April 1, 2015
John Thomas, Director,
Clinical Standards Group, Center for Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Re:
CMS Conditions for Coverage for ESRD Facilities
Dear Mr. Thomas:
The Renal Physicians Association (RPA) is the professional organization of nephrologists whose
goals are to ensure optimal care under the highest standards of medical practice for patients with
renal disease and related disorders. RPA acts as the national representative for physicians
engaged in the study and management of patients with kidney disease. We are writing to provide
comments on the Conditions for Coverage for ESRD Facilities.
RPA generally believes that the Conditions themselves have proven to be a useful tool in
ensuring that quality kidney disease care is delivered in ESRD facilities on a national scale. The
scope and reach of regulations such as the ESRD Conditions for Coverage virtually requires
them to be broadly drafted in order to account for the multiplicity and variation of scenarios they
are intended to address, and in that context they are appropriately crafted.
Rather than having concerns or recommendations for updating or revising any conditions
specifically, RPA believes that CMS should consider the following overarching issues:
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The frequency for reviewing the Conditions, to account for scientific and technologic
advancement;
Alignment of the Conditions with other regulatory tools such as the Measures
Assessment Tool and the State Operations Manual, and the impact of the
interrelationships on surveying at the individual facility level; and
Increased uniformity in the survey and certification process.
Frequency for Reviewing the Conditions
As the Agency knows, the Conditions for Coverage for ESRD facilities had not been updated for
over two decades before occurring in 2008, and the current solicitation was announced in
February 2015. RPA commends CMS for initiating an open and meaningful process prior to
2008 that resulted in the development of an effective set of Conditions that have also benefitted
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from kidney community buy-in. However, we would also offer that given the rapid pace of
scientific progress, even the seven years (from 2008 to 2015) is too long of an interval to wait
before initiating update of the conditions. Similar to other rule-making cycles this would allow
the kidney community and CMS to better prepare for and accommodate changes that may need
to be reflected within the Conditions.
Recommendation: RPA recommends that CMS develop and promulgate a process
that utilizes a four- or five-year time horizon that would avoid unnecessary
regulatory development while providing an opportunity to address overly
prescriptive rules that may not be reflective of the latest science or technological
innovation.
Alignment of Conditions with Other Regulatory Structures
While as previously noted RPA believes the current Conditions to be working effectively, there
are other regulatory and oversight vehicles such as the Measures Assessment Tool (MAT) and
the State Operations Manual (SOM) whose content overlaps with the Conditions and which may
include instructions and requirements that do not align with the Conditions or other Medicare
programs. This misalignment results in varying interpretations at the point-of-contact between
surveyors and the facilities being reviewed.
For example, the MAT continues to require monitoring of anemia management using a measure
(the Hgb < 10 g/dL measure) that has been discontinued in the ESRD Prospective Payment
System (PPS) Quality Incentive Program (QIP). The SOM does not reflect updates in the ESRD
Application and Survey and Certification Report (CMS Form 3427), which has been modified
three times.
Recommendation: RPA recommends that when an update to any of these regulatory
guidance vehicles is under consideration, CMS should prospectively review all
related guidance to ensure that the instruction is complementary rather than
contradictory and that clarity is provided to surveyors and other personnel
responsible for interpreting the guidance.
Increased Uniformity in the Survey and Certification Process.
RPA recognizes that that the Clinical Standards Group seeks input on the ESRD Conditions for
Coverage and not on the dialysis facility survey process per se, however, given that the
Conditions form the foundation for performing the surveys, we would be remiss to not note that
the current system for surveying dialysis facilities often results in the quality of the surveys being
compromised. While the dialysis facility certification process in some states is a positive and
educational exercise that fosters the development of effective processes of patient care at the
institution, in other states facility surveys can be arbitrary and punitive, and contrary to the needs
of the local kidney patient population. Lack of uniformity in the training and education of the
surveyors causes significant variability in the caliber of inspections from state to state. Some
dialysis facility medical directors have noted that surveyors unfamiliar with renal care processes
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will often focus on issues peripheral or even unrelated to the delivery of safe dialysis while
ignoring the more critical elements of ESRD services, or will cite the facility for “violations” that
do not reflect deviation from the Conditions or from state regulations governing ESRD facilities.
Recommendation: RPA strongly recommends that CMS enhance the uniformity and
quality of the survey process in an effort to improve patient care.
As always, RPA welcomes the opportunity to work collaboratively with CMS in its efforts to
improve the quality of care provided to the nation’s kidney patients, and we stand ready as a
resource to CMS in its future endeavors. Any questions or comments regarding this
correspondence should be directed to RPA’s Director of Public Policy, Rob Blaser, at 301-4683515, or by email at rblaser@renalmd.org.
Sincerely,
Rebecca Schmidt, DO
President
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