The long-awaited final rule replacing the “Conditions for Coverage” (the
“Conditions”) for End-Stage Renal Disease (“ESRD”) facilities to participate in
Medicare was released by the Centers for Medicare and Medicaid (“CMS”) on April
3, 2008. The final rule marks the first revision to the Conditions since they
were originally enacted in 1976, dramatically altering the requirements from a
process-oriented to a patient-centered, outcome-oriented approach. The final
rule will become effective once it is published in the Federal Register, which
we anticipate should occur in the coming week.
The following responds to some of the key questions, which the new Conditions
raise for ESRD suppliers:
Who will the new Conditions impact?
Changes to the Conditions will impact all existing ESRD facilities certified
to provide dialysis services under Medicare and any new ESRD facilities seeking
certification. However, the new Conditions are likely to have a greater impact
on independently-owned facilities not associated with a major dialysis chain
since, according to CMS, those facilities are less likely to have adopted Life
and Safety Code recommendations and other national standards incorporated by
reference into the new Conditions. CMS reports that approximately one-third of
existing Medicare-certified ESRD facilities fall into this category.
The final Conditions have a significant impact on certain personnel
qualifications, which may open doors for some, close doors for others and cause
a number to seek certification in order to maintain their positions.
- Medical Directors: Medical directors formerly could be either
board eligible or board certified in internal medicine or pediatrics.
Board eligibility is no longer sufficient under the new Conditions. All
physicians are now required to be board certified in internal medicine or
pediatrics in order to serve as a medical director of a Medicare-certified
ESRD facility. Existing medical directors will have 180 days in order to
become board certified. The new rule does not provide for grandfathering of
existing medical directors, but does permit the Secretary of the Department
of Health and Human Services to approve a physician that does not meet such
requirements to serve as a medical director in the absence of a qualified
physician. Under the new Conditions, medical directors are accountable to
governing body of the facility for the quality of medical care provided to
- Patient Care Technicians: Under the proposed rule, patient care
technicians would have been required to spend three months under the direct
supervision of a licensed registered nurse (“RN”). The final Conditions
decline to adopt that requirement, and instead require that all patient care
technicians obtain certification under a state or national commercially
available certification program within 18 months of being hired, or if
already employed, then within 18 months of publication of the final rule.
- Licensed Registered Nurses: ESRD facilities were formerly
required to have a licensed physician, licensed practical nurse or RN onsite
at all times patients were dialyzed. The new Conditions eliminate the option
to rely exclusively on LPN supervision and specify that a RN must be present
at times patients are dialyzed.
- Medical Record Practitioner: Under the former Conditions, a
medical record practitioner had to complete a particular course of study.
The new Conditions eliminate the position and requirements for a medical
record supervisor in its entirety.
- Chief Executive Officer: Under the former Conditions, CEOs were
required to meet one of three alternative criteria. The new Conditions
eliminate any specific qualification requirements that facility CEOs must
meet, which should allow facilities greater flexibility in hiring.
How much time do ESRD facilities have in order to comply?
Once the final rule is published in the Federal Register (which CMS reported
was to occur on April 4, 2008, but has not yet taken place), ESRD facilities
will have 180 days to comply with the new Conditions, with the following
- ESRD facilities will be given an additional four months (300 days total
from the date of publication) in order to comply with:
- Isolation room requirements for HBV-infected patients in order to
allow for project development, construction approvals, architectural
design, contractor bids and obtaining building permits.
- Applicable provisions of the 2000 Edition of the Life Safety Code of
the National Fire Protection Association (“LSC”) in order to accomplish
necessary changes in building structure.
- The provision pertaining to furnishing data and information in
electronic format to CMS, including cost reports, ESRD administrative forms,
patient survival information and existing and future clinical performance
measures will not take effect until February 1, 2009 in order for facilities
to develop programs or obtain software to meet electronic requirements.
What are some of the increased burdens ESRD facilities will face under the
In addition to those personnel burdens described above for medical directors
and patient care technicians, ESRD facilities may face the need for
construction, changes in policies and procedures, personnel training and
- Construction: Existing facilities may be forced to commence construction
in order to create separate demarcated areas for HBV-infected patients, and
install systems in order to meet LSC requirements, such as fire department
alarm connections. Facilities may seek and be granted a reprieve from such
construction requirements if they can demonstrate that the health and safety
of patients and staff would not be adversely affected. CMS has the ability
to waive specific provisions of the LSC, which if rigidly applied would
result in unreasonable hardship for the facility. Further, facilities may
apply for an isolation room waiver when a sufficient number of isolation
rooms exist locally for HBV-infected patients.
- Policies and Procedures:
- Emergencies: Plans must be developed to obtain emergency medical
system assistance and annually review emergency and disaster plans.
Specific materials will need to be provided to patients in cases of
emergencies as well.
- Patient Care: The final Conditions modify a variety of care,
counseling and assessments the interdisciplinary team is responsible for
conducting, including: monthly measurement of a patient’s albumin level
and body weight, necessary care for management of mineral metabolism to
prevent or treat renal bone disease, evaluation of whether patient is
potential candidate for arteriovenous fistula placement, training of
patients in infection prevention and personal care, home dialysis and
self-care, and benefits and risks of various vascular access types. The
Conditions also mandate patient privacy when being examined, reasonable
accommodations for discomfort from temperature in facility, and that
patients be within physical view of staff at all times during
- Patient Rights: Facilities must also develop and prominently display
written patients’ rights policies containing information regarding
advance directives, how to contact entities in regard to complaints and
dialysis modalities not offered by the facility, including scheduling
options for working patients. Facilities are also required to implement
an in-house grievance procedure.
- Personnel Training: Facility patient care staff must maintain current
CPR certification, and water system technicians and patient care technicians
must attend required training programs.
- Equipment: The following emergency equipment must be immediately
available in facility: oxygen, airways, suction, and a defibrillator or
automated external defibrillator.
Will any burdens be alleviated by the new Conditions?
The final Conditions provide greater flexibility in the maintenance of
medical records, eliminate the requirement for translators, remove the
requirement for a separate long-term care program, reduce the frequency of
formal care planning after initial 6 months of dialysis, and no longer require
CEOs to be involved in the annual review for emergency preparedness. Moreover,
in light of the increased scrutiny that the Office of Inspector General of the
Department of Health and Human Services (“OIG”) is placing on quality of care in
investigating health care fraud, the new Conditions should serve as important
benchmarks for ESRD facilities to implement quality of care initiatives.
1. Those facilities that
have already incorporated some of the following standard policies and procedures
will have a head start on complying with the final CFC requirements: (i) AAMI
“Dialysate for hemodialysis” water purity guidelines; (ii) AAMI guidelines for
the “Reuse of hemodialyzers”; (iii) procedures for monthly review of patient’s
dialysis prescription; (iv) transplantation referral tracking; (v) quality
assessment and performance improvement program; and (vi) guidelines for the
Prevention of Intravascular Catheter-Related Infections pertaining to placement
of intravascular catheters and Central Venous Catheters.
2. 42 CFR 2102(e).