[Federal Register Volume 72, Number 218 (Tuesday, November 13, 2007)]
[Notices]
[Pages 63906-63911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22083]


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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).

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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 [email protected].

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