Notice: This CMS-approved document has been submitted - Philips ...
Notice: This CMS-approved document has been submitted - Philips ... Notice: This CMS-approved document has been submitted - Philips ...
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. 1016 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
CMS-1403-FC to several associated information collections that are not discussed in the regulation text which have already received OMB approval. These include the following: Part B Drug Payment Section II.F.1 of the preamble of this final rule with comment period discusses payment for Medicare Part B drugs and biologicals under the ASP methodology. Drug manufacturers are required to submit ASP data to us on a quarterly basis. The collection of ASP data imposes a reporting requirement on the public. The burden associated with this requirement is the time and effort required by manufacturers of Medicare Part B drugs and biologicals to calculate, record, and submit the required data to CMS. While the burden associated with this requirement is subject to the PRA, it is currently approved under OMB control number 0938–0921, with an expiration date of May 31, 2009. Competitive Acquisition Program (CAP) Section II.F.2. of this final rule with comment period discusses the Part B CAP issues. While we are not imposing any new burden, it should be noted that all of the information collection components of the CAP have been reviewed and approved by OMB. They are approved under OMB 1017
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<strong>CMS</strong>-1403-FC<br />
to several associated information collections that are not<br />
discussed in the regulation text which have already<br />
received OMB approval.<br />
These include the following:<br />
Part B Drug Payment<br />
Section II.F.1 of the preamble of this final rule with<br />
comment period discusses payment for Medicare Part B drugs<br />
and biologicals under the ASP methodology. Drug<br />
manufacturers are required to submit ASP data to us on a<br />
quarterly basis. The collection of ASP data imposes a<br />
reporting requirement on the public. The burden associated<br />
with this requirement is the time and effort required by<br />
manufacturers of Medicare Part B drugs and biologicals to<br />
calculate, record, and submit the required data to <strong>CMS</strong>.<br />
While the burden associated with this requirement is<br />
subject to the PRA, it is currently <strong>approved</strong> under OMB<br />
control number 0938–0921, with an expiration date of<br />
May 31, 2009.<br />
Competitive Acquisition Program (CAP)<br />
Section II.F.2. of this final rule with comment period<br />
discusses the Part B CAP issues. While we are not imposing<br />
any new burden, it should be noted that all of the<br />
information collection components of the CAP have <strong>been</strong><br />
reviewed and <strong>approved</strong> by OMB. They are <strong>approved</strong> under OMB<br />
1017