After almost 40 years, the government proposing to bring nation's ESRD program "up-do-date".

For the first time in nearly 40 years, the US government is proposing a major overhaul of the nation's 4,700 Medicare-approved renal dialysis facilities that provide life-saving services to more than 325,000 patients with chronic kidney disease.

On February 4, the Centers for Medicare and Medicaid (CMS) published a proposed rule aimed at modernizing the Medicare End Stage Renal Disease (ESRD) conditions for coverage by promoting higher quality care amongst dialysis facilities that want to participate in the Medicare program.

The proposed regulation reflects important advances in dialysis technology and standard care practices because the requirements have not been revised in their entirety since 1976, CMS said in a press release.

"This new rule brings our dialysis regulations up-to-date in a way that makes it easier for patients to be assured of the best possible care," said Mark McClellan, MD, CMS administrator.

There is a 90-day public comment period that went into effect on February 4, the date the rule was published in the Federal Register. The proposed ESRD rule can be found online at: www.gpoaccess.gov/fr/ind.

CMS said the regulations, when made final, will serve as the minimum quality standards applied during the Medicare survey and certification process. The proposed rule lessens prescriptive and burdensome requirements for dialysis facilities and provides flexibility for such facilities regarding the use of their resources to meet the needs of individual patients and achieve better outcomes of care.

The agency emphasized the patient-centered rule also reflects current clinical and scientific advances in dialysis technology and standard care practices, including clinical practice guidelines developed by the National Kidney Foundation's Kidney Disease 

Outcomes Quality Initiative (NKF-K/DOQI).

The proposed changes to the existing ESRD rule include several of interest to the transplant community.

The CMS is proposing that a more comprehensive dialysis patient assessment be conducted, including a patient's suitability for a transplantation referral and criteria to identify potentially unstable patients.

The agency said it is specifically seeking comments on the following proposal on transplantation status.

"Although we are proposing to remove the existing requirements for a separate long-term program from the conditions, we are proposing to retain the concept of transplant planning. Within the plan of care, the interdisciplinary team must address whether the patient is a transplant candidate and identify the plan for obtaining a transplant. The plan and the actions necessary to make the transplant a reality must be addressed in the plan of care. Necessary actions would include, for example, patient transplant referral for evaluation by a transplant center, communication with the transplant center, and monthly blood draws for antigen/antibody testing. We are soliciting public comment on whether the 'necessary actions' listed above should be a requirement for dialysis facilities.

When the patient is not suitable for transplantation referral evaluation, the reason for nonreferral must be written in the patient's assessment and notated in the patient plan of care. The reason(s) for nonreferral must be consistent with the criteria developed by the prospective transplantation center and surgeon. In cases when the patient meets the transplantation criteria but declines referral, there must be documentation in the patient plan of care that the patient has made an informed decision to decline renal transplantation."

Transplantation Referral Tracking

"We are proposing that the interdisciplinary team track the results of each kidney transplant center referral and monitor the status of any facility patients who are on the transplant wait list. The routine exchange of information between the dialysis facility and the transplant center is important so that both facilities know who is active on the transplant wait list, who is temporarily or permanently inactive, and who is under evaluation. In addition, there may be a need to coordinate histocompatibility testing, which must be completed on a monthly basis. We invite comment on the coordination of the transplant process and the method and frequency of communication with the transplantation center."

The only other direct reference to transplantation discusses whether or not a transplant surgeon must automatically be a part of the patient's interdisciplinary team, "Because not every patient is medically suited for a transplant, we believe the transplant surgeon need not be involved with the team unless a possible candidate has been identified." CMS said it is seeking comments on the appropriate role of the transplant surgeon in developing the patient plan of care.

In the area of patient clinical care, CMS proposed changes include:

*A more comprehensive patient assessment, including a patient's suitability for a transplantation referral and criteria to identify unstable patients;

*Improvements to the existing patient plan of care, including a care-planning provision for transplantation status, a provision for regular patient-physician contact, and a requirement for transplantation referral tracking;

*A separate condition for coverage addressing the special needs of some home dialysis patients, including a provision to ensure that services are at least equivalent to services provided in dialysis facilities; and

*A Quality Assessment and Performance program designed by the facility and focused on improving patient outcomes of care, including provisions to identify medical injuries and medical errors, patient satisfaction, and grievances.

For additional information contact: Robert Miller - [phone]