Privacy Act of 1974; Report of a Modified or Altered System, 63906-63911 [E7-22083]
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63906
Federal Register / Vol. 72, No. 218 / Tuesday, November 13, 2007 / Notices
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E7–22079 Filed 11–9–07; 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
Modified or Altered System
Department of Health and
Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a Modified or Altered
System of Records (SOR).
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AGENCY:
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
we are proposing to modify or alter an
SOR titled ‘‘Home Health Agency (HHA)
Outcome and Assessment Information
Set (OASIS),’’ System No. 09–70–9002,
last modified at 66 Federal Register
66903 (December 27, 2001). We propose
to assign a new CMS identification
number to this system to simplify the
obsolete and confusing numbering
system originally designed to identify
the Bureau, Office, or Center that
maintained information in the Health
Care Financing Administration systems
of records. The new assigned identifying
number for this system should read:
System No. 09–70–0522.
We propose to modify existing routine
use number 1 that permits disclosure to
agency contractors and consultants to
include disclosure to CMS grantees who
perform a task for the agency. CMS
grantees, charged with completing
projects or activities that require CMS
data to carry out that activity, are
classified separate from CMS
contractors and/or consultants. The
modified routine use will remain as
routine use number 1. We will modify
existing routine use number 4 that
permits disclosure to Peer Review
Organizations (PRO). Organizations
previously referred to as PROs will be
renamed to read: Quality Improvement
Organizations (QIO). Information will be
disclosed to QIOs relating to assessing
and improving HHA quality of care. The
modified routine use will remain as
routine use number 4.
CMS proposes to broaden the scope of
the disclosure requirement for routine
use number 5, authorizing disclosure to
national accrediting organizations that
have been approved by CMS for
deeming authority for Medicare
requirements for home health services.
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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: (1) Provide
identifying information for HHAs that
have an accreditation status with the
requesting deemed organization, (2)
submission of a finder file identifying
beneficiaries/patients receiving HHA
services, (3) safeguard the
confidentiality of the data and prevent
unauthorized access, and (4) upon
completion of a signed data exchange
agreement or a CMS data use agreement.
We will delete routine use number 7
authorizing disclosure to support
constituent requests made to a
congressional representative. If an
authorization for the disclosure has
been obtained from the data subject,
then no routine use is needed. The
Privacy Act allows for disclosures with
the ‘‘prior written consent’’ of the data
subject. We will broaden the scope of
published routine uses number 8 and 9,
authorizing disclosures to combat fraud
and abuse in the Medicare and
Medicaid programs to include
combating ‘‘waste’’ which refers
increasingly more to specific beneficiary
or recipient practices that result in
unnecessary cost to Federally-funded
health benefit programs.
We are modifying the language in the
remaining routine uses to provide a
proper explanation as to the need for the
routine use and to provide clarity to
CMS’s intention to disclose individualspecific information contained in this
system. The routine uses will then be
prioritized and reordered according to
their usage. We will also take the
opportunity to update any sections of
the system that were affected by the
recent reorganization or because of the
impact of the Medicare Prescription
Drug, Improvement, and Modernization
Act of 2003 (MMA) (Pub. L. 108–173)
provisions and to update language in
the administrative sections to
correspond with language used in other
CMS SORs.
The primary purposes of the SOR are
to collect and maintain information to:
(1) Study and help ensure the quality of
care provided by home health agencies
(HHA); (2) aid in administration of the
survey and certification of Medicare/
Medicaid HHAs; (3) enable regulators to
provide HHAs with data for their
internal quality improvement activities;
(4) support agencies of the state
government to determine, evaluate and
assess overall effectiveness and quality
of HHA services provided in the state;
(5) provide for the validation, and
refinements of the Medicare Prospective
Payment System; (6) aid in the
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administration of Federal and state HHA
programs within the state; and (7)
monitor the continuity of care for
patients who reside temporarily outside
of the state. Information maintained in
this system will also be disclosed to: (1)
Support regulatory, reimbursement, and
policy functions performed within the
Agency or by a contractor, consultant, or
grantee; (2) assist another Federal and/
or state agency, agency of a state
government, an agency established by
state law, or its fiscal agent, for
evaluating and monitoring the quality of
home health care and contribute to the
accuracy of health insurance operations;
(3) support research, evaluation, or
epidemiological projects related to the
prevention of disease or disability, or
the restoration or maintenance of health,
and for payment related projects; (4)
support the functions of Quality
Improvement Organizations (QIO); (5)
support the functions of national
accrediting organizations; (6) support
litigation involving the Agency; (7)
combat fraud, waste, and abuse in
certain health care 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 routine uses, CMS
invites comments on all portions of this
notice. See EFFECTIVE DATES section for
comment period.
CMS filed a modified
or altered 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
November 6, 2007. To ensure that all
parties have adequate time in which to
comment, the modified 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.
EFFECTIVE DATES:
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
ADDRESSES:
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Federal Register / Vol. 72, No. 218 / Tuesday, November 13, 2007 / Notices
hours, Monday through Friday from 9
a.m.–3 p.m., eastern time zone.
FOR FURTHER INFORMATION CONTACT:
Patricia Sevast, Nurse Consultant,
Division of Continuing Care Providers,
Survey and Certification Group, Center
for Medicaid and State Operations,
CMS, 7500 Security Boulevard, S2–12–
25, Baltimore, Maryland 21244–1850.
The telephone number is (410) 786–
8135, or via e-mail at
patricia.sevast@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Description of the Modified or
Altered System of Records
A. Statutory and Regulatory Basis for
System
Authority for maintenance of this
system is given under Sections 1102(a),
1154, 1861(m), 1861(o), 1861(z), 1863,
1864, 1865, 1866, 1871, 1891, and 1902
of the Social Security Act. These
provisions of the Act authorize the
Administrator of CMS to require HHAs
participating in the Medicare and
Medicaid programs to complete a
standard, valid, patient assessment data
set; i.e., the OASIS, as part of their
comprehensive assessments and
updates when evaluating adult, nonmaternity patients as required by
section 484.55 of the Conditions of
Participation. Authority is also given
under section 951 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (Pub. L. 108–
173).
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B. Collection and Maintenance of Data
in the System
The system collects and maintains
information on all patients, except those
in a category exempted by
administrative policies and procedures,
who receive services from an HHA
certified for Medicare and Medicaid
payments. The OASIS data set includes
identifiers. It also includes information
on: (1) Patient History, (2) Living
Arrangements, (3) Supportive
Assistance, (4) Sensory Status, (5)
Integumentary Status, (6) Respiratory
Status, (7) Elimination Status, (8)
Neuro/Emotional/Behavioral Status, (9)
Activities of Daily Living/Instrumental
Activities of Daily Living (ADL/IADL),
(10) Medications, (11) Equipment
Management, (12) Emergent Care, and
(13) Discharge. Identifiers are patient
name, social security number, Medicare
number and Medicaid number. A
masked identifier is one in which an
encrypted value is permanently
substituted for an identifier to prevent
recipients of the information from
identifying the individual.
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The OASIS information will be
submitted by the HHA to the
government for all patients, except prepartum and postpartum patients,
patients under 18 years of age, and
patients receiving other than personal
care or health care services; i.e.,
housekeeping services and chore
services. Identifiers will be included for
all patients receiving services paid for
by Medicare traditional fee-for-service,
Medicaid traditional fee-for-service,
Medicare HMO/managed care or
Medicaid HMO/managed care. For
patients with only a non-Medicare or
non-Medicaid payment source, the HHA
will submit OASIS information with
masked identifiers and will retain the
identifier and masked identifier at the
HHA. In other words, the patient
identifier for non-Medicare and nonMedicaid patients will only be known
and retained by the HHA and not by the
government.
II. Agency Policies, Procedures, and
Restrictions on Routine Uses
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 OASIS 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 OASIS. 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
evaluate and monitor the quality of
home health care and contribute to the
accuracy of health insurance operations.
2. Determines:
a. That the purpose for which the
disclosure is to be made can only be
accomplished if the record is provided
in individually identifiable form;
b. That the purpose for which the
disclosure is to be made is of sufficient
importance to warrant the potential
effect and/or risk on the privacy of the
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individual that additional exposure of
the record might bring; and
c. That 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; and
b. Remove or destroy at the earliest
time all patient-identifiable information.
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 support 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 assist another Federal or state
agency, agency of a state government, an
agency established by state law, or its
fiscal agent to:
a. Contribute to the accuracy of CMS’s
proper payment of Medicare benefits,
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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. Evaluate and monitor the quality of
home health care and contribute to the
accuracy of health insurance operations.
Other Federal or state agencies in
their administration of a Federal health
program may require OASIS
information in order to support
evaluations and monitoring of
reimbursement for services provided.
3. To assist an individual or
organization for research, evaluation or
epidemiological projects related to the
prevention of disease or disability, or
the restoration or maintenance of health,
and for payment-related projects.
The collected data will provide the
research, evaluation and
epidemiological projects a broader,
longitudinal, national perspective of the
data. CMS anticipates that many
researchers will have legitimate requests
to use these data in projects that could
ultimately improve the care provided to
Medicare patients and the policy that
governs the care. CMS understands the
concerns about the privacy and
confidentiality of the release of data for
a research use. Disclosure of data for
research and evaluation purposes may
involve aggregate data rather than
individual-specific data.
4. To support Quality Improvement
Organizations (QIO) in order to assist
the QIO to perform Title XI and Title
XVIII functions relating to assessing and
improving HHA quality of care.
QIOs will work with HHAs to
implement quality improvement
programs, provide consultation to CMS,
its contractors, and to state agencies.
The QIOs will provide a supportive role
to HHAs in their endeavors to comply
with Medicare Conditions of
Participation; will assist the state
agencies in related monitoring and
enforcement efforts; assist CMS and
help regional home health
intermediaries in home health program
integrity assessment; and prepare
summary information about the nation’s
home health care for release to
beneficiaries.
5. To support national accrediting
organizations with approval for deeming
authority for Medicare requirements for
home health services (i.e., the Joint
Commission on Accreditation of
Healthcare Organizations, Accreditation
Commission for Health Care, Inc., and
the Community Health Accreditation
Program). Information will be released
to these organizations upon specific
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request, and only for those facilities that
they accredit and that participate in the
Medicare program and if they meet the
following requirements:
a. Provide identifying information for
HHAs that have an accreditation status
with the requesting deemed
organization,
b. submit a finder file identifying
beneficiaries/patients receiving HHA
services,
c. complete a signed data exchange
agreement or a CMS data use agreement,
and
d. safeguard the confidentiality of the
data and prevent unauthorized access.
CMS anticipates providing these
national accrediting organizations with
OASIS information to enable them to
target potential or identified problems
during the organization’s accreditation
review process of that facility.
6. To support 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 assist 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, or abuse in such program.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
into a contractual relationship or grant
with a third party to assist in
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accomplishing CMS functions relating
to the purpose of combating fraud,
waste, and abuse.
CMS occasionally contracts out
certain of its functions and makes grants
when doing so would contribute to
effective and efficient operations. CMS
must be able to give a contractor or
grantee whatever information is
necessary for the contractor or grantee to
fulfill its duties. In these situations,
safeguards are provided in the contract
prohibiting the contractor or grantee
from using or disclosing the information
for any purpose other than that
described in the contract and requiring
the contractor or grantee to return or
destroy all information.
8. To assist another Federal agency or
to an instrumentality of any
governmental jurisdiction within or
under the control of the United States
(including any State or local
governmental agency), that administers,
or that has the authority to investigate
potential fraud, waste, or abuse in, a
health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud, waste, or abuse in such
programs.
Other agencies may require OASIS
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 Fed. Reg. 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).
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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.
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V. Effects of the Modified System of
Records on Individual Rights
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Jkt 214001
Dated: November 7, 2007.
Charlene Frizzera,
Chief Operating Officer, Centers for Medicare
& Medicaid Services.
SYSTEM NO. 09–70–0522
SYSTEM NAME:
‘‘Home Health Agency (HHA)
Outcome and Assessment Information
Set (OASIS),’’ HHS/CMS/CMSO.
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 South Building, Baltimore,
Maryland 21244–1850.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
The system of records (SOR) will
contain clinical assessment information
(OASIS) for all patients receiving the
services of a Medicare and/or Medicaid
approved HHA, except pre-partum and
post-partum patients, patients under 18
years of age, and patients receiving
other than personal care or health care
services; i.e., housekeeping services and
chore services. Identifiable information
will be maintained in the SOR only for
those individuals whose payments come
from Medicare or Medicaid.
CATEGORIES OF RECORDS IN THE SYSTEM:
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 (see item IV above) 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
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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.
This SOR will contain individuallevel demographic and identifying data,
as well as clinical status data for
patients with the payment sources of
Medicare traditional fee for service,
Medicaid traditional fee for service,
Medicare HMO/managed care or
Medicaid HMO/managed care.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authority for maintenance of this
system is given under Sections 1102(a),
1154, 1861(m), 1861(o), 1861(z), 1863,
1864, 1865, 1866, 1871, 1891, and 1902
of the Social Security Act. These
provisions of the Act authorize the
Administrator of CMS to require HHAs
participating in the Medicare and
Medicaid programs to complete a
standard, valid, patient assessment data
set; i.e., the OASIS, as part of their
comprehensive assessments and
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updates when evaluating adult, nonmaternity patients as required by
section 484.55 of the Conditions of
Participation. Authority is also given
under section 951 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (Pub. L. 108–
173).
PURPOSE(S) OF THE SYSTEM:
The primary purposes of the SOR are
to collect and maintain information to:
(1) Study and help ensure the quality of
care provided by home health agencies
(HHA); (2) aid in administration of the
survey and certification of Medicare/
Medicaid HHAs; (3) enable regulators to
provide HHAs with data for their
internal quality improvement activities;
(4) support agencies of the state
government to determine, evaluate and
assess overall effectiveness and quality
of HHA services provided in the state;
(5) provide for the validation, and
refinements of the Medicare Prospective
Payment System; (6) aid in the
administration of Federal and state HHA
programs within the state; and (7)
monitor the continuity of care for
patients who reside temporarily outside
of the state. Information maintained in
this system will also be disclosed to: (1)
Support regulatory, reimbursement, and
policy functions performed within the
Agency or by a contractor, consultant, or
grantee; (2) assist another Federal and/
or state agency, agency of a state
government, an agency established by
state law, or its fiscal agent, for
evaluating and monitoring the quality of
home health care and contribute to the
accuracy of health insurance operations;
(3) support research, evaluation, or
epidemiological projects related to the
prevention of disease or disability, or
the restoration or maintenance of health,
and for payment related projects; (4)
support the functions of Quality
Improvement Organizations (QIO); (5)
support the functions of national
accrediting organizations; (6) support
litigation involving the Agency; (7)
combat fraud, waste, and abuse in
certain health care 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
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following routine use disclosures of
information maintained in the system:
1. To support 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 assist another Federal or state
agency, agency of a state government, an
agency established by state law, or its
fiscal agent 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. evaluate and monitor the quality of
home health care and contribute to the
accuracy of health insurance operations.
3. To assist an individual or
organization for research, evaluation or
epidemiological projects related to the
prevention of disease or disability, or
the restoration or maintenance of health,
and for payment related projects.
4. To support Quality Improvement
Organizations (QIO) in order to assist
the QIO to perform Title XI and Title
XVIII functions relating to assessing and
improving HHA quality of care.
5. To support national accrediting
organizations with approval for deeming
authority for Medicare requirements for
home health services (i.e., the Joint
Commission on Accreditation of
Healthcare Organizations, Accreditation
Commission for Health Care, Inc., and
the Community Health Accreditation
Program). Information will be released
to these organizations upon specific
request, and only for those facilities that
they accredit and that participate in the
Medicare program and if they meet the
following requirements:
a. Provide identifying information for
HHAs that have an accreditation status
with the requesting deemed
organization,
b. Submit a finder file identifying
beneficiaries/patients receiving HHA
services,
c. Complete a signed data exchange
agreement or a CMS data use agreement,
and
d. Safeguard the confidentiality of the
data and prevent unauthorized access.
6. To support 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
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15:30 Nov 09, 2007
Jkt 214001
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 assist 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, or abuse in such program.
8. To assist another Federal agency or
to an instrumentality of any
governmental jurisdiction within or
under the control of the United States
(including any State or local
governmental agency), that administers,
or that has the authority to investigate
potential fraud, waste, or abuse in, a
health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud, waste, or abuse in such
programs.
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 Fed. Reg. 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
PO 00000
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Fmt 4703
Sfmt 4703
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 paper and
magnetic disk.
RETRIEVABILITY:
The Medicare and Medicaid records
are retrieved by health insurance claim
number, Social Security number (SSN)
or by state assigned Medicaid number.
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:
CMS will retain identifiable OASIS
assessment data for a total period not to
exceed fifteen (15) years.
SYSTEM MANAGER AND ADDRESS:
Director, Division of Continuing Care
Providers, Survey and Certification
E:\FR\FM\13NON1.SGM
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63911
Federal Register / Vol. 72, No. 218 / Tuesday, November 13, 2007 / Notices
Group, Center for Medicaid and State
Operations, CMS, 7500 Security
Boulevard, S2–12–25, Baltimore,
Maryland 21244–1850.
the reasons for the correction with
supporting justification. (These
Procedures are in accordance with
Department regulation 45 CFR 5b.7).
NOTIFICATION PROCEDURE:
RECORDS SOURCE CATEGORIES:
For purpose of access, the subject
individual should write to the system
manager who will require the system
name, health insurance claim number,
and for verification purposes, the
subject individual’s name (woman’s
maiden name, if applicable), SSN
(furnishing the SSN is voluntary, but it
may make searching for a record easier
and prevent delay), address, date of
birth, and sex.
The data contained in this system of
records are obtained from The Outcome
and Assessment Information Set.
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
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E7–22083 Filed 11–9–07; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Office of Community Services
(OCS) Evaluation Initiative: Community
Economic Development (CED) and Job
Opportunities for Low-Income (JOLI)
Individuals.
OMB Control No. 0907–0317.
Description: The Office of Community
Services (OCS) is a component of the
Administration for Children and
Families (ACF), which is part of the U.S.
Department of Health and Human
Services (HHS). Part of OCS’
responsibilities is the program
administration of Federal grants
awarded through an annual competitive
process to support urban and rural
community economic development
projects carried out by local, non-profit,
community-based organizations. OCS is
collecting key program information
about the CED and the JOLI projects in
the United States. The legislative
requirement for these two programs is in
Title IV of the Community
Opportunities, Accountability and
Training and Educational Services Act
(COATES Human Services
Reauthorization Act) of October 27,
1998, Pub. L. 105–285, section 680(b) as
amended. The information collection
questionnaire will gather significant
updated information concerning
program outcomes and management.
OCS will use the data to critically
review and improve the overall design
and effectiveness of each program.
Respondents: OCS Grantees.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
rfrederick on PROD1PC67 with NOTICES
Questionnaire for OCS–CED Grantees in the United States
Questionnaire for OCS–JOLI Grantees in the United States
Estimated Total Annual Burden
Hours: 258.
In compliance with the requirements
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
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15:30 Nov 09, 2007
Jkt 214001
Number of
responses per
respondent
147
25
1
1
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: November 6, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–5609 Filed 11–9–07; 8:45 am]
BILLING CODE 4184–01–M
PO 00000
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Sfmt 4703
Average burden
hours per
response
Total burden
hours
1.5
1.5
220.5
37.5
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Data Collection Plan for the
Customer Satisfaction Evaluation of
Child Welfare Information Gateway.
OMB No.: 0970–0303.
Description: The National
Clearinghouse on Child Abuse and
Neglect Information (NCCAN) and the
National Adoption Information
Clearinghouse (NAIC) received OMB
approval to collect data for a customer
satisfaction evaluation under OMB
control number 0970–0303. On June 20,
2006, NCCAN and NAIC were
consolidated into Child Welfare
Information Gateway (CWIG). In
response to this consolidation, the
E:\FR\FM\13NON1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 218 (Tuesday, November 13, 2007)]
[Notices]
[Pages 63906-63911]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22083]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of a Modified or Altered System
AGENCY: Department of Health and Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a Modified or Altered System of Records (SOR).
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to modify or alter an SOR titled ``Home Health
Agency (HHA) Outcome and Assessment Information Set (OASIS),'' System
No. 09-70-9002, last modified at 66 Federal Register 66903 (December
27, 2001). We propose to assign a new CMS identification number to this
system to simplify the obsolete and confusing numbering system
originally designed to identify the Bureau, Office, or Center that
maintained information in the Health Care Financing Administration
systems of records. The new assigned identifying number for this system
should read: System No. 09-70-0522.
We propose to modify existing routine use number 1 that permits
disclosure to agency contractors and consultants to include disclosure
to CMS grantees who perform a task for the agency. CMS grantees,
charged with completing projects or activities that require CMS data to
carry out that activity, are classified separate from CMS contractors
and/or consultants. The modified routine use will remain as routine use
number 1. We will modify existing routine use number 4 that permits
disclosure to Peer Review Organizations (PRO). Organizations previously
referred to as PROs will be renamed to read: Quality Improvement
Organizations (QIO). Information will be disclosed to QIOs relating to
assessing and improving HHA quality of care. The modified routine use
will remain as routine use number 4.
CMS proposes to broaden the scope of the disclosure requirement for
routine use number 5, authorizing disclosure to national accrediting
organizations that have been approved by CMS for deeming authority for
Medicare requirements for home health services. 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: (1) Provide identifying information for
HHAs that have an accreditation status with the requesting deemed
organization, (2) submission of a finder file identifying
beneficiaries/patients receiving HHA services, (3) safeguard the
confidentiality of the data and prevent unauthorized access, and (4)
upon completion of a signed data exchange agreement or a CMS data use
agreement.
We will delete routine use number 7 authorizing disclosure to
support constituent requests made to a congressional representative. If
an authorization for the disclosure has been obtained from the data
subject, then no routine use is needed. The Privacy Act allows for
disclosures with the ``prior written consent'' of the data subject. We
will broaden the scope of published routine uses number 8 and 9,
authorizing disclosures to combat fraud and abuse in the Medicare and
Medicaid programs to include combating ``waste'' which refers
increasingly more to specific beneficiary or recipient practices that
result in unnecessary cost to Federally-funded health benefit programs.
We are modifying the language in the remaining routine uses to
provide a proper explanation as to the need for the routine use and to
provide clarity to CMS's intention to disclose individual-specific
information contained in this system. The routine uses will then be
prioritized and reordered according to their usage. We will also take
the opportunity to update any sections of the system that were affected
by the recent reorganization or because of the impact of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
(Pub. L. 108-173) provisions and to update language in the
administrative sections to correspond with language used in other CMS
SORs.
The primary purposes of the SOR are to collect and maintain
information to: (1) Study and help ensure the quality of care provided
by home health agencies (HHA); (2) aid in administration of the survey
and certification of Medicare/Medicaid HHAs; (3) enable regulators to
provide HHAs with data for their internal quality improvement
activities; (4) support agencies of the state government to determine,
evaluate and assess overall effectiveness and quality of HHA services
provided in the state; (5) provide for the validation, and refinements
of the Medicare Prospective Payment System; (6) aid in the
administration of Federal and state HHA programs within the state; and
(7) monitor the continuity of care for patients who reside temporarily
outside of the state. Information maintained in this system will also
be disclosed to: (1) Support regulatory, reimbursement, and policy
functions performed within the Agency or by a contractor, consultant,
or grantee; (2) assist another Federal and/or state agency, agency of a
state government, an agency established by state law, or its fiscal
agent, for evaluating and monitoring the quality of home health care
and contribute to the accuracy of health insurance operations; (3)
support research, evaluation, or epidemiological projects related to
the prevention of disease or disability, or the restoration or
maintenance of health, and for payment related projects; (4) support
the functions of Quality Improvement Organizations (QIO); (5) support
the functions of national accrediting organizations; (6) support
litigation involving the Agency; (7) combat fraud, waste, and abuse in
certain health care 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 routine uses, CMS
invites comments on all portions of this notice. See Effective Dates
section for comment period.
EFFECTIVE DATES: CMS filed a modified or altered 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 November 6, 2007. To
ensure that all parties have adequate time in which to comment, the
modified 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
[[Page 63907]]
hours, Monday through Friday from 9 a.m.-3 p.m., eastern time zone.
FOR FURTHER INFORMATION CONTACT: Patricia Sevast, Nurse Consultant,
Division of Continuing Care Providers, Survey and Certification Group,
Center for Medicaid and State Operations, CMS, 7500 Security Boulevard,
S2-12-25, Baltimore, Maryland 21244-1850. The telephone number is (410)
786-8135, or via e-mail at patricia.sevast@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Description of the Modified or Altered System of Records
A. Statutory and Regulatory Basis for System
Authority for maintenance of this system is given under Sections
1102(a), 1154, 1861(m), 1861(o), 1861(z), 1863, 1864, 1865, 1866, 1871,
1891, and 1902 of the Social Security Act. These provisions of the Act
authorize the Administrator of CMS to require HHAs participating in the
Medicare and Medicaid programs to complete a standard, valid, patient
assessment data set; i.e., the OASIS, as part of their comprehensive
assessments and updates when evaluating adult, non-maternity patients
as required by section 484.55 of the Conditions of Participation.
Authority is also given under section 951 of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173).
B. Collection and Maintenance of Data in the System
The system collects and maintains information on all patients,
except those in a category exempted by administrative policies and
procedures, who receive services from an HHA certified for Medicare and
Medicaid payments. The OASIS data set includes identifiers. It also
includes information on: (1) Patient History, (2) Living Arrangements,
(3) Supportive Assistance, (4) Sensory Status, (5) Integumentary
Status, (6) Respiratory Status, (7) Elimination Status, (8) Neuro/
Emotional/Behavioral Status, (9) Activities of Daily Living/
Instrumental Activities of Daily Living (ADL/IADL), (10) Medications,
(11) Equipment Management, (12) Emergent Care, and (13) Discharge.
Identifiers are patient name, social security number, Medicare number
and Medicaid number. A masked identifier is one in which an encrypted
value is permanently substituted for an identifier to prevent
recipients of the information from identifying the individual.
The OASIS information will be submitted by the HHA to the
government for all patients, except pre-partum and postpartum patients,
patients under 18 years of age, and patients receiving other than
personal care or health care services; i.e., housekeeping services and
chore services. Identifiers will be included for all patients receiving
services paid for by Medicare traditional fee-for-service, Medicaid
traditional fee-for-service, Medicare HMO/managed care or Medicaid HMO/
managed care. For patients with only a non-Medicare or non-Medicaid
payment source, the HHA will submit OASIS information with masked
identifiers and will retain the identifier and masked identifier at the
HHA. In other words, the patient identifier for non-Medicare and non-
Medicaid patients will only be known and retained by the HHA and not by
the government.
II. Agency Policies, Procedures, and Restrictions on Routine Uses
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 OASIS 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 OASIS. 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 evaluate and monitor
the quality of home health care and contribute to the accuracy of
health insurance operations.
2. Determines:
a. That the purpose for which the disclosure is to be made can only
be accomplished if the record is provided in individually identifiable
form;
b. That the purpose for which the disclosure is to be made is of
sufficient importance to warrant the potential effect and/or risk on
the privacy of the individual that additional exposure of the record
might bring; and
c. That 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; and
b. Remove or destroy at the earliest time all patient-identifiable
information.
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 support 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 assist another Federal or state agency, agency of a state
government, an agency established by state law, or its fiscal agent to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits,
[[Page 63908]]
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. Evaluate and monitor the quality of home health care and
contribute to the accuracy of health insurance operations.
Other Federal or state agencies in their administration of a
Federal health program may require OASIS information in order to
support evaluations and monitoring of reimbursement for services
provided.
3. To assist an individual or organization for research, evaluation
or epidemiological projects related to the prevention of disease or
disability, or the restoration or maintenance of health, and for
payment-related projects.
The collected data will provide the research, evaluation and
epidemiological projects a broader, longitudinal, national perspective
of the data. CMS anticipates that many researchers will have legitimate
requests to use these data in projects that could ultimately improve
the care provided to Medicare patients and the policy that governs the
care. CMS understands the concerns about the privacy and
confidentiality of the release of data for a research use. Disclosure
of data for research and evaluation purposes may involve aggregate data
rather than individual-specific data.
4. To support Quality Improvement Organizations (QIO) in order to
assist the QIO to perform Title XI and Title XVIII functions relating
to assessing and improving HHA quality of care.
QIOs will work with HHAs to implement quality improvement programs,
provide consultation to CMS, its contractors, and to state agencies.
The QIOs will provide a supportive role to HHAs in their endeavors to
comply with Medicare Conditions of Participation; will assist the state
agencies in related monitoring and enforcement efforts; assist CMS and
help regional home health intermediaries in home health program
integrity assessment; and prepare summary information about the
nation's home health care for release to beneficiaries.
5. To support national accrediting organizations with approval for
deeming authority for Medicare requirements for home health services
(i.e., the Joint Commission on Accreditation of Healthcare
Organizations, Accreditation Commission for Health Care, Inc., and the
Community Health Accreditation Program). Information will be released
to these organizations upon specific request, and only for those
facilities that they accredit and that participate in the Medicare
program and if they meet the following requirements:
a. Provide identifying information for HHAs that have an
accreditation status with the requesting deemed organization,
b. submit a finder file identifying beneficiaries/patients
receiving HHA services,
c. complete a signed data exchange agreement or a CMS data use
agreement, and
d. safeguard the confidentiality of the data and prevent
unauthorized access.
CMS anticipates providing these national accrediting organizations
with OASIS information to enable them to target potential or identified
problems during the organization's accreditation review process of that
facility.
6. To support 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 assist 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, or abuse in such
program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual relationship or
grant 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 and makes
grants when doing so would contribute to effective and efficient
operations. CMS must be able to give a contractor or grantee whatever
information is necessary for the contractor or grantee to fulfill its
duties. In these situations, safeguards are provided in the contract
prohibiting the contractor or grantee from using or disclosing the
information for any purpose other than that described in the contract
and requiring the contractor or grantee to return or destroy all
information.
8. To assist another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any State or local governmental agency), that
administers, or that has the authority to investigate potential fraud,
waste, or abuse in, a health benefits program funded in whole or in
part by Federal funds, when disclosure is deemed reasonably necessary
by CMS to prevent, deter, discover, detect, investigate, examine,
prosecute, sue with respect to, defend against, correct, remedy, or
otherwise combat fraud, waste, or abuse in such programs.
Other agencies may require OASIS 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 Fed. Reg. 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).
[[Page 63909]]
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 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 (see item IV above) 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.
Dated: November 7, 2007.
Charlene Frizzera,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0522
System Name:
``Home Health Agency (HHA) Outcome and Assessment Information Set
(OASIS),'' HHS/CMS/CMSO.
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 South Building, Baltimore, Maryland 21244-1850.
Categories of Individuals Covered by the System:
The system of records (SOR) will contain clinical assessment
information (OASIS) for all patients receiving the services of a
Medicare and/or Medicaid approved HHA, except pre-partum and post-
partum patients, patients under 18 years of age, and patients receiving
other than personal care or health care services; i.e., housekeeping
services and chore services. Identifiable information will be
maintained in the SOR only for those individuals whose payments come
from Medicare or Medicaid.
Categories of Records in the System:
This SOR will contain individual-level demographic and identifying
data, as well as clinical status data for patients with the payment
sources of Medicare traditional fee for service, Medicaid traditional
fee for service, Medicare HMO/managed care or Medicaid HMO/managed
care.
Authority for Maintenance of the System:
Authority for maintenance of this system is given under Sections
1102(a), 1154, 1861(m), 1861(o), 1861(z), 1863, 1864, 1865, 1866, 1871,
1891, and 1902 of the Social Security Act. These provisions of the Act
authorize the Administrator of CMS to require HHAs participating in the
Medicare and Medicaid programs to complete a standard, valid, patient
assessment data set; i.e., the OASIS, as part of their comprehensive
assessments and updates when evaluating adult, non-maternity patients
as required by section 484.55 of the Conditions of Participation.
Authority is also given under section 951 of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173).
Purpose(s) of the System:
The primary purposes of the SOR are to collect and maintain
information to: (1) Study and help ensure the quality of care provided
by home health agencies (HHA); (2) aid in administration of the survey
and certification of Medicare/Medicaid HHAs; (3) enable regulators to
provide HHAs with data for their internal quality improvement
activities; (4) support agencies of the state government to determine,
evaluate and assess overall effectiveness and quality of HHA services
provided in the state; (5) provide for the validation, and refinements
of the Medicare Prospective Payment System; (6) aid in the
administration of Federal and state HHA programs within the state; and
(7) monitor the continuity of care for patients who reside temporarily
outside of the state. Information maintained in this system will also
be disclosed to: (1) Support regulatory, reimbursement, and policy
functions performed within the Agency or by a contractor, consultant,
or grantee; (2) assist another Federal and/or state agency, agency of a
state government, an agency established by state law, or its fiscal
agent, for evaluating and monitoring the quality of home health care
and contribute to the accuracy of health insurance operations; (3)
support research, evaluation, or epidemiological projects related to
the prevention of disease or disability, or the restoration or
maintenance of health, and for payment related projects; (4) support
the functions of Quality Improvement Organizations (QIO); (5) support
the functions of national accrediting organizations; (6) support
litigation involving the Agency; (7) combat fraud, waste, and abuse in
certain health care 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
[[Page 63910]]
following routine use disclosures of information maintained in the
system:
1. To support 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 assist another Federal or state agency, agency of a state
government, an agency established by state law, or its fiscal agent 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. evaluate and monitor the quality of home health care and
contribute to the accuracy of health insurance operations.
3. To assist an individual or organization for research, evaluation
or epidemiological projects related to the prevention of disease or
disability, or the restoration or maintenance of health, and for
payment related projects.
4. To support Quality Improvement Organizations (QIO) in order to
assist the QIO to perform Title XI and Title XVIII functions relating
to assessing and improving HHA quality of care.
5. To support national accrediting organizations with approval for
deeming authority for Medicare requirements for home health services
(i.e., the Joint Commission on Accreditation of Healthcare
Organizations, Accreditation Commission for Health Care, Inc., and the
Community Health Accreditation Program). Information will be released
to these organizations upon specific request, and only for those
facilities that they accredit and that participate in the Medicare
program and if they meet the following requirements:
a. Provide identifying information for HHAs that have an
accreditation status with the requesting deemed organization,
b. Submit a finder file identifying beneficiaries/patients
receiving HHA services,
c. Complete a signed data exchange agreement or a CMS data use
agreement, and
d. Safeguard the confidentiality of the data and prevent
unauthorized access.
6. To support 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 assist 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, or abuse in such
program.
8. To assist another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any State or local governmental agency), that
administers, or that has the authority to investigate potential fraud,
waste, or abuse in, a health benefits program funded in whole or in
part by Federal funds, when disclosure is deemed reasonably necessary
by CMS to prevent, deter, discover, detect, investigate, examine,
prosecute, sue with respect to, defend against, correct, remedy, or
otherwise combat fraud, waste, or abuse in such programs.
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 Fed. Reg. 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 paper and magnetic disk.
Retrievability:
The Medicare and Medicaid records are retrieved by health insurance
claim number, Social Security number (SSN) or by state assigned
Medicaid number.
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:
CMS will retain identifiable OASIS assessment data for a total
period not to exceed fifteen (15) years.
System Manager and Address:
Director, Division of Continuing Care Providers, Survey and
Certification
[[Page 63911]]
Group, Center for Medicaid and State Operations, CMS, 7500 Security
Boulevard, S2-12-25, Baltimore, Maryland 21244-1850.
Notification Procedure:
For purpose of access, the subject individual should write to the
system manager who will require the system name, health insurance claim
number, and for verification purposes, the subject individual's name
(woman's maiden name, if applicable), SSN (furnishing the SSN is
voluntary, but it may make searching for a record easier and prevent
delay), address, date of birth, and sex.
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:
The data contained in this system of records are obtained from The
Outcome and Assessment Information Set.
Systems Exempted from Certain Provisions of the Act:
None.
[FR Doc. E7-22083 Filed 11-9-07; 8:45 am]
BILLING CODE 4120-03-P
