Are we ready for revisions in Medicare's conditions of coverage for ESRD suppliers?

It has been 8 years since Medicare officials began predicting that the conditions of coverage of Suppliers of ESRD services would be revised. These regulations (also known as “Subpart U”) govern the organization and operation of dialysis facilities. They went into effect in 1976 and have been virtually unchanged since then. One could argue that revisions are warranted, given changes in the delivery of dialytic therapy during the last quarter of a century (eg, increased utilization of dialysis technicians, introduction of anemia therapy) and the older and sicker patient population that is being served.

Conversely, consolidation in the management of dialysis providers and the development of clinical practice guidelines and performance measures might suggest that regulatory requirements have less impact on patient care than they once might have. Nevertheless, given the interest of the Select Committee on Aging in the U.S. Senate and recommendations from the Inspector General of the Department of Health and Human Services and the U.S. General Accounting Office (GAO), the Centers for Medicare and Medicaid Services (CMS) may be bound to act. For instance, the title of the GAO Report is “Oversight of Kidney Dialysis Facilities Needs Improvement.”

The existing conditions of coverage specify qualifications for personnel (e.g. dietitian, nurse responsible for nursing service, physician-director), outline patient rights and responsibilities, and mandate various services (dietetic, laboratory, social work). They do not, however, mention staffing levels. Nor do they address dialysis technicians.

If the conditions of coverage are revised, they will probably include outcome standards, such as URR and hematocrit levels. Is there a consensus in the nephrology community and among Medicare officials as to which outcomes should be included in the regulations? Should an outcome standard related to nutritional status be part of the conditions of coverage, given the lack of reimbursement for dietary supplements? Will such outcomes be mandated as minimum standards or specified as goals for quality improvement efforts? If they are minimum standards, what percentage of patients must achieve the desired level for a dialysis clinic to be in compliance with the regulation? Should it be 75%, 80%, or 90%? Should the revised conditions of coverage recognize any new categories of health care personnel, such as dietetic technicians? Will CMS attempt to impose additional requirements on medical directors in an effort to impact physician services in the dialysis clinic? Should the regulations specify patient/staff ratios?

Because of the Administrative Procedures Act, Medicare cannot impose new rules without providing an opportunity for public comment. CMS must publish a draft regulation, known as a Notice of Proposed Rule Making, in the Federal Register. After the draft regulation is published, the nephrology community will have 60 days to respond. A unanimous response is the most effective one. Therefore, it is important that the nephrology community institute a dialogue to achieve consensus on the key issues that should be addressed in the conditions of coverage in the future.