[Federal Register: September 28, 2007 (Volume 72, Number 188)]
[Notices]
[Page 55225-55231]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se07-102]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of a 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 Privacy Act of 1974, we are proposing
to establish a new SOR, ``Post-Acute Care Payment Reform / Continuity
of Assessment Record and Evaluation Demonstration and Evaluation (PAC-
CARE),'' System No. 09-70-0569. Information maintained in this system
will continue to 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. Additionally, as
required by Section 5008 of the Deficit Reduction Act of 2005, CMS is
developing a comprehensive assessment for use at the time of hospital
discharge which identifies the needs and clinical characteristics of
the patient. Additionally, this standardized patient assessment
instrument shall be used across post-acute care sites, including
skilled nursing facilities, home health agencies, long term care
hospitals and inpatient rehabilitation facilities, to measure
functional status and other factors during treatment and at discharge
from each provider.
CMS proposes to broaden the scope of the disclosure requirement by
adding a new routine use number 6, authorizing disclosure of personal
health information to providers to facilitate the proper transfer of
health information for beneficiaries being discharged from their site
of care to an admitting provider's care. Individuals from the admitting
providers will only be granted access to personal health information,
if they have the approved, authenticated, role based authority to do
so, and the need to know and review the admitted patient's personal
health information. Individuals will only be granted access to this
information if they meet the following requirements: they must (1)
provide an attestation or other qualifying information that they are
providing assistance to qualified acute care or post-acute care
beneficiaries admitted to their care site, (2) have physically admitted
the beneficiary to their site and have initiated an assessment of the
beneficiary, (3) safeguard the confidentiality of the data and prevent
unauthorized access, and (4) accept an on-line statement attesting to
the information recipient's understanding of and willingness to abide
by these provisions. The routine uses will then be prioritized and
reordered according to their usage.
The primary purpose of this proposed system is to collect and
maintain, and release when appropriate, demographic, health records,
and health resource use related data on the target population of
Medicare and potentially, Medicaid beneficiaries who require treatment
by a designated acute care or post-acute care provider. 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
[[Page 55226]]
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 accreditation
organizations; (6) permit the release of personal health information to
complete a transfer-out (discharge) event and/or a transfer-in
(admission) event; (7) support litigation involving the agency; and (8)
combat fraud, waste, and abuse in certain Federally-funded health
benefits programs. We have provided background information about the
modified 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 modified or altered routine
uses, CMS invites comments on all portions of this notice. See
EFFECTIVE DATES section for comment period.
EFFECTIVE DATES: CMS filed a new system 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 September 21, 2007. To ensure that all
parties have adequate time in which to comment, the new system,
including routine uses, will become effective 30 days from the
publication of the notice, or 40 days from the date it was submitted to
OMB and Congress, whichever is later, unless CMS receives comments that
require alterations to this notice.
ADDRESSES: The public should address comments to: CMS Privacy Officer,
Division of Privacy Compliance, Enterprise Architecture and Strategy
Group, Office of Information Services, CMS, Room 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 zone.
FOR FURTHER INFORMATION CONTACT: Shannon Flood, Division of Research on
Traditional Medicare, 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: As required by Section 5008 of the Deficit
Reduction Act of 2005, CMS is developing a comprehensive assessment for
use at the time of hospital discharge which identifies the needs and
clinical characteristics of the patient. Additionally this standardized
patient assessment instrument shall be used across post-acute care
sites, including skilled nursing facilities, home health agencies, long
term care hospitals and inpatient rehabilitation facilities, to measure
functional status and other factors during treatment and at discharge
from each provider. This standardized patient assessment instrument is
being developed under a contract between the CMS Office of Clinical
Standards & Quality and the Research Triangle International (RTI) is
referred to as ``Continuity Assessment Record and Evaluation (CARE).''
CARE consists of a set of assessment items under 5 major domains:
medical, functional, social/environmental, cognitive and continuity of
care. This assessment data, as well as demographic, medication,
procedure, and treatment information will be collected for Medicare and
potentially Medicaid beneficiaries. The CARE instrument will provide a
foundation for a continuity of care record for patients across
settings, over time. The new proposed routine use (6) refers only to
data contained within the CARE tool and not the other data used in the
project. The CARE tool is one of the data collection aspects of the
demonstration. In addition, the demonstration will make use of such
information as claims, staff time measurement logs, and unstructured
staff interviews in its analyses.
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for SOR
The statutory authority for this system is given under Sections
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 and potentially Medicaid beneficiaries
who require treatment in a designated acute care or post-acute care
provider. 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, health insurance claims number
(HICN), social security number (SSN) (the submission of a beneficiary's
SSN is optional), race/ethnicity, gender, date of birth, provider name,
unique CMS Certification Number (CCN), medical record number, as well
as clinical, demographic, medication, procedure, treatment information,
health/well-being, 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 Routine Uses
A. Agency Policies, Procedures, and Restrictions on the Routine Use
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 this 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,
and release when appropriate, demographic, health, and health resource
use related data on the
[[Page 55227]]
target population of Medicare and potentially Medicaid beneficiaries
who require treatment by a designated acute care or post-acute care
provider. 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 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 accreditation organization(s) whose
accredited facilities are deemed to meet certain Medicare conditions of
participation for inpatient hospital rehabilitation services (e.g., the
Joint Commission and the American Osteopathic Association) with their
survey process information will be released by CMS for only those
providers that they deem and that participate in the Medicare program
if they meet the following requirements:
a. Provide identifying information for post acute care facilities
that have deemed status with the requesting accreditation 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 accreditation 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 assist with a transfer-out event from a discharging acute or
post-acute care provider and/or a transfer-in event to an admitting
acute or post-acute care provider to:
a. Contribute to the accuracy of CMS' proper payment of Medicare
benefits; and
b. Enable such providers to ensure the proper transfer of health
records, and/or as necessary to enable such a provider to fulfill a
requirement of a Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal fund.
Individuals from the admitting providers will only be granted
access to personal health information, if they have the approved,
authenticated, role-based authority, and the defined need for access to
that information. Individuals will only be granted access to
information if they meet the following requirements:
a. Provide an attestation or other qualifying information that they
are providing assistance to a qualified acute or post-acute care
beneficiary receiving care/services through their provider site;
b. Have physically admitted the beneficiary to their care site, and
are initiating an assessment of the
[[Page 55228]]
beneficiary, and can validate the beneficiary's name, HICN (or payer
number or SSN), date of birth, and gender;
c. Safeguard the confidentiality of the data and prevent
unauthorized access; and
d. Accept a written, on-line statement attesting to the information
recipient's understanding of and willingness to abide by these
provisions.
The PAC-CARE data will give the provider patient-specific personal
health information which may facilitate the provider's required
utilization reviews and medication management program activities; and
assist in quality of care issues as they relate to the beneficiary.
7. 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.
8. To a CMS contractor (including, but not necessarily limited to,
Medicare Administrative Contractors (MAC), 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.
9. 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 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 include 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 NIST
publications; the DHHS Information Systems Program Handbook and the CMS
Information Security Handbook.
V. Effects of the Modified System of Records on Individual Rights
CMS proposes to modify 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 the 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.
[[Page 55229]]
Dated: September 18, 2007.
Charlene Frizzera,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0569
SYSTEM NAME:
``Post-Acute Care Payment Reform / Continuity of Assessment Record
and Evaluation Demonstration and Evaluation (PAC-CARE),'' HHS/CMS/ORDI.
SECURITY CLASSIFICATION:
Level Three Privacy Act Sensitive Data.
SYSTEM LOCATION:
The Centers for Medicare & Medicaid Services (CMS) Data Center,
7500 Security Boulevard, North Building, First Floor, Baltimore,
Maryland 21244-1850 and at various contractor sites and at CMS Regional
Offices.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
This system will collect and maintain individually identifiable and
other data collected on Medicare and potentially, Medicaid
beneficiaries who require treatment in a designated acute care or post-
acute care provider. 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, health insurance claims
number (HICN), social security number (SSN) (the submission of a
beneficiary's SSN is optional), race/ethnicity, gender, date of birth,
provider name, unique CMS Certification Number (CCN), medical record
number, as well as clinical, demographic, medication, procedure,
treatment information, health/well-being, 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 Sections
5008 of the Deficit Reduction Act of 2005.
PURPOSE(S) OF THE SYSTEM:
The primary purpose of this proposed system is to collect and
maintain, and release when appropriate, demographic, health records,
and health resource use related data on the target population of
Medicare and potentially, Medicaid beneficiaries who require treatment
by a designated acute care or post-acute care provider. 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 accreditation
organizations; (6) permit the release of personal health information to
complete a transfer-out (discharge) event and/or a transfer-in
(admission) event; (7) support litigation involving the agency; and (8)
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 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 accreditation organization(s) whose
accredited facilities are deemed to meet certain Medicare conditions of
participation for inpatient hospital rehabilitation services (e.g., the
Joint Commission and the American Osteopathic Association) with their
survey process, information will be released by CMS for only those
providers that they deem 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 deemed status with the requesting accreditation 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 assist with a transfer-out event from a discharging acute or
post-acute care provider and/or a transfer-in event to an admitting
acute or post-acute care provider to:
a. Contribute to the accuracy of CMS' proper payment of Medicare
benefits; and
b. Enable such providers to ensure the proper transfer of health
records, and/or as necessary to enable such a provider to fulfill a
requirement of a Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal fund.
Individuals from the admitting providers will only be granted
access to personal health information, if they have the approved,
authenticated, role-based authority, and the defined need for access to
that information. Individuals will only be granted access
[[Page 55230]]
to information if they meet the following requirements:
a. Provide an attestation or other qualifying information that they
are providing assistance to a qualified acute or post-acute care
beneficiary receiving care/services through their provider site;
b. Have physically admitted the beneficiary to their care site, and
are initiating an assessment of the beneficiary, and can validate the
beneficiary's name, HICN (or payer number or SSN), date of birth, and
gender;
c. Safeguard the confidentiality of the data and prevent
unauthorized access; and
d. Accept a written, on-line statement attesting to the information
recipient's understanding of and willingness to abide by these
provisions.
7. 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.
8. To a CMS contractor (including, but not necessarily limited to,
Medicare Administrative Contractors (MAC), 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.
9. 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 magnetic media.
RETRIEVABILITY:
The Medicare records are retrieved by the HICN and SSN.
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 DHHS
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(S) AND ADDRESS:
Director, 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.
NOTIFICATION PROCEDURE:
For purpose of access, the subject individual should write to the
system manager who will require the system name, HICN, address, date of
birth, and gender, and for verification purposes, the subject
individual's name (woman's maiden name, if applicable), and 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 specify the
record contents being sought. (These procedures are in accordance with
department regulation 45 CFR 5b.5(a)(2)).
CONTESTING RECORDS PROCEDURES:
The subject individual should contact the system manager named
above, and reasonably identify the records 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
[[Page 55231]]
(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. E7-19110 Filed 9-27-07; 8:45 am]
BILLING CODE 4120-03-P