Privacy Act of 1974; Report of a New System of Records, 19711-19716 [E7-7404]
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Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Notices
Contact: Paul Boben, 410–786–6629
• Expansion of Coverage of Chiropractic
Services Demonstration
Contact: Carol Magee, 410–786–6611
• Frontier Extended Stay Clinic
Demonstration Project
Contact: Sid Mazumdar, 410–786–6673
• Home Health Agency Prospective Payment
Demonstration
Contact: J. Sherwood, 410–786–6651
• Impact of Payment Reform for Part B
Covered Outpatient Drugs and Biologicals
Contact: Usree Bandyopadhyay, 410–786–
6650
• Informatics for Diabetes Education and
Telemedicine Demonstration (IDEATel)
Contact: Diana Ayres: 410–786–7203
• Inhalation Drug Therapy Demonstration
Contact: Debbie Vanhoven, 410–786–6625
• Life Masters
Contact: Linda Colantino, 410–786–3343
• Low Vision Rehabilitation Demonstration
Contact: James Coan, 410–786–9168
• Massachusetts Senior Care Options
Contact: William Clark, 410–786–1484
• Medical Adult Day Care Services
Demonstration
Contact: Armen Thoumaian, PhD, 410–
786–6672
• Medicare + Choice Phase II—PPO
Demonstration
Contact: Debbie Vanhoven, 410–786–6625
• Medicare Advantage CCRC (Erickson)
Demonstration
Contact: Henry Bachofer, 410–786–0340
• Medicare Cancer Registry Record System
Contact: Gerald Riley, 410–786–6699
• Medicare Care Management Performance
Demonstration
Contact: Jody Blatt, 410–786–6921
• Medicare Clinical Laboratory Services
Competitive Bidding Demonstration
Project
Contact: Linda Lebovic, 410–786–3402
• Medicare Coordinated Care Demonstration
Contact: Cynthia Mason, 410–786–6680
• Medicare Drug Replacement
Demonstration
Contact: Jody Blatt, 410–786–6921
• Medicare Health Care Quality
Demonstration Programs
Contact: Cynthia Mason, 410–786–6680
• Medicare Home Health Independence
Demonstration
Contact: Armen Thoumaian, Ph.D., 410–
786–6672
• Medicare Hospital Gainsharing
Demonstration
Contact: Lisa Waters, 410–786–6615
• Medicare Preventive Services—Medicare
Lifestyle Modification Program
Demonstration
Contact: Armen Thoumaian, PhD, 410–
786–6672
• Mercy Medicare Skilled Nursing Facility
Payment Demonstration
Contact: J. Sherwood, 410–786–6651
• Minnesota Senior Health Options
Contact: Susan Radke, 410–786–4450
• Municipal Health Services Program
Demonstration
Contact: Michael Henesch, 410–786–6685
• New York Graduate Medical Education
Demonstration
Contact: Sid Mazumdar, 410–786–6673
• Nursing Home Value-Based Purchasing
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Contact: Ronald Lambert, 410–786–6624
• PACE-for-Profit Demonstration
Contact: Michael Henesch, 410–786–6685
• Payment Development, Implementation
and Monitoring for the BIPA Disease
Management Demonstration
Contact: J. Sherwood, 410–786–6651
• Person-Level Medicaid Data System
Contact: Dave Baugh, 410–786–7716
• Physician Group Practice Demonstration
Contact: John Pilotte, 410–786–6658
• Premier Hospital Quality Incentive
Demonstration
Contact: Katharine Pirotte, 410–786–6774
• Rural Community Hospital Demonstration
Contact: Sid Mazumdar, 410–786–6673
• Rural Hospice Demonstration: Quality
Assurance Metrics Implementation
Support
Contact: Cindy Massuda, 410–786–0652
• Senior Risk Reduction Demonstration
Contact: Pauline Lapin, 410–786–6883
• Social Health Maintenance Organization
for Long-Term Care Demonstration
Contact: Thomas Theis, 410–786–6654
• State-based Home Health Agency TPL
Payments
Contact: J. Sherwood, 410–786–6651
• United Mine Workers of America
Demonstration
Contact: Jason Petroski, 410–786–4681
• Utah Graduate Medical Education
Contact: Sid Mazumdar, 410–786–6673
• Wisconsin Partnership Program
Contact: James Hawthorne, 410–786–6689
[FR Doc. E7–7403 Filed 4–18–07; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Privacy Act of 1974; Report of a New
System of Records
Department of Health and
Human Services (HHS), Center for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a New System of
Records (SOR).
AGENCY:
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
we are proposing to establish a new
system titled, ‘‘Post-Acute Care Payment
Reform / Continuity of Assessment
Report and Evaluation Demonstration
and Evaluation (PAC–CARE), System
No. 09–70–0569.’’ The program is
authorized under Section 5008 of the
Deficit Reduction Act of 2005, which
allows for the establishment of a
demonstration program for purposes of
understanding costs and outcomes
across different post-acute care sites.
The PAC–CARE will collect information
that will enable CMS to better
understand the relationships among
patient needs, post-acute care
placement, patient outcomes, and post-
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19711
acute care related costs in the Medicare
program. Anticipated results of the
PAC–CARE include a standardized
assessment instrument for post-acute
care patients and a proposal for siteneutral payment for post-acute care
services.
The purpose of this system is to
collect and maintain demographic,
health, and health resource use related
data on the target population of
Medicare beneficiaries who require
treatment in a designated acute care or
post-acute care facility. We will also
collect certain identifying information
on Medicare providers who provide
services to such beneficiaries.
Information retrieved from this system
may be disclosed to: (1) Support
regulatory, reimbursement, and policy
functions performed within the agency
or by a contractor, grantee, consultant or
other legal agent; (2) assist another
Federal or state agency with information
to contribute to the accuracy of CMS’s
proper payment of Medicare benefits,
enable such agency to administer a
Federal health benefits program, or to
enable such agency to fulfill a
requirement of Federal statute or
regulation that implements a health
benefits program funded in whole or in
part with Federal funds; (3) support an
individual or organization for a research
project or in support of an evaluation
project related to the prevention of
disease or disability, the restoration or
maintenance of health, or payment
related projects; (4) support the
functions of Quality Improvement
Organizations; (5) support the functions
of national accrediting organizations; (6)
support litigation involving the agency;
and (7) combat fraud, waste, and abuse
in certain Federally-funded health
benefits programs. We have provided
background information about the new
system in the SUPPLEMENTARY
INFORMATION section below. Although
the Privacy Act requires only that CMS
provide an opportunity for interested
persons to comment on the proposed
routine uses, CMS invites comments on
all portions of this notice. See ‘‘Effective
Dates’’ section for comment period.
DATES: Effective Date: CMS filed a new
SOR report with the Chair of the House
Committee on Government Reform and
Oversight, the Chair of the Senate
Committee on Homeland Security &
Governmental Affairs, and the
Administrator, Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB) on
April 13, 2007. To ensure that all parties
have adequate time in which to
comment, the new system will become
effective 30 days from the publication of
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the notice, or 40 days from the date it
was submitted to OMB and the
Congress, whichever is later. We may
defer implementation of this system or
one or more of the routine use
statements listed below if we receive
comments that persuade us to defer
implementation.
The public should address
comments to the CMS Privacy Officer,
Division of Privacy Compliance,
Enterprise Architecture and Strategy
Group, Mail-stop N2–04–27, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850. Comments
received will be available for review at
this location by appointment during
regular business hours, Monday through
Friday from 9 a.m.–3 p.m., eastern time.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Shannon Flood, Division of Payment
Research, Research and Evaluation
Group, Office of Research Development
& Information, Mail Stop C3–19–26,
Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, MD 21244–1849. She can be
reached by telephone at 410–786–2583,
or via e-mail at
Shannon.Flood@cms.hhs.gov.
Medicare
beneficiaries frequently require postacute care for rehabilitation and
recovery following a hospital stay. The
level and length of care required varies
with the individual patient and the
condition(s) requiring hospitalization.
The type of care ranges from outpatient
therapy to multi-day stays in a variety
of post-acute care settings. The PAC–
CARE will study Medicare beneficiaries
as they are discharged from
participating hospitals and move among
post-acute care settings. Patient
functional assessments will be
performed at regular intervals beginning
at hospital discharge and continuing as
patients move among post-acute care
settings until the episode of care has
completed. Cost data will be collected
from the post-acute care settings,
combined with other cost information
collected by Medicare Fiscal
Intermediaries or Carriers, and
combined with claims and patient
outcome data to develop a payment
reform proposal.
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SUPPLEMENTARY INFORMATION:
I. Description of the Proposed System of
Records
A. Statutory and Regulatory Basis for
SOR
The statutory authority for this system
is given under Section 5008 of the
Deficit Reduction Act of 2005.
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B. Collection and Maintenance of Data
in the System
This system will collect and maintain
individually identifiable and other data
collected on Medicare beneficiaries who
require treatment in a designated acute
care or post-acute care facility. We will
also collect certain identifying
information on Medicare providers who
provide services to such beneficiaries.
The collected information will include,
but is not limited to: Medicare claims
and eligibility data, name, address,
telephone number, health insurance
claims number, race/ethnicity, gender,
date of birth, provider name, unique
provider identification number, medical
record number, as well as clinical,
demographic, health/well-being, family
and/or caregiver contact information,
and background information relating to
Medicare issues. Data will be collected
from Medicare administrative and
claims records, PAC–CARE site
administrative data systems, patient
medical charts, physician records, and
via information submitted by
beneficiaries and providers.
II. Agency Policies, Procedures, and
Restrictions on the Routine Use
A. The Privacy Act permits us to
disclose information without an
individual’s consent if the information
is to be used for a purpose that is
compatible with the purpose(s) for
which the information was collected.
Any such disclosure of data is known as
a ‘‘routine use.’’ The Government will
only release PAC-CARE information that
can be associated with an individual as
provided for under ‘‘Section III.
Proposed Routine Use Disclosures of
Data in the System.’’ Both identifiable
and non-identifiable data may be
disclosed under a routine use. We will
only collect the minimum personal data
necessary to achieve the purpose of
PAC–CARE.
CMS has the following policies and
procedures concerning disclosures of
information that will be maintained in
the system. Disclosure of information
from the system will be approved only
to the extent necessary to accomplish
the purpose of the disclosure and only
after CMS:
1. Determines that the use or
disclosure is consistent with the reason
that the data is being collected; e.g., to
collect and maintain demographic,
health, and health resource use related
data on the target population of
Medicare beneficiaries who require
treatment in a designated acute care or
post-acute care facility. We will also
collect certain identifying information
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on Medicare providers who provide
services to such beneficiaries.
2. Determines that:
a. The purpose for which the
disclosure is to be made can only be
accomplished if the record is provided
in individually identifiable form;
b. The purpose for which the
disclosure is to be made is of sufficient
importance to warrant the effect and/or
risk on the privacy of the individual that
additional exposure of the record might
bring; and
c. There is a strong probability that
the proposed use of the data would in
fact accomplish the stated purpose(s).
3. Requires the information recipient
to:
a. Establish administrative, technical,
and physical safeguards to prevent
unauthorized use of disclosure of the
record;
b. Remove or destroy, at the earliest
time, all patient-identifiable
information; and
c. Agree to not use or disclose the
information for any purpose other than
the stated purpose under which the
information was disclosed.
4. Determines that the data are valid
and reliable.
III. Proposed Routine Use Disclosures
of Data in the System
A. The Privacy Act allows us to
disclose information without an
individual’s consent if the information
is to be used for a purpose that is
compatible with the purpose(s) for
which the information was collected.
Any such compatible use of data is
known as a ‘‘routine use.’’ The proposed
routine uses in this system meet the
compatibility requirement of the Privacy
Act. We are proposing to establish the
following routine use disclosures of
information maintained in the system:
1. To agency contractors, consultants
or grantees, who have been engaged by
the agency to assist in the performance
of a service related to this collection and
who need to have access to the records
in order to perform the activity.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
into a contractual or similar agreement
with a third party to assist in
accomplishing CMS function relating to
purposes for this system.
CMS occasionally contracts out
certain of its functions when doing so
would contribute to effective and
efficient operations. CMS must be able
to give a contractor, consultant or
grantee whatever information is
necessary for the contractor or
consultant to fulfill its duties. In these
situations, safeguards are provided in
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the contract prohibiting the contractor,
consultant or grantee from using or
disclosing the information for any
purpose other than that described in the
contract and requires the contractor,
consultant or grantee to return or
destroy all information at the
completion of the contract.
2. To another Federal or state agency
to:
a. Contribute to the accuracy of CMS’s
proper payment of Medicare benefits;
b. Enable such agency to administer a
Federal health benefits program, or, as
necessary, to enable such agency to
fulfill a requirement of a Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal funds; and/or
c. Assist Federal/state Medicaid
programs within the state.
Other Federal or state agencies, in
their administration of a Federal health
program, may require PAC–CARE
information in order to support
evaluations and monitoring of Medicare
claims information of beneficiaries,
including proper reimbursement for
services provided.
3. To an individual or organization for
a research project or in support of an
evaluation project related to the
prevention of disease or disability, the
restoration or maintenance of health, or
payment related projects.
The PAC–CARE data will provide for
research or support of evaluation
projects and a broader, longitudinal,
national perspective of the status of
Medicare beneficiaries. CMS anticipates
that researchers may have legitimate
requests to use these data in projects
that could ultimately improve the care
provided to Medicare beneficiaries and
the policies that govern their care.
4. To support Quality Improvement
Organizations (QIO) in connection with
review of claims, or in connection with
studies or other review activities
conducted pursuant to Part B of Title XI
of the Act, and in performing affirmative
outreach activities to individuals for the
purpose of establishing and maintaining
their entitlement to Medicare benefits or
health insurance plans.
The QIO may use this data to support
quality improvement activities and
other QIO responsibilities as detailed in
Title XI §§ 1151–1164.
The QIO will work to implement
quality improvement programs, provide
consultation to CMS, its contractors,
and to state agencies. The QIO will
assist state agencies in related
monitoring and enforcement efforts,
assist CMS and intermediaries in
program integrity assessment, and
prepare summary information for
release to CMS.
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5. To assist national accrediting
organization(s) whose accredited
facilities are presumed to meet certain
Medicare requirements for inpatient
hospital rehabilitation services (e.g., the
Joint Commission for the Accreditation
of Healthcare Organizations, the
American Osteopathic Association, or
the Commission on Accreditation of
Rehabilitation Facilities). Information
will be released to these organizations
for only those facilities that they
accredit and that participate in the
Medicare program and if they meet the
following requirements:
a. Provide identifying information for
post acute care facilities that have an
accreditation status with the requesting
deemed organization;
b. Submission of a finder file
identifying beneficiaries/patients
receiving post acute care services;
c. Safeguard the confidentiality of the
data and prevent unauthorized access;
and
d. Upon completion of a signed data
exchange agreement or a CMS data use
agreement.
At this time, CMS anticipates
providing accrediting organizations
with PAC–CARE information to enable
them to target potential identified
problems during the organization’s
accreditation review process of the
facility.
6. To the Department of Justice (DOJ),
court or 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 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.
Whenever CMS is involved in
litigation, and occasionally when
another party is involved in litigation
and CMS policies or operations could be
affected by the outcome of the litigation,
CMS would be able to disclose
information to the DOJ, court or
adjudicatory body involved.
7. To a CMS contractor (including, but
not necessarily limited to, fiscal
intermediaries and carriers) that assists
in the administration of a CMSadministered health benefits program,
or to a grantee of a CMS-administered
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19713
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, and abuse in such program.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
into a contractual, grantee, cooperative
agreement or consultant relationship
with a third party to assist in
accomplishing CMS functions relating
to the purpose of combating fraud,
waste, and abuse. CMS occasionally
contracts out certain of its functions or
makes grants or cooperative agreements
when doing so would contribute to
effective and efficient operations. CMS
must be able to give a contractor,
grantee, consultant or other legal agent
whatever information is necessary for
the agent to fulfill its duties. In these
situations, safeguards are provided in
the contract prohibiting the agent from
using or disclosing the information for
any purpose other than that described in
the contract and requiring the agent to
return or destroy all information.
8. To 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.
Other agencies may require PAC–
CARE information for the purpose of
combating fraud, waste, and abuse in
such Federally funded programs.
B. Additional Provisions Affecting
Routine Use Disclosures
To the extent this system contains
Protected Health Information (PHI) as
defined by HHS regulation ‘‘Standards
for Privacy of Individually Identifiable
Health Information’’ (45 CFR parts 160
and 164, subparts A and E) 65 FR 82462
(12–28–00). Disclosures of such PHI that
are otherwise authorized by these
routine uses may only be made if, and
as, permitted or required by the
‘‘Standards for Privacy of Individually
Identifiable Health Information.’’ (See
45 CFR 164.512(a)(1)).
In addition, our policy will be to
prohibit release even of data not directly
identifiable, except pursuant to one of
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the routine uses or if required by law,
if we determine there is a possibility
that an individual can be identified
through implicit deduction based on
small cell sizes (instances where the
patient population is so small that
individuals could, because of the small
size, use this information to deduce the
identity of the beneficiary).
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IV. Safeguards
CMS has safeguards in place for
authorized users and monitors such
users to ensure against unauthorized
use. 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.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations may apply
but are not limited to: the Privacy Act
of 1974; the Federal Information
Security Management Act of 2002; the
Computer Fraud and Abuse Act of 1986;
the Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: all pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
V. Effects of the Proposed System of
Records on Individual Rights
CMS proposes to establish this system
in accordance with the principles and
requirements of the Privacy Act and will
collect, use, and disseminate
information only as prescribed therein.
Data in this system will be subject to the
authorized releases in accordance with
the routine uses identified in this
system of records.
CMS will take precautionary
measures to minimize the risks of
unauthorized access to the records and
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the potential harm to individual privacy
or other personal or property rights of
patients whose data are maintained in
this system. CMS will collect only that
information necessary to perform the
system’s functions. In addition, CMS
will make disclosure from the proposed
system only with consent of the subject
individual, or his/her legal
representative, or in accordance with an
applicable exception provision of the
Privacy Act. CMS, therefore, does not
anticipate an unfavorable effect on
individual privacy as a result of
information relating to individuals.
Dated: April 12, 2007.
Charlene Frizzera,
Acting Chief Operating Officer, Centers for
Medicare & Medicaid Services.
SYSTEM NO. 09–70–0569
SYSTEM NAME:
‘‘Post-Acute Care Payment Reform/
Continuity of Assessment Report and
Evaluation Demonstration and
Evaluation (PAC–CARE),’’ HHS/CMS/
ORDI.
SECURITY CLASSIFICATION:
Level Three Privacy Act Sensitive
Data.
SYSTEM LOCATION:
Centers for Medicare & Medicaid
Services (CMS) Data Center, 7500
Security Boulevard, North Building,
First Floor, Baltimore, Maryland 21244–
1850 and at various co-locations of CMS
agents.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
This system will collect and maintain
individually identifiable and other data
collected on Medicare beneficiaries who
require treatment in a designated acute
care or post-acute care facility. We will
also collect certain identifying
information on Medicare providers who
provide services to such beneficiaries.
submitted by beneficiaries and
providers.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The statutory authority for this system
is given under Section 5008 of the
Deficit Reduction Act of 2005.
PURPOSE(S) OF THE SYSTEM:
The purpose of this system is to
collect and maintain demographic,
health, and health resource use related
data on the target population of
Medicare beneficiaries who require
treatment in a designated acute care or
post-acute care facility. We will also
collect certain identifying information
on Medicare providers who provide
services to such beneficiaries.
Information retrieved from this system
may be disclosed to: (1) Support
regulatory, reimbursement, and policy
functions performed within the agency
or by a contractor, grantee, consultant or
other legal agent; (2) assist another
Federal or state agency with information
to contribute to the accuracy of CMS’s
proper payment of Medicare benefits,
enable such agency to administer a
Federal health benefits program, or to
enable such agency to fulfill a
requirement of Federal statute or
regulation that implements a health
benefits program funded in whole or in
part with Federal funds; (3) support an
individual or organization for a research
project or in support of an evaluation
project related to the prevention of
disease or disability, the restoration or
maintenance of health, or payment
related projects; (4) support the
functions of Quality Improvement
Organizations; (5) support the functions
of national accrediting organizations; (6)
support litigation involving the agency;
and (7) combat fraud, waste, and abuse
in certain Federally-funded health
benefits programs.
CATEGORIES OF RECORDS IN THE SYSTEM:
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OR USERS AND
THE PURPOSES OF SUCH USES:
The collected information will
include, but is not limited to: Medicare
claims and eligibility data, name,
address, telephone number, health
insurance claims number, race/
ethnicity, gender, date of birth, provider
name, unique provider identification
number, medical record number, as well
as clinical, demographic, health/wellbeing, family and/or caregiver contact
information, and background
information relating to Medicare issues.
Data will be collected from Medicare
administrative and claims records,
PAC–CARE site administrative data
systems, patient medical charts,
physician records, and via information
A. The Privacy Act allows us to
disclose information without an
individual’s consent if the information
is to be used for a purpose that is
compatible with the purpose(s) for
which the information was collected.
Any such compatible use of data is
known as a ‘‘routine use.’’ The proposed
routine uses in this system meet the
compatibility requirement of the Privacy
Act. We are proposing to establish the
following routine use disclosures of
information maintained in the system:
1. To agency contractors, consultants
or grantees, who have been engaged by
the agency to assist in the performance
of a service related to this collection and
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who need to have access to the records
in order to perform the activity.
2. To another Federal or state agency
to:
a. Contribute to the accuracy of CMS’s
proper payment of Medicare benefits;
b. Enable such agency to administer a
Federal health benefits program, or, as
necessary, to enable such agency to
fulfill a requirement of a Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal funds; and/or
c. Assist Federal/state Medicaid
programs within the state.
3. To an individual or organization for
a research project or in support of an
evaluation project related to the
prevention of disease or disability, the
restoration or maintenance of health, or
payment related projects.
4. To support Quality Improvement
Organizations (QIO) in connection with
review of claims, or in connection with
studies or other review activities
conducted pursuant to Part B of Title XI
of the Act, and in performing affirmative
outreach activities to individuals for the
purpose of establishing and maintaining
their entitlement to Medicare benefits or
health insurance plans.
5. To assist national accrediting
organization(s) whose accredited
facilities are presumed to meet certain
Medicare requirements for inpatient
hospital rehabilitation services (e.g., the
Joint Commission for the Accreditation
of Healthcare Organizations, the
American Osteopathic Association, or
the Commission on Accreditation of
Rehabilitation Facilities). Information
will be released to these organizations
for only those facilities that they
accredit and that participate in the
Medicare program and if they meet the
following requirements:
a. Provide identifying information for
post acute care facilities that have an
accreditation status with the requesting
deemed organization;
b. Submission of a finder file
identifying beneficiaries/patients
receiving post acute care services;
c. Safeguard the confidentiality of the
data and prevent unauthorized access;
and
d. Upon completion of a signed data
exchange agreement or a CMS data use
agreement.
6. To the Department of Justice (DOJ),
court or 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 employee of the agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
VerDate Aug<31>2005
15:39 Apr 18, 2007
Jkt 211001
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 a CMS contractor (including, but
not necessarily limited to, 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, and abuse in such program.
8. To 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.
B. Additional Provisions Affecting
Routine Use Disclosures
To the extent this system contains
Protected Health Information (PHI) as
defined by HHS regulation ‘‘Standards
for Privacy of Individually Identifiable
Health Information’’ (45 CFR parts 160
and 164, subparts A and E) 65 FR 82462
(12–28–00). Disclosures of such PHI that
are otherwise authorized by these
routine uses may only be made if, and
as, permitted or required by the
‘‘Standards for Privacy of Individually
Identifiable Health Information.’’ (See
45 CFR 164.512(a) (1)).
In addition, our policy will be to
prohibit release even of data not directly
identifiable, except pursuant to one of
the routine uses or if required by law,
if we determine there is a possibility
that an individual can be identified
through implicit deduction based on
small cell sizes (instances where the
patient population is so small that
individuals could, because of the small
size, use this information to deduce the
identity of the beneficiary).
PO 00000
Frm 00037
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19715
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
All records are stored on electronic
media.
RETRIEVABILITY:
The collected data are retrieved by an
individual identifier; e.g., beneficiary
name or HICN.
SAFEGUARDS:
CMS has safeguards in place for
authorized users and monitors such
users to ensure against unauthorized
use. 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.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations may apply
but are not limited to: the Privacy Act
of 1974; the Federal Information
Security Management Act of 2002; the
Computer Fraud and Abuse Act of 1986;
the Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: all pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
RETENTION AND DISPOSAL:
Records will be retained until an
approved disposition authority is
obtained from the National Archives
and Records Administration. All claimsrelated records are encompassed by the
document preservation order and will
be retained until notification is received
from DOJ.
SYSTEM MANAGER AND ADDRESS:
Director, Research and Evaluation
Group, Office of Research Development
E:\FR\FM\19APN1.SGM
19APN1
19716
Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Notices
& Information, Mail Stop C3–19–26,
Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, MD 21244–1849.
ACTION:
NOTIFICATION PROCEDURE:
For purpose of access, the subject
individual should write to the system
manager who will require the system
name, employee identification number,
tax identification number, national
provider number, and for verification
purposes, the subject individual’s name
(woman’s maiden name, if applicable),
HICN, and/or SSN (furnishing the SSN
is voluntary, but it may make searching
for a record easier and prevent delay).
RECORD ACCESS PROCEDURE:
For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR 5b.5
(a)(2)).
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
procedures are in accordance with
Department regulation 45 CFR 5b.7).
RECORDS SOURCE CATEGORIES:
Data will be collected from Medicare
administrative and claims records
(Outcome and Assessment Information
Set, Inpatient Rehabilitation Facilities
Patient Assessment Instrument, Long
Term Care Minimum Data Set), postacute care site administrative data
systems, patient medical charts,
physician records, and via information
submitted by beneficiaries and
providers.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E7–7404 Filed 4–18–07; 8:45 am]
BILLING CODE 4120–03–P
Notice.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of three new animal drug
applications (NADAs) for intermediate
premixes used to manufacture Type C
medicated feeds. In a final rule
published elsewhere in this issue of the
Federal Register, FDA is amending the
animal drug regulations to remove
portions reflecting approval of these
NADAs.
FOR FURTHER INFORMATION CONTACT:
Pamela K. Esposito, Center for
Veterinary Medicine (HFV–212), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–276–
9067, e-mail:
pamela.esposito@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Custom
Feed Services Corp., 2100 N. 13th St.,
Norfolk, NE 68701, has requested that
FDA withdraw approval of NADA 121–
200 for Tylosin 10 Premix (tylosin),
NADA 129–159 for TYLAN 40 Sulfa-G
(tylosin and sulfamethazine), and
NADA 137–484 for Swine Guard-BN
(pyrantel). All are intermediate
premixes used to manufacture Type C
medicated feeds. This action is
requested because the products are no
longer manufactured or marketed.
Therefore, under authority delegated
to the Commissioner of Food and Drugs,
redelegated to the Center for Veterinary
Medicine, and in accordance with 21
CFR 514.115 Withdrawal of approval of
applications, notice is given that
approval of NADA 121–200, NADA
129–159, and NADA 137–484, and all
supplements and amendments thereto,
are hereby withdrawn, effective April
30, 2007.
In a final rule published elsewhere in
this issue of the Federal Register, FDA
is amending the animal drug regulations
to reflect the withdrawal of approval of
these NADAs.
Dated: April 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–7461 Filed 4–18–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
cprice-sewell on PROD1PC66 with NOTICES
Food and Drug Administration
Food and Drug Administration
[Docket No. 2007N–0077]
[Docket No. 2007N–0078]
Withdrawal of Approval of New Animal
Drug Applications; Pyrantel; Tylosin;
Tylosin and Sulfamethazine
AGENCY:
Food and Drug Administration,
AGENCY:
SUMMARY: The Food and Drug
Administration (FDA) has withdrawn
approval of two new animal drug
applications (NADAs) for a suspension
implant of estradiol benzoate
microspheres used in steers and heifers
fed in confinement for slaughter for
increased rate of weight gain and
improved feed efficiency, and in
suckling beef calves for increased rate of
weight gain. In a final rule published
elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to remove portions
reflecting approval of these NADAs.
FOR FURTHER INFORMATION CONTACT:
Pamela K. Esposito, Center for
Veterinary Medicine (HFV–212), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–276–
9067; e-mail:
pamela.esposito@fda.hhs.gov.
PR
Pharmaceuticals, Inc., 1716 Heath
Pkwy., Fort Collins, CO 80524, has
requested that FDA withdraw approval
of NADA 141–040 for DURALEASE
(estradiol benzoate), a suspension
implant of estradiol benzoate
microspheres used in steers and heifers
fed in confinement for slaughter for
increased rate of weight gain and
improved feed efficiency and NADA
141–041 for CELERIN-C (estradiol
benzoate), a similar product used in
suckling beef calves for increased rate of
weight gain. This action is requested
because the products are no longer
manufactured or marketed.
Therefore, under authority delegated
to the Commissioner of Food and Drugs,
redelegated to the Center for Veterinary
Medicine, and in accordance with 21
CFR 514.115, notice is given that
approval of NADA 141–040 and NADA
141–041 and all supplements and
amendments thereto, were withdrawn
as of September 29, 2006.
In a final rule published elsewhere in
this issue of the Federal Register, FDA
is amending the animal drug regulations
to reflect the withdrawal of approval of
these NADAs.
SUPPLEMENTARY INFORMATION:
Dated: April 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. 07–1941 Filed 4–18–07; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration,
HHS.
HHS.
VerDate Aug<31>2005
Withdrawal of Approval of New Animal
Drug Applications; Estradiol Benzoate
Notice.
15:39 Apr 18, 2007
Jkt 211001
PO 00000
Frm 00038
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E:\FR\FM\19APN1.SGM
19APN1
Agencies
[Federal Register Volume 72, Number 75 (Thursday, April 19, 2007)]
[Notices]
[Pages 19711-19716]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-7404]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of a New System of Records
AGENCY: Department of Health and Human Services (HHS), Center for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a New System of Records (SOR).
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to establish a new system titled, ``Post-Acute
Care Payment Reform / Continuity of Assessment Report and Evaluation
Demonstration and Evaluation (PAC-CARE), System No. 09-70-0569.'' The
program is authorized under Section 5008 of the Deficit Reduction Act
of 2005, which allows for the establishment of a demonstration program
for purposes of understanding costs and outcomes across different post-
acute care sites. The PAC-CARE will collect information that will
enable CMS to better understand the relationships among patient needs,
post-acute care placement, patient outcomes, and post-acute care
related costs in the Medicare program. Anticipated results of the PAC-
CARE include a standardized assessment instrument for post-acute care
patients and a proposal for site-neutral payment for post-acute care
services.
The purpose of this system is to collect and maintain demographic,
health, and health resource use related data on the target population
of Medicare beneficiaries who require treatment in a designated acute
care or post-acute care facility. We will also collect certain
identifying information on Medicare providers who provide services to
such beneficiaries. Information retrieved from this system may be
disclosed to: (1) Support regulatory, reimbursement, and policy
functions performed within the agency or by a contractor, grantee,
consultant or other legal agent; (2) assist another Federal or state
agency with information to contribute to the accuracy of CMS's proper
payment of Medicare benefits, enable such agency to administer a
Federal health benefits program, or to enable such agency to fulfill a
requirement of Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal funds; (3)
support an individual or organization for a research project or in
support of an evaluation project related to the prevention of disease
or disability, the restoration or maintenance of health, or payment
related projects; (4) support the functions of Quality Improvement
Organizations; (5) support the functions of national accrediting
organizations; (6) support litigation involving the agency; and (7)
combat fraud, waste, and abuse in certain Federally-funded health
benefits programs. We have provided background information about the
new system in the SUPPLEMENTARY INFORMATION section below. Although the
Privacy Act requires only that CMS provide an opportunity for
interested persons to comment on the proposed routine uses, CMS invites
comments on all portions of this notice. See ``Effective Dates''
section for comment period.
DATES: Effective Date: CMS filed a new SOR report with the Chair of the
House Committee on Government Reform and Oversight, the Chair of the
Senate Committee on Homeland Security & Governmental Affairs, and the
Administrator, Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB) on April 13, 2007. To ensure that all
parties have adequate time in which to comment, the new system will
become effective 30 days from the publication of
[[Page 19712]]
the notice, or 40 days from the date it was submitted to OMB and the
Congress, whichever is later. We may defer implementation of this
system or one or more of the routine use statements listed below if we
receive comments that persuade us to defer implementation.
ADDRESSES: The public should address comments to the CMS Privacy
Officer, Division of Privacy Compliance, Enterprise Architecture and
Strategy Group, Mail-stop N2-04-27, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850. Comments received will be available for review at
this location by appointment during regular business hours, Monday
through Friday from 9 a.m.-3 p.m., eastern time.
FOR FURTHER INFORMATION CONTACT: Shannon Flood, Division of Payment
Research, Research and Evaluation Group, Office of Research Development
& Information, Mail Stop C3-19-26, Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. She can be
reached by telephone at 410-786-2583, or via e-mail at
Shannon.Flood@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: Medicare beneficiaries frequently require
post-acute care for rehabilitation and recovery following a hospital
stay. The level and length of care required varies with the individual
patient and the condition(s) requiring hospitalization. The type of
care ranges from outpatient therapy to multi-day stays in a variety of
post-acute care settings. The PAC-CARE will study Medicare
beneficiaries as they are discharged from participating hospitals and
move among post-acute care settings. Patient functional assessments
will be performed at regular intervals beginning at hospital discharge
and continuing as patients move among post-acute care settings until
the episode of care has completed. Cost data will be collected from the
post-acute care settings, combined with other cost information
collected by Medicare Fiscal Intermediaries or Carriers, and combined
with claims and patient outcome data to develop a payment reform
proposal.
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for SOR
The statutory authority for this system is given under Section 5008
of the Deficit Reduction Act of 2005.
B. Collection and Maintenance of Data in the System
This system will collect and maintain individually identifiable and
other data collected on Medicare beneficiaries who require treatment in
a designated acute care or post-acute care facility. We will also
collect certain identifying information on Medicare providers who
provide services to such beneficiaries. The collected information will
include, but is not limited to: Medicare claims and eligibility data,
name, address, telephone number, health insurance claims number, race/
ethnicity, gender, date of birth, provider name, unique provider
identification number, medical record number, as well as clinical,
demographic, health/well-being, family and/or caregiver contact
information, and background information relating to Medicare issues.
Data will be collected from Medicare administrative and claims records,
PAC-CARE site administrative data systems, patient medical charts,
physician records, and via information submitted by beneficiaries and
providers.
II. Agency Policies, Procedures, and Restrictions on the Routine Use
A. The Privacy Act permits us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such disclosure of data is known as a ``routine use.''
The Government will only release PAC-CARE information that can be
associated with an individual as provided for under ``Section III.
Proposed Routine Use Disclosures of Data in the System.'' Both
identifiable and non-identifiable data may be disclosed under a routine
use. We will only collect the minimum personal data necessary to
achieve the purpose of PAC-CARE.
CMS has the following policies and procedures concerning
disclosures of information that will be maintained in the system.
Disclosure of information from the system will be approved only to the
extent necessary to accomplish the purpose of the disclosure and only
after CMS:
1. Determines that the use or disclosure is consistent with the
reason that the data is being collected; e.g., to collect and maintain
demographic, health, and health resource use related data on the target
population of Medicare beneficiaries who require treatment in a
designated acute care or post-acute care facility. We will also collect
certain identifying information on Medicare providers who provide
services to such beneficiaries.
2. Determines that:
a. The purpose for which the disclosure is to be made can only be
accomplished if the record is provided in individually identifiable
form;
b. The purpose for which the disclosure is to be made is of
sufficient importance to warrant the effect and/or risk on the privacy
of the individual that additional exposure of the record might bring;
and
c. There is a strong probability that the proposed use of the data
would in fact accomplish the stated purpose(s).
3. Requires the information recipient to:
a. Establish administrative, technical, and physical safeguards to
prevent unauthorized use of disclosure of the record;
b. Remove or destroy, at the earliest time, all patient-
identifiable information; and
c. Agree to not use or disclose the information for any purpose
other than the stated purpose under which the information was
disclosed.
4. Determines that the data are valid and reliable.
III. Proposed Routine Use Disclosures of Data in the System
A. The Privacy Act allows us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such compatible use of data is known as a ``routine
use.'' The proposed routine uses in this system meet the compatibility
requirement of the Privacy Act. We are proposing to establish the
following routine use disclosures of information maintained in the
system:
1. To agency contractors, consultants or grantees, who have been
engaged by the agency to assist in the performance of a service related
to this collection and who need to have access to the records in order
to perform the activity.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual or similar
agreement with a third party to assist in accomplishing CMS function
relating to purposes for this system.
CMS occasionally contracts out certain of its functions when doing
so would contribute to effective and efficient operations. CMS must be
able to give a contractor, consultant or grantee whatever information
is necessary for the contractor or consultant to fulfill its duties. In
these situations, safeguards are provided in
[[Page 19713]]
the contract prohibiting the contractor, consultant or grantee from
using or disclosing the information for any purpose other than that
described in the contract and requires the contractor, consultant or
grantee to return or destroy all information at the completion of the
contract.
2. To another Federal or state agency to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits;
b. Enable such agency to administer a Federal health benefits
program, or, as necessary, to enable such agency to fulfill a
requirement of a Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal funds; and/or
c. Assist Federal/state Medicaid programs within the state.
Other Federal or state agencies, in their administration of a
Federal health program, may require PAC-CARE information in order to
support evaluations and monitoring of Medicare claims information of
beneficiaries, including proper reimbursement for services provided.
3. To an individual or organization for a research project or in
support of an evaluation project related to the prevention of disease
or disability, the restoration or maintenance of health, or payment
related projects.
The PAC-CARE data will provide for research or support of
evaluation projects and a broader, longitudinal, national perspective
of the status of Medicare beneficiaries. CMS anticipates that
researchers may have legitimate requests to use these data in projects
that could ultimately improve the care provided to Medicare
beneficiaries and the policies that govern their care.
4. To support Quality Improvement Organizations (QIO) in connection
with review of claims, or in connection with studies or other review
activities conducted pursuant to Part B of Title XI of the Act, and in
performing affirmative outreach activities to individuals for the
purpose of establishing and maintaining their entitlement to Medicare
benefits or health insurance plans.
The QIO may use this data to support quality improvement activities
and other QIO responsibilities as detailed in Title XI Sec. Sec. 1151-
1164.
The QIO will work to implement quality improvement programs,
provide consultation to CMS, its contractors, and to state agencies.
The QIO will assist state agencies in related monitoring and
enforcement efforts, assist CMS and intermediaries in program integrity
assessment, and prepare summary information for release to CMS.
5. To assist national accrediting organization(s) whose accredited
facilities are presumed to meet certain Medicare requirements for
inpatient hospital rehabilitation services (e.g., the Joint Commission
for the Accreditation of Healthcare Organizations, the American
Osteopathic Association, or the Commission on Accreditation of
Rehabilitation Facilities). Information will be released to these
organizations for only those facilities that they accredit and that
participate in the Medicare program and if they meet the following
requirements:
a. Provide identifying information for post acute care facilities
that have an accreditation status with the requesting deemed
organization;
b. Submission of a finder file identifying beneficiaries/patients
receiving post acute care services;
c. Safeguard the confidentiality of the data and prevent
unauthorized access; and
d. Upon completion of a signed data exchange agreement or a CMS
data use agreement.
At this time, CMS anticipates providing accrediting organizations
with PAC-CARE information to enable them to target potential identified
problems during the organization's accreditation review process of the
facility.
6. To the Department of Justice (DOJ), court or 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 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.
Whenever CMS is involved in litigation, and occasionally when
another party is involved in litigation and CMS policies or operations
could be affected by the outcome of the litigation, CMS would be able
to disclose information to the DOJ, court or adjudicatory body
involved.
7. To a CMS contractor (including, but not necessarily limited to,
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, and abuse in such program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual, grantee,
cooperative agreement or consultant relationship with a third party to
assist in accomplishing CMS functions relating to the purpose of
combating fraud, waste, and abuse. CMS occasionally contracts out
certain of its functions or makes grants or cooperative agreements when
doing so would contribute to effective and efficient operations. CMS
must be able to give a contractor, grantee, consultant or other legal
agent whatever information is necessary for the agent to fulfill its
duties. In these situations, safeguards are provided in the contract
prohibiting the agent from using or disclosing the information for any
purpose other than that described in the contract and requiring the
agent to return or destroy all information.
8. To 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.
Other agencies may require PAC-CARE information for the purpose of
combating fraud, waste, and abuse in such Federally funded programs.
B. Additional Provisions Affecting Routine Use Disclosures
To the extent this system contains Protected Health Information
(PHI) as defined by HHS regulation ``Standards for Privacy of
Individually Identifiable Health Information'' (45 CFR parts 160 and
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI
that are otherwise authorized by these routine uses may only be made
if, and as, permitted or required by the ``Standards for Privacy of
Individually Identifiable Health Information.'' (See 45 CFR
164.512(a)(1)).
In addition, our policy will be to prohibit release even of data
not directly identifiable, except pursuant to one of
[[Page 19714]]
the routine uses or if required by law, if we determine there is a
possibility that an individual can be identified through implicit
deduction based on small cell sizes (instances where the patient
population is so small that individuals could, because of the small
size, use this information to deduce the identity of the beneficiary).
IV. Safeguards
CMS has safeguards in place for authorized users and monitors such
users to ensure against unauthorized use. 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.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations may apply but are not limited to: the Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include but are not limited to: all pertinent National
Institute of Standards and Technology publications; the HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
V. Effects of the Proposed System of Records on Individual Rights
CMS proposes to establish this system in accordance with the
principles and requirements of the Privacy Act and will collect, use,
and disseminate information only as prescribed therein. Data in this
system will be subject to the authorized releases in accordance with
the routine uses identified in this system of records.
CMS will take precautionary measures to minimize the risks of
unauthorized access to the records and the potential harm to individual
privacy or other personal or property rights of patients whose data are
maintained in this system. CMS will collect only that information
necessary to perform the system's functions. In addition, CMS will make
disclosure from the proposed system only with consent of the subject
individual, or his/her legal representative, or in accordance with an
applicable exception provision of the Privacy Act. CMS, therefore, does
not anticipate an unfavorable effect on individual privacy as a result
of information relating to individuals.
Dated: April 12, 2007.
Charlene Frizzera,
Acting Chief Operating Officer, Centers for Medicare & Medicaid
Services.
SYSTEM NO. 09-70-0569
System Name:
``Post-Acute Care Payment Reform/Continuity of Assessment Report
and Evaluation Demonstration and Evaluation (PAC-CARE),'' HHS/CMS/ORDI.
Security Classification:
Level Three Privacy Act Sensitive Data.
System Location:
Centers for Medicare & Medicaid Services (CMS) Data Center, 7500
Security Boulevard, North Building, First Floor, Baltimore, Maryland
21244-1850 and at various co-locations of CMS agents.
Categories of Individuals Covered by the System:
This system will collect and maintain individually identifiable and
other data collected on Medicare beneficiaries who require treatment in
a designated acute care or post-acute care facility. We will also
collect certain identifying information on Medicare providers who
provide services to such beneficiaries.
Categories of Records in the System:
The collected information will include, but is not limited to:
Medicare claims and eligibility data, name, address, telephone number,
health insurance claims number, race/ethnicity, gender, date of birth,
provider name, unique provider identification number, medical record
number, as well as clinical, demographic, health/well-being, family
and/or caregiver contact information, and background information
relating to Medicare issues. Data will be collected from Medicare
administrative and claims records, PAC-CARE site administrative data
systems, patient medical charts, physician records, and via information
submitted by beneficiaries and providers.
Authority for Maintenance of the System:
The statutory authority for this system is given under Section 5008
of the Deficit Reduction Act of 2005.
Purpose(s) of the System:
The purpose of this system is to collect and maintain demographic,
health, and health resource use related data on the target population
of Medicare beneficiaries who require treatment in a designated acute
care or post-acute care facility. We will also collect certain
identifying information on Medicare providers who provide services to
such beneficiaries. Information retrieved from this system may be
disclosed to: (1) Support regulatory, reimbursement, and policy
functions performed within the agency or by a contractor, grantee,
consultant or other legal agent; (2) assist another Federal or state
agency with information to contribute to the accuracy of CMS's proper
payment of Medicare benefits, enable such agency to administer a
Federal health benefits program, or to enable such agency to fulfill a
requirement of Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal funds; (3)
support an individual or organization for a research project or in
support of an evaluation project related to the prevention of disease
or disability, the restoration or maintenance of health, or payment
related projects; (4) support the functions of Quality Improvement
Organizations; (5) support the functions of national accrediting
organizations; (6) support litigation involving the agency; and (7)
combat fraud, waste, and abuse in certain Federally-funded health
benefits programs.
Routine Uses of Records Maintained in the System, Including Categories
or Users and the Purposes of Such Uses:
A. The Privacy Act allows us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such compatible use of data is known as a ``routine
use.'' The proposed routine uses in this system meet the compatibility
requirement of the Privacy Act. We are proposing to establish the
following routine use disclosures of information maintained in the
system:
1. To agency contractors, consultants or grantees, who have been
engaged by the agency to assist in the performance of a service related
to this collection and
[[Page 19715]]
who need to have access to the records in order to perform the
activity.
2. To another Federal or state agency to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits;
b. Enable such agency to administer a Federal health benefits
program, or, as necessary, to enable such agency to fulfill a
requirement of a Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal funds; and/or
c. Assist Federal/state Medicaid programs within the state.
3. To an individual or organization for a research project or in
support of an evaluation project related to the prevention of disease
or disability, the restoration or maintenance of health, or payment
related projects.
4. To support Quality Improvement Organizations (QIO) in connection
with review of claims, or in connection with studies or other review
activities conducted pursuant to Part B of Title XI of the Act, and in
performing affirmative outreach activities to individuals for the
purpose of establishing and maintaining their entitlement to Medicare
benefits or health insurance plans.
5. To assist national accrediting organization(s) whose accredited
facilities are presumed to meet certain Medicare requirements for
inpatient hospital rehabilitation services (e.g., the Joint Commission
for the Accreditation of Healthcare Organizations, the American
Osteopathic Association, or the Commission on Accreditation of
Rehabilitation Facilities). Information will be released to these
organizations for only those facilities that they accredit and that
participate in the Medicare program and if they meet the following
requirements:
a. Provide identifying information for post acute care facilities
that have an accreditation status with the requesting deemed
organization;
b. Submission of a finder file identifying beneficiaries/patients
receiving post acute care services;
c. Safeguard the confidentiality of the data and prevent
unauthorized access; and
d. Upon completion of a signed data exchange agreement or a CMS
data use agreement.
6. To the Department of Justice (DOJ), court or 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 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 a CMS contractor (including, but not necessarily limited to,
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, and abuse in such program.
8. To 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.
B. Additional Provisions Affecting Routine Use Disclosures
To the extent this system contains Protected Health Information
(PHI) as defined by HHS regulation ``Standards for Privacy of
Individually Identifiable Health Information'' (45 CFR parts 160 and
164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI
that are otherwise authorized by these routine uses may only be made
if, and as, permitted or required by the ``Standards for Privacy of
Individually Identifiable Health Information.'' (See 45 CFR 164.512(a)
(1)).
In addition, our policy will be to prohibit release even of data
not directly identifiable, except pursuant to one of the routine uses
or if required by law, if we determine there is a possibility that an
individual can be identified through implicit deduction based on small
cell sizes (instances where the patient population is so small that
individuals could, because of the small size, use this information to
deduce the identity of the beneficiary).
Policies and Practices for Storing, Retrieving, Accessing, Retaining,
and Disposing of Records in the System:
Storage:
All records are stored on electronic media.
Retrievability:
The collected data are retrieved by an individual identifier; e.g.,
beneficiary name or HICN.
Safeguards:
CMS has safeguards in place for authorized users and monitors such
users to ensure against unauthorized use. 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.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations may apply but are not limited to: the Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include but are not limited to: all pertinent National
Institute of Standards and Technology publications; the HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
Retention and Disposal:
Records will be retained until an approved disposition authority is
obtained from the National Archives and Records Administration. All
claims-related records are encompassed by the document preservation
order and will be retained until notification is received from DOJ.
System Manager and Address:
Director, Research and Evaluation Group, Office of Research
Development
[[Page 19716]]
& Information, Mail Stop C3-19-26, Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, Baltimore, MD 21244-1849.
Notification Procedure:
For purpose of access, the subject individual should write to the
system manager who will require the system name, employee
identification number, tax identification number, national provider
number, and for verification purposes, the subject individual's name
(woman's maiden name, if applicable), HICN, and/or SSN (furnishing the
SSN is voluntary, but it may make searching for a record easier and
prevent delay).
Record Access Procedure:
For purpose of access, use the same procedures outlined in
Notification Procedures above. Requestors should also reasonably
specify the record contents being sought. (These procedures are in
accordance with Department regulation 45 CFR 5b.5 (a)(2)).
Contesting Record Procedures:
The subject individual should contact the system manager named
above, and reasonably identify the record and specify the information
to be contested. State the corrective action sought and the reasons for
the correction with supporting justification. (These procedures are in
accordance with Department regulation 45 CFR 5b.7).
Records Source Categories:
Data will be collected from Medicare administrative and claims
records (Outcome and Assessment Information Set, Inpatient
Rehabilitation Facilities Patient Assessment Instrument, Long Term Care
Minimum Data Set), post-acute care site administrative data systems,
patient medical charts, physician records, and via information
submitted by beneficiaries and providers.
Systems Exempted From Certain Provisions of the Act:
None.
[FR Doc. E7-7404 Filed 4-18-07; 8:45 am]
BILLING CODE 4120-03-P