Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants and Supporting Regulations in 42 CFR 482.74, 482.94, 482.100, 482.102, 488.61
ICR 201310-0938-009
OMB: 0938-1069
Federal Form Document
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0938-1069 can be found here:
Conditions of Participation:
Requirements for Approval and Reapproval of Transplant Centers to
Perform Organ Transplants and Supporting Regulations in 42 CFR
482.74, 482.94, 482.100, 482.102, 488.61
Reinstatement with change of a previously approved collection
The CoPs and accompanying requirements
specified in the regulations are used by our surveyors 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.
US Code:
42
USC 1395bb Name of Law: Limitation of the deeming authority of
the Joint Commission
US Code: 42
USC 1395rr Name of Law: Limitation of deeming authority of the
Joint Commission
US Code: 42
USC 1302 Name of Law: Regulation
US Code: 42
USC 1395hh Name of Law: Regulations
US Code: 42
USC 1395aa Name of Law: Use of State agencies to determine
compliance by providers of services with CoPs
US Code: 42
USC 1395bb Name of Law: Use of Joint Commission on Accrediation
of Hospitals
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 re-entry 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.
$0
No
No
No
No
No
Uncollected
Denise King 410 786-1013
Denise.King@cms.hhs.gov
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
CMS-10266 Supporting Statement - Part A PRA comments 062113.pdf
Requirements in 482.94 (c)(1) & (2)