The publication of the proposed new regulations for the ESRD Program: an historic event for Nephrology Nursing

Nephrology Nursing Journal, Jan-Feb, 2005 by Lesley C. Dinwiddie

The majority of ANNA members have been in nephrology nursing less than 20 years and very few of us were caring for kidney failure patients when an historic event in 1972 created our roles and directed our practice environment as it exists today. That event was the passage of Public Law 92 603, Section 2991. This law amended the Social Security Act, Title XVIII to make end stage renal disease (ESRD) a Medicare-covered disability for all citizens and their dependents with kidney failure who qualified for Social Security (Parker, 1998).

"The Regs:" Turning the Law Into Reality

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Turning the law into reality was achieved by the publication of the Conditions for Coverage (CfC) on, June 3rd, 1976 (Department of Health, Education and Welfare [DHEW], 1976). Frequently and casually referred to as "the regs," the CfC have governed almost all aspects of care for patients with ESRD in the nearly 30 years since. When a state surveyor comes to your unit, their inspection focuses on whether or not your unit meets the conditions defined by "the regs". If deficiencies are found and not corrected in a well-defined period of time, your unit may be restricted from receiving Medicare reimbursement for the Medicare patients it treats.

In the years following this initial rule making, many pieces of legislation have been passed and turned into additional regulations that:

* amended payment systems and incentives,

* constructed rules for transplantation centers and organ procurement agencies, reconfigured the ESRD Network oversight program, and

* established reimbursement rules for erythropoietin and other medication (Bocchino, Burrows Hudson & Smith, 2001).

But the majority of the regulations that govern all aspects of in center dialysis treatment and patient care, with the exception of the implementation of reuse rules in 1988, has remained the same since 1976.

Is this because the original and additional regulations have adequately covered all the scientific and social innovations that have changed the delivery of dialysis and transplant care? Not at all! Back in the early 1990s Tom Hoyer, now retired Director, Office of the Health Care Financing Administration (HCFA) Chronic Care Policy, believed that ESRD regulations stood in greatest need of revision because the requirements for payment were the most out of date. A group of experts and stakeholders was convened by then HCFA to discuss how to proceed and to identify outcomes that might be required. He said the conference was something of a "first" in the ESRD community, that there was a mixture of hope and skepticism in the crowd, not to mention the usual concerns that HCFA might do some thing that might impinge on someone's business model. On balance, it was a very positive experience and HCFA felt it had the basis for moving forward with a solid package of new regulations. However, as frequently happens, an internal reorganization of HCFA resulted in the responsibility for the revision being assigned to another department. Then, along with Balanced Budget Act of 1997 and other priorities, the ESRD regulatory reform project was temporarily crowded out. Work continued sporadically at first, and then resumed with renewed focus.

The NPRM: 10 Years in the Making!

So now, on January 28, 2005, after 10-plus years in the making, the Notice for Proposed Rule Making (NPRM) for the new ESRD Conditions of Coverage has been made public. In addition, regulations for transplantation are being proposed and the regulations for organ procurement organizations are being revised. The process from this point is as follows:

a) The comment period for the transplant and organ procurement organization proposed rules will be 60 days from February 4, 2005. The dialysis proposed rules get a 90-day comment period, which will close early in May 200,5.

b) After the comment period has closed, the Center for Medicare and Medicaid Services (CMS, formerly HCFA) will have 3 years to study all the comments, respond, and consider the incorporation of some of the suggestions.

c) Then, CMS will publish the Final Rules lot each of these sets, with effective dates from 30-60 days after those Final Rules are published (CMS, 200,5).

An Historic Event for ANNA and Nephrology Nursing!

Why is this NPRM publication an historic event for nephrology nursing and ANNA? Because we are the largest body of ESRD patient health care providers and, in the history of the ESRD Program, there has never been a bigger or better opportunity for us to make a difference in our patients' lives and in our profession. Representing over 11,000 practicing nephrology nurses, ANNA's input will be given careful attention and high credence.

To make sure this input is very' thorough and of high quality, the ANNA Board of Directors has approved the formation of a task force to stud), the revised Conditions for Coverage and formulate our collective response. This task force is chaired by Immediate Past President Caroline Counts, and has as its members, Clare Sasak, chair-designate of the Professional Practice Committee; Norma Gomez, chair of the Administration SIG and ANNA's Treasurer- Elect; Sheila Doss, chair of the Health Policy Committee; Clara Neyhart, chair of the Transplantation SIG; Kim Alleman, chair of the SIG Leadership commit tee; Marien Saade, an executive director for an organ procurement organization; and Barbara Bednar, a past president of ANNA. Supported by evidence whenever possible, these highly' qualified and committed nephrology nurses will single out and respond, either positively or negatively, to every item that impacts nephrology nursing and patient care in these proposed regulations. A comprehensive and detailed response from the ANNA Board of Directors will be sent to CMS in April. In the meantime, we want input into this process from you, our members, and strongly encourage you to contact any of these leaders with your input, or you can respond directly to CMS through the link on our ANNA website, www.annanurse.org.

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The publication of the proposed new regulations for the ESRD Program: an historic event for Nephrology Nursing

Nephrology Nursing Journal, Jan-Feb, 2005 by Lesley C. Dinwiddie

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