Privacy Act of 1974; Report of New System of Records, 32547-32550 [2014-13012]
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Federal Register / Vol. 79, No. 108 / Thursday, June 5, 2014 / Notices
FEDERAL RESERVE SYSTEM
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Change in Bank Control Notices;
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies;
Correction
Centers for Medicare & Medicaid
Services
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This notice corrects a notice (FR Doc.
2014–12672) published on page 31335
of the issue for Monday, June 2, 2014.
Under the Federal Reserve Bank of
Dallas heading, the entry for Kenneth D.
Willmon, individually and as co-trustee
of AIM Bancshares, Inc. 401(k) and
Employee Stock Ownership Program;
Lanny B. Modawell; Marjorie Willmon;
and Debra Willmon, all of Lubbock,
Texas, is revised to read as follows:
1. Kenneth D. Willmon, individually
and as co-trustee of AIM Bancshares,
Inc. 401(k) and Employee Stock
Ownership Program; Lanny B.
Modawell; Marjorie Willmon; and Debra
Willmon, all of Lubbock, Texas; to retain
voting shares of AIM Bancshares, Inc.,
Levelland, Texas, and thereby indirectly
retain voting shares of AimBank,
Littlefield, Texas.
Comments on this application must
be received by June 17, 2014.
In addition, this notice also corrects a
notice (FR Doc. 2014–12361) published
on page 30844 of the issue for Thursday,
May 29, 2014.
Under the Federal Reserve Bank of
Minneapolis heading, the entry for Carol
A. Nelson, Baxter, Minnesota, and Lee
W. Anderson, Tower, Minnesota,
individually, and, with Doug B. Junker,
Brainerd, Minnesota, as a group acting
in concert, is revised to read as follows:
1. Carol A. Nelson, Lake Shore,
Minnesota, and Lee W. Anderson,
Tower, Minnesota, individually, and,
with Doug B. Junker, Brainerd,
Minnesota, as a group acting in concert;
to acquire voting shares of Timberland
Bancorp, Baxter, Minnesota, and
thereby indirectly acquire voting shares
of First National Bank of Buhl,
Mountain Iron, Minnesota.
Comments on this application must
be received by June 11, 2014.
Board of Governors of the Federal Reserve
System, June 2, 2014.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2014–13040 Filed 6–4–14; 8:45 am]
BILLING CODE 6210–01–P
Privacy Act of 1974; Report of New
System of Records
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Notice of a New System of
Records (SOR).
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
CMS is establishing a new SOR titled,
‘‘Open Payments,’’ System No. 09–70–
0507, to implement the requirements in
Section 6002 of the Patient Protection
and Affordable Care Act of 2010 (ACA)
(Pub. L. 111–148), which added section
1128G to the Social Security Act (the
Act). The Open Payments program
requires applicable manufacturers and
applicable Group Purchasing
Organizations (GPOs) to report
payments and other transfers of value to
covered physician recipients as defined
by 42 CFR 403.902, as well as certain
ownership or investment interests held
by physicians and/or their immediate
family members in such applicable
manufacturers and/or applicable GPOs.
CMS is required to publish the data
submitted by applicable manufacturers
or GPOs on a public Web site.
DATES: Effective Dates: July 7, 2014.
Written comments should be submitted
on or before the effective date. HHS/
CMS/Center for Program Integrity (CPI)
may publish an amended SORN in light
of any comments received.
ADDRESSES: The public should address
comments to: CMS Privacy Officer,
Privacy Policy Compliance Group,
Office of E-Health Standards & Services,
Office of Enterprise Management, CMS,
7500 Security Boulevard, Baltimore, MD
21244–1870, Mailstop: S2–24–25,
Office: (410) 786–5357, Email:
walter.stone@cms.hhs.gov. Comments
received will be available for review at
this location, by appointment, during
regular business hours, Monday through
Friday from 9:00 a.m.–3:00 p.m., Eastern
Time zone.
FOR FURTHER INFORMATION CONTACT: Data
Sharing and Partnership Group, Center
for Program Integrity, Centers for
Medicare & Medicaid Services, 7210
Ambassador Road, Mail Stop AR–18–50,
Baltimore, MD 21244. Email:
veronika.peleshchukfradlin@
cms.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Applicable Manufacturers and/or
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32547
applicable GPOs are required to report
payments and other transfers of value to
covered physician recipients.
Additionally, applicable manufacturers
and/or applicable GPOs are required to
report information pertaining to certain
ownership or investment interests held
by physicians and/or their immediate
family members in such applicable
manufacturers and/or applicable GPOs.
Such reports are to be made annually to
CMS in an electronic format. Applicable
Manufacturers and/or applicable GPOs
are subject to civil monetary penalties
for failing to comply with the reporting
requirements. CMS will publish the
reported data on a public Web site. The
data must be downloadable, easily
searchable, and aggregated. In addition,
CMS must submit annual reports to the
Congress and each state summarizing
the data reported.
Title 42 Code of Federal Regulations
(CFR) 403.908(g) provides covered
physician recipients and physicians
who are owners or investors a 45-day
review period to review data submitted
about them and submit corrections prior
to the data becoming available to the
public. Additionally, 42 CFR
403.908(g)(3)(iv) and (v) provides
covered physician recipients and
physicians who are owners or investors
an opportunity to dispute the accuracy
of such information. Covered physician
recipients and physician owners or
investors will indicate which
information regarding a specific
payment or other transfer of value is
being disputed. Applicable
Manufacturers and/or applicable GPOs
will receive a notification that a covered
physician recipient and/or a physician
who is an owner or investor is disputing
reported information. The dispute
resolution process is between the
applicable manufacturers and/or the
applicable GPOs, and the covered
physician recipients and physicians
who are owners or investors. If a dispute
is resolved or if errors/omissions are
discovered, the applicable manufacturer
or applicable GPO is required to submit
corrected data to CMS. Upon receipt,
CMS notifies the affected covered
physician recipient and/or the
physician who is an owner or investor
that the additional information has been
submitted and is available for review.
CMS updates the Web site at least once
annually with corrected information.
The Privacy Act
The Privacy Act governs the
collection, maintenance, use, and
dissemination of certain information
about individuals by agencies of the
Federal Government.
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Federal Register / Vol. 79, No. 108 / Thursday, June 5, 2014 / Notices
A ‘‘SOR’’ is a group of any records
under the control of a Federal agency
from which information about
individuals is retrieved by name or
other personal identifier. The Privacy
Act requires each agency to publish in
the Federal Register a description of the
type and character of each system of
records that the agency maintains, and
the routine uses that are contained in
each system to make agency
recordkeeping practices transparent, to
notify individuals regarding the uses to
which their records are put, and to
assist individuals to more easily find
such files within the agency.
System Number: 09–70–0507
SYSTEM NAME:
Open Payments System.
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
that were made in relation to a
particular covered drug, device,
biological, or medical supply, the name
of that covered drug, device, biological,
or medical supply shall also be
reported. With respect to physicians
who hold certain ownership or
investment interests in such
manufacturers and/or GPOs, or who
have immediate family members who
hold such ownership or investment
interests in such manufacturers and/or
GPOs, collected information will
include the dollar amount invested; the
value and terms of such ownership or
investment, and information pertaining
to any payment or other transfer of
value provided to a physician holding
such an ownership interest.
Teaching hospital information also
includes profile information for the
users interacting with the Open
Payments system on the hospital’s
behalf. Such information includes but
may not be limited to user’s first name
and last name, business contact
information, and job title.
Lockheed Martin’s Virtual Data Center
hosted by Terremark Network Access
Point (NAP) of the National Capital
Region (NCR) facility located at
Culpeper, Virginia and CMS Data
Center, Baltimore, Maryland 21244–
1850.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
PURPOSE(S) OF THE SYSTEM:
The system will contain information
about the following categories of
individuals covered by the Open
Payments program: (1) Physicians and
authorized representatives of physicians
and teaching hospitals and, (2) any
applicable manufacturers and
applicable GPO system users.
The purpose(s) of this SOR is to
maintain information submitted by
applicable manufacturers and/or
applicable GPOs regarding payments or
other transfers of value provided to
covered physician recipients, as well as
certain ownership or investment
interests in such entities held by
physicians and/or their immediate
family members. CMS may use
information from this system to: (1)
Support regulatory, reimbursement, and
policy functions performed by Agency
contractors, consultants, or CMS
grantees; (2) assist Federal agencies and
their fiscal agents in performing the
statutory functions of the Open
Payments; (3) assist applicable
manufacturers or applicable GPOs with
the statutory reporting requirements; (4)
comply with the requirements of 42
U.S.C. 1320a–7h, and publish the
information submitted on a public Web
site; (5) support research and program
evaluation activities; (6) support
litigation involving the agency; (7) assist
with fraud, waste, and abuse detection
and prevention activities; (8) assist
agencies, entities, contractors, or
persons tasked with the response and
remedial efforts in the event of a breach
of information, and (9) assist the U.S.
Department of Homeland Security
(DHS) cyber security personnel.
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CATEGORIES OF RECORDS IN THE SYSTEM:
Information collected about
applicable manufacturers or applicable
GPOs includes but is not limited to
profile information for the company and
users interacting with the Open
Payments system on the applicable
manufacturers or applicable GPOs’
behalf. Such information includes but
may not be limited to user first name
and last name, business contact
information and job title.
Information collected about
physicians in the Open Payments
system includes but is not limited to
physician’s name, specialty, business
address, business phone number,
National Provider Identifier (NPI)
number, state license numbers, types
and descriptions as to the nature and
form of payments received from
applicable manufacturers or applicable
GPOs, amounts of payments, natures
and context of payments and dates of
payments. With respect to payments
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Authority for the SOR is given by
Title 42 U.S.C. § 1128G [42 U.S.C.
1320a–7h].
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ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OR USERS AND
THE PURPOSES OF SUCH USES:
These routine uses specify
circumstances, in addition to those
provided by statute in the Privacy Act
of 1974, under which CMS may release
information from Open Payments
without the consent of the individual to
whom such information pertains. Each
proposed disclosure of information
under these routine uses will be
evaluated to ensure that the disclosure
is legally permissible, including but not
limited to ensuring that the purpose of
the disclosure is compatible with the
purpose for which the information was
collected. We propose to establish the
following routine use disclosures of
information maintained in the system:
1. To support Agency personnel,
contractors, consultants, or CMS
grantees who have been engaged by the
Agency to assist in accomplishment of
a CMS function relating to the purposes
for this collection and who need to have
access to the records in order to assist
CMS.
2. To assist another Federal, agency of
a State government, an agency
established by State law, or its fiscal
agents with information that is
necessary and/or required in order to
perform the statutory functions of Open
Payments.
3. To provide applicable
manufacturers and applicable GPOs
with information they need to meet any
statutory requirements of the program,
assist with other reports as required by
CMS, and to assist in the
implementation of statutory reporting
requirements.
4. To comply with the requirements of
Section 6002 of the ACA and 42 CFR
Part 403 to publish payment or other
transfers of value and investment
interest information submitted by
applicable manufacturers or applicable
GPOs on a public Web site. CMS will
notify covered recipients, physician
owners and investors, and applicable
manufacturers or applicable GPOs when
data are available for public viewing via
a public announcements and listserv
messages.
5. To support an individual or
organization for research, program
evaluation or epidemiological projects
related to transparency initiatives
around financial relationships between
drug and medical device manufacturers
and physicians, and teaching hospitals.
6. To provide information to the U.S.
Department of Justice (DOJ), a court, or
an adjudicatory body when (a) the
Agency or any component thereof, or (b)
any employee of the Agency in his or
her official capacity, or (c) any
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Federal Register / Vol. 79, No. 108 / Thursday, June 5, 2014 / Notices
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employee of the Agency in his or her
individual capacity where the DOJ has
agreed to represent the employee, or (d)
the United States Government, is a party
to litigation or has an interest in such
litigation, and by careful review, CMS
determines that the records are both
relevant and necessary to the litigation
and that the use of such records by the
DOJ, court, or adjudicatory body is
compatible with the purpose for which
the agency collected the records;
7. To assist a CMS contractor
(including, but not limited to Medicare
Administrative Contractors, fiscal
intermediaries, and carriers) that assists
in the administration of a CMSadministered health benefits program,
or to a grantee of a CMS-administered
grant program, when disclosure is
deemed reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud,
waste or abuse in such program;
8. To assist another Federal agency or
to an instrumentality of any
governmental jurisdiction within or
under the control of the United States
(including any state or local
governmental agency), that administers
or that has the authority to investigate
potential fraud, waste or abuse in a
health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud, waste or abuse in such
programs;
9. To disclose records to appropriate
Federal agencies and Department
contractors that have a need to know the
information for the purpose of assisting
the Department’s efforts to respond to a
suspected or confirmed breach of the
security or confidentiality of
information maintained in this system
of records, and the information
disclosed is relevant and necessary for
that assistance; and
10. To assist the U.S. Department of
Homeland Security (DHS) cyber security
personnel, if captured in an intrusion
detection system used by HHS and DHS
pursuant to the Einstein 2 program.
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM.
STORAGE:
All records are stored is a relational
database in CMS Virtual Data Center
hosted by Terremark Network Access
Point (NAP) of the National Capital
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32549
Region (NCR) facility located at
Culpeper, Virginia.
with CMS to receive notification about
the review processes.
RETRIEVABILITY:
RECORD ACCESS PROCEDURE:
Information about physicians and
their authorized representatives may be
retrieved by any of these personal
identifiers: physicians’ name, address,
license number, or National Provider
Identifier (NPI). Profile information
about applicable manufacturer and GPO
system users may be retrieved by these
identifiers: applicable manufacturers or
applicable GPOs’ DUNS, name and
address. Information may be extracted
through a backend database access or
through a business intelligence
reporting tool by authorized personnel.
SAFEGUARDS:
Personnel having access to the system
have been trained in the Privacy Act
and information security requirements.
Employees who maintain records in this
system are instructed not to release data
until the intended recipient agrees to
implement appropriate management,
operational and technical safeguards
sufficient to protect the confidentiality,
integrity and availability of the
information and information systems
and to prevent unauthorized access.
Access to records in the Open
Payments database system will be
limited to CMS personnel and
contractors through password security,
encryption, firewalls, and secured
operating system. Any electronic copies
which contain information about an
individual at CMS and contractor
locations will be kept in secure
electronic files.
RETENTION AND DISPOSAL:
All records in the Open Payments
database will be maintained for a period
of up to 10 years from the end of the
calendar year in which files were made
publically available on CMS Web site.
Any records that are needed longer,
such as audit or other exceptions, will
be retained until such matters are
resolved.
SYSTEM MANAGER AND ADDRESS:
Director, Data Sharing and
Partnership Group, Center for Program
Integrity, Centers for Medicare &
Medicaid Services, 7210 Ambassador
Road, Mail Stop AR–18–50, Baltimore,
MD 21244.
NOTIFICATION PROCEDURE:
Physician covered recipients and
physicians who are owners or investors,
as well as members of their immediate
families will be notified by CMS via an
online posting and notifications on
CMS’s listservs. They may also register
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Physician covered recipients and
physicians who are owners or investors,
as well as representatives from teaching
hospitals, applicable manufacturers and
GPOs will be able log into the Open
Payments system through a secure Web
site to directly view records pertaining
to them for the previous reporting year
as well as access their profile
information.
CONTESTING RECORD PROCEDURES:
Title 42 Code of Federal Regulations
(CFR.) § 403.908(g) provides covered
physician recipients and physicians
who are owners or investors, as well as
teaching hospitals, a 45-day review
period to review data submitted about
them and dispute its accuracy and
completeness prior to the data becoming
available to the public. Additionally, 42
CFR 403.908(g) (3) (iv) and (v) provides
covered physician recipients and
physicians who are owners or investors
an opportunity to dispute the accuracy
of such information. Covered recipients
and physicians who are owners or
investors will indicate which
information regarding a specific
payment or other transfer of value is
being disputed. Applicable
Manufacturers and/or applicable GPOs
will receive a notification that a covered
recipient or physician owner or investor
is disputing reported information. The
dispute resolution process is between
applicable manufacturers, applicable
GPOs, covered recipients and physician
owners or investors. When a dispute is
resolved and/or errors or omissions are
discovered, 42 C.F.R § 403.908(g)(4) and
(h)(1) require the applicable
manufacturer or applicable GPO to
submit corrected data to CMS. Upon
receipt, CMS notifies the affected
covered recipient or physicians who are
owner or investor that the additional
information has been submitted and is
available for review. CMS updates the
Web site at least once annually with
corrected information after the initial
publication.
RECORD SOURCE CATEGORIES:
Information collected and maintained
in this database is submitted by
applicable manufacturers and/or
applicable GPOs.
EXEMPTIONS CLAIMED FOR THIS SYSTEM:
None.
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Federal Register / Vol. 79, No. 108 / Thursday, June 5, 2014 / Notices
Dated: May 30, 2014.
Niall Brennan,
Acting Director, Offices of Enterprise
Management, Centers for Medicare &
Medicaid Services.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2014–13012 Filed 5–30–14; 5:00 pm]
Proposed Information Collection
Activity; Comment Request
Administration for Children and
Families
BILLING CODE 4120–03–P
Proposed Projects
Title: Freedom of Information Act
(FOIA) Online Request Form
OMB No.:
Description: The proposal is for an
online form for filing a request for ACF
documents under the Freedom of
Information Act (FOIA). The form
prompts requesters to provide all the
information necessary to ensure the
most efficient processing of the request:
name, address, telephone number, email
address, description of the documents
sought, date or time frame for the
documents sought, limit on fees
requester is willing to pay, whether
expedited processing or a fee waiver is
sought and the justification for the
waiver or expedited processing. The
online form is voluntary; it is provided
purely for the convenience of the
requester and is not required to file a
FOIA request.
Respondents: Individuals, private
organizations, businesses, state or local
governments seeking access to ACF
records under the FOIA.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
200
1.15
.25
58
Estimated Total Annual Burden Hours: ....................................................
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FOIA Online Request Form .............................................................................
........................
........................
........................
58
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
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comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–13043 Filed 6–4–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Low Income Home Energy
Assistance Program Performance
Measures.
OMB No.: New Collection.
Description
The Low Income Home Energy
Assistance Program (LIHEAP) block
grant (42 U.S.C. 8621 et seq.) was
established under Title XXVI of the
Omnibus Budget Reconciliation Act of
1981, Public Law 97–35. The Office of
Community Services (OCS) within the
U.S. Department of Health and Human
Services (HHS), Administration for
Children and Families (ACF)
administers LIHEAP at the federal level.
The LIHEAP statute requires HHS to
develop performance measures and
report to Congress annually on program
impacts on recipient and eligible
households. The primary program goals,
as articulated in the statute, are to
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ensure that benefits are targeted to those
households where the greatest program
impacts are expected, and to assure that
timely resources are available to
households experiencing home energy
crises.
OCS is seeking authorization to
collect data from all state grantees and
the District of Columbia that will
establish performance indicators of the
impact of LIHEAP services on its
recipients. Specific data elements OCS
is seeking to collect are detailed below.
Broken down by main heating fuel
type, report for all households receiving
any type of LIHEAP-funded energy bill
assistance and for all high energy
burden households receiving any type
of LIHEAP-funded energy bill assistance
(‘‘high energy burden households’’ is
defined as the top 25% of all bill
assistance households sorted by energy
burden for that state):
• Total number of unduplicated
households receiving LIHEAP-funded
energy bill assistance. Note that the total
number of unduplicated households
served with LIHEAP funds is a current
reporting requirement for the LIHEAP
Household Report—Long Form. This
new requirement is in addition to that
requirement and is a slight variation in
that grantees will be asked to exclude
households receiving only LIHEAP
services that are not related to payment
of energy bills (such as weatherization
assistance or heating/cooling equipment
repairs/replacements).
• Average household income.
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]]>Agencies
[Federal Register Volume 79, Number 108 (Thursday, June 5, 2014)]
[Notices]
[Pages 32547-32550]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13012]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of New System of Records
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Notice of a New System of Records (SOR).
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, CMS is establishing a new SOR titled, ``Open Payments,'' System
No. 09-70-0507, to implement the requirements in Section 6002 of the
Patient Protection and Affordable Care Act of 2010 (ACA) (Pub. L. 111-
148), which added section 1128G to the Social Security Act (the Act).
The Open Payments program requires applicable manufacturers and
applicable Group Purchasing Organizations (GPOs) to report payments and
other transfers of value to covered physician recipients as defined by
42 CFR 403.902, as well as certain ownership or investment interests
held by physicians and/or their immediate family members in such
applicable manufacturers and/or applicable GPOs. CMS is required to
publish the data submitted by applicable manufacturers or GPOs on a
public Web site.
DATES: Effective Dates: July 7, 2014. Written comments should be
submitted on or before the effective date. HHS/CMS/Center for Program
Integrity (CPI) may publish an amended SORN in light of any comments
received.
ADDRESSES: The public should address comments to: CMS Privacy Officer,
Privacy Policy Compliance Group, Office of E-Health Standards &
Services, Office of Enterprise Management, CMS, 7500 Security
Boulevard, Baltimore, MD 21244-1870, Mailstop: S2-24-25, Office: (410)
786-5357, Email: walter.stone@cms.hhs.gov. Comments received will be
available for review at this location, by appointment, during regular
business hours, Monday through Friday from 9:00 a.m.-3:00 p.m., Eastern
Time zone.
FOR FURTHER INFORMATION CONTACT: Data Sharing and Partnership Group,
Center for Program Integrity, Centers for Medicare & Medicaid Services,
7210 Ambassador Road, Mail Stop AR-18-50, Baltimore, MD 21244. Email:
veronika.peleshchukfradlin@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: Applicable Manufacturers and/or applicable
GPOs are required to report payments and other transfers of value to
covered physician recipients. Additionally, applicable manufacturers
and/or applicable GPOs are required to report information pertaining to
certain ownership or investment interests held by physicians and/or
their immediate family members in such applicable manufacturers and/or
applicable GPOs. Such reports are to be made annually to CMS in an
electronic format. Applicable Manufacturers and/or applicable GPOs are
subject to civil monetary penalties for failing to comply with the
reporting requirements. CMS will publish the reported data on a public
Web site. The data must be downloadable, easily searchable, and
aggregated. In addition, CMS must submit annual reports to the Congress
and each state summarizing the data reported.
Title 42 Code of Federal Regulations (CFR) 403.908(g) provides
covered physician recipients and physicians who are owners or investors
a 45-day review period to review data submitted about them and submit
corrections prior to the data becoming available to the public.
Additionally, 42 CFR 403.908(g)(3)(iv) and (v) provides covered
physician recipients and physicians who are owners or investors an
opportunity to dispute the accuracy of such information. Covered
physician recipients and physician owners or investors will indicate
which information regarding a specific payment or other transfer of
value is being disputed. Applicable Manufacturers and/or applicable
GPOs will receive a notification that a covered physician recipient
and/or a physician who is an owner or investor is disputing reported
information. The dispute resolution process is between the applicable
manufacturers and/or the applicable GPOs, and the covered physician
recipients and physicians who are owners or investors. If a dispute is
resolved or if errors/omissions are discovered, the applicable
manufacturer or applicable GPO is required to submit corrected data to
CMS. Upon receipt, CMS notifies the affected covered physician
recipient and/or the physician who is an owner or investor that the
additional information has been submitted and is available for review.
CMS updates the Web site at least once annually with corrected
information.
The Privacy Act
The Privacy Act governs the collection, maintenance, use, and
dissemination of certain information about individuals by agencies of
the Federal Government.
[[Page 32548]]
A ``SOR'' is a group of any records under the control of a Federal
agency from which information about individuals is retrieved by name or
other personal identifier. The Privacy Act requires each agency to
publish in the Federal Register a description of the type and character
of each system of records that the agency maintains, and the routine
uses that are contained in each system to make agency recordkeeping
practices transparent, to notify individuals regarding the uses to
which their records are put, and to assist individuals to more easily
find such files within the agency.
System Number: 09-70-0507
System Name:
Open Payments System.
Security Classification:
Unclassified.
System Location:
Lockheed Martin's Virtual Data Center hosted by Terremark Network
Access Point (NAP) of the National Capital Region (NCR) facility
located at Culpeper, Virginia and CMS Data Center, Baltimore, Maryland
21244-1850.
Categories Of Individuals Covered By The System:
The system will contain information about the following categories
of individuals covered by the Open Payments program: (1) Physicians and
authorized representatives of physicians and teaching hospitals and,
(2) any applicable manufacturers and applicable GPO system users.
Categories Of Records In The System:
Information collected about applicable manufacturers or applicable
GPOs includes but is not limited to profile information for the company
and users interacting with the Open Payments system on the applicable
manufacturers or applicable GPOs' behalf. Such information includes but
may not be limited to user first name and last name, business contact
information and job title.
Information collected about physicians in the Open Payments system
includes but is not limited to physician's name, specialty, business
address, business phone number, National Provider Identifier (NPI)
number, state license numbers, types and descriptions as to the nature
and form of payments received from applicable manufacturers or
applicable GPOs, amounts of payments, natures and context of payments
and dates of payments. With respect to payments that were made in
relation to a particular covered drug, device, biological, or medical
supply, the name of that covered drug, device, biological, or medical
supply shall also be reported. With respect to physicians who hold
certain ownership or investment interests in such manufacturers and/or
GPOs, or who have immediate family members who hold such ownership or
investment interests in such manufacturers and/or GPOs, collected
information will include the dollar amount invested; the value and
terms of such ownership or investment, and information pertaining to
any payment or other transfer of value provided to a physician holding
such an ownership interest.
Teaching hospital information also includes profile information for
the users interacting with the Open Payments system on the hospital's
behalf. Such information includes but may not be limited to user's
first name and last name, business contact information, and job title.
Authority For Maintenance Of The System:
Authority for the SOR is given by Title 42 U.S.C. Sec. 1128G [42
U.S.C. 1320a-7h].
Purpose(S) Of The System:
The purpose(s) of this SOR is to maintain information submitted by
applicable manufacturers and/or applicable GPOs regarding payments or
other transfers of value provided to covered physician recipients, as
well as certain ownership or investment interests in such entities held
by physicians and/or their immediate family members. CMS may use
information from this system to: (1) Support regulatory, reimbursement,
and policy functions performed by Agency contractors, consultants, or
CMS grantees; (2) assist Federal agencies and their fiscal agents in
performing the statutory functions of the Open Payments; (3) assist
applicable manufacturers or applicable GPOs with the statutory
reporting requirements; (4) comply with the requirements of 42 U.S.C.
1320a-7h, and publish the information submitted on a public Web site;
(5) support research and program evaluation activities; (6) support
litigation involving the agency; (7) assist with fraud, waste, and
abuse detection and prevention activities; (8) assist agencies,
entities, contractors, or persons tasked with the response and remedial
efforts in the event of a breach of information, and (9) assist the
U.S. Department of Homeland Security (DHS) cyber security personnel.
Routine Uses Of Records Maintained In The System, Including Categories
Or Users And The Purposes Of Such Uses:
These routine uses specify circumstances, in addition to those
provided by statute in the Privacy Act of 1974, under which CMS may
release information from Open Payments without the consent of the
individual to whom such information pertains. Each proposed disclosure
of information under these routine uses will be evaluated to ensure
that the disclosure is legally permissible, including but not limited
to ensuring that the purpose of the disclosure is compatible with the
purpose for which the information was collected. We propose to
establish the following routine use disclosures of information
maintained in the system:
1. To support Agency personnel, contractors, consultants, or CMS
grantees who have been engaged by the Agency to assist in
accomplishment of a CMS function relating to the purposes for this
collection and who need to have access to the records in order to
assist CMS.
2. To assist another Federal, agency of a State government, an
agency established by State law, or its fiscal agents with information
that is necessary and/or required in order to perform the statutory
functions of Open Payments.
3. To provide applicable manufacturers and applicable GPOs with
information they need to meet any statutory requirements of the
program, assist with other reports as required by CMS, and to assist in
the implementation of statutory reporting requirements.
4. To comply with the requirements of Section 6002 of the ACA and
42 CFR Part 403 to publish payment or other transfers of value and
investment interest information submitted by applicable manufacturers
or applicable GPOs on a public Web site. CMS will notify covered
recipients, physician owners and investors, and applicable
manufacturers or applicable GPOs when data are available for public
viewing via a public announcements and listserv messages.
5. To support an individual or organization for research, program
evaluation or epidemiological projects related to transparency
initiatives around financial relationships between drug and medical
device manufacturers and physicians, and teaching hospitals.
6. To provide information to the U.S. Department of Justice (DOJ),
a court, or an adjudicatory body when (a) the Agency or any component
thereof, or (b) any employee of the Agency in his or her official
capacity, or (c) any
[[Page 32549]]
employee of the Agency in his or her individual capacity where the DOJ
has agreed to represent the employee, or (d) the United States
Government, is a party to litigation or has an interest in such
litigation, and by careful review, CMS determines that the records are
both relevant and necessary to the litigation and that the use of such
records by the DOJ, court, or adjudicatory body is compatible with the
purpose for which the agency collected the records;
7. To assist a CMS contractor (including, but not limited to
Medicare Administrative Contractors, fiscal intermediaries, and
carriers) that assists in the administration of a CMS-administered
health benefits program, or to a grantee of a CMS-administered grant
program, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud, waste or abuse in such program;
8. To assist another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any state or local governmental agency), that
administers or that has the authority to investigate potential fraud,
waste or abuse in a health benefits program funded in whole or in part
by Federal funds, when disclosure is deemed reasonably necessary by CMS
to prevent, deter, discover, detect, investigate, examine, prosecute,
sue with respect to, defend against, correct, remedy, or otherwise
combat fraud, waste or abuse in such programs;
9. To disclose records to appropriate Federal agencies and
Department contractors that have a need to know the information for the
purpose of assisting the Department's efforts to respond to a suspected
or confirmed breach of the security or confidentiality of information
maintained in this system of records, and the information disclosed is
relevant and necessary for that assistance; and
10. To assist the U.S. Department of Homeland Security (DHS) cyber
security personnel, if captured in an intrusion detection system used
by HHS and DHS pursuant to the Einstein 2 program.
Policies And Practices For Storing, Retrieving, Accessing, Retaining,
And Disposing Of Records In The System.
Storage:
All records are stored is a relational database in CMS Virtual Data
Center hosted by Terremark Network Access Point (NAP) of the National
Capital Region (NCR) facility located at Culpeper, Virginia.
Retrievability:
Information about physicians and their authorized representatives
may be retrieved by any of these personal identifiers: physicians'
name, address, license number, or National Provider Identifier (NPI).
Profile information about applicable manufacturer and GPO system users
may be retrieved by these identifiers: applicable manufacturers or
applicable GPOs' DUNS, name and address. Information may be extracted
through a backend database access or through a business intelligence
reporting tool by authorized personnel.
Safeguards:
Personnel having access to the system have been trained in the
Privacy Act and information security requirements. Employees who
maintain records in this system are instructed not to release data
until the intended recipient agrees to implement appropriate
management, operational and technical safeguards sufficient to protect
the confidentiality, integrity and availability of the information and
information systems and to prevent unauthorized access.
Access to records in the Open Payments database system will be
limited to CMS personnel and contractors through password security,
encryption, firewalls, and secured operating system. Any electronic
copies which contain information about an individual at CMS and
contractor locations will be kept in secure electronic files.
Retention And Disposal:
All records in the Open Payments database will be maintained for a
period of up to 10 years from the end of the calendar year in which
files were made publically available on CMS Web site. Any records that
are needed longer, such as audit or other exceptions, will be retained
until such matters are resolved.
System Manager And Address:
Director, Data Sharing and Partnership Group, Center for Program
Integrity, Centers for Medicare & Medicaid Services, 7210 Ambassador
Road, Mail Stop AR-18-50, Baltimore, MD 21244.
Notification Procedure:
Physician covered recipients and physicians who are owners or
investors, as well as members of their immediate families will be
notified by CMS via an online posting and notifications on CMS's
listservs. They may also register with CMS to receive notification
about the review processes.
Record Access Procedure:
Physician covered recipients and physicians who are owners or
investors, as well as representatives from teaching hospitals,
applicable manufacturers and GPOs will be able log into the Open
Payments system through a secure Web site to directly view records
pertaining to them for the previous reporting year as well as access
their profile information.
Contesting Record Procedures:
Title 42 Code of Federal Regulations (CFR.) Sec. 403.908(g)
provides covered physician recipients and physicians who are owners or
investors, as well as teaching hospitals, a 45-day review period to
review data submitted about them and dispute its accuracy and
completeness prior to the data becoming available to the public.
Additionally, 42 CFR 403.908(g) (3) (iv) and (v) provides covered
physician recipients and physicians who are owners or investors an
opportunity to dispute the accuracy of such information. Covered
recipients and physicians who are owners or investors will indicate
which information regarding a specific payment or other transfer of
value is being disputed. Applicable Manufacturers and/or applicable
GPOs will receive a notification that a covered recipient or physician
owner or investor is disputing reported information. The dispute
resolution process is between applicable manufacturers, applicable
GPOs, covered recipients and physician owners or investors. When a
dispute is resolved and/or errors or omissions are discovered, 42 C.F.R
Sec. 403.908(g)(4) and (h)(1) require the applicable manufacturer or
applicable GPO to submit corrected data to CMS. Upon receipt, CMS
notifies the affected covered recipient or physicians who are owner or
investor that the additional information has been submitted and is
available for review. CMS updates the Web site at least once annually
with corrected information after the initial publication.
Record Source Categories:
Information collected and maintained in this database is submitted
by applicable manufacturers and/or applicable GPOs.
Exemptions Claimed For This System:
None.
[[Page 32550]]
Dated: May 30, 2014.
Niall Brennan,
Acting Director, Offices of Enterprise Management, Centers for Medicare
& Medicaid Services.
[FR Doc. 2014-13012 Filed 5-30-14; 5:00 pm]
BILLING CODE 4120-03-P
