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Informed consent requires that physicians and patients discuss treatment options, risks, and benefits, and mutually decide on a treatment. This approach and the explicit demands of medical professionalism acknowledge the patient’s right of self-determination and assume high moral integrity of physicians, who are expected to place the patient’s welfare above all other considerations.

AAOS Now

Published 8/1/2009
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Jeffrey R. Binder

Will new healthcare policies erode surgeon freedom of choice?

Reform efforts should not undermine surgeon judgment

Surgeon judgment, skillfully applied to each patient’s unique condition and expectations, is essential for the delivery of excellent care. Yet this judgment is increasingly called into question by policymakers, payors, and hospital administrators. Mounting financial pressure is driving a disturbing trend that could constrain the free exercise of surgeon choice and dramatically alter the physician’s traditional role as patient advocate.

Jeffrey R. Binder

Various government healthcare agencies have adopted “The right treatment for the right patient at the right time” as an informal motto. This phrase reasonably reflects the tacit social contract between patients and the healthcare system. The government, however, clearly intends to emphasize “value,” which it defines as quality divided by cost.

Certainly, payors are within their rights to demand the best quality possible for their benefit payments. The difficulty is in defining and measuring quality.

What is “quality”?
Quality in health care is neither an abstract concept nor a discrete metric that can be easily scored, particularly in orthopaedics, where outcomes are measured for years following treatment. Quality is defined one patient at a time and is delivered when the surgeon and patient collaborate to choose the appropriate treatment for that patient’s unique condition and expectations.

It is difficult to imagine how the government can create general quality guidelines with the nuance required to manage differing conditions and expectations without denying some patients access to the best available treatment. Thus far, payor-defined quality incentive programs do not seem to result in improved outcomes.

Will value-based purchasing improve quality?
Despite the inherent difficulty in defining quality and value, the Centers for Medicare & Medicaid Services (CMS) is formulating a plan to transition from traditional fee-for-service payments to “value-based purchasing” for hospital and physician services.

As part of that effort, CMS is conducting demonstration projects to evaluate different payment and reporting mechanisms. These programs largely measure compliance to process guidelines, although some also measure short-term complications and re-admissions.

The Premier/CMS Health Quality Incentive Demonstration illustrates the difficulties inherent in scoring quality. Participating hospitals had higher composite quality scores for joint replacement than nonparticipating hospitals. Most of the measures were process guidelines; only two—re-admission and mortality—measured outcomes. Thus, a hospital could have high composite quality scores without improved outcomes. High performance correlated to high volume, greater specialization in arthroplasty, and teaching hospital status, but not to reduced re-admission or mortality.

Other pay-for-performance programs have also reported discouraging results. One study found poor correlation between adherence to payor-defined guidelines and outcomes or cost of care in total joint replacement procedures.

Physician quality reporting has also proven problematic. Only 15.8 percent of eligible physicians participated in the national Physician Quality Reporting Initiative (PQRI) and evidence of actual improvements in outcomes is scant.

Evidence-based guidelines can provide useful information to clinicians and hospitals. Following guidelines does not guarantee improved outcomes, however, any more than adhering to a coach’s playbook ensures victory. Even the most carefully crafted guidelines may not anticipate the wide variety of patients’ conditions and expectations. Surgeon skill and judgment will always be crucial to delivering the optimal result for each patient.

Comparative effectiveness research
Congress also recently mandated the creation of the Federal Coordinating Council for Comparative Effectiveness Research to provide information to healthcare providers on the relative effectiveness of various treatments. Comparative effectiveness research is a reasonable pursuit that may deliver useful data. The orthopaedic community should support comparative effectiveness research in principle, because careful analysis will undoubtedly demonstrate that orthopaedic procedures are highly cost-effective, particularly when compared to other surgical interventions.

The legislation states clearly that the Council is not permitted to mandate coverage or reimbursement policies. It does not, however, prevent CMS from using comparative effectiveness research for that purpose.

What is “effective”?
The problem in defining effectiveness is the same as in defining quality. The effectiveness of any given treatment depends on each patient’s unique condition and expectations. Long-term survivorship may define effectiveness for the patient who wants to avoid additional surgery, while a working parent may find that the promise of rapidly improving function outweighs the additional risk of undergoing a relatively unproven treatment.

As a result, it is unrealistic to think that the government can create definitive studies that will be universally applicable. Such a daunting task requires research projects robust enough to define and measure effectiveness in meeting the entire range of patient conditions and expectations, and deliver timely and useful data to clinicians.

Comparative effectiveness research may contribute to the knowledge base but should not be stretched beyond its usefulness. Orthopaedic treatments, particularly those involving implantable devices, are generally evaluated over the long term. Short-term comparative effectiveness studies may not be sensitive enough to demonstrate the benefits of new treatments and technologies.

Because the Council’s 15-member board consists entirely of government officials, political appointees will have the authority to gauge the relative effectiveness of treatment, which may then be used to reward—and punish—certain clinical practices. It is imperative that the council’s activities, priorities, and research results be transparent and open to public comment.

Comparative effectiveness studies should not be used to limit surgeons’ ability to choose a treatment, but to provide information that aids in making a judgment.

Achieving a balance
Payors may appropriately reward quality and expect value in return for benefit payments. A centralized definition of quality and effectiveness, however, will not apply to all patients. An appropriate policy will balance the government’s need to achieve value with the recognition that patients will define quality on their own terms, in consultation with their doctors.

The government can control the cost component of the value equation, but should not erect obstacles to the development and availability of quality treatments. Using comparative effectiveness research and value-based purchasing to define options for certain conditions could stifle innovation and deny patients access to effective but relatively expensive treatments and technologies.

To provide access to the best available treatment and personalized care within a value-based purchasing system, the government could eliminate the requirement that providers accept Medicare payment as full reimbursement. If a patient and a provider agree that a more expensive technology or treatment is appropriate, and the patient is willing to pay the difference, Medicare should not stand in the way.

Additionally, surgeons should track their own outcomes. Only orthopaedic surgeons fully understand the variables that affect the quality of each patient’s result. Because surgeons are responsible for defining and delivering quality, they should also measure and report it. Without such data, surgeons risk ceding control to payors.

In a fluid political environment, patient advocacy must remain constant. Striking the proper balance of access, quality, and affordability will require active participation by orthopaedic surgeons, and a more nuanced understanding by policymakers of the importance of surgeon judgment in delivering excellent outcomes.

Jeffrey R. Binder is President and CEO, Biomet, Inc.

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