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[Federal Register Volume 78, Number 87 (Monday, May 6, 2013)]
[Notices]
[Pages 26370-26371]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10681]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10419]

Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.
    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid 
Services (CMS), Department of Health and Human Services, is publishing 
the following summary of proposed collections for public comment. 
Interested persons are invited to send comments regarding this burden 
estimate or any other aspect of this collection of information, 
including any of the following subjects: (1) The necessity and utility 
of the proposed information collection for the proper performance of 
the Agency's function; (2) the accuracy of the estimated burden; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) the use of automated collection techniques or 
other forms of information technology to minimize the information 
collection burden.
    1. Type of Information Collection Request: New collection (request 
for a new OMB control number); Title of Information Collection: 
Transparency Reports and Reporting of Physician Ownership or Investment 
Interests; Use:

Reports of Payments or Other Transfers of Value to Covered Recipients

    The regulations at 42 CFR 403.904 require direct and indirect 
payments or other transfers of value provided by an applicable 
manufacturer to a covered recipient, and that direct and indirect 
payments or other transfers of value provided to a third party at the 
request of (or designated by) the applicable manufacturer on behalf of 
a covered recipient, be reported by the applicable manufacturer to CMS 
on an annual basis.

Reports of Physician Ownership and Investment Interests

    Under Sec.  403.906, each applicable manufacturer and applicable 
group purchasing organization must report to CMS on an annual basis all 
ownership and investment interests in the applicable manufacturer or 
applicable group purchasing organization that were held by a physician 
or an immediate family member of a physician during the preceding 
calendar year.

Data Collection

    The data templates will provide detailed information about the data 
to be collected including the data element name, format, allowable 
values, required versus optional fields, and other associated rules 
intended to aid the applicable manufacturers and applicable group 
purchasing organizations as they prepare for and participate in data 
collection. Applicable manufacturers and applicable GPOs will engage in 
data collection external to CMS within their own systems or tracking 
tools. If we intend to make changes to the data templates, we will 
provide them at least 90 days prior to first day of data collection for 
the next reporting year. In providing revised templates, we will also 
comply with the requirements of the Paperwork Reduction Act to seek 
public comments on the proposed changes to the information collections, 
as required by law. This will allow applicable manufacturers and 
applicable GPOs to make any necessary changes to prepare for the next 
reporting year. This is the same time as the date by which we will 
publish the list of teaching hospitals.

Data Submission

    Section 403.908 requires that reports must be electronically 
submitted to CMS by March 31, 2014, and by the 90th day of each 
subsequent calendar year. Additionally, applicable manufacturers and 
applicable group purchasing organizations may submit an entirely 
optional assumptions document, explaining the reasonable assumptions 
made and methodologies used when reporting payments or other transfers 
of value, or ownership or investment interests. The assumptions 
documents will not be made available to covered recipients, physician 
owners or investors, or the public.

Dispute Resolution and Corrections

    There are several situations which may necessitate that data 
previously submitted be updated. These cases include corrections based 
on disputes, or corrections known by the applicable manufacturer or 
applicable GPO through another mechanism. For example, if an applicable 
manufacturer or applicable group purchasing organization discovers an 
error or omission in its annual report, under Sec.  703.908(h), 
applicable manufacturers and applicable GPOs must notify CMS 
immediately upon discovering errors or omissions in their reports and 
must submit corrected information to CMS immediately upon confirmation 
of the error or omission. CMS will update the Web site at least once 
annually with corrected information. Form Number: CMS-10461 (OCN: 0938-
New). Frequency: Annual; Affected Public: Private Sector (business or 
other for-profit and not-for-profit institutions); Number of 
Respondents: 396,414. Total Annual Responses: 396,414. Total Annual 
Hours: 13,327,065. (For policy questions regarding this collection 
contact Doug Brown at 410-786-0028. For all other issues call 410-786-
1326.)
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS Web 
site address at http://www.cms.hhs.gov/PaperworkReductionActof1995, or 
Email your request, including your address, phone number, OMB number,

[[Page 26371]]

and CMS document identifier, to Paperwork@cms.hhs.gov, or call the 
Reports Clearance Office on (410) 786-1326.
    To be assured consideration, comments and recommendations for the 
proposed information collections must be received by the OMB desk 
officer at the address below, no later than 5 p.m. on June 3, 2013.
    OMB, Office of Information and Regulatory Affairs Attention: CMS 
Desk Officer Fax Number: (202) 395-6974 Email: OIRA_submission@omb.eop.gov.

    Dated: May 1, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-10681 Filed 5-3-13; 8:45 am]
BILLING CODE 4120-01-P
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