Medicare's version of surgical quality


The quality of surgical care should be on everyone’s minds. As we all know, the government’s current plan to halt the nonsustainable rate of health care expenditure increases includes the use of Accountable Care Organizations (ACOs).

The idea is to make care "accountable" by partnering providers and hospitals to provide more efficient care. Efficient care in this context translates to reductions in unnecessary expenditures that do not add value, whether they are imaging, physician office visits, specialist consultations, lab tests, or procedures while retaining quality.

Dr. Jeffrey Punch

The high degree of variability of some expenditures by region and the lack of positive correlation between expenditures on the one hand, and healthcare outcome, patient satisfaction, or quality measures on the other, suggests that reducing expenditures without harming patients is possible. To date, it remains unclear how surgical practice will be affected by the introduction of ACOs, although it is hard to imagine how it could be immune to these pressures. One thing that seems certain is that quality of care will be a centerpiece of the new strategy. Therefore, it seems inevitable that quality standards will eventually be applied to surgical care. Your wound infection rate is statistically above average? Either fix it or stop operating.

Does it sound far-fetched that a regulatory body could determine the quality of a surgeon’s work based purely on measurement of outcome, and further, that this body could determine who can practice and who can’t? Consider the case of organ transplantation. Medicare began certifying heart, liver, and lung transplant programs in 1986, 1991, and 1995, respectively. In order to meet Medicare’s standard and to be Medicare approved, programs had to meet a raw survival threshold as well as a volume standard. The survival standard for heart transplantation in 1986 was 73% 1-year patient surviva

For liver transplantation, the initial standard was 77% 1-year survival; and for lung transplantation; the standard was 79%. Over the next decades survival rates gradually rose as better immunosuppression appeared and other advances in the field were made. As a consequence, the Medicare standards were eventually out of date since they no longer represented state of the art care. Surprisingly, Medicare never actually enforced the quality, nor the volume standards until a string of high-profile scandals involving several transplant programs prompted the agency to release a new set of "Conditions of Participation" in 2007. This document was published in the Federal Register meaning the rules essentially have the force of federal law. Among these rules was the establishment of minimum outcome standards for patient and graft survival. Want to do organ transplants? You must work in a program in which outcomes are within two standard deviations of the risk-adjusted national norm.

The approximately 250 hospitals in the United States at which organ transplants are performed have been functioning under the Conditions of Participation for more than 5 years now. Several things are becoming very clear. First, while Medicare approval, meaning compliance with Medicare standards, is necessary only in order to transplant Medicare beneficiaries, it is impossible for a program to be financially solvent if it is not Medicare approved. In addition to having to turn away Medicare patients, the other players in the field of organ transplantation are large transplant networks of secondary insurers, all of which require Medicare approval as a prerequisite to inclusion in their network. Medicare approval is therefore understood with in the transplant community to be mandatory. Second, the agency is serious about enforcing these regulations and holding transplant programs accountable for outcomes. Programs that do not meet their standards receive a written notice that their Medicare approval has been terminated. Appeal, through a process called mitigating factors, is allowed, as is a structured attempt to correct deficiencies called a Service Level Agreement. The sense in the transplantation community is that Medicare is pleased by the effect the new standards have had. The standards are viewed as a model for how regulation could be applied to future areas of medicine. Surgical care, since it tends to have easily tracked binary outcomes, will likely be affected in the future by Medicare experience with standard setting to date. This last bit is why surgeons outside of Transplantation need to pay attention.

Only time will tell if the outcome requirements for transplantation have had an overall positive impact. One benefit is that programs are clearly doing a better job now of tracking and paying attention to their outcomes. Quality-improvement programs have absolutely been made more robust. On the other hand, concerns have been raised that such standards will stifle innovation. Medicare has said they are willing to listen and discuss how this problem can be alleviated. For now, there is a profound disincentive to perform transplants on patients whose chance of survival is poorly measured by current algorithms or is unknown. At one point not that long ago, hepatocellular carcinoma was considered to be a contraindication to liver transplantation. Thanks to groundbreaking work at a few centers that refused to deny transplant patients purely because outcome has historically bad, hepatocellular cancer is one of the most common indications for liver transplantation today. Would these advances have been made if programs were watching outcomes like a hawk and basing decisions only on likely outcomes? Concerns have also been raised that these rules will limit access to transplantation through a variety of mechanisms. When programs are terminated by Medicare, the patients on their waiting list must be transferred to other programs. This process takes time and patients’ lives will hang in the balance. Finally, the issue of whether the standards really measure quality of care is now being thought about in much greater depth. The risk-adjustment methodologies were designed with quality improvement in mind, not to be a test for programmatic effectiveness. These issues will be included in a future editorial on the evaluation of surgical quality in the context of organ transplantation. Stay tuned.

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