P4P has nothing to do with Easter Peeps

As long as the public believes that “quality” of health care means measures shown to improve patient health outcomes, save lives, reduce medical errors or reduce healthcare costs, then the doublespeak will continue to be used in ways that cost them.

Doctors, medical professionals and healthcare providers already know that “quality” measures, also known as “pay for performance” measures, have not been shown in clinical research to result in the benefits being claimed. Instead, they can even increase risks for many patients. They are not the same as evidence-based medical care, although some confuse the terms. Pay for performance (P4P) measures, do however, make money for the stakeholders who create them.

P4P guidelines — by basing reimbursement, accreditation and standing of healthcare providers on their compliance — have the force and effect of law. For medical professionals and providers, wavering from P4P measures and providing clinical care that may be best for individual patients, adheres to the soundest science, follows their best clinical judgment or abides by the choices of patients, comes at considerable expense and risks to careers.

One of the largest and oldest P4P programs is from Leapfrog, which ranks hospitals based on their adherence to its “quality” measures and Leapfrog’s members are encouraged to incentivize and pay hospitals accordingly. About 1,100 urban hospitals recently completed its 13-point Safe Practices Survey, which is part of the National Quality Forum’s Safe Practices for Better Healthcare and is used by the Centers for Medicare and Medicaid Services (CMS).

A study published in the current issue of the Journal of the American Medical Association compared patient outcomes and mortalities to hospitals’ scores on Leapfrog’s safe practices measures. It was led by R. Adams Dudley, M.D. with the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco.

The authors then tried a secondary analysis, using patients they hypothesized might be more sensitive to adherence to their measures: patients older than 65 years of age and of high risk, with greater than 5 percent expected mortality. They also factored for characteristics of the hospitals that they thought could confound their results, such as rural versus urban locations, size and whether the hospitals were teaching hospitals.

They found: no relationship between scores and in-hospital mortality, regardless of whether they adjusted for expected mortality risk and hospital characteristics.

Catch Up

P4Ps are nothing new, but surprisingly few consumers outside the medical profession understand them. The Leapfrog Group, as JFS readers remember, was founded nearly a decade ago, in November 2000, by the Robert Wood Johnson Foundation. Its mission is to assist programs supported by grants from RWJF, the California HealthCare Foundation and the Commonwealth Fund, and to change provider behavior.

Leapfrog is a partner in the Partnership to Fight Chronic Disease and the National Priorities Partnership, for instance, stakeholders working to transform the nation’s healthcare system. In the past decade these stakeholders have made extraordinary inroads into the highest levels of federal and private healthcare and influencing clinical guidelines, public policies and legislation. P4P measures are part and parcel of managed care (medical homes and health management companies, formerly called health insurance companies) and government-provided health coverage (Medicare and Medicaid).

The 74 clinical quality measures recently launched by CMS in its P4P program encourages doctors to write some 15 different prescriptions for adults over age 50 in order to meet the requisite metabolic indices. Never mind that metabo measures are actually not good measures of those people following healthy lifestyles or at risk for heart disease, diabetes, cancer or premature death. The CMS now has at least 134 performance measures just for doctors’ practices. As we’ve seen repeatedly, none of the most onerous guidelines has held up in a single study as reducing mortality or improving clinical outcomes.

Among Leapfrog’s “Rewarding Results” projects are incentivizing such things as type 2 diabetes screenings for young people (to address that “epidemic of type 2 diabetes in young people”), the faster adoption of electronic medical records (and integrated health IT), annual mammograms and preventive screenings, and disease case management — most of which have failed to hold up to scientific scrutiny.

Leapfrog is also a partnering organization on the National Quality Forum, supported by RWJF, and serves on its National Priorities Partners Committee, working on developing the government’s national strategy for healthcare reform, payment incentives, public reporting, “quality” oversight programs and professional norms.

Slowly, the truth is beginning to find its way outside medical journals and the blogosphere to reach the public. This week, the Wall Street Journal published a must-read article by doctors Jerome Groopman and Pamela Hartzband, echoing what JFS has been reporting for years. They write:

Why 'Quality' Care Is Dangerous

The Obama administration is working with Congress to mandate that all Medicare payments be tied to "quality metrics." But an analysis of this drive for better health care reveals a fundamental flaw in how quality is defined and metrics applied… Since 2003, the federal government has piloted Medicare projects at more than 260 hospitals to reward physicians and institutions that meet quality metrics. The program is called "pay-for-performance." Many private insurers are following suit with similar incentive programs.

In Massachusetts, there are not only carrots but also sticks; physicians who fail to comply with quality guidelines from certain state-based insurers are publicly discredited and their patients required to pay up to three times as much out of pocket to see them. Unfortunately, many states are considering the Massachusetts model for their local insurance… governmental and private insurance regulators now have overreached. They've turned clinical guidelines for complex diseases into iron-clad rules, to deleterious effect…

They go on to describe the latest clinical study showing that tight control of blood sugars in critical care patients worsened their outcomes and increased deaths. Of course, as we’ve seen, this is not the first clinical trial to find that stricter blood sugar control has no effect on reducing diabetes-related or overall mortality and can increase risks for patients. In fact, as Drs. Groopman and Hartzband also explain, so many diabetics died in the ACCORD study in the tightly regulated group that the researchers discontinued the trial. And the clinical trial evidence for statins and keeping cholesterol levels low continues to contradict guidelines, they write… and for nearly everyone (children, young people, babies, seniors, female, etc.).

They continue:

These and other recent examples show why rigid and punitive rules to broadly standardize care for all patients often break down. Human beings are not uniform in their biology. A disease with many effects on multiple organs, like diabetes, acts differently in different people. Medicine is an imperfect science, and its study is also imperfect. Information evolves and changes. Rather than rigidity, flexibility is appropriate in applying evidence from clinical trials. To that end, a good doctor exercises sound clinical judgment by consulting expert guidelines and assessing ongoing research, but then decides what is quality care for the individual patient. And what is best sometimes deviates from the norms.

Yet too often quality metrics coerce doctors into rigid and ill-advised procedures. Orwell could have written about how the word "quality" became zealously defined by regulators, and then redefined with each change in consensus guidelines…

Tragically, the public has yet to understand that these quality measures are discriminatory and most target those who are aging and the most vulnerable among our population. The consequences that medical professionals have been cautioning, and JFS reporting, have increasingly become reality. As Drs. Groopman and Hartzband note:

State pay-for-performance programs also provide disturbing data on the unintended consequences of coercive regulation. Another report in the most recent Health Affairs evaluating some 35,000 physicians caring for 6.2 million patients in California revealed that doctors dropped noncompliant patients, or refused to treat people with complicated illnesses involving many organs, since their outcomes would make their statistics look bad. And research by the Brigham and Women's Hospital published last month in the Journal of the American College of Cardiology indicates that report cards may be pushing Massachusetts cardiologists to deny lifesaving procedures on very sick heart patients out of fear of receiving a low grade if the outcome is poor.

True “evidence-based medicine” values sound science and recognizes the importance of learning and experienced clinical judgment. As they wrote: “Science depends upon such a sentiment, and honors the doubter and iconoclast who overturns false paradigms.”

“We need a national time-out in the rush to mandate what policy makers term quality care to prevent doing more harm than good,” they concluded.

But policy makers are politicians, not medical professionals, and politicians are now making medical decisions for us.

© 2009 Sandy Szwarc