Performance Measures, MIPPA, and Public Health Headline ASN Policy Sessions

Clinical Performance Measures

The growing tide of new metrics for evaluating delivery of care for chronic kidney disease (CKD) and other outpatient services warrants a healthy look at their efficacy, according to speakers at the policy sessions at Renal Week. Even as physicians and other care providers gear up to meet the new requirements, they must also take part in evaluating how well the measures work, speakers said.

Historically, there has been a lack of quality measures for CKD, but as some care services move away from hospitals and toward ambulatory care providers, a plethora of new measures for CKD and other outpatient services are on the horizon.

Quality measures for kidney disease need to be carefully developed and evaluated to be most effective, said Neil Powe, MD, director of the Welch Center for Prevention, Epidemiology and Clinical Research at Johns Hopkins. Future needs for CKD quality measures include demonstrating that measures are related to outcomes, creating more measures for early stages of CKD, and using performance measures to address health-care inequalities. These measures must not only be tested during their application, but also during all stages of development. Powe gave the Christopher Blagg Endowed Lecture at the Public Policy Forum on “Clinical Performance Measures: How Will You Be Measured?”

Louis Diamond, MBChB, medical director of the Medstat Group, spoke about recent trends by government and the private sector to assess physician performance and link performance to relicensure. The “elephant in the room,” Diamond said, is “we still don’t know how best to assess physician performance.” As policymakers and professionals look toward the future, he urged a closer look at the efficacy of using both process and outcome measures and called for national, coordinated efforts—with funding attached—to develop and evaluate guidelines for a robust system of physician performance measures.

Jay Wish, MD, professor of medicine at University Hospitals of Cleveland, explored the future of clinical performance measures, starting with the 1998 “core indicators” for end stage renal disease (ESRD), some of which are still in use, and ending with the 2008 Phase III ESRD guidelines, recently released to coincide with the new ESRD facility conditions for coverage. These Phase III guidelines include 26 new measures, some of which have not been approved by the National Quality Forum [contracted by the Centers for Medicare and Medicaid Services (CMS) to approve ESRD guidelines], including hemodialysis adequacy metrics and anemia management. The new measures move from being solely facility-based to now covering facilities, clinicians, and patients.

State surveyors will look at implementation of these new guidelines as they review compliance with the new ESRD conditions for coverage, but it is likely they will not be used as pay-for-performance measures until the implementation of bundling in 2010. Wish advised the health-care community to “proceed with caution” because not all of the new measures have been validated and process measures are not currently being collected.

Understanding the Medicare Improvements for Patients and Providers Act of 2008

A “perfect storm” of variables led to passage of the landmark Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), said Jonathan Himmelfarb, MD, chair of ASN’s Public Policy Council. Himmelfarb, director of the Kidney Research Institute and professor of medicine at the University of Washington in Seattle, spoke at a special session on “Medicare Implications for Nephrology.”

A “gathering storm” of unsustainable costs and questionable health-care quality, combined with government unease with “perverse incentives” (read: anemia management) and the convergence of a broad base of powerful advocacy groups including private and academic physicians, patients, and the dialysis industry, created an environment conducive to legislatively based changes to Medicare, Himmelfarb said.

The dialysis provisions include an annual update framework for the composite rate starting in 2010 and a bundled system for Medicare reimbursement, which includes a case-mix adjustment and an optional four-year phase-in period, with all dialysis providers compliant by 2012.

Educational provisions are also included in the bill. Starting in January 2010, Medicare will reimburse providers for up to six educational sessions for stage 4 CKD beneficiaries. The purpose of these sessions is to explain all options for renal replacement therapy and to educate patients on how to manage their disease and its co-morbidities. The legislation includes a provision that will award funding to at least three states to implement demonstration projects focused on increasing public awareness, as well as CKD screening and surveillance. These two educational provisions are currently unfunded and will need legislative action to appropriate funds.

While MIPPA has been hailed as a victory for both the renal community and Congress, there is still work to do as the bill now moves from the legislative stage to the implementation process and details are worked out with CMS and the Department of Health and Human Services. Congress has given enormous discretion to these two agencies for the interpretation of the bill, and only time will tell if renal community interests stay aligned, Himmelfarb said.

CKD and Public Health

The ASN Public Policy Board Symposium focused on the economic and health burdens of CKD and national efforts to educate, screen, and treat those at risk for or with CKD.

The Chronic Kidney Disease Surveillance Pilot is one such project. A partnership between the Centers for Disease Control (CDC), Johns Hopkins University, and the University of Michigan, the project assesses the prevalence, impact, and resource utilization of CKD. The surveillance project integrates 11 data sources into a comprehensive system that tracks factors associated with CKD, including awareness, risk, and health outcomes.

Among the challenges to creating this type of surveillance project are data procurement, missing data, and comparison across data sources, said Rajiv Saran, MD, associate director of the University of Michigan Kidney Epidemiology and Cost Center. Results from the CDC pilot program have not yet been released, but a copy of the executive summary is available upon request from

The burden of ESRD, coupled with the risk factors of diabetes, hypertension, and cardiovascular disease, provide a strong rationale for focusing on programs that increase early detection of CKD, said Alan Collins, director of the Chronic Disease Research Group (CDRG). The “Cherish Your Kidneys” program, a partnership between the CDC, the CDRG, and the National Kidney Foundation, targets patients at high risk for kidney disease, screening those older than 50 with self-reported diabetes and/or hypertension.

Andrew Narva, MD, director of the National Kidney Disease Education Program (NKDEP), described the efforts of NKDEP to improve CKD care at both a provider and patient level through education, outreach, and collaboration with other federal agencies. The NKDEP’s community health center CKD pilot project works to improve screening, detection, and management of CKD care for vulnerable populations, typically uninsured or underinsured, who use community health centers.

L. Ebony Bouleware, MD, associate professor of medicine and epidemiology at Johns Hopkins University, noted that expenditures for CKD—both direct and indirect—are on the rise. In her studies on the economic impact of CKD, Bouleware found that annual screenings were not cost-effective unless used with targeted groups. She stressed that targeting patients at greatest risk for progression to kidney disease may be the most cost-effective practice.

As the burden of kidney disease continues to grow, government agencies and private entities are taking notice and working to create policies that combine cost-cutting and quality measure development for current CKD and ESRD. Agencies are also working on early detection through screening and educational initiatives to catch CKD in the early stages and slow the progression to ESRD. The renal community can help by staying informed and lending a voice to policy development both now and in the future.