[Federal Register Volume 79, Number 86 (Monday, May 5, 2014)]
[Notices]
[Pages 25596-25597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10228]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10495]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
ACTION: Notice.
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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the 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 functions; (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.
DATES: Comments must be received by June 2, 2014.
ADDRESSES: When commenting on the proposed information collections,
please reference the document identifier or OMB control number. To be
assured consideration, comments and recommendations must be received by
CMS or the OMB desk officer via one of the following transmissions:
1. Electronically. You may send your comments electronically to
http://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number --------, Room C4-26-05, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
3. OMB, Office of Information and Regulatory Affairs, Attention:
CMS Desk Officer, Fax Number: (202) 395-5806 or, Email: [email protected].
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. The term ``collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Registration,
Attestation, Dispute & Resolution, Assumptions Document and Data
Retention Requirements for Open Payments; Use: Section 6002 of the
Affordable Care Act added section 1128G to the Social Security Act
(Act), which requires applicable manufacturers and applicable group
purchasing organizations (GPOs) of covered drugs, devices, biologicals,
or medical supplies to report annually to CMS certain payments or other
transfers of value to physicians and teaching hospitals, as well as,
certain information regarding the ownership or investment interests
held by physicians or their immediate family members in applicable
manufacturers or applicable GPOs.
Specifically, applicable manufacturers of covered drugs, devices,
biologicals, and medical supplies are required to submit on an annual
basis the information required in section 1128G(a)(1) of the Act about
certain payments or other transfers of value made to physicians and
teaching hospitals (collectively called covered recipients) during the
course of the
[[Page 25597]]
preceding calendar year. Similarly, section 1128G(a)(2) of the Act
requires applicable manufacturers and applicable GPOs to disclose any
ownership or investment interests in such entities held by physicians
or their immediate family members, as well as information on any
payments or other transfers of value provided to such physician owners
or investors. Applicable manufacturers must report the required payment
and other transfer of value information annually to CMS in an
electronic format. The statute also provides that applicable
manufacturers and applicable GPOs must report annually to CMS the
required information about physician ownership and investment
interests, including information on any payments or other transfers of
value provided to physician owners or investors, in an electronic
format by the same date. Applicable manufacturers and applicable GPOs
are subject to civil monetary penalties (CMPs) for failing to comply
with the reporting requirements of the statute. We are required by
statute to publish the reported data on a public Web site. The data
must be downloadable, easily searchable, and aggregated. In addition,
we must submit annual reports to the Congress and each state
summarizing the data reported. Finally, section 1128G of the Act
generally preempts state laws that require disclosure of the same type
of information by manufacturers.
With this notice, we are announcing the addition of the dispute
resolution and corrections process to this information collection
request (ICR). The dispute resolution and corrections process was
discussed in our initial submission to OMB. However, based on the
detailed processes of review and corrections as well as the
sensitivities around these processes, we felt it appropriate to solicit
additional public feedback on how these interactions would occur.
Therefore we are resubmitting a revised ICR for OMB review and
approval. While we are submitting a revision of the entire ICR, we are
specifically seeking comments on the dispute resolution and comment
process. Form Number: CMS-10495 (OCN: 0938-1237); Frequency: Once;
Affected Public: Private sector--business or other for-profits; Number
of Respondents: 227,157; Total Annual Responses: 457,454; Total Annual
Hours: 3,099,297. (For policy questions regarding this collection
contact Melissa Heesters at 410-786-0618.)
Dated: April 30, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2014-10228 Filed 5-1-14; 11:15 am]
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