CMS-10266 Supporting Statement - Part A PRA comments 062113

Supporting Statement For Paperwork Reduction Act (PRA) Submissions
Conditions of Participation: Requirements for Approval and Reapproval of
Transplant Centers to Perform Organ Transplants

A. Introduction
This information collection package is a request for a reinstatement of a previously approved
information collection requirements (ICRs) under CMS-10266.
We are not including burden associated with data submission and most patient-care-related
activities such as patient and living donor selection criteria, care plans, patient records, quality
assessment and performance improvement, human resources, and patient and living donor
rights because these activities would occur in the absence of the Medicare program. These
activities are considered usual and customary business practices and as stated in 5 CFR
1320(b)(2) are exempt from the PRA.
We are also not including any burden associated with application for re-entry into the
Medicare Program because these activities would affect fewer than 10 transplant centers
annually and as stated in 5 CFR 1320.3(c) are not subject to the PRA.
B. Background
In recent decades, the number of transplant centers has grown significantly and the complexity
of transplantation has evolved substantially. To keep current with transplant practices, CMS
published new conditions of participation (CoPs) for Approval and Re-approval of Transplant
Centers to Perform Organ Transplants on March 30, 2007.
According to CMS, there are currently approximately 845 Medicare-approved transplant
centers. Of those 845 centers, there are approximately 226 kidney transplant centers. The
ICRs described herein are needed to implement the Medicare CoPs for these 845 Medicareapproved organ transplant centers. These transplant centers that must meet the transplant
centers CoPs to receive Medicare payment for services provided to Medicare patients.
This information collection captures burden necessary to support the implementation and/or
maintenance of the transplant centers CoPs for these 845 transplant centers. We obtained the
salary data from the May 2011 National Occupational Employment and Wage Estimates
United States at the United States Bureau of Labor Statistics website at
http://www.bls.gov/oes/current/oes_nat.htm that we accessed on August 15, 2012. To ensure
that fringe benefits and overhead are included in the estimated hourly wage for each position,
we calculated and added in the amount that would ensure that 30 percent of the total
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compensation was for overhead and fringe benefits. We also rounded all amounts to the
nearest dollar.
“Medical director” refers to the physician or surgeon who is responsible for the medical care
transplant recipients and living donors, if applicable, receive in the transplant center.
Physicians in management positions earn an average hourly salary of $101. We added $43
dollars to that amount to allow for fringe benefits and overhead for an average hourly wage of
$144.
“Administrator” refers to the administrator who runs the day to day operation of a
transplant center. Administrators earn an average hourly salary of $54. We added $23 to that
amount to allow for fringe benefits and overhead for an average hourly wage of $77.
“Transplant coordinator” refers to the registered nurse or clinician who coordinates the
continuity of care of transplant patients and, if applicable, living donors. We used the
average hourly wage for a registered nurse in a specialty hospital, excluding psychiatric and
substance abuse hospitals, which is $36. We added $15 to allow for fringe benefits and
overhead for an average hourly wage of $51.
“Secretary” refers to an administrative support individual. We used the average hourly wage
of $16 for medical secretaries in general medical and surgical hospitals. We added $6 for
fringe benefits and overhead for an average hourly wage of $22.
“General Counsel” refers to the attorney who provides legal advice and services to the
transplant center. We used the average hourly wage of $89 for attorneys in specialty hospitals,
excluding psychiatric and substance abuse hospitals. We added $38 to allow for fringe
benefits and overhead for an average hourly wage of $127.
Some of the estimates in this renewal/extension package are different from the estimates in the
original information collection package due to two factors. First, we based the estimates in
this package on salary information from the United States Bureau of Labor Statistics’ current
wage estimates, as described above. In addition, we now have data upon which we can make
better estimates of average annual instances for the various requirements in this rule.
This document represents all transplant center CoPs currently effective.
C. Justification
1. Need and Legal Basis
The regulations containing these information collection requirements are located at 42 CFR
Part 482. These regulatory requirements implement sections 1102, 1861(e), 1871(a), and
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1881(b)(1) of the Social Security Act (the Act). The Secretary may impose additional
requirements if the requirements are necessary and in the interest of the health and safety of
the individuals who are furnished services by hospitals. Section 1102 of the Act authorizes
the Secretary to publish rules and regulations “necessary for the efficient administration of the
functions” with which the Secretary is charged under the Act. Section 1861(e) of the Act
authorizes promulgation of regulations in the interests of the health and safety of individuals
who are furnished services by a hospital. Section 1871(a) of the Act authorizes the Secretary
to “prescribe such regulations as may be necessary to carry out the administration of the
insurance programs under this title.” Section 1881(b)(1) of the Act contains specific
authority for prescribing the health and safety requirements for facilities, including renal
transplant centers, that furnish end stage renal disease (ESRD) care to beneficiaries.
2. Information Users
Our surveyors use the CoPs and accompanying requirements specified in the regulations as a
basis for determining whether a transplant center qualifies for approval or re-approval under
Medicare. CMS and the healthcare industry believe that the availability to the facility of the
type of records and general content of records, which this regulation specifies, is standard
medical practice and is necessary in order to ensure the well-being and safety of patients and
professional treatment accountability.
3. Use of Information Technology
Transplant centers may use various information technologies to store and manage patient
medical records as long as they are consistent with the existing confidentiality in recordkeeping regulations at 42 CFR 485.638. This regulation in no way prescribes how the facility
should prepare or maintain these records. Facilities are free to take advantage of any
technological advances that they find appropriate for their needs.
4. Duplication of Efforts
These requirements do not require a transplant center to duplicate its efforts. If a facility
already performs activities or maintains records that satisfy the ICRs for this final rule,
regardless of format, they are in compliance with the applicable ICR.
5. Small Businesses
These requirements will not have a significant impact on most hospitals and other providers
that are small entities. Most of the requirements in this rule are part of transplant centers’
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standard practices.
6. Less Frequent Collection
CMS does not collect information directly from transplant centers, with the exception of
information collected based on requirements at §§482.74 and 488.61. This information is not
collected on a routine basis but only under specific circumstances. In most cases, the rule
does not prescribe the manner, timing, or frequency of the records or information that must be
available. Transplant center records are reviewed at the time of a survey for initial or
continued participation in the Medicare program. Less frequent information collection would
impede efforts to establish compliance with the Medicare CoPs.
7. Special Circumstances
This collection of information does not require any special circumstances.
8. Federal Register/Outside Consultation
The 60-day Federal Register notice published on June 28, 2013.
9. Payments/Gifts to Respondents
There will not be any payment or gifts to respondents for the collection of this information.
10. Confidentiality
Normal medical confidentiality practices assure the confidentiality of this information.
11. Sensitive Questions
There are no questions of a sensitive nature associated with this information collection.
12. Burden Estimates (Hours & Wages)
Section 482.74 – Standard: Notification to CMS
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Section 482.74(a) requires transplant centers to immediately notify CMS of any significant
changes related to the center’s transplant program or changes that could affect its compliance
with the CoPs. Instances in which CMS should be notified include, but are not limited to, :
changes in key staff members of the transplant team; a decrease in the number of the center’s
transplants or survival rates that could result in the transplant center being out of compliance
with §482.82, Condition of Participation: Data submission, clinical experience, and outcome
requirements for re-approval of transplant centers; termination of the agreement between the
hospital in which the transplant center is located and an OPO for the recovery and receipt of
organs; and inactivation of the transplant center.
In the original information collection package in 2007, we estimated that a transplant center
would utilize a medical director, an administrator, a transplant coordinator, and appropriate
support or administrative staff to complete and submit a notification report of a change to
CMS. We estimated that a transplant center would notify CMS three times a year about its
significant changes and that each notification would require a medical director, senior
administrator, transplant coordinator, and secretary for a total of 2 hours to prepare and submit
each report of notification of change to us. Therefore, it would require an estimated 45
minutes or .75 hours annually for each center to notify CMS of any significant changes for a
cost of $75.
Annual Burden Hours and Cost Estimates for Each Transplant Center
to Make Required Notifications of Significant Changes to CMS
Position
Medical
Director
Administrator
Totals

Hourly
Hours
Cost
Wage for Position Required for Each Report Estimate for
Each Report
$144
$77

.25
.50
.75

$36
$39
$75

Based upon our experience with transplant centers making these required notifications, we
estimate that we would receive an average of 275 notifications annually. Therefore, we estimate
that the annual burden to transplant centers for making these notifications would be 206 burden
hours (.75 burden hours x 275 notifications = 206.25 or about 206 burden hours) at a cost of
$20,625 ($75 for each notification x 275 notifications = $20,625).
Section 482.94 (c)(1) and (2) – Standard: Patient and living donor management
Section 482.94(c)(1) requires transplant centers to inform all of the patients who received an
evaluation for placement on the center’s waiting list of his or her transplant status. These
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notifications include: the patient’s placement on the center’s waiting list; the center’s decision not
to place the patient on its waiting list; or the center’s inability to make a determination regarding
the patient’s placement on its waiting list because further clinical testing or documentation is
needed. For kidney transplant patients, the patient’s usual dialysis center must also be notified of
the patient’s status. The center must also document in the patient’s record that those notifications
were made. In addition, §482.94(c)(2) requires transplant centers to notify patients, and the usual
dialysis center for kidney patients, when a patient is removed from its waiting list for any reason
other than death or transplantation no later than 10 days after the patient was removed from the
center’s waiting list. The center must also document that those notifications were made in the
patient’s record.
Transplant centers are required to be located in a transplant hospital that is a member of and abides
by the rules and requirements of the Organ Procurement and transplantation Network (OPTN).
OPTN Policies already require transplant centers to notify each patient of his or her status on the
waiting list (OPTN Policy 3.2.07). However, the OPTN policy does not require that kidney
transplant centers notify the patient’s usual dialysis center. Therefore, the notification of the
dialysis center does constitute a new burden.
We believe that rather than notifying dialysis facilities on a flow basis for each patient, transplant
centers will update dialysis centers quarterly about the status of all patients. We estimate that a
kidney transplant center would use one transplant coordinator for two hours and one secretary for
half an hour to notify their kidney transplant patients’ usual dialysis facilities about each of their
patient’s waiting list status or a change in their waiting list status. For each notification, we
estimate that it would require each transplant center 2.5 burden hours at a cost of $113.
Annual Burden Hours and Cost Estimate to
Notify Dialysis Facilities of Their Patients’ Waiting List Status
Position

Transplant

Coordinator

Secretary
Totals

Hourly Burden
Wage Hours
Per
Event*
$ 51
$22

2.00
.50
2.50

Cost
Total Annual
Estimate Per Hours
Required
Event*
(for 4 Events)
$102
$11
$113

8.0
2.0
10.0

Total
Annual Cost
Estimate (for 4
Events)
$408
$ 44
$452

There are approximately 226 kidney transplant centers. Thus, for all of the kidney transplant
centers, we estimate it would require 2,260 (10 burden hours for each kidney transplant center x
226 kidney transplant centers = 2,260 burden hours) at a cost of $102,152 ($452 for each kidney
transplant center x 226 kidney transplant centers = $102,152).
Section 482.102 (c)(2) and (3) Patient and living donor rights
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Section 482.102(c)(2) requires transplant center to inform patients on their waiting list at least 30
days prior to the center’s termination of Medicare approval, whether that termination is voluntary
or involuntary, of the center’s loss of Medicare approval and that Medicare will no longer pay for
transplants performed after the effective date of the center’s termination of approval. Section
102(c)(3) requires transplant centers that voluntarily inactivate their programs to inform the
patients on their waiting list. Generally, centers that voluntarily inactivate do so because they
anticipate losing their Medicare approval. Therefore, they are included in the estimate for the
center that would lose their Medicare approval. In the original information collection package in
2007, we estimated that 10 transplant centers would lose their Medicare approval each year.
However, based on our experience with transplant centers that lose their Medicare approval, we
now estimate that an average of 15 transplant centers lose their Medicare approval annually and
that each of these centers has about 136 individuals on their waiting list.
We believe that transplant centers would inform their waiting list patients by mail. We also
estimate that it would require an administrator about 30 minutes or .5 hours to draft a letter, and it
would take a secretary or other administrative support staff 2.5 hours to copy and mail these letters
to patients. Thus, we estimate that complying with this requirement would require three burden
hours at a cost of $94.
Burden Hours and Cost Estimate for Notifying Patients on a Center’s
Waiting List of a Transplant Center’s Loss of Medicare Approval
Position
Senior
Administrator
Secretary
Totals

Hourly
Wage

Hours
Required
$77
$22

Total
Cost Estimate
.50
2.50
3.00

$39
$55
$94

Thus, for the 15 centers, it would require 45 burden hours (3 hours for each instance x 15
transplant centers = 45 burden hours) at a cost of $940 ($94 for each instance x 15 transplant
centers = $1,410).
Section 488.61(a) and (b) Special procedures for approval and re-approval of organ transplant
centers
Section 488.61(a) and (b) requires transplant centers that want to apply for Medicare approval to
submit a request to CMS for Medicare approval. The request must be signed by a person
authorized to represent the center and the request must include the hospital’s Medicare provider
identification number; the name(s) of the designated primary transplant surgeon and primary
transplant physician; and a statement from the OPTN that the center has complied with all data
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submission requirements. We estimate that it would take a medical director and a senior
administrator about 30 minutes or .5 hours each to complete this request for a total of one burden
hour at a cost of $111.
Annual Burden Hours and Cost for a Transplant Center
to Apply for Medicare Approval2
Position
Medical Director
Senior
Administrator
Totals

Hourly
Wage

$144

Hours
Required

$ 77

.50

Total
Cost Estimate

.50
1

$72
$39
$111

In the original information collection package in 2007, we estimated that only 10 new transplant
centers would apply for Medicare approval each year. However, based on our experience with
transplant centers, we now estimate that an average of 12 programs will apply for Medicare
approval annually. Thus, for those 12 transplant centers to apply for Medicare approval it would
require 12 burden hours (1 burden hour for each transplant centers x 12 transplant centers = 12
burden hours) at a cost of $1,332 ($111 for each transplant centers x 12 transplant centers =
$1,332).
488.61(d) Application to Re-enter Medicare Program
Section 488.61(d) sets forth the requirements for transplant centers that have lost their Medicare
approval to request re-entry into the Medicare Program. In the original information collection in
2007, we estimated that as many as 10 centers would apply for re-entry into the Medicare program
annually. However, based on our experience with transplant centers that have lost their Medicare
approval since the final rule became effective, we now estimate that only about two centers would
apply for re-entry into the Medicare program annually. Under 5 CFR 1320.3(c), a “collection of
information” does not include requirements imposed on fewer than ten entities. Therefore, the
requirements under $488.61(d) are not subject to the PRA.
Based on the analysis above, we estimate that for all 845 transplant centers to comply with the
ICRs in this final rule, it would require 2,509 burden hours at a cost of $125,519.
Total Annual Burden Hours and Cost for all 845 Transplant
Centers to Comply with the ICRs Required by CMS-3835-F
Section
§482.74(a)
§482.94(c)(1) & (2)

Responses
275
226

Burden
Hours

8

Cost
Estimates
206
$ 20,625
2,260
$102,152

§482.102(c)(2) & (3)
§488.61(a) & (b)
Totals

15
12
528

45
12
2,523

$ 1,410
$ 1,332
$125,519

13. Capital Costs
There are no additional capital costs.
14. Cost to Federal Government
There are minimal costs associated with these requirements that are accrued at the Federal
level and especially at the regional office (RO) levels. For example, RO staff is responsible
for acting on the information collections requirements discussed in this package as it relates to
transplant center compliance. Once state survey agencies have completed their surveys and if
a final decision to terminate a transplant center for noncompliance is to be made, the Central
Office and the RO make such decisions.
15. Changes to Burden
In this information collection package, we have updated our estimates. We have used the
latest wage estimates available from the United States Bureau of Labor Statistics as described
above. We have also modified our estimates based upon our experience with transplant
centers since the final rule was published. For §488.61(a) and (b), we had originally estimated
that only 10 new transplant centers would apply for Medicare approval each year. However,
we now estimate that an average of 12 new programs apply each year. In addition, for
§488.61(d), we originally estimated that as many as 10 transplant centers would apply for reentry into the Medicare program each year. We now estimate that an average of two centers
would apply for re-entry to the Medicare program. Since the requirements for §488.61(d)
would impose ICRs upon fewer than ten entities, those requirements are not subject to the
PRA under 5 CFR 1320.3(c). Thus, we have not any estimate for the burden under that
section.
16. Publication/Tabulation Dates
We do not plan to publish any of the information collected.
17. Expiration Date

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This collection does not lend itself to the displaying of an expiration date.

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