CMS-R-52 Supporting Statement 8-8-2013 - 508 Compliant

Supporting Statement For Paperwork Reduction Act Submissions
End Stage Renal Disease (ESRD) Conditions for Coverage and Supporting Regulations
A.

Background
The Centers for Medicare and Medicaid Services (CMS) is requesting reinstatement of
OMB Control number 0938-0386 (CMS-R-52) in compliance with the Paperwork
Reduction Act (PRA). This package applies to existing Medicare End-stage Renal Disease
(ESRD) conditions for coverage (CfCs) at 42 CFR 405, Subpart U, and at 42 CFR 494.
Section 299I of the Social Security Amendments of 1972 (P.L. 92-603) originally extended
Medicare coverage to insured individuals, their spouses, and their dependent children with
ESRD who require dialysis or transplantation. Subsequently, the ESRD Amendments of
1978 (Pub. L. 95-292) amended title XVIII of the Social Security Act (the Act) by adding
section 1881. Section 1881(b)(1) of the Act authorizes the Secretary to prescribe health
and safety requirements (known as conditions for coverage) that a facility providing
dialysis and transplantation services to ESRD patients must meet to qualify for Medicare
reimbursement. Final regulations were published June 3, 1976. Subsequent to the
publication of the final regulations, the ESRD Amendments of 1978 were enacted to
amend title XVIII of the Act to include section 1881(c). This section establishes ESRD
network areas and Network organizations to assure the effective and efficient
administration of ESRD program benefits. The requirements from section 1881(b) and (c)
are implemented in regulations at 42 CFR part 405, subpart U, Conditions for Coverage for
ESRD facilities.
On April 7, 1986, the Consolidated Omnibus Budget Reconciliation Act of 1975
(COBRA) (P.L. 99-272) was enacted which requires the Secretary to maintain renal
disease Network organizations as authorized under section 1881(c) of the Act, and not
merge the Network organizations into other organizations or entities. On April 15, 1986,
we published a notice of proposed rulemaking to implement section 9214 of P.L. 99-272.
A final rule (HSQ-115) was published August 26, 1986. This rule revised the
requirements in regulations pertaining to the ESRD networks and organizations and
establishes new, more efficient Network organizations.
Revisions resulting from two additional rules: HSQ-137--ESRD: Responsibilities of
Network Organizations, published January 21, 1988; and BERC-434--Medicare Program:
Standards for the Reuse of Hemodialyzer Filters and Other Dialysis Supplies, published
October 2, 1987, are also included. Currently, these requirements are approved under
OMB control number 0938-0386.
A major revision of the ESRD CfCs at 42 CFR 494 was issued in a final rule on April 15,
2008. This final rule focused on the patient and the results of care provided to the patient,
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established performance expectations for facilities, encouraged patients to participate in
their plan of care and treatment, eliminated many procedural requirements from the
previous conditions for coverage, and preserved strong process measures when necessary
to promote meaningful patient safety, well-being, and continuous quality improvement.
An explanation of the requirements and the associated burden is listed under section B12
of the supporting statement.
B.
1.

Justification
Need and Legal Basis
The information collection requirements described herein are part of the Medicare and
Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities. The
requirements fall into two categories: record keeping requirements and reporting
requirements. With regard to the record keeping requirements, CMS uses these conditions
for coverage to certify health care facilities that want to participate in the Medicare or
Medicaid programs. These record keeping requirements are no different than other
conditions for coverage in that they reflect comparable standards developed by industry
organizations such as the Renal Physicians Association, American Society of Transplant
Surgeons, National Kidney Foundation, and the American Association of Kidney Patients.
For the reporting requirements, the information is needed to assess and ensure proper
distribution and effective utilization of ESRD treatment resources while maintaining or
improving quality of care. All of the reports specified in this document are geared toward
ensuring that facilities achieve quality and cost-effective service provision. Collection of
this information is authorized by Section 1881 of the Act and required by 42 CFR
405.2100 through 405.2171 (now at 42 CFR 414.330, 488.60, and 494.100-494.180).

2.

Information Users
The general record keeping requirements prescribed in this regulation are used by dialysis
facilities. CMS and the health care industry believe that the availability to the facility of
the type of records and general content of records are routine and consistent with health
care facility standards.
The reporting associated with this regulation is used in reports to Congress, by CMS, and
the facilities. The reporting requirements are to assist in improving quality of care as well
as to provide the most economic services available. The reports that are submitted are used
by CMS to analyze for budgetary issues, which enables CMS to maximize utilization rates
and also make sure all services are available throughout the ESRD program. The reports
are used by the facilities as self-assessment tools to measure their performance and
available services to those facilities throughout the networks. The Secretary is required by
the Act to submit to Congress each year a report on the ESRD program. The Congress
uses this report as a basis to make legislative changes.
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Some information is also made available to the public through the Dialysis Facility
Compare Website (http://www.medicare.gov/dialysisfacilitycompare/), so that dialysis
patients can compare clinical performance when choosing where to receive dialysis care.
3.

Use of Information Technology
This regulation does not prescribe how the facility should prepare or maintain reports and
records. Facilities are free to take advantage of any technological advances which they
find appropriate for their needs.
However, this regulation does require that data submitted to CMS be submitted
electronically, through a web-enabled system. The web-enabled system, known as
CROWNWeb, went into national use in June 2012. Facilities have the option to submit
data to CROWNWeb through traditional data entry or through “batch entry” facilitated by
electronic health records.

4.

Duplication of Efforts
These are unique requirements which are specified in a way so as not to duplicate existing
facility practice. If a facility already maintains these general records, regardless of format,
they are in compliance with these requirements.

5.

Small Businesses
These requirements do affect some small businesses. However, the general nature of the
requirements allows the flexibility for facilities to meet the requirement in a way consistent
with their existing operations.

6.

Less Frequent Collection
The reporting associated with this regulation is statutorily mandated and must be collected
regularly. The reports must be submitted because ESRD facilities have timeframes they
must meet in order to qualify for reimbursement for the next calendar year. The Secretary
establishes the rates for reimbursement based on the most recent information available.
Clinical performance data submitted to CMS through the CROWNWeb system must be
submitted on a monthly basis.

7.

Special Circumstances
There are no special circumstances for collecting information, with the following
exceptions:
•

Clinical performance data submitted to CMS through the CROWNWeb system
must be submitted on a monthly basis.
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•

8.

Patient records must be retained for a period of time not less than that required by
State law, or in the absence of State law, 5 years from the date of discharge,
transfer or death and 3 years for minors or until the patient reaches legal age under
State law, whichever is longer, from the date of the patient's discharge, transfer or
death.

Federal Register/Outside Consultation
The 60-day Federal Register notice published on August 16, 2013.

9.

Payments/Gifts to Respondents
There were no payments/gifts to respondents.

10. Confidentiality
CMS does not pledge confidentiality.
11. Sensitive Questions
There are no sensitive questions.
12. Burden Estimates (Hours & Wages)
NOTE: We estimate the current number of ESRD facilities to be 5,840. We predict the average
number of existing facilities each year from 2013 to 2017 will be 6,464 facilities. We predict that
approximately 213 facilities will open each year over the same time period.

414.330

Payment for home dialysis equipment, supplies, and support
services.

(a)(2)(iii)(C) Suppliers must report to the ESRD facility providing support services, at
least every 45 days, all data (meaning information showing what supplies
and services were provided to the patient and when each was provided) for
each patient regarding services and items furnished to the patient in
accordance with § 494.100(c)(2) of this chapter.
The burden to ESRD home dialysis suppliers associated with this
requirement would be the time and effort necessary to collect all data for
each patient receiving home dialysis care with respect to services and items
furnished. However, the payment method that covered these suppliers was
eliminated in 2011 (http://www.gpo.gov/fdsys/pkg/FR-2010-0812/pdf/2010-18466.pdf) and there are no longer any such entities.
Therefore there are no actual costs associated with this requirement.
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488.60

Special procedures for approving end stage renal disease
facilities.

(a)(1-4)

An ESRD facility that wishes to be approved or that wishes an expansion of
dialysis services to be approved for Medicare coverage, in accordance with
part 494 of this subchapter, must submit the documents and data as outlined
in §488.60(a)(1) through (a)(4).
We estimate that it will take 40 hours for each of the 213 new and renovated
facilities to gather and submit the necessary documentation for
consideration by the Secretary. The estimated annual burden is 8,520
annual hours. This number of hours is previously approved.

494.30
(a)(ii)

Condition: Infection control.
New dialysis facilities must include an isolation room or request an
isolation room waiver approved by the Secretary. We estimate that
90 percent (about 192) of new dialysis facilities would request a waiver.
This task would take approximately 1 hour for each of these 192 newly built
dialysis facilities, for a total of 192 hours, annually.

494.30

Condition: Infection control.

(b)(3)

Facilities must report infection control issues to the dialysis facility's
medical director (see § 494.150 of this part) and the quality improvement
committee. We estimate that it would take staff 5 minutes per incident to
notify the medical director and the quality improvement committee. Such
infection control issues are rare, and so we estimate that only 1 percent of
facilities would experience an incident annually. Therefore, for
65 facilities, we estimate a total annual burden of 5 hours.

494.30

Condition: Infection control.

(c)

The facility must report incidences of communicable diseases as required
by Federal, State and local laws. While this requirement is subject to the
PRA, the fact that this requirement is a usual and customary business
practice and may be required under State or local law, exempts the burden
associated with this requirement from the PRA as stipulated under
5 CFR 1320.3(b)(2) or (b)(3) or both.

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494.40

Condition: Water quality.

(b)(2)(ii)(C)

If the test results from the last component or carbon tank are greater than the
parameters for chlorine or chloramine specified in paragraph (b)(2)(i) of this
section, the facility must immediately notify the medical director. We
estimate that it would take staff 5 minutes per incident to notify the medical
director. Such incidents are rare, and so we estimate that only 1 percent of
facilities would experience an incident annually. Therefore, for 65
facilities, we estimate a total annual burden of 5 hours.

494.40

Condition: Water quality.

(c)

Facilities are required to create a corrective action plan that ensures patient
safety. Specifically, when water testing results, including but not limited to
chemical, microbial, and endotoxin levels meet levels considered unsafe by
AAMI or deviate from the AAMI standards, the dialysis facility must
develop a corrective action plan. We estimate that it would take
65 facilities 30 minutes each to develop and implement a corrective action
plan that ensures patient safety. Therefore, we estimate a total annual
burden of 33 hours.

494.50

Condition: Reuse of hemodialyzers and bloodlines.

(c)(1-2)

The dialysis facility must monitor patient reactions, undertake evaluation of
its dialyzer reprocessing and water purification system, and report any
adverse outcomes to FDA and other Federal, State, or local government
agencies as required by law. While this requirement is subject to the PRA,
the fact that this requirement is a usual and customary business practice and
is required under other Federal, State, and local laws, exempts the burden
associated with this requirement from the PRA as stipulated under
5 CFR 1320.3(b)(2) or (b)(3) or both.

494.60

Physical environment.

(b)

The dialysis facility must implement and maintain a program to ensure that
all equipment (including emergency equipment, dialysis machines and
equipment, and the water treatment system) are maintained and operated in
accordance with the manufacturer’s recommendations. While this
requirement is subject to the PRA, the fact that this requirement is a usual
and customary business practice and may be required under State or local
law, exempts the burden associated with this requirement from the PRA as
stipulated under 5 CFR 1320.3(b)(2) or (b)(3) or both.

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494.60

Physical environment.

(d)(4)

The dialysis facility must have a plan to obtain emergency medical system
assistance when needed, evaluate at least annually the effectiveness of
emergency and disaster plans, and update them as necessary. We estimate
that it will take each of the 213 new facilities 5 hours to comply with the
requirements in this section. We estimate that it will take 1 hour each for
6,464 existing facilities to annually comply with the requirements in this
section. The total estimated annual burden for new and existing facilities is
7,529 hours.

494.70

Condition: Patients’ rights.
The dialysis facility must inform patients (or their representatives) of their
rights and responsibilities when they begin their treatment. The dialysis
facility must prominently display a copy of the patients' rights in the
facility, including the current State agency and ESRD Network mailing
addresses and telephone complaint numbers, where it can be easily seen and
read by patients. We estimate that it will take 6,464 facilities 1.5 hours each
on an annual basis to update their patient rights materials to comply with
this requirement. The total estimated annual burden is 9,696 hours.

494.80

Condition: Patient Assessment.
The facility's interdisciplinary team is responsible for providing each patient
with an individualized and comprehensive assessment of his or her needs.
The comprehensive patient assessment must be documented in the medical
record. While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice and may be required
under State or local law, exempts the burden associated with this
requirement from the PRA as stipulated under 5 CFR 1320.3(b)(2) or (b)(3)
or both.

494.90

Condition: Patient plan of care.
The interdisciplinary team must develop and implement a written,
individualized comprehensive plan of care that meets the requirements of
§ 494.90. While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice and may be required
under State or local law, exempts the burden associated with this
requirement from the PRA as stipulated under 5 CFR 1320.3(b)(2) or (b)(3)
or both.
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494.100

Condition: Care at home.

(a)

The interdisciplinary team must provide training to the home dialysis
patient, the designated caregiver, or the self-dialysis patient before the
initiation of home dialysis or self-dialysis (as defined in § 494.10 of this
part) and when the home dialysis caregiver or home dialysis mortality
changes. While these requirements are subject to the PRA, they are exempt
as stated under 5 CFR 1320.3(h)(5); facts or opinions obtained initially or in
follow-on requests, from individuals under treatment or clinical
examination in connection with research on or prophylaxis to prevent a
clinical disorder, direct treatment of that disorder, or the interpretation of
biological analyses of body fluids, tissues, or other specimens, or the
identification or classification of such specimens are not subject to the PRA.
In addition, facilities are required to meet these requirements as stated under
Federal, State, and local laws and thereby exempt under 5 CFR
1320.3(b)(3).

494.100

Condition: Care at home.

(b)

The dialysis facility must document in the patient's medical record, that the
patient, the caregiver, or both received and demonstrated adequate
comprehension of the training. In addition, the facility must document, in
the patient's medical record, that the self-monitoring data and other
information from self-care were reviewed, at least every 2 months. While
this requirement is subject to the PRA, the fact that this requirement is a
usual and customary business practice, or is required under other Federal,
State, and local laws, or both, exempts the burden associated with this
requirement from the PRA as stipulated under 5 CFR 1320.3(b)(2) or (b)(3)
or both.

494.100

Condition: Care at home.

(c)(1)

Section 494.100(c) contains the standards for support services. As required
by § 494.100(c)(1)(i), a facility must periodically monitor the patient’s
home adaptation. Section 494.100(c)(1)(ii) requires a member of the
facilities interdisciplinary team to coordinate the home patient’s care.
Section 494.100(c)(1)(iii) requires a facility to develop and periodically
review each patient’s plan of care. Section 494.100(c)(1)(v) that the facility
must monitor the quality of water and dialysate used by home hemodialysis
patients. The monitoring must include onsite evaluations and tests of the
water and dialysate system. We estimate that facilities would have to meet
these requirements for 66,600 care at home patients, and that it would take
them approximately 6 hours per patient, per year. We estimate a total
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annual burden of 399,600 hours.

494.100

Condition: Care at home.

(c)(2)

The dialysis facility must maintain a recordkeeping system that ensures
continuity of care and patient privacy. While this requirement is subject to
the PRA, the fact that this requirement is a usual and customary business
practice and may be required under State or local law, exempts the burden
associated with this requirement from the PRA as stipulated under
5 CFR 1320.3(b)(2) or (b)(3) or both.

494.110

Condition: Quality assessment and performance improvement.
The dialysis facility must develop, implement, maintain, and evaluate an
effective, data-driven quality assessment and performance improvement
program that reflects the complexity of the dialysis facility's organization
and services. The dialysis facility must maintain and demonstrate evidence
of its quality improvement and performance improvement program for
review by CMS.
The burden associated with all of the requirements of this section is the time
and effort necessary to develop, implement, maintain, evaluate, and
demonstrate evidence of a quality assessment and performance
improvement program. It would take 212 new facilities each approximately
48 hours to meet these requirements. The annual burden associated with
this requirement is estimated to be 10,176 hours.
Additionally, all facilities are subject to an annual burden to maintain,
evaluate, and demonstrate evidence of a quality assessment and
performance improvement program. The facility must analyze and
document the incidence of infection and identify trends and establish
baseline information on infection incidence; and develop recommendations
and an action plan to minimize infection transmission, promote
immunization, and take actions to reduce future incidents. The burden
associated with this requirement is the time and effort it would take for a
facility to document the incidence of infection and develop
recommendations and an action plan to reduce future incidents. We
estimate it would take 6,464 facilities 12 hours annually each to meet this
requirement, for a total annual burden of 77,568 hours.

494.120

Condition: Special purpose renal dialysis facilities.

(d)

Facilities must contact the patient's physician, if possible, prior to initiating
dialysis in the special purpose renal dialysis facility, to discuss the patient's
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current condition to assure care provided in the special purpose renal
dialysis facility is consistent with the plan of care (described in §494.90 of
this part). While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice and may be required
under State or local law, exempts the burden associated with this
requirement from the PRA as stipulated under 5 CFR 1320.3(b)(2) or (b)(3)
or both.

494.120

Condition: Special purpose renal dialysis facilities.

(e)

Facilities must document all patient care provided in the special purpose
facility and forward the documentation to the patient's dialysis facility, if
possible, within 30 days of the last scheduled treatment in the special
purpose renal dialysis facility. While this requirement is subject to the
PRA, the fact that this requirement is a usual and customary business
practice and may be required under State or local law, exempts the burden
associated with this requirement from the PRA as stipulated under
5 CFR 1320.3(b)(2) or (b)(3) or both.

494.170

Condition: Medical records.
The dialysis facility must maintain complete, accurate, and accessible
records on all patients, including home patients who elect to receive dialysis
supplies and equipment from a supplier that is not a provider of ESRD
services and all other home dialysis patients whose care is under the
supervision of the facility. While this requirement is subject to the PRA,
the fact that this requirement is a usual and customary business practice and
may be required under State or local law, exempts the burden associated
with this requirement from the PRA as stipulated under 5 CFR 1320.3(b)(2)
or (b)(3) or both.

494.170

Condition: Medical records.

(a)(3)

The dialysis facility must obtain written authorization from the patient or
legal representative before releasing information that is not authorized by
law. While this requirement is subject to the PRA, the fact that this
requirement is a usual and customary business practice and is required
under existing law (specifically, the Health Insurance Portability and
Accountability Act of 1996 (HIPAA; Pub.L. 104–191), exempts the burden
associated with this requirement from the PRA as stipulated under
5 CFR 1320.3(b)(2) or (b)(3) or both.

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494.170

Condition: Medical records.

(c)

Patient records must be retained for a period of time not less than that
required by State law, or in the absence of State law, 5 years from the date
of discharge, transfer or death and 3 years for minors or until the patient
reaches legal age under State law, whichever is longer, from the date of the
patient's discharge, transfer or death. While this requirement is subject to
the PRA, the fact that this requirement is a usual and customary business
practice, or is required under other Federal, State, and local laws, or both,
exempts the burden associated with this requirement from the PRA as
stipulated under 5 CFR 1320.3(b)(2) or (b)(3) or both.

494.170

Condition: Medical records.

(d)

When a dialysis patient is transferred, the dialysis facility releasing the
patient must send all requested medical record information to the receiving
facility within 1 working day of the transfer.
While it is usual and customary for healthcare providers to send medical
information to another provider when a patient transfers care, it is not
typically done within 1 working day. The burden associated with this
requirement is the time and effort it would take for a facility to compile,
copy, and send the information requested. This could be a simple task if the
facilities involved use interoperable electronic health records, but it could
take longer for facilities that keep paper records. We estimate it would take
facilities 10 minutes per transferring patient, and that approximately 8% of
patients (estimating 450,000 dialysis patients) transfer annually, for an
estimated 36,000 transfers per year. We estimate a total annual burden of
6,000 hours.

494.180

Condition: Governance.

(e)

Section 494.180(e) discusses the standard for a facility’s internal grievance
process. This section requires that the facility’s internal grievance process
be implemented so that the patient may file an oral or written grievance
with the facility without reprisal or denial of services. In addition,
§ 494.180(e)(1)-(3) details the required contents of the process. The burden
associated with this requirement is the time and effort necessary to develop
and implement the internal grievance process. We estimate that it will take
213 new facilities 1 hour each to develop grievance processes. We estimate
a total annual burden of 213 hours.

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494.180

Condition: Governance.

(f)(4)(ii)

The interdisciplinary team must notify the patient with a 30-day written
notice of planned involuntary discharge, and also notify the ESRD Network
that services the area and the State agency of the discharge. The burden
associated with this requirement is the time and effort it would take for the
team to notify the patient and ESRD Network 30 days prior to the
involuntary discharge and the State agency at the time of involuntary
discharge. We estimate it would take 10 minutes to provide such
notification. We expect that 6,464 facilities would each have one or less
patients involuntarily discharged each year. We estimate a total annual
burden of 1,077 hours.

494.180

Condition: Governance.

(f)(4)(iii)

The interdisciplinary team must obtain a written physician's order that must
be signed by both the medical director and the patient's attending physician
concurring with the patient's discharge or transfer from the facility. They
must also document any attempts to place the patient in another facility and
notify the State survey agency of the involuntary transfer or discharge.
While obtaining one patient discharge physician signature is a usual and
customary business practice, or is required under other Federal, State, and
local laws, or both, the requirement for the second signature from the
medical director is new. We estimate that it would take 5 minutes to for the
medical director to sign the discharge order. We expect that one or less
patients would be involuntarily discharged from a facility annually. We
estimate that the total annual additional burden for 6,464 facilities would be
539 hours.

494.180

Condition: Governance.

(g)(2)

The dialysis facility must have available at the nursing/monitoring station, a
roster with the names of physicians to be called for emergencies, when they
can be called, and how they can be reached. We estimate that it would take
213 new facilities 10 minutes each to develop such a roster. We estimate
that the total annual burden would be 35 hours.

494.180

Condition: Governance.

(g)(3)

The dialysis facility must have an agreement with a hospital that can
provide inpatient care, routine and emergency dialysis, and other hospital
services, and emergency medical care that is available 24 hours a day,
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7 days a week. We estimate that it would take 213 new facilities
45 minutes each to develop such an agreement. We estimate that the total
annual burden for new facilities would be 160 hours. We estimate it would
take 6,464 existing facilities 10 minutes annually each to maintain such an
agreement, for a total annual burden of 1,077 hours. We estimate a total
annual burden for new and existing facilities of 1,237 hours.

494.180

Condition: Governance.

(h)

The dialysis facility must furnish data and information (both clinical and
administrative) electronically to CMS at intervals specified by the
Secretary, which meet the requirements referenced in this section. These
requirements are subject to the PRA, and are currently approved under the
following OMB approval numbers: 0938-0046 and 0938-0657.
We note that there is a burden associated with this requirement that involves
training individuals in ESRD facilities to use the electronic data submission
system under development. Training is available through in-person or webbased training program. We estimate that it would take 212 new facilities
8 hours each for one individual to complete the training program. We
estimate that the total annual burden would be 1,696 hours.

494.180

Condition: Governance.

(j)

In accordance with §§ 420.200 through 420.206 of this chapter, the
governing body must report ownership interests of 5 percent or more to its
State survey agency. These requirements are subject to the PRA, and are
currently approved under OMB approval number 0938-0685.

13. Capital Costs
There are no capital costs associated with this regulation.
14. Cost to Federal Government
There is no significant additional survey cost since collection and reporting requirement
compliance is generally accomplished by record review and data submission rather than
extensive onsite survey activity. We estimate that the annual cost of the CROWNWeb
data collection system is approximately $1.3 million.
15. Changes to Burden
The estimated burden for this request is based on the current number of Medicareparticipating ESRD facilities, with a prediction for 213 new facilities each year. Changes
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to ongoing burden reflect these new facility counts. There have been no new paperwork
requirements implemented since the last revision of CM-R-52.
The burden previously associated with 42 CFR 414.330(a)(2)(iii)(C) no longer exists
because the relevant program was eliminated in 2011. Therefore there has been a reduction
in burden due to this change.
From 2008-2012, the average yearly growth in dialysis facilities seeking approval was
3.4 percent. We anticipate a similar rate of growth in dialysis facilities over the next few
years. Thus, we believe that a total of 1,298 new and renovated dialysis facilities will
request Medicare approval over the five-year period from 2013 to 2017. We estimate the
average number of new facilities per year requesting approval would be 213 facilities per
year, over 5 five years. We estimate the average number of existing facilities each year
from 2013 to 2017 to be 6,464 facilities. Since these provisions are currently in effect, we
are using 2013 estimates of the numbers for new and renovated dialysis facilities for onetime burdens. Therefore, there has been an increase in some burden estimates due to the
number of respondents.
Previously, from 2000-2008, the average yearly growth rate in the number of dialysis
facilities was approximately 4 percent. This means that some of the burden estimates
associated with requirements only for new facilities have gone down.
16. Publication/Tabulation Dates
There are no publication or tabulation dates. Some information collected through
CROWNWeb is available to the public, so that dialysis patients can compare clinical
performance when choosing where to receive dialysis care. This information will be
shared through CMS websites.
17. Expiration Date
CMS would like to display the expiration date.

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