
law has the potential to facilitate robust quality relevant activities
and provider groups would do well to consider taking advantage
of whatever protections it does offer.
A recent study in JAMA makes
the argument that clinical
practice guidelines applied in combinations for elderly,
frail patients with co-morbidities if used for payment can lead
to unintended
negative consequences. Increased costs as well as overmedication
and adverse pharmaceutical interactions are all possibilities.
In some ways the article stands for the proposition that clinical
practice guidelines are still some distance from ideal construction.
While the Institute of Medicine stated attributes of good guidelines,
among which are specificity and applicability of the guidelines
to appropriate patient populations, the IOM did not speak to the
notion of how the guidelines would be applied programmatically
and that their construction ought to reflect those uses. As pay
for performance programs and performance measurement continue generally
to turn on the contents of guidelines, this issue will become even
more significant.
Another consideration of clinical practice guidelines
speaks to our longstanding concern about availability of time
to deliver
evidence based medicine. In a recent article in the Annals
of Family Medicine
researchers applied guidelines recommendations for ten common chronic
diseases to a panel of 2500 primary care patients with an age-sex
distribution and chronic disease prevalences similar to those of
the general population. They estimated the minimum physician time
required to deliver care called for in clinical practice guidelines.
While the conclusion of the researchers was to caution guideline
developers to consider carefully the time required to follow recommendations,
or to suggest development of models of care management that require
less time of primary care physicians, they neglect to address the
external forces within which guidelines are operating that create
these time demands. Whether the issue is literally the time it
takes to interact with the patient to deliver EBM or all of the
activities associated with seeing the patient (eg. documentation
, prior authorizations) is not addressed in this consideration.
Nonetheless, the issue of time and touch continues as a theme that
deserves additional consideration if we are to advance quality
in significant ways.
In California, flow of dollars to physicians is somewhat
anomalous by comparison with other markets. In a recent article
in Community
Oncology,
Linda Bosserman, M.D. describes some of the more pernicious effects
of health plans subcontracting with for-profit
networks to manage the payment to physicians providing
specialty care. Her practice in Beverly Hills has been well organized around
evidence-based medicine for some time. Still, the implementation
of the payment model there and the positions taken by intermediary
networks in allocating specialist payment has undermined their
ability to provide quality care to their patients. There are controversies
around the California structuring of these payment relationships.
Despite her criticisms, Linda calls for physician practices to
organize themselves in a way that will maximize their opportunities
in such a restrictive environment.
In an article in Community Oncology, Alice
makes the argument that because of the perverse impact of the Medicare
drug payment
model on oncology practices, they have neglected to focus on their
own business case for some time. When much of your income is driven
by profits made on the provision of pharmaceuticals to patients,
a reduction in that payment can result in significant practice
dislocation. For oncologists, the moment may well be optimal to
really consider clinical integration. In “Better
Quality, Better Margins: Seizing the Moment” Alice
elucidate these connections in relationship to the application
of UFT-A principles.
For health care organizations
to achieve significant advances in quality, the role of leaders
is essential. Jim and his colleagues
at the IHI have developed a set of seven leadership leverage
points for leaders to consider if their aim
is to achieve system level results. These leverage points are described
in a paper that also
forms the core framework of the IHI Executive Quality Academy,
an intense one year program for teams of senior executives seeking
to break through to the next level in quality performance. Jim
directs the Academy which is a one year program. More information
about both can be found at his website.
The dual themes of improving quality
of care and physician quality of life including the physician business
case
are evident in the New Model of Family Medicine which
is being promulgated by the Future of Family Medicine Project
of the American
Academy of Family Medicine and other family medicine organizations.
In addition to proposals for change in medical education, residency
training and practice organization "to better meet the health
care needs of patients in a changing environment" the project
has proposed that family medicine roeritent practices to provide
a personal medical home for each patient, patient centered care,
a team approach to care, advanced IT systems, redesigned, functional
offices, whole person orientation, care provided within a community
context, emphasis on quality and safety, enhanced practice finances
through operating efficiencies and new revenue streams and a
commitment to provide family medicine's 'basket of services.'
Bruce Bagley
, MD, AAFP's medical director of quality improvement, explains
the practical implications of this approach to family physicians
in "The
New Model of Family Medicine: What's In It For You?" Many
of the implications of this new model resonate with UFT-A principles
including standardization,
highest and best use of clinicians in a team approach, engagement
of the patient and more. In a companion consideration, "Is
the New Model of Family Medicine Financially Viable?",
Stephen Spann, MD, reports the business case for the new model
including calculations
of practice savings and improved revenues for adopters of the
model based on predictive modeling by the Lewin Group measured
against
fee for service and other alternative payment approaches such
as P4P. Obviously they did not model any UFT-A based payment
system
explicitly, but their assessment of economies and benefits to
be achieved track closely to what we have propounded theoretically
in our work.
P4P continues to garner attention
as an initiative to motivate care improvement. In
addition to the JCAHO and NQF
principles, others continue to posit still
more principles and programs for design.
MedPac has called for expansion of P4P in Medicare. The American
College of Physicians, which sees P4P
as no longer optional, has convened
a small P4P advisory group in which Alice Gosfield is participating.
A still unnamed further group of individuals including some previously
involved in the design of the Bridges to Excellence program are
developing a provider payment model that goes beyond P4P in the
hopes that this will be eligible for piloting by the first of 2006.
Alice Gosfield participates in that project as well.
In its Jan/Feb 2005 issue, Health Affairs offered
a range of articles confronting issues in evidence based medicine.
One of them, by
Timmermans and Mauck, cited a number of barriers to widespread
physician adoption of clinical practice guidelines. We noted that
where guidelines are nothing but an add on to a system which imposes
unmanageable administrative burdens already, there is little to
motivate physicians to use them. Our
letter to the editor, published
in the May/June 2005 issue of Health Affairs,
points out that to use CPGs as the foundation for all processes,
both administrative and clinical, makes a far better business case
for their use.
Since the inception of the DRG program in 1982, hospitals
have been trying to find a way to motivate the physicians on their
staffs
to work with them to lower expenses by sharing savings generated.
These 'gainsharing' notions had been virtually precluded to them
going back as far as a Paracelsus hospital company program in 1983,
and then in more modern iterations, by virtue of the OIG's
Special Advisory Bulletin on Gainsharing Arrangements in
1999. Although the OIG approved one gainsharing program 18 months
after the Bulletin (see discussion in Alice Gosfield's article
on "Making Quality
Happen: In Search of Legal Weightlessness"),
the structure and operation of that program seemed sufficiently
idiosyncratic as not to offer
much by way of a model. Now the OIG
has published six
advisory opinions approving 'gainsharing' programs, where cardiologists and cardiac surgeons will
be permitted to share
in the savings hospitals generate by virtue of standardization
of surgical supplies and their uses. As we note in our five principles
for UFT-A, standardization for purposes of quality is important
as an element of a business case for quality; but the advent of
these gainsharing approvals further supports a business case for
broad and deep standardization to the evidence. On the other hand,
the gainsharing programs are time limited, appear to be predominately
applicable in surgical contexts or analogous circumstances and
hardly will serve to drive a sustainable business model for physicians.
Clinical integration has been held
out by the FTC in every physician network settlement into which
they have entered
in the last few
years. "You can't do this, but if you were clinically integrated
you could." Some have questioned whether clinical integration
is really available as an option to facilitate providers bargaining
with payors. Brown and Toland in California was the subject of
an FTC
enforcement action in 2003 for their PPO
bargaining activities.
When they
eventually settled, they agreed not to undertake any PPO bargaining
unless the FTC prior approved what they were doing as sufficient
clinical integration. The FTC has now reviewed Brown
and Toland's ( B & T) approach and
has said it represents enough clinical integration to
permit negotiations, but they will still be subject
to review for conformity with the integration principles. B& T
says that the elements
of integration they have adopted are a utilization
review program, disease management and case management activities
and an electronic medical record.
This is meaningful because until this point there has been only
one advisory opinion which
addressed acceptable elements of clinical integration and now the
B & T program is different. The FTC says it will review
their actual implementation;
but this action stands for the proposition that clinical integration
is alive and well. It also means clinical integration does not
require a uniform approach consistent in every respect with the
hypothetical facts set forth when its permissibility was first
published by the FTC in 1996. We think that UFT-A offers an option
which will, by its implementation, create appropriate clinical
integration to qualify for joint bargaining.
In December 2004, Anthem Blue
Cross Blue Shield convened their Fall Health Care Leadership Forum
with the theme of "Paying
for Clinical Excellence: Strategies for Crossing the Quality Chasm." Alice
Gosfield keynoted the event with a presentation on "Doing
Well by Doing Good: Improving The Physician Business Case
for Quality," which,
as in the original white paper of the same title, draws on Jim
Reinertsen's "axioms" (as Alice refers to them). The
assembled participants, representing leadership stakeholders from
medicine, business, insurance, consumer, hospital and other interests
then broke into discussion groups to consider the points raised
in the keynote, oriented around four questions. They reported their
findings to the group. Caz Matthews, CEO of Anthem of Colorado,
summed up the conference which essentially supported UFT-A and
considered some practicalities in applying its principles. A report
of the meeting and findings of the participants has now been published
as a monograph.
In the efforts to embed clinical
integration and care coordination into the health care system physicians
have feared the risk of
liability for performing coordination, rather than direct care
delivery. Mark Hall, a law professor in North Carolina, has conducted
a study both in terms of caselaw
and survey of malpractice insurers among others, that
documents that there is no
increased liability for physicians who perform care coordination. See
appendix here.
Pay
for Performance (P4P) is
rapidly growing as a technique to improve quality and motivate
physician behavior. There
are so many P4P programs around the country that the Leapfrog Group
has now compiled a searchable compendium
of programs.
In California, performance data has been issued to participating
medical groups and health
plans have paid out $50 million dollars collectively as the first
payments under the Integrated Health Association's program. There
are questions about what the $50 million represents Is it only
new money or does it include preexisting program payments primarily
oriented around efficiency? Alice Gosfield continues to raise questions
both for physicians about the potential
impact of these programs
generally and
for plans about how to implement
them.
The bona fides of P4P
programs is now in play. The JCAHO which rarely strays into any
payment concerns has published
principles
for constructing P4P programs.
Similarly, the National Quality Forum is going beyond performance
measurement to evaluate
P4P programs as
well. The extent to which some standardization in P4P will emerge
is entirely unclear, especially
given the limits of standardization
in the current state of the art of performance
measurement, where
both NQF and JCAHO are major players.
In May, 2004, Jim Reinertsen
participated in a full-day program sponsored by Health Alliance
Plan in Detroit dealing with
a plethora of approaches to paying for quality performance. As
can be seen in the attached proceedings his presentation addressed implementation of UFT-A. Other presenters
provided information
on the need to create new quality incentives, the IHA experience
in California, Medicare incentives for quality, and leadership
challenges to quality improvement. A panel discussion addressed
how actionable goals and measures drive performance and improve
outcomes in multiple practice settings.
"You cannot improve what you cannot measure". "What
gets measured, gets done." These truisms about quality improvement
reflect the importance of performance measurement which is being
used not only for P4P but also for network selection, reorganizing
care delivery processes, and transforming the culture of health
care organizations. For all of the policy interest in core data
sets and standardization of measures, the current context offers
anything but. The varieties of measures and measurers seems to
be proliferating rather than consolidating. There are controversies
and quandaries in performance measurement, as well as lurking legal
liabilities both for those who would select and use measures as
well as those who do not or do so ineffectively. In "The
Performance Measures Ball: Too Many Tunes, Too Many Dancers?" Alice
Gosfield offers a view of the new Medicare Modernization Act initiatives
which relate to measurement; explores why the explosion of interest
in measurement and measures now; clarifies concepts around measurement;
provides a snapshot of the major players and their approaches including
CMS, NQF, JCAHO, AHRQ and IHI; considers the significant controversies
surrounding measurement initiatives; and speculates on legal pitfalls
in this essential component of quality improvement and a business
case for quality.
As quality policy
has focused on improved content in quality improvement policies,
CMS has both added to its conditions
of participation and clarified medical staff privileging procedures
to comply. Directing state surveyors regarding bases
for Medicare participation
CMS has refocused on the hospital’s privileging activities,
reemphasizing that “the Medical Staff, as a group, is responsible
for the quality of care provided to patients by the hospital, for
establishing the bylaws, rules regulations, policies, etc, for
the Medical Staff and for overseeing the quality of care provided
by all the individual practitioners who provide a medical level
of care or who conduct surgical procedures at the hospital.” CMS’s
specific attention is directed to the extent to which privileging
clearly and completely recognizes the specific competencies of
individual practitioners. “It cannot be assumed that a practitioner
can perform every task/activity/privilege listed/specified for
the applicable category of practitioner. The individual practitioner’s
ability to perform each task/activity/privilege must be assessed
and not assumed.”
Recognizing the frequently practiced “paper
chase” quality
of medical staff privileging, CMS instructs its surveyors that “The
Medical Staff much actually examine each individual practitioner’s
qualifications and demonstrated competencies to perform each task/activity/privilege
he/she has requested from the applicable scope of privileges for
their category of practitioner.” Many commenters have taken
the position that this direction regarding individualized competencies
implicates the practice of “core privileging” which
establishes threshold clinical criteria to demonstrate competence
within a specialty area. The basic concept is that in order to
have privileges within a department, the physician must be able
to demonstrate core competency in a threshold bundled set of privileges.
Anything more than the “core set” are “special
privileges.” This reemphasis on how to privilege further
draws attention to the potential utility in using clinical
practice guidelines to
establish criteria and evaluate core competency.
Even as JCAHO has expanded its attention on quality
improvement activities in the hospital, hospitals that do not rely
on “deemed status” based on their JCAHO survey will
have to meet the CMS conditions of participation now require the
hospital to develop, implement and maintain a data driven quality
assessment and performance improvement program (42 CFR ' 482.21)
which must rely on quality indicator data. The Board itself is
held accountable for the operation of the program. (42 CFR ' 482.21(e)).
This reemphasis further propels the initiative of hospital boards
in stewarding the data driven quality improvement of their organizations.
There have been a number of attempts
to articulate a “business
case for quality” by defining measures of whether a quality
intervention is worth undertaking. Last year in an article in Health
Affairs (“The Business Case
for Quality: Case Studies and an Analysis”, 22 Health
Affairs (Mar/Apr 2003)), Sheila Leatherman and her colleagues posited the
following two measures to determine the business value of a quality
intervention: (1) Does the investing entity realize a financial
return in a reasonable time frame, whether actual profit, reduced
losses or avoided costs?; and (2) Does the entity believe there
is a positive indirect effect on organizational function and sustainability
will accrue within a reasonable time? These measures focus solely
on the impact on the entity engaging in the intervention.
We believe that this approach can not define a truly realistic,
sustainable and likely to be implemented intervention. Rather,
we believe that a business case can only be made strong if it takes
into account its impact on other stakeholders. Consequently, we
would propose the following measure of a business case: Is
the intervention consistent with strategic goals, understandable,
not
too capital intensive relatively speaking, with positive impacts
across stakeholders, and able to produce sustainable, acceptable
margins, near term and long term? We believe that margins are vitally
important and frequently ignored in considering the likelihood
that an intervention will be adopted. Under this definition, we
believe UFT-A principles do state a realistic business case.
At the June 2004 session of The
American College of Cardiology Strategies for Success meeting,
a program focused on the business
aspects of cardiology, the 125 or so physician and manager attendees
had the opportunity to interact with the speakers in a blind, survey
format. Hardly scientific, the responses
of the
attendees
to
questions posed by Alice Gosfield with respect to UFT-A relevant
issues are telling. These responses
support some of our principal beliefs regarding physician perceptions
of their current business environment and that increasing physician “touch
time” with patients is important to a business case for quality.
Further supporting the urgent need
for different payment systems that reflect what we want health
care providers to provide, the
Pittsburgh Regional Health Initiative
published in June 2004, a list generated by their own members of
11 different
ways in which the current payment system manifests “Reimbursement’s
perverse incentives”.
Their readers are continuing to generate additional examples.
The essential nature of the transaction
that takes place between physician and patient, as first articulated
by Jim Reinertsen in
1997, in “Health Care: Past, Present and Future” (Group
Practice Journal, March/April 1997—Vol. 46, No. 2)
is the critical touchstone for UFT-A principles. It has also
been
acknowledged
in the Crossing the Quality Chasm statement that “Transferring
knowledge is care.” High quality care, therefore, is care
that occurs when the conditions permitting the most effective
transfer of knowledge have been optimized. In her article, “The
Doctor-Patent Relationship as The Business Case for Quality”, Alice Gosfield elaborates on these themes and the legal predicates
for
UFT-A.
In an interview in MetroDcotors: The Journal of the Hennepin and Ramsey County
Medical Societies (July/August 2004),
Jim Reinertsen was interviewed with regard to his optimism for
improving quality over the next ten years, and what he would do
if given the opportunity to make one single change in the health
care system. Projecting “If I were King,” in this free
wheeling interview he covers a range of topics from health system
and insurance reform, to physician report cards and responses to
physician anxieties about ‘cookbook medicine.’
James G. Sheehan of the United
States Attorney’s Office
in Philadelphia is probably the leading prosecutor in the country
on cutting edge fraud and abuse issues. He spoke in June, 2004
in Orlando on a panel organized by Alice Gosfield at the American
College of Cardiology Strategies for Success meeting, to address
the types of issues associated with quality failure which will
be attractive to prosecutors. These are new and focused observations
that go beyond where the law is today.
Failure of providers or other entities to report quality problems,
or to meet state and federal regulatory obligations to report,
or which entail fudging data which is reported, whether to the
JCAHO or otherwise, he thinks are actionable as fraud. He is particularly
interested in the increase in quality-relevant advertising by all
players: “we have the best quality”; "we have
the most advanced patient safety program", "we have the
best doctors". He thinks that these statements open the door
to false claims charges and other challenges based on 'promises
made but not kept' (his phrase). He opined that "Crossing
the Quality Chasm" is creating a new standard of care with
reference to the STEEEP values, and that he can find a basis to
make claims on failures to measure up. He thinks that staffing
issues are a particularly ripe area for his notions since understaffing
inevitably leads to quality failures.
He says he will find the cases he will bring from the following
sources: whistleblowers (staff, patients and competitors); private
insurers who will begin to raise their own concerns; proactive
government projects and programs; private lawsuits between parties
in disputes over contracts; investigative reporting in all forms
of media and self-disclosure by well motivated entities.
Alice Gosfield and Jim Sheehan have been worthy opponents of each
other for twenty years. Providers should take heed. Mr. Sheehan
is remarkably direct about his prosecutorial initiatives. He told
audiences for at least ten years that at some point he would find
the right fact pattern to go after billing problems in academic
medical centers and eventually the University of Pennsylvania settlement
became real. New forms of enforcement related to these issues are
inevitable. He has begun to develop his campaign strategy.
To what extent does quality command
the attention of health care organization leaders in the
fast growing world of
'pay for performance', CMS hospital reporting mandates and
the Leapfrog Group, among other initiatives? In January 2004,
Jim Reinertsen facilitated a conversation among a highly selected
group
of health
care executives focused around three questions: (1) Has clinical
quality moved from “something that is professionally good
to do, but not strategic,” to “I’d better make
sure I hit my quality targets, or my job is on the line?”;
(2) If quality has moved onto the strategic agenda, what
do the new pay-for-performance models have to do with the
shift?;
(3)
If quality is now strategic, and if health systems need to
hit tough quality targets as reliably as they hit financial
targets,
how are they planning to succeed? His white paper, Straight
Talk About Clinical Quality From Health Care CEOs offers a
fascinating glimpse of how some of our finest health care leaders
answer these
questions.
In the January 22, 2004 issue
of the New England Journal of Medicine, Arnold Epstein, MD, and
colleagues presented a review of the new physician “pay for
performance” models
being implemented in regional trials around the country. For
a variety of reasons we felt the piece should be addressed. In Paying
Physicians for High Quality Care, you can read our response
to Epstein’s paper, along with some other responses, and Epstein’s
reply. Pay-for-performance is getting a lot of attention these
days. But these early versions of “paying for quality” tend
to focus on the problem of underuse, and don't address the very
big quality problems of overuse and misuse. Furthermore, the
revenue incentives tend to be small in comparison with the costs
of correcting
the underuse problems (which by definition require additional
services to be delivered) and so the actual business case in
many of these
new payment systems is rather weak.
“Pay for Performance” (P4P)
is a new phenomenon intended to incentivize physicians and hospitals
to render high quality by paying them differently if they perform
in accordance with criteria. From Leapfrog, to CMS, to the Bridges
to Excellence program and the activities of the Integrated Health
Association in California, there are many variations on this
theme. That the government is in this game can also be seen their physician
group practice demonstration and Premier
Hospital Quality Incentive program. In “Contracting
for Provider Quality: Then, Now and P4P” Alice
Gosfield explores the impetus for these programs, describes and
analyzes their principal manifestations and considers how they
relate to the contractual context within which they arise, both
for hospitals and physicians. She concludes that while pay for
performance is an important development, it is, at best, transitional
and, as we first discussed in our White Paper “Doing
Well by Doing Good: Improving the Business Case for Quality” these
initiatives do not make an adequate case for offering physicians
improved financial margins despite increased revenue. In addition,
because these are ‘add-ons’ to the existing contractual
environment and the P4P programs often unfold with no supporting
contract at all, they present real and unexplored challenges
for the providers who participate. We continue to believe that
payment
systems that carve out a new approach with many of the same goals
and features of these P4P programs are better.
To move health care organizations
to truly transformed cultures and systems, especially for improved
quality, requires extraordinary leadership skills. For health care
organizations to embed improved quality as a driving core value
throughout the enterprise demands very clear understandings regarding
the specific role of leaders in making change happen. Jim Reinertsen
has propounded “A Theory
of Leadership for the Transformation of Health Care Organizations” which
draws on his work with the organizations involved with the Institute
for Healthcare Improvement’s Pursuing Perfection projects
as well as his fifteen years as CEO of two major complex health
care organizations. He identifies six specific leadership challenges
which are particularly relevant to transformations for quality.
He considers four specific routes to transformation and enumerates
eight practical steps to the preferred route to change. He sees
this work as evolving and seeks reports from the field on its implementation.
The principles of UFT-A are applicable
in many ways throughout the health care system. One of their primary
potential uses is in managed care. In the report “Evidence-Based
Medicine and Managed Care: Applications, Challenges and Opportunities” Paul
Keckley, Ph.D., and his colleagues at the Vanderbilt Center for
Evidence-Based Medicine report on a series of meetings they convened
and surveys they conducted of the medical directors of 89 health
plans around the country regarding issues associated with EBM.
The study focuses on five aspects of medical management in health
plans: (1) coverage denial management; (2) provider profiling;
(3) reimbursement; (4) disease management; and (5) consumer driven
care. The current hot button in many plans is pharmacy benefits
management. In addition, tensions between plans and physicians
are expected to intensify. Among the findings most relevant to
UFT-A included medical director perceptions that (1) increasing
the delivery of EBM is critical to the future success of health
plans; (2) the need to demonstrate return on investment for any
initiatives is increasingly mandated by plan CFOs; (3) focus on
physicians will continue to be essential; (4) physicians need financial
incentives to change their behavior; and (5) tiering all physicians
to get financial performance will increase. The latter recognition
demonstrates an opportunity for plans to be more creative for some
providers and physician groups, so they can be paid differently
if they perform differently. The implications of this study are
significant in terms of opportunities for plans, providers and
physicians to collaborate around UFT-A-like strategies. This study
should be carefully considered and used by providers and physician
groups who are approaching plans about their business case to subscribe
to UFT-A principles.
One of the major thorns in the
side of physicians confronting managed care payors has been their
antitrust risk if they bargain
for fees collectively. We have posited that ‘clinical integration’,
which the antitrust regulators have said can permit otherwise collusive
bargaining among competing physicians, is part of the business
case for quality.
In each of the physician and hospital network settlements in
the last months, the FTC has noted that the physician groups were
not sufficiently integrated
financially or clinically. In the settlement with Brown and Toland,
the FTC imposed a new requirement that if they chose to bargain
based on clinical integration they would have to submit their approach
to the FTC before implementation. Given the dearth of regulatory
guidance on point, and only one advisory opinion to date, it is
with great pleasure that we are able to make available an important
article from our 2004 HEALTH
LAW HANDBOOK by Bob Leibenluft who was the head of the health care
division of the FTC when the clinical integration opportunity was
made available. In “Clinical
Integration: Assessing the Antitrust Issues” Bob,
and his colleague Tracy Weir, elaborate on what clinical integration
is about and acknowledge that the
antitrust regulators have not seen much real clinical integration.
We think that is probably true since much of what we are familiar
with as purported to demonstrate clinical integration, in fact,
does not go far enough. Still this article supports our case that
doing what we suggest in our ‘unified field theory’ work
would likely meet the regulators’ criteria.
At the beginning of the year, Managed
Care magazine went looking for predictions from health experts
on the future of health plans
in America. All were asked to predict what the health plan
of 2009 would look like. Although they somehow managed to find a photo
of Alice Gosfield from 15 years ago, her predictions
are published along with other experts such as
Helen Darling, Newt Gingrich, Joe Newhouse and JD Kleinke. Enjoy
your reading, but don’t
bet the farm.
CMS launched its ‘voluntary
hospital quality reporting’ initiative
last year, seeking voluntary
hospital reporting on ten quality measures. Not satisfied with
the level of participation, Congress enacted a provision in the
Medicare reform legislation which will lower by 0.4% the annual
Medicare reimbursement for hospitals which fail to ‘voluntarily’ report.
An anomalous report, regarding the
implications of EBM in a malpractice case runs
counter to the clear data in the Ransom study which
documented the malpractice protection EBM offers in terms of the
use of clinical practice guidelines.
In an essay in the New England Journal of Medicine, a young family
practice resident reported on the “Winners
and Losers”
in a situation where he saw a patient and did some screening tests,
but did not perform a PSA test for screening purposes, explaining
to the patient and documenting their discussions of risks and benefits
of screening for prostate cancer. The resident never saw the patient
again. The patient presented to a new doctor who found he had a
very high PSA. The patient ultimately died of prostate cancer.
At trial, EBM was characterized as a cost saving method and the
plaintiff’s counsel in closing argument apparently urged
the jury to return a verdict to “teach residencies not to
send any more residents on the street believing in EBM.” While
the implications are extremely troubling, this case stands more
for the disparity between the standard of care in the locality
and what the evidence demonstrates ought to be done, than as a
precedent in any way regarding the benefits of EBM. Because the
physician was a resident, the issue of the payment system is not
reported on. That is a legal matter that would be relevant as well.
While chilling in its outcome, the report is thought provoking
with respect to the applications of EBM.
In a study of surveys of Dissatisfaction with Medical Practice , Dr. Abigail Zuger, et al., note in 2004 that one of the
reasons we have proposed to subscribe to UFT-A principles persists.
Data suggests that dissatisfaction on the part of physicians breeds
poor clinical management as well as dissatisfaction and non-compliance
among patients and that the rapid turnover of unhappy doctors in
offices and hospitals may lead to discontinuous, substandard medical
care.” Among the factors contributing to such dissatisfaction
remains the strongly felt perception of lack of time. One sociologist
noted that “Doctors’ anguish seems to come from violating
everyday what they know they ought to be doing.” Interestingly,
in addressing possible solutions, the author observed that some
authorities advocate a conscious re-emphasis on professionalism
in medicine; others suggest that non-professional sources of happiness
such as time with family and friends and exercise is more important;
and some propose that encounters between doctors and patients may
provide “enough joy to serve as antidotes to other woes.” Astonishingly,
the quality implications of solving this problem are not addressed
at all. The study supports the need to develop an environment in
which physician satisfaction can increase to avoid exacerbation
of the quality problems that have been identified elsewhere.
One of the sub principles of UFT-A
is for physicians to be saved for their highest and best
use. This
principle applied throughout
health care would also free up time and improve results. This has
been demonstrated in situations where innovation gives advanced
practice nurses more responsibility in fulfilling the patient’s
needs. At Hackensack University Medical Center, as reported in
August 22, 2002, Modern Healthcare, physicians find themselves “Following
Nurses’ Orders” (you must be a registered user).
The hospital experienced very significant cost savings as well
as time saving for the physicians. Peter Gross, MD, one of the
participants in our original confab, is quoted in the article as
indicating that by using advanced practice pulmonary nurses to
scrutinize compliance in pneumonia care, within six months performance
on most measures improved to 90% or better in the majority of cases.
The system is now being expanded throughout the hospital. This
approach supports the proposition that organizing care with an
explicit focus on which clinician is best most appropriately to
deliver care to the patient at a specific moment in time is also
an important part of a business case for quality.
One
of the challenges in using CPGs is the ‘quality’ of
the CPG itself. When, in 1989, Congress gave AHCPR the responsibility
to develop and publish CPGs, the agency turned to the Institute
of Medicine for guidance on how to proceed. The IOM convened
two committees -- one to advise the agency directly and then
the second to look at CPG issues generally -- both committees
in which Ms. Gosfield participated. In addition to establishing
eight attributes of good CPGs, the second committee developed
a ‘provisional’ document to be used to assess the
extent to which any CPG manifested the eight attributes. (See,
Lohr and Field, “A Provisional Instrument for Assessing
Clinical Practice Guidelines” in Guidelines For Clinical
Practice, National Academy Press: Wash. D.C., 1992, pp. 346-410).
A decade later Crossing The Quality Chasm (a study
in which Dr. Reinertsen participated), looked again at the
quality of
the evidence and the nature of the measures used in guidelines
and evidence-based decision making. (See pp. 145- 159). Still
the notion of ‘standards for the standards’ has
not been widely addressed. The
National Quality Forum is developing some
standards to defuse the Tower of Babel effect of the proliferation
of measures and standards for quality,
but national standards for good CPGs have not been enunciated
since the IOM’s eight attributes. Since UFT-A is predicated
on deep application of CPGs or EBM, what defines a “good” CPG
is important. A recent study reports a proposal for guideline
standardization on
a nine-point scale. The report by Shiffman et al, intends
their scale to be used prospectively
in the development of CPGs. The criteria track closely to
but are more refined than the IOM standards. They, like the
IOM,
avoid the thorny issue of the extent to which costs should
be taken into account in developing CPGs. Our UFT-A approach
finesses this issue by confronting it squarely – to
get to a new payment model, anyone implementing a CPG, whether
for a chronic or acute condition, will want to cost it out.
As the malpractice insurance crisis intensifies
around the country, the link between malpractice prevention
and quality becomes even more important. Throughout the history
of attempts to standardize care to the evidence, there has
always been some anxiety about whether using clinical guidelines
would prove valuable from a risk management perspective. Although
there has been some work in the past looking at whether CPGs
used in malpractice litigation more often inculpate or exonerate
the physician, there is now a study that shows that in obstetrical
care, “noncompliance with the clinical pathway in our
retrospective analysis was associated with a six-fold
increase in the odds of a malpractice claim.” (Ransom et al., “Reduced
Medicolegal Risk by Compliance with Obstetric Clinical Pathways:
A Case-Control Study”, Obstetrics & Gynecology (April
2003) pp. 751-755. In addition to the long supported proposition
that a truly engaged patient, one with a good doctor patient
relationship, is far less likely to sue the physician even
in truly bad circumstances, there is now good evidence that
standardizing to the science itself is more likely to prevent
claims in the first instance.
UFT-A is likely to have its most significant
payment reform opportunities in chronic care applications.
A related delivery concept has been enunciated by Edward Wagner
and colleagues in their work on articulating a chronic
care model (CCM)
which adopts five fundamental principles to improve chronic care
within communities .
This approach to care was considered extensively in May, 2003
in a meeting of
critical stakeholders in six New England states addressing
how to advance the quality of chronic care delivery with a new
payment model. Although not characterized in these
terms, much of what was discussed is consistent with elements
of UFT-A – particularly standardizing to the science,
engaging the patient actively and using clinicians at their
highest and best use. The CCM may offer a good opportunity
to bridge this complementary approach in chronic care to an
improved payment model with broader applications of UFT-A principles.
On the other side of the country, in Whatcom
County Washington, implementation of a communitywide chronic
care model in the treatment of diabetes and CHF has been able
to project both major health outcomes benefits and cost savings in
a program which is not focused so much on payment as on care
delivery.
Here, analyzing the impact of standardized care which incorporates
intense nurse/case manager involvement, the researchers project
savings to the total health care system in the sixth year of
implementation. Even so, meaningful impacts will be felt as
early as the third year. Medicare and the pharmaceutical companies
are the biggest winners over all, with Medicare appreciating
significant savings from avoided hospitalizations; and pharmaceutical
companies appreciating significantly increased revenues because
of baseline underuse of appropriate pharmacologic treatments.
Revenues to physicians and hospitals fall off though, and there
is little attention yet to what type of payment model can effectively
confront this effect. The study does at least frame the issue.
Will the resulting shifts in care free these providers to provide
more expensive services in substitution? Is there an explicit
payment model – something other than basic capitation
or fee-for-service – that more fairly confronts the interrelationships
of the parties? This study does not get to those issues yet
since its primary import is the fact that making these projections
proved significant in obtaining buy-in from potential participants
who could see clearly their part in an overall scheme.
Prosecutors are becoming increasingly
interested in how quality implicates the fraud and
abuse statutes.
The
OIG
2004 Work Plan targets
9 specifically noted medical necessity issues and 4 quality
issues. From understaffing
in hospitals, to care which
does not meet professionally recognized standards, to over-utilization,
the Department of Justice is separately using new theories
of false claims and flat out fraud based on the clinical care
rendered. Initially used to force some 40+ false claims settlements
around the country with nursing homes, prosecutors have now
made it clear they intend to use similar quality-based theories
to prosecute hospitals for false claims. In the current environment
of diminishing reimbursement and heightened attention to quality,
the fraud and abuse risks from less than optimal clinical behavior
can no longer be ignored. Unless these issues are addressed
in compliance programs, those initiatives will remain mired
in the narrow focus of the administrative minutiae of billing
problems, leaving the health care enterprise vulnerable and
their compliance staff isolated from the principal focus of
the organization – delivering high quality care. At the
same time, how to set priorities for compliance activities
is beginning to stymie those compliance programs that addressed
initial, low hanging fruit with corrective, voluntary actions.
Many of the entities we work with are struggling with where
to go next. Many seem to believe that the role of compliance
is to forever search out errors to report and repay. We do
not share this view. We believe compliance is about doing it
right in the first place and cleaning up problems found. It
is not about eternal internal inspection. In the AGG
Note, “The
Quality/Compliance Nexus: Moving to Programmatic Integration” Ms.
Gosfield examines the developing enforcement environment, sets
forth liabilities already on the books, and then discusses
how using UFT-A in compliance can integrate its import into
the fundamental mission of a health care enterprise.
Economic credentialing is
only one of a growing number of sources of tension between
medical staffs
and the hospitals to which they relate, which tensions are
growing as the dynamics of health care change. While the struggles
within medical staffs engage the members whose oxen are being
gored, they are far afield from the critical quality surveillance
responsibilities hospital medical staffs could undertake in
the American health care system. Because of the path many medical
staffs have taken, in many ways, it is not unreasonable to
ask ‘what is the value of the organized medical staff
in the current quality-concerned environment?’ In a presentation
to the Organized Medical
Staff Section of the AMA in
June, Dr. Reinertsen and Ms. Gosfield challenged medical staff
leaders
to confront the far more critical issues of quality to which
they could address their attention. By doing so,
and in fact far more explicitly adopting principles
of UFT-A to guide the medical staff-hospital-board relationships, we
believe medical staffs can be revitalized to perform roles
more satisfying to them, more productive to the facilities
and other clinicians working there and more meaningful to the
patients in them to which they relate.
In the AGG
Note, "The Organized
Medical Staff: Should Anyone Care Any More?"
Ms. Gosfield presents information regarding the genesis and
legal basis for the medical staff,
how bylaws relate to the new environment, typical bylaws contents
and typical bylaws mindsets. She offers 7 principles of interaction
along with 5 suggestions regarding how to revitalize and make
easier certain key medical staff functions. She also reviews
5 of the hot potatoes in medical staff-hospital relationships
including economic credentialing, EMTALA obligations, and cross-department
privileging, among others. For a more extensive consideration
of these issues see Alice Gosfield's article “Whither
Medical Staffs?”,
Dr.
Reinertsen’s article in Trustees magazine,
and his article which addresses barriers
to quality within hospital
processes ,
all incorporating aspects of UFT-A which we believe can be
consolidated as a unifying principle for hospital-medical staff
interactions, too.
On March 28, 2003 in Chicago, Alice G.
Gosfield and James L. Reinertsen, MD, FACP,
convened, with the generous support of Sanofi-Synthelabo, a unique meeting of 30 senior
leaders (CEOs, CMOs, Senior VPs) from a variety of leading institutions such as
Intermountain Health, Pacificare, Sutter, Scripps, Massachusetts General Hospital,
CareGroup's Provider Service Network, HealthTexas (Baylor), Hackensack University Medical
Center, Catholic Healthcare Partners, Mayo, EBM Solutions, Anthem, Institute for Clinical
Systems Improvement, Oregon Health and Sciences University and others to consider, react
to and develop further ideas first expounded in the AGG Note 'Gosfield's Unified
Field Theory'. This theory, which Reinertsen and Gosfield now seek to move to practice and
application ("the Unified Field Theory-Applied ["UFT-A"])
posits how to use clinical practice guidelines to drive physician payment and many
other aspects of the health care system.
Informed by the conference discussions, Reinertsen and Gosfield have
authored a White Paper, "Doing Well By
Doing Good: Improving the Business Case for Quality." The paper considers
Current barriers to a physician business case for quality,
The limits of current attempts to address the business case,
The centrality of physicians to the American health care system,
Why physician time and touch with patients are essential quality
problems,
Five principles for change which could revolutionize health care,
How clinical practice guidelines can provide a firm foundation for a
unified system to reorder major aspects of health care delivery and accountability, not
just for physicians, but throughout the system; and
Implementation challenges that will have to be addressed to make the
theory real.
The goal of the paper is to stimulate rapid-fire trials in multiple
venues. The conference attendees were interested in remaining in contact regarding
initiatives, experiments and experiences applying these ideas. We have now established a listserve for those who seek to communicate in an
on-going way about successes, obstacles and challenges to do this in local markets. We are
hopeful this will be the beginning for broader initiatives that will expand to others.
The malpractice insurance
crisis is affecting physicians and hospitals as never before. Physicians
are retiring early and leaving states where premiums have risen
to unmanageable levels. Picketing at state capitols, closing their
offices for days at a
time to demonstrate the impact of limited access, hurled invectives
among trial lawyers, physicians and those who manage insurance
companies have only shown how intense the stakes
are. Although physicians and the current Administration in Washington
have focused initially on caps on jury awards, none of the dialogue
has focused on the link between
quality and tort reform. For one proposal that focuses on another
way of rewarding quality see Gosfield, "Liability for Quality:
A Modest Proposal, " Managed
Care
& Cancer, (Jan/Feb 2000)
