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CMS-1403-FC
are currently required to maintain written ordering and
referring documentation for 7 years from the date of
service within the CMS Program Integrity Manual. The
burden associated with these recordkeeping requirements is
the time and effort associated with maintaining the
aforementioned documentation for 7 years, which is merely
the codification of the requirements that already exist.
While these requirements are subject to the PRA, we believe
the burden is exempt because the requirement is part of a
usual and customary business practice. As stated in 5 CFR
1320.3(b)(2), the time, effort, and financial resources
necessary to comply with a COI that would incurred by
persons in the normal course of their activities (for
example, in compiling and maintaining business records) is
not subject to the PRA.
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TABLE 46: ESTIMATED ANNUAL REPORTING AND RECORDKEEPING
BURDEN
Regulation
Section(s)
OMB control
number
Respondents Responses
Burden per
response
(hours)
Total
annual
burden
(hours)
§410.33 0938-0685 400,000 400,000 2.5 1,001,503
Total 400,000 400,000 2.5 1,001,503
This final rule with comment period imposes COI
requirements as outlined in the regulation text and
specified above. However, this rule also makes reference