Clinical Guidelines, the Politics of Value, and the Practice of Medicine: Physicians at the Crossroads

Abstract

Best practice guidelines are being used to an increasing degree, not only by physicians to improve the level of care, but also by bureaucrats to constrain reimbursement and guide the pathways of care.

Full text

Original Contribution
Clinical Guidelines, the Politics of Value, and the Practice of
Medicine: Physicians at the Crossroads
By Richard A. Cooper, MD, and David J. Straus, MD
Center for the Future of the Healthcare Workforce, New York Institute of Technology; and Memorial
Sloan-Kettering Cancer Center, New York, NY
Introduction
Guidelines have been important adjuncts to clinical decision
making. However, guidelines have also been used in regulatory
processes, including the Patient Protection and Affordable Care
Act (ACA), in ways that stretch them well beyond their in-
tended use. Guidelines are not standards. They are guides. They
are provisional. Their application as standards in the regulatory
framework is cause for concern.
Standards are quite different from guidelines. They deal with
clinical circumstances that can be defined with precision. The first
standards were developed in the early 1900s to deal with matters
such as tuberculosis prevention and radiation safety.
1
Over time,
standards have been applied to many discrete therapeutic interven-
tions and procedures,
2
and in recent years they have come to in-
clude checklists for defined processes.
3
Although guidelines have existed for millennia in authorita-
tive texts, the form in which we know them today is compara-
tively recent. Starting with only a handful in the late 1950s,
their numbers increased sufficiently to prompt the establish-
ment of a clearing house in the early 1990s.
1
Some conditions
now have multiple guidelines, whereas others have none. Their
use by physicians in the course of treatment decisions has
proved to be invaluable. But even with the aid of guidelines,
quality care depends on the judgment of competent physicians
who are trained to cope with complexity and uncertainty and
who understand the nuanced characteristics of their patients’
particular circumstances.
Regulators were quick to use guidelines, starting as early as
1980, when utilization review was introduced. In subsequent
years, guidelines were incorporated into pay-for-performance
(P4P) measures,
4
the Physician Quality Reporting System
(PQRS),
5
and other, similar instruments. And they are essential
elements in the value-based purchasing systems and account-
able care organizations (ACOs) established by the ACA.
The Value Culture
Placed in a broader context, the use of guidelines in regulatory
processes can be seen as part of the struggle between physicians,
who value their professional autonomy, and government and
industry, who have sought to wrest control from a profession
that they have seen as too powerful.
1
Concern that just such a
struggle might ensue is reflected in the original Medicare Act of
1965, which declared that “nothing in this title shall be con-
strued to authorize any Federal officer or employee to exercise
any supervision or control over the practice of medicine.”
6
In
fact, considerable control has been exercised, although not spe-
cifically over the practice of medicine. The lever of control is
“value,” a paradigm that links quality and cost. Indeed, it is
through the politics of value that clinical decision making has
been progressively wrested from physicians’ control,
4
and it is
the regulatory application of guidelines that has become an
instrument in this process.
The value culture builds from a belief that costs are high
because quality is low. One oft-cited example is the many thou-
sands of deaths that have been attributed to physicians’ errors,
7
although the numbers claimed may be exaggerated.
8
Another is
the broadly refuted
9
claim that 30% of health care spending is
due to unexplained geographic variation in physician prac-
tices,
10,11
although most such variation is explained by geo-
graphic differences in poverty and its high toll on health care
resources.
9,12
Yet, these beliefs are rooted in a simple truth.
Physicians’ practices are imperfect. And they are powerful be-
liefs. They have fueled the conclusion that someone is doing
something wrong and something must be remedied.
1
Part of the remedy has been found in the reimbursement sys-
tem, where excessive spending has been attributed to misaligned
incentives that lead physicians to choose volume instead of value.
The favored solution is to cease paying for service and start paying
for the “right care.”
13
Moreover, because it is physicians who have
traditionally defined the right care, that responsibility must now be
placed elsewhere. As framed in statements by former Center for
Medicare & Medicaid Services (CMS) Administrator Donald Ber-
wick, “In the past, physicians’ commitment to the patient ensured
the provision of appropriate care.
14(p168)
However, “no longer is the
physician, paternalistically committed to the patient, the driving force
in medical care. Health care is being rationalized through critical path-
ways, guidelines and integrated business structures.”
14(p24)
Regulating
for improved medical care involves designing appropriate rules in-
vested with authority.”
14(p9)
Achieving these goals demands “re-
striction of the autonomy of health care professionals.”
15(p759)
This
shift in the locus of control from physicians to regulators has been
fostered by thought leaders within and beyond the profession, and
too often, guidelines are tools to that end.
The Tyranny of Guidelines
Guidelines are expressions of the optimal pathway for the aver-
age patient, but, of course, most patients are not average. An
example of how the doctrinaire application of guidelines to all
Focus on Quality
JULY 2012 • jop.ascopubs.org 233Copyright © 2012 by American Society of Clinical Oncology

patients can be harmful was provided in a recent study which
showed that the inflexible use of the most widely accepted hy-
pertension guidelines would lead to inferior outcomes.
16
More-
over, although many of the most clinically useful guidelines deal
with important issues, it is through their exercise of judgment in
myriad small decisions that physicians display their compe-
tence. The following two cases illustrate how the inflexible use
of guidelines can adversely affect such decisions
Case Report 1
Patient No. 1 is a morbidly obese 37-year-old man who, 16
years previously, was treated for stage IIBX Hodgkin’s lym-
phoma, nodular sclerosis type with standard chemotherapy fol-
lowed by radiation therapy to the neck and mediastinum.
Reviews of patients with Hodgkin’s lymphoma treated at Me-
morial Sloan-Kettering Cancer Center (MSKCC)
17
and else-
where
18-20
have found striking increases in carotid and coronary
atherosclerosis 10 years and more after radiation to these ports.
As a result, follow-up at MSKCC includes screening for early
coronary artery disease. Although the current National Com-
prehensive Cancer Network (NCCN) guidelines for Hodgkin’s
lymphoma note that cardiovascular symptoms may occur at a
young age, they make no specific recommendations for screen-
ing.
21
Lacking such a guideline, this patient’s insurance carrier
denied payment.
Case Report 2
Patient No. 2 is a 46-year-old man with diffuse large B-cell
lymphoma who is being treated on a protocol that includes
combination chemotherapy with rituximab, cyclophospha-
mide, doxorubicin, vincristine, and prednisone (R-CHOP)
with growth factor support every 2 weeks. Because this regimen
is emetogenic, MSKCC supportive care policy includes pro-
phylactic treatment with aprepitant. Although NCCN guide-
lines include an option of R-CHOP treatment every 2 weeks
rather than every 3 weeks,
22
treatment at this interval was not
within the guidelines followed by the patient’s insurance car-
rier, and coverage for aprepitant was denied.
The two circumstances described above do not represent
major decisions, but they were important decisions, and the
inflexible application of guidelines influenced them adversely.
Such actions are not unique to oncology practice. In a recent
example, patient care was harmed by the denial of payment for
medication in two psychiatric patients with mood disorders,
one because the dose was considered too low and the other
because it was considered too high, although symptom control
was good in both patients.
23
From PQRS to P4P to ACOs and
Comparative Effectiveness
The broad application of guidelines as regulatory tools is illus-
trated by the PQRS program, which uses more than 250 mea-
sures. Most are quite narrow, and many deal with processes of
care or patient satisfaction, neither of which correlate with clin-
ical outcomes.
2,24
In England, adherence to specific perfor-
mance standards by Primary Care Trusts simply led to the
decreased use of other elements of care of equal or greater im-
portance.
25,26
Nonetheless, such standards are being incorpo-
rated into P4P programs, even though P4P has generally failed
to reduce expenditures,
2,27,28
even in Massachusetts, whose
health care reform was used as the model for the ACA.
29
Despite these experiences, guidelines will soon be applied to
value-based purchasing and ACOs, through both rewards for
providers who meet the stated standards and penalties for those
who do not. In announcing its proposed rules for ACOs, the
Centers for Medicare & Medicaid Services noted that “we
could provide a detailed description of evidence-based guide-
lines for various conditions and diseases for which we would
hold ACOs accountable. However, we have concerns that a
prescriptive approach would be premature and potentially im-
pede the goals of this program.”
30(p77)
But without a doubt, the
goal is to use rules invested with authority.
To fairly assess the use of guidelines and standards, risk
adjustment will be essential. Comorbidities are one important
element, but income is even more important. Costs are highest
and outcomes are worst among patients who are poorest and
most disadvantaged.
9,12
Unfortunately, the administrative data
commonly used to assess value lack sufficient information to
properly adjust for poverty. It is not surprising, therefore, that
concerns have been raised that incentive payments might harm
providers who disproportionately care for the poor,
2,31
as has
occurred in California already
29
; that the financial goals of
ACOs could create incentives to avoid low-income patients,
32
as has occurred in medical homes already, both in the United
States and Canada
33,34
; and that the application of value-based
quality standards could harm providers who disproportionately
care for the poor.
35
Finally, although most guidelines have been the product of
work by expert physicians, they soon will be the product of the
comparative effectiveness panels mandated by the ACA. Al-
though the federal government is currently constrained from
applying the results of such panels in a regulatory manner, the
New York Times has editorialized that they should,
36
and others
have noted that value can only be achieved by requiring adher-
ence to clinical guidelines.
37
Yet, concern about the validity of
even the highest quality guidelines currently in use has
prompted the Institute of Medicine to issue a set of rigorous
standards for trustworthy guidelines.
38
Conclusion
Best practice guidelines are being used to an increasing degree,
not only by physicians to improve the level of care, but also by
bureaucrats to constrain reimbursement and guide the path-
ways of care. Physicians recognize that most guidelines simply
reflect the provisional opinions of so-called experts about care
under modal circumstances, and they know that all are subject
to change in accordance with the constant flow of new infor-
mation.
38,39
In the hands of a knowledgeable physician, the
integration of guidelines into decision making can aid in reduc-
ing expenditures and raising quality. However, their inflexible
application can be an impediment to both, and the pervasive
Cooper and StraussCooper and Strauss
234 JOURNAL OF ONCOLOGY PRACTICE •VOL.8,ISSUE 4Copyright © 2012 by American Society of Clinical Oncology

expansion of their use by regulators should be greeted with deep
alarm. In the last analysis, high-quality care depends on the auton-
omous exercise of sound clinical judgment by competent and car-
ing physicians.
40-42
Preserving that elusive and endangered
professional characteristic should be a matter of utmost concern.
Accepted for publication on February 21, 2012.
Author’s Disclosures of Potential Conflicts of Interest
The author(s) indicated no potential conflicts of interest.
Author Contributions
Conception and design: All authors
Administrative support: Richard A. Cooper
Collection and assembly of data: Richard A. Cooper
Data analysis and interpretation: All authors
Manuscript writing: All authors
Final approval of manuscript: All authors
Corresponding author: Richard A. Cooper, MD, New York Institute of
Technology, 400 E. 56th St, Suite 32R, New York, NY 10022; e-mail:
cooperra@wharton.upenn.edu.
DOI: 10.1200/JOP.2011.000500; published online ahead of print
at jop.ascopubs.org on May 29, 2012.
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