Size Matters: Implementing Medicare’s Conditions for Coverage


ASN Kidney News invited three dialysis providers to talk about the impact the new Conditions for Coverage (CfC) are having on their organizations. Ellen G. Wood, MD, is director of a four-bed pediatric hemodialysis unit within Cardinal Glennon Children’s Hospital in St. Louis, MO. Karen Wiseman, RN, is director of policy and regulatory affairs for Renal Advantage Inc., a moderate-sized network of dialysis providers. Carol A. Topjian, is vice president of the regulatory affairs department for Fresenius Medical Services. Topjian was spokesperson for a team of respondents from Fresenius, one of the largest dialysis delivery companies.

Describe the process your organization used to develop strategies for meeting the requirements of the new regulations and identify key resources needed to carry out the implementation of the strategies.

Wood: Our small pediatric unit employs three RNs who are responsible for the chronic hemodialysis program, the peritoneal dialysis with home training program, and all acute dialysis and continuous renal replacement therapy for inpatients. We first divided up all the Conditions for Coverage into sections with each of our nurses working on a separate regulatory area. The groups held numerous meetings.

Summary data from our network has been helpful to be sure we are meeting all major changes. Meetings with the pharmacy, the hospital administration, infection control nursing for the hospital, and nursing administration have been needed as we are a chronic unit housed within the Children’s Hospital, performing acute and chronic dialysis. We are currently piloting a new comprehensive needs assessment form. The CfC required changes to numerous policies and construction of a dedicated drug area within our unit as well.

Wiseman: We did a thorough and detailed review of each draft document that was released by CMS to determine what changes would be necessary. Renal Advantage Inc. (RAI) is considered a medium-size dialysis company. As draft documents were received, we would task appropriate individuals in different departments with a detailed review to provide us input on significant changes that might be needed and potential difficulties in implementing the new processes.

To implement the revised regulations, we had to provide training on the changes in the actual regulations, as well as the processes specific within RAI for meeting the regulations. We selected a core CfC training group that modeled the interdisciplinary team approach. We also used this group to develop the tools and processes needed within RAI to implement the new regulations. This included center directors, dietitians, and social workers. In addition, RAI is committed to electronic medical documentation, and we had to integrate any changes into our existing systems. Without the support and input of our information systems staff, we would not have been able to provide tools and processes that readily fit into our existing system.

Topjian: The old CfC presented a retrospective look at facility operations, while the new CfC take a dynamic look at facility operations through the patient safety and outcome/quality of care lexicon. Fresenius Medical Services (FMS) established a wide scope “New Conditions Committee” comprised of subject matter expert (SME) teams, with each Condition having its own dedicated team. Each team was comprised of an SME team captain and SMEs from both the field and corporate office. Each team was charged with analyzing the new CfC, identifying gaps between what was in place and the new requirements, and implementing actions to address these gaps.

Staff training and education were undertaken. Although our gap analysis revealed that FMS was well positioned to meet the new CfC, it required an enormous workload to implement the changes within the allotted time. It was also expensive in many ways. Given the broad sweep of changes affecting industry operations, the implementation period of six months was unduly short. One-time implementation and preparation costs (conference calls, meetings, and patient and staff educational materials) were very high, especially for large dialysis organizations (LDOs), where the costs ran into hundreds of thousands of dollars. Reports from industry are that it can cost an LDO anywhere from $1.35 to $2 per treatment to implement the new CfC. In addition, many team members were, literally, taken away from routine functions during the long and intense implementation period.

To date, CMS has not published final Interpretive Guidelines and, thus, many related questions remain unanswered. This creates an ongoing requirement for these implementation processes and consideration for their costs.

The new regulations mandate a comprehensive needs assessment of newly admitted patients and implementation of the plan of care by an interdisciplinary team including the patient. A 30-day timeframe is designated. What challenges have been faced in putting processes in place to meet this requirement?

Topjian: A large training initiative was required to roll out policies and procedures and train all interdisciplinary team members about the new policies and procedures. The Plan of Care Condition mandates that social workers assess patients’ physical and mental function using a standardized assessment tool. Although the regulations do not require a specific assessment, CMS does require, through the Clinical Performance Measures that will be reported to CROWNWeb, that facilities use the KDQOL-36. This has required us to develop an internal process to make the KDQOL-36 survey and scoring program available for use by our social workers, as well as providing education for both social workers and patients regarding this instrument.

Facilities face challenges in scheduling all team members for assessment and plan of care meetings within the timeframes mandated. Despite our educational efforts, some interdisciplinary team members are challenged by the many new requirements for comprehensive assessments and plans of care. We believe that, over time and through use, this issue will dissipate.

Wiseman: It has been difficult to ensure that key staff members are present and able to complete these tasks within the 30-day window, especially in some of our smaller centers that share key members of the team. It is very difficult to track all patients and where they are in the process of assessment and development/implementation of treatment plans, especially since our patients go in and out of the hospital and move between stable and unstable status, which completely changes the timeline for assessments and treatment plans.

RAI was particularly challenged with this because we use an electronic medical records documentation system. It takes time to program such systems, and because the final CMS regulations weren’t issued until April 2008, there was little time to determine how the company would meet the regulatory requirements and complete necessary programming to develop documents and tools necessary for these processes. It was an incredible challenge to do all this and continue with normal work activity.

Wood: Our head nurse has developed a new form based directly on CfC to meet the requirement of a comprehensive needs assessment for new patients within 30 days and again in three months. We are conducting a trial of completing/signing off on the forms monthly at the end stage renal disease meetings where all members of the multidisciplinary team are usually present. The form will take a larger commitment of time for all members of the team to review and complete.

As CMS moves to a pay-for-performance model for reimbursing dialysis services, the new regulations are being used as a platform to track and evaluate quality. CMS extended the February 1, 2009, deadline for all facilities to submit clinical performance measures (CPMs) and cost data monthly using the CMS web-based system, Consolidated Renal Operations in a Web-enabled Network (CROWNWeb). But ultimately, dialysis providers will be required to do so. How will implementation of these changes impact individual facilities in your organization?

Wiseman: Before the CROWNWeb delay, our chief information officer and his staff worked very hard to develop processes and tools that would facilitate the entry of lab data into CROWNWeb and help ensure accurate data entry. There were serious concerns about the amount of time it would take our staff to enter this volume of data into CROWNWeb.

We see the delay in implementing CROWNWeb as a benefit for both CMS and dialysis providers. For RAI it means that we will have more time to refine our internal processes with the goal of making data entry as easy as possible, minimizing the amount of time it takes and ensuring accuracy of the data entered. We believe that CMS will see the benefits of doing the smaller pilot by having the chance to identify problems and solve them on a small scale, and our hope is that when CROWNWeb is rolled out to the dialysis community at large it will be a reliable product with some assurance that data in the system is accurate (since most problems were hopefully identified and addressed during the pilot).

Wood: We are very happy that there is going to be a trial period for selected units to determine problems and solutions before mandating CROWNWeb’s use for all facilities. We are hopeful that a mechanism will be worked out for small units to be able to download the information needed rather than having to hand enter all data, which is so time consuming and more subject to human error.

Topjian: FMS continues to prepare our facility staff with the needed training on the CROWNWeb system. As an LDO, our goal is to have all patient data electronically submitted to CMS. The expectation is that utilization of a batch system will keep the impact on the workload of individual staff members within the facilities to a minimum. As CMS continues to change the project parameters for completion, our facilities are doing their best to remain flexible with such a complex and integrated project.

In light of the new regulation requiring patient care technicians (PCTs) to pass a national certification exam within 18 months of their hire date, and in light of the national nursing shortage, do you foresee challenges with recruitment and retention of qualified and competent personnel? Are strategies in place to meet the challenges?

Wood: Our small unit does not employ dialysis technicians.

Topjian: The challenges of recruiting qualified and competent RNs continue to exist and are magnified in times of a nursing shortage. FMS views the national certification of PCTs as a wonderful opportunity to help us establish baseline knowledge for PCTs that will augment our FMS training programs, allowing nurses to feel more confident in their team’s ability and commitment in caring for our patient population. It also will allow PCTs to further qualify their contribution in the nephrology setting and participate in a career pathway. We do not, to date, know which states having PCT certification programs will be exempted from the PCT certification requirement. In the meantime, we must move forward with development and implementation of PCT certification preparation classes that, for many individuals, may not be required.


Wiseman: One state we operate in recently passed a state regulation requiring certification of PCTs by a national certification body. We anticipated a loss of technicians as a result, but that was not our experience. We are hopeful that this experience will be the case as the PCT certification requirement expands to all states.

Using the model we already have in place (we used it for the state previously mentioned), we plan to provide our dialysis technicians with all the information they need to make informed decisions about the certification options best for them. Support in terms of review courses and provision of review materials has been beneficial to our PCTs who successfully took national certification exams. RAI is hopeful that national certification of PCTs will enhance not only their baseline knowledge of hemodialysis but also their sense of professionalism and their ability to function as an integral part of the caregiving team in the ever-changing, fast-paced dialysis environment.