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The Publication of the Proposed New Regulations for the ESRD Program: An Historic Event for Nephrology Nursing
by ANNA President 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
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 something 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:
- 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 2005.
- 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.
- Then,
CMS will publish the Final Rules for each of these sets, with effective
dates from 30 – 60 days after those Final Rules are published (CMS,
2005).
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 study
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
committee; 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.
ANNA is also very fortunate to have Glenda Payne, who works for CMS in
the ESRD Program, on our Board of Directors at this time. Her initial
reaction to the content of these proposed rules was to encourage ANNA
to accept the multiple invitations to comment that appear within the
document. The preamble is about three times as long as the proposed
regulations themselves and is cross-referenced for each proposed
regulation. While putting the proposed rules into context historically
and giving the rationale for changes made, the preamble also invites
comments and suggestions in many areas. The actual regulations,
which are much shorter than the preamble, are organized into separate
sections for General Conditions, Patient Safety, Patient Care, and
Administration: called Subparts A, B, C & D (notice that “Subpart
U” is no more!).
New “Regs” Will Be Good for Patients and Our Practice!
We
are delighted to note that for the first time there are requirements
mandating quality assessment and performance improvement, and that
these encompass all patients, not just those covered by Medicare. This
is a positive indication that “the new regs” will be good for patients
and our practice. Nursing specific-related highlights include a
proposed requirement that an RN be present in the facility at all times
while a patient is being dialyzed. While there is no language requiring
staffing ratios, there is a call for comments concerning the adoption
of an acuity-based staffing system. In addition, the proposed rule
endorses the current and recently adopted AAMI dialysate and water
standards as well as introduces language addressing a “hot” topic
today, the involuntary transfer of patients.
While these new regs have taken a long time to come to public comment,
the preliminary review suggests that they are more comprehensive and
certainly, more aligned with current practice. However, it appears that
the case for specific quantitative outcomes such as minimum standards
for adequacy outcomes still has not been made. Also these proposed
rules, as did those of the past, fall short of spelling out exactly
what constitutes acceptable nursing care. Perhaps that is both the
challenge and opportunity for ANNA, as we publish our newly revised
nephrology nursing standards of practice. We must welcome this historic
event and enthusiastically take the invitation to diligently respond
and make the world of nephrology nursing and patient care, a safer and
more satisfying place to be.
Lesley C. Dinwiddie, MSN, RN, FNP, CNN
ANNA President
References
Bocchino,
C., Burrows -Hudson, S., & Smith, K.T. (2001). Other salient issues
related to ESRD and its treament. In L. Lancaster (Ed.), Core
curriculum for nephrology nursing (pp. 567-604). Pitman, NJ: American
Nephrology Nurses’ Association.
Center
for Medicare and Medicaid Services (CMS). (2005, February 4). RENAL
DISEASE: NPRM of Coverage of Suppliers of End Stage Services.
Proposed RULES AND REGULATIONS: Subpart A,B,C,D: Conditions of
Coverage of Suppliers of End Stage Renal Disease (ESRD) Services.
Federal Register, 70.
Department
of Health, Education and Welfare (DHEW). (1976, June 3). RENAL
DISEASE: Implementation of Coverage of Suppliers of End Stage
Services. RULES AND REGULATIONS: Subpart U: Conditions of Coverage of
Suppliers of End Stage Renal Disease (ESRD) Services. Federal
Register, 41(108), 22511-22522.
Parker
J. (1998). The End Stage Renal Disease Program. In J. Parker (Ed.),
Contemporary nephrology nursing (pp. 795-813) Pitman, NJ: American
Nephrology Nurses’ Association.
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