[Federal Register Volume 64, Number 117 (Friday, June 18, 1999)]
[Notices]
[Pages 32992-32998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15530]



[[Page 32992]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration


Privacy Act of 1974; Report of New System

AGENCY: Department of Health and Human Services (HHS), Health Care 
Financing Administration (HCFA).

ACTION: Notice of new system of records.

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    The provisions in this system of records are unique to the OASIS 
data set, and therefore, are not necessarily representative of current 
or future HCFA system of records.

SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to establish a new system of records. The 
proposed system is titled ``Home Health Agency Outcome and Assessment 
Information Set (HHA OASIS), HHS/HCFA/CMSO, 09-70-9002.'' HCFA proposes 
to establish a new system of records containing data on the physical, 
mental, functional, and psychosocial status of all patients receiving 
the services of Home Health Agencies (HHAs) that are approved to 
participate in the Medicare and/or Medicaid programs. Information 
retained in this system for those individuals who have only non-
Medicare and non-Medicaid payment sources will be in a non-patient 
identifiable format.
    The primary purposes of the system of records are to provide for 
the development, validation, and refinements of the Medicare 
Prospective Payment System and to study and help ensure the quality of 
care provided by HHAs. Information retrieved from this system of 
records will be used to aid in administration of the survey and 
certification of Medicare/Medicaid HHAs; enable regulators to provide 
HHAs with data for their internal quality improvement activities; 
support agencies of the State government to determine, evaluate and 
assess overall effectiveness and quality of HHA services provided in 
the State; aid in the administration of Federal and State HHA programs 
within the State; monitor the continuity of care for patients who 
reside temporarily outside of the State; support regulatory, 
reimbursement, and policy functions performed within the agency or by a 
contractor or consultant; support constituent requests made to a 
Congressional representative; support litigation involving the agency; 
and 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. We have 
provided background information about the proposed system in the 
``Supplementary Information'' section below. Although the Privacy Act 
requires only that the ``routine use'' portion of the system be 
published for comment, HCFA invites comments on all portions of this 
notice. See ``Effective Dates'' section for comment period.

EFFECTIVE DATES: HCFA filed a new system of records report with the 
Chair of the House Committee on Government Reform and Oversight, the 
Chair of the Senate Committee on Governmental Affairs, and the 
Administrator, Office of Information and Regulatory Affairs, Office of 
Management and Budget (OMB) on June 15, 1999. We have requested a 
waiver of the OMB 40-day advance notice period for this system of 
records. If OMB grants the waiver, the system of records is effective 
on June 18, 1999. If OMB does not grant the waiver, we will implement 
the system on July 28, 1999. In any event, we will not disclose any 
information under a routine use until 40 days after publication. We may 
defer implementation of this system of records or one or more of the 
routine use statements listed below if we receive comments that 
persuade us to defer implementation.

ADDRESSES: The public should address comments to: Director, Division of 
Data Liaison and Distribution (DDLD), HCFA, Room N2-04-27, 7500 
Security Boulevard, Baltimore, Maryland 21244-1850. Comments received 
will be available for review at this location, by appointment, during 
regular business hours, Monday through Friday from 9 am.-3 pm., eastern 
time zone.

FOR FURTHER INFORMATION CONTACT: Helene Fredeking, Director, Division 
of Outcomes and Improvements, Center for Medicaid and State Operations, 
HCFA, 7500 Security Boulevard, S2-14-26, Baltimore, Maryland 21244-
1850. The telephone number is (410) 786-7304.

SUPPLEMENTARY INFORMATION:

Description of the Proposed System of Records.

A. Glossary of OASIS Terms

OASIS Data Set

    The OASIS data set is the sum of the identifiers and information.

Identifiers

    Identifiers are the data elements that can be used to determine a 
patient's identity.
    These are: patient's name, social security number, Medicare number 
and Medicaid number.

OASIS Information

    OASIS information includes the clinical items listed below and case 
mix adjusters (e.g. age, sex, race, residence, etc.).

Patient History
Living Arrangements
Supportive Assistance
Sensory Status
Integumentary Status
Respiratory Status
Elimination Status
Neuro/Emotional/Behavioral Status
Activities of Daily Living/Instrumental Activities of Daily Living 
(ADL/IADLs)
Medications
Equipment Management
Emergent Care
Discharge

Masked Identifiers

    A masked identifier is created when an encrypted value is 
substituted for an identifier prior to transmission of data. Thus the 
government receives non-identifiable data (see below). Only the HHA has 
identifiable data.

Identifiable Data

    Identifiable data includes individual records with OASIS 
information and identifiers.

Non-Identifiable Data

    Non-identifiable data includes individual records with OASIS 
information and masked identifiers or OASIS information without 
identifiers.

B. Statutory and Regulatory Basis for System of Records

    Sections 1102(a), 1871, 1861(o), 1861(z), and 1891(b) of the Social 
Security Act authorize the Administrator of HCFA 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 Sec. 484.55 of the Conditions of 
Participation. On March 10, 1997, we published in the Federal Register, 
at 62 FR 11035, a proposed rule with an opportunity for public comment, 
titled ``Medicare and Medicaid Programs: Use of the OASIS as Part of 
the Conditions of Participation for Home Health Agencies.'' On January 
25, 1999, some provisions of this rule were published as a Final Rule 
in the Federal Register, titled ``Medicare and Medicaid Program:

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Comprehensive Assessment and Use of the OASIS as Part of the Conditions 
of Participation for Home Health Agencies.'' The rule required that all 
HHAs participating in the Medicare and Medicaid programs be required 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 Sec. 484.55 of 
the Conditions of Participation. Also published in the Federal 
Register, was an interim final rule with comment titled ``Medicare and 
Medicaid: Reporting Outcome and Assessment Information Set.'' This 
interim rule established an additional requirement of the Conditions of 
Participation for HHAs approved to participate in Medicare and/or 
Medicaid, to encode and report OASIS electronically into a national 
database. Information retained in this system for those individuals who 
have only non-Medicare and non-Medicaid payment sources will be in a 
non-patient identifiable format and will be used only for statistical 
purposes and to ensure quality of care for all patients. Information on 
Medicare and Medicaid patients will be identified for quality of care 
and reimbursement purposes.
    OASIS also serves as the backbone of the home health prospective 
payment system. The Balanced Budget Act of 1997 requires Medicare to 
implement a prospective payment system for HHAs by October 1, 2000. 
OASIS not only contains data items that indicate quality, but 
information necessary to develop a reliable prospective payment system 
that pays HHAs appropriately according to the different level of 
services patients need. If HCFA opted not to use OASIS for the 
prospective payment system, HCFA would have had to collect another set 
of data items from HHAs.
    The system of records will contain clinical assessment information 
(OASIS records) for all Medicare and Medicaid 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. The OASIS data set contains 
statistically proven valid and reliable items which have been shown to 
be effective in measuring outcomes for patients receiving home health 
services.

C. Purpose for System of Records

    In 1987, Congress changed the Social Security Act to require HCFA 
to survey the quality of care and services furnished by HHAs using a 
``standardized, reproducible assessment instrument.'' The next year, 
HCFA entered into a contract with the University of Colorado to develop 
an assessment instrument that would help oversee the quality of care 
patients receive in HHAs and improve HHA performance. University of 
Colorado researchers, doctors, and clinicians developed the Outcome 
Assessment Instrument Set (OASIS) as the standardized, reproducible 
assessment instrument.
    OASIS is not an interview or a survey. Rather, it is part of an 
assessment of the patient that is conducted by a registered nurse or 
therapist. To determine the type of care a patient needs, HHAs already 
do an assessment of each patient's physical and emotional condition. 
HHAs will continue to do these comprehensive assessments, but now they 
will report a portion of that assessment to HCFA so that we can perform 
several critical functions, such as calculating the appropriate amount 
for the government to pay for home health services or ensuring HHAs are 
providing the highest quality of care for the entire agency and for 
each individual patient.
    Home health patients are one of the most vulnerable populations 
because services are provided in the homes where it is difficult to 
oversee the quality of services provided. For the first time, OASIS 
will allow HCFA to measure how well HHAs care for their patients. HHAs 
caring for Medicare beneficiaries will submit OASIS data through secure 
communications to HCFA, which will analyze the information to develop 
performance profiles for each agency. This process is similar to what 
we now do for managed-care plans--a system that has been widely praised 
by consumers and health-care professionals.
    These ``performance reports'' can serve several important purposes: 
(1) HHAs can use them to identify their own weaknesses and improve the 
quality of care they provide; (2) HCFA can use them to identify HHAs 
that provide substandard care and then require such agencies to correct 
problem areas or risk losing Medicare funding; and (3) patients may be 
able to use this information in the form of ``report cards'' as a means 
of comparing HHAs in their area. All patient-specific information will 
be kept confidential with access carefully limited to ensure that 
privacy remains protected.
    OASIS represents a significant advancement in home health care. It 
will ensure accurate payments to HHAs under the new prospective payment 
system, improve quality of patient care and allow HCFA to monitor the 
quality of care it purchases for its beneficiaries.

II. Collection and Maintenance of Data in the System

A. Scope of the Data Collected

    The OASIS will be completed 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:

Patient History
Living Arrangements
Supportive Assistance
Sensory Status
Integumentary Status
Respiratory Status
Elimination Status
Neuro/Emotional/Behavioral Status
Activities of Daily Living/Instrumental Activities of Daily Living 
(ADL/IADLs)
Medications
Equipment Management
Emergent Care
Discharge

    Identifiers are patient name, social security number, Medicare 
number and Medicaid number. A masked identifier is one in which an 
encrypted value is substituted for an identifier so that recipients of 
the information cannot identify the individual.
    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 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.

B. Agency Policies, Procedures, and Restrictions on the Routine Use

    The Privacy Act permits us to disclose information without an 
individual's consent if the information is to be used for a purpose 
which is compatible with the purpose(s) for which the

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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 HHA patient as provided for 
under ``Section III.A. Entities Who May Receive Disclosures Under 
Routine Use.'' Both identifiable and non-identifiable data may be 
disclosed under a routine use. Identifiable data includes individual 
records with OASIS information and identifiers. Non-identifiable data 
includes individual records with OASIS information and masked 
identifiers or OASIS information with identifiers stripped out of the 
file.
    We will only disclose the minimum personal data necessary to 
achieve the purpose of OASIS. HCFA has the following policies and 
procedures concerning disclosures of information which will be 
maintained in the system. In general, disclosure of information from 
the system of records will be approved only for the minimum information 
necessary to accomplish the purpose of the disclosure after HCFA:
    (a) Determines that the use or disclosure is consistent with the 
reason that the data is being collected; e.g., developing and refining 
payment systems and monitoring the quality of care provided to 
patients.
    (b) Determines:
    (1) That the purpose for which the disclosure is to be made can 
only be accomplished if the record is provided in individually 
identifiable form;
    (2) That the purpose for which the disclosure is to be made is of 
sufficient importance to warrant the effect and/or risk on the privacy 
of the individual that additional exposure of the record might bring; 
and
    (3) That there is a strong probability that the proposed use of the 
data would in fact accomplish the stated purpose(s).
    (c) Requires the information recipient to:
    (1) Establish administrative, technical, and physical safeguards to 
prevent unauthorized use of disclosure of the record;
    (2) Remove or destroy at the earliest time all patient-identifiable 
information; and
    (3) Agree to not use or disclose the information for any purpose 
other than the stated purpose under which the information was 
disclosed.
    (d) Determines that the data are valid and reliable.

III. Proposed Routine Use Disclosures of Data in the System

A. Entities Who May Receive Disclosures Under Routine Use

    The routine use disclosures in this system may occur only to the 
following seven (7) categories of entities (i.e., the entities which 
can get identifiable data only if we apply the policies and procedures 
in Section II.B. above). In addition, our policy will be to prohibit 
release even of non-identifiable data, beyond the seven listed 
categories, if 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 
who are familiar with the home health agency enrollees could, because 
of the small size, use this information to deduce the patient 
identity).
    1. To the Department of Justice (DOJ), court or adjudicatory body 
when:
    (a) The agency or any component thereof; or
     (b) Any employee of the agency in his or her official capacity; or
     (c) Any employee of the agency in his or her individual capacity 
where the DOJ has agreed to represent the employee; or
    (d) The United States Government;

is a party to litigation or has an interest in such litigation, and by 
careful review, HCFA determines that the records are both relevant and 
necessary to the litigation and the use of such records by the DOJ, 
court or adjudicatory body is therefore deemed by the agency to be for 
a purpose that is compatible with the purpose for which the agency 
collected the records.
     Whenever HCFA is involved in litigation, or occasionally when 
another party is involved in litigation and HCFA's policies or 
operations could be affected by the outcome of the litigation, HCFA 
would be able to disclose information to the DOJ, court or adjudicatory 
body involved. A determination would be made in each instance that, 
under the circumstances involved, the purposes served by the use of the 
information in the particular litigation is compatible with a purpose 
for which HCFA collects the information.
    2. To agency contractors, or consultants who have been engaged by 
the agency to assist in the performance of a service related to this 
system of records and who need to have access to the records in order 
to perform the activity. Recipients shall be required to comply with 
the requirements of the Privacy Act of 1974, as amended, pursuant to 5 
U.S.C. 552a(m).
     We contemplate disclosing information under this routine use only 
in situations in which HCFA may enter into a contractual or similar 
agreement with a third party to assist in accomplishing HCFA functions 
relating to purposes for this system of records.
     HCFA occasionally contracts out certain of its functions when this 
would contribute to effective and efficient operations. HCFA must be 
able to give a contractor whatever information is necessary for the 
contractor to fulfill its duties. In these situations, safeguards (like 
ensuring that the purpose for which the disclosure is to be made is of 
sufficient importance to warrant the effect and/or risk on the privacy 
of the individual that additional exposure of the record might bring 
and those stated in II.B. above), are provided in the contract 
prohibiting the contractor from using or disclosing the information for 
any purpose other than that described in the contract and to return or 
destroy all information at the completion of the contract.
    3. To the agency of a State Government, or established by State 
law, for purposes of determining, evaluating and/or assessing overall 
or aggregate cost, effectiveness, and/or the quality of HHA services 
provided in the State; for developing and operating Medicaid 
reimbursement systems; or for the purpose of administration of Federal/
State HHA programs within the State. Data will be released to the State 
only on those individuals who are either patients under the services of 
a HHA within the State, or are legal residents of the State, regardless 
of the location of the HHA in which the patient is receiving services.
    State government components in partnership with HCFA will use OASIS 
information to enhance the monitoring of HHAs' performance in providing 
patient care. States will also use this information to study the cost 
effectiveness and quality of Medicaid programs. In addition some States 
will use OASIS information for case mix Medicaid reimbursement systems. 
States will use OASIS data to monitor the continuity of care delivered 
to patients who, for whatever reason, temporarily reside in another 
State and receive HHA services during that stay.
    4. To another Federal or State agency (e.g. State survey agencies 
and State Medicaid agencies) to contribute to the accuracy of HCFA's 
health insurance operations (payment, treatment and coverage) and/or to 
support State agencies in the evaluations and monitoring of care 
provided by HHAs.
    Other State agencies in their administration of a Federal health

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program may require OASIS information in order to support evaluations 
and monitoring of quality of care for special populations or special 
care area, including proper reimbursement for services provided. 
Releases of information would be allowed if the proposed use(s) for the 
information proved compatible with the purpose for which HCFA collects 
the information.
    5. To a Peer Review Organization (PRO) in order to assist the PRO 
to perform Title XI and Title XVIII functions relating to assessing and 
improving HHA quality of care. PROs will work with HHAs to implement 
quality improvement programs, provide consultation to HCFA, its 
contractors, and to State agencies. The PROs 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 HCFA 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.
    6. To an individual or organization for a research, evaluation, or 
epidemiological project related to the prevention of disease or 
disability, the restoration or maintenance of health, or payment 
related projects.
    The OASIS data will provide the research, evaluations and 
epidemiological projects a broader, longitudinal, national perspective 
of the status of HHA patients. HCFA anticipates that many researchers 
will have legitimate requests to use these data in projects that could 
ultimately improve the care provided to HHA patients and the policy 
that governs the care.
    7. To a member of Congress or to a Congressional staff member in 
response to an inquiry of the Congressional Office made at the written 
request of the constituent about whom the record is maintained.
    Beneficiaries sometimes request the help of a Member of Congress in 
resolving some issue relating to a matter before HCFA. The Member of 
Congress then writes HCFA, and HCFA must be able to give sufficient 
information to be responsive to the inquiry.

IV. Compatibility of the Proposed Routine Uses

    The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. Our disclosure regulation allows us to 
disclose information under a routine use when the disclosure will be 
used to administer one of our programs or a similar program of another 
government agency, or when disclosure is required by law.
     In all of the routine use disclosures described above, the 
recipient of the information will use the information in connection 
with a matter relating to one of HCFA's programs; e.g., disclosures 
related to the administration of the survey and certification of 
Medicare/Medicaid HHAs, disclosures to contractors assisting HCFA with 
an administrative function, or disclosure in connection with litigation 
relating to, or affecting, a program administered by HCFA.

V. Safeguards

    The HHS OASIS system will conform with applicable law and policy 
governing the privacy and security of Federal automated information 
systems. These include but are not limited to: the Privacy Act of 1984, 
Computer Security Act of 1987, the Paperwork Reduction Act of 1995, the 
Clinger-Cohen Act of 1996, and OMB Circular A-130, Appendix III, 
``Security of Federal Automated Information Resources.'' HCFA has 
prepared a comprehensive system security plan as required by OMB 
Circular A-130, Appendix III. This plan conforms fully to guidance 
issued by the National Institute for Standards and Technology (NIST) in 
NIST Special Publication 800-18, ``Guide for Developing Security Plans 
for Information Technology Systems.'' Paragraphs A-C of this section 
highlight some of the specific methods that HCFA is using to ensure the 
security of this system and the information within it.
    A. Authorized users: Personnel having access to the system have 
been trained in Privacy Act and systems security requirements. 
Employees who maintain records in the system are instructed not to 
release any data until the intended recipient agrees to implement 
appropriate administrative, technical, procedural, and physical 
safeguards sufficient to protect the confidentiality of the data and to 
prevent unauthorized access to the data. In addition, HCFA is 
monitoring the authorized users to ensure against excessive or 
unauthorized use. Records are used in a designated work area or work 
station and the system location is attended at all times during working 
hours.
     To assure security of the data, the proper level of class user is 
assigned for each individual user as determined at the State agency 
level. This prevents unauthorized users from accessing and modifying 
critical data. The system database configuration includes five classes 
of database users:
     Database Administrator class owns the database objects; 
e.g., tables, triggers, indexes, stored procedures, packages, and has 
database administration privileges to these objects;
     Quality Control Administrator class has read and write 
access to key fields in the database;
     QI Report Generator class has read-only access to all 
fields and tables;
     Policy Research class has query access to tables, but are 
not allowed to access confidential patient identification information; 
and
     Submitter class has read and write access to database 
objects, but no database administration privileges. This class is used 
by the OASIS data submission applications to receive and validate HHA 
file uploads.
    B. Physical Safeguards: All server sites have implemented the 
following minimum requirements to assist in reducing the exposure of 
computer equipment and thus achieve an optimum level of protection and 
security for the HHA OASIS system:
     Access to all servers is controlled, with access limited to only 
those support personnel with a demonstrated need for access. Servers 
are to be kept in a locked room accessible only by specified management 
and system support personnel. Each server requires a specific log on 
process. All entrance doors are identified and marked. A log is kept of 
all personnel who were issued a security card, key and/or combination 
which grants access to the room housing the server, and all visitors 
are escorted while in this room. All servers are housed in an area 
where appropriate environmental security controls are implemented, 
which include measures implemented to mitigate damage to Automated 
Information System (AIS) resources caused by fire, electricity, water 
and adequate climate controls.
     Protection applied to the workstations, servers and databases 
include:
     User Log ons--Authentication is performed by the Primary 
Domain Controller/Backup Domain Controller of the log on domain.
     Workstation Names--Workstation naming conventions may be 
defined and implemented at the State agency level.
     Hours of Operation--May be restricted by Windows NT. When 
activated all applicable processes will automatically shut down at a 
specific time and not be permitted to resume until the predetermined 
time. The appropriate hours of operation are determined and implemented 
at the State agency level.

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     Inactivity Lockout--Access to the NT workstation is 
automatically locked after a specified period of inactivity.
     Warnings--Legal notices and security warnings display on 
all servers and when servers are accessed by workstations.
     Remote Access Security--Windows NT Remote Access Service 
(RAS) security handles resource access control. Access to NT resources 
is controlled for remote users in the same manner as local users, by 
utilizing Windows NT file and sharing permissions. Dial-in access can 
be granted or restricted on a user-by-user basis through the Windows NT 
RAS administration tool.
     There are several levels of security found in the HHA OASIS 
system. Windows NT provides much of the overall system security. The 
Windows NT security model is designed to meet the C2-level criteria as 
defined by the U.S. Department of Defense's Trusted Computer System 
Evaluation Criteria document (DoD 5200.28-STD, December 1985). Netscape 
Enterprise Server is the security mechanism for all HHA transmission 
connections to the system. As a result, Netscape controls all HHA 
information access requests. Anti-virus software is applied at both the 
workstation and NT server levels.
    Access to different areas on the Windows NT server are maintained 
through the use of file, directory and share level permissions. These 
different levels of access control provide security that is managed at 
the user and group level within the NT domain. The file and directory 
level access controls rely on the presence of an NT File System (NTFS) 
hard drive partition. This provides the most robust security and is 
tied directly to the file system. Windows NT security is applied at 
both the workstation and NT server levels.
    C. Procedural Safeguards: All automated systems must comply with 
Federal laws, guidance, and policies for information systems security 
as stated previously in this section. Each automated information system 
should ensure a level of security commensurate with the level of 
sensitivity of the data, risk, and magnitude of the harm that may 
result from the loss, misuse, disclosure, or modification of the 
information contained in the system.

VI. Effect of the Proposed System of Records on Individual Rights.

    HCFA proposes to establish this system in accordance with the 
principles and requirements of the Privacy Act and will collect, use, 
and disseminate information only as prescribed therein. Data in this 
system will be subject to the authorized releases in accordance with 
the routine uses identified in this system of records.
    HCFA will monitor the collection and reporting of OASIS data. OASIS 
information on patients is completed by the HHA and submitted to HCFA 
through standard systems located at the State agencies. Accuracy of the 
data is important since incorrect information could result in the wrong 
reimbursement for services and a less effective process for assuring 
quality of services. HCFA will utilize a variety of onsite and offsite 
edits and audits to increase the accuracy of OASIS data.
    HCFA will take precautionary measures (see item V. above) to 
minimize the risks of unauthorized access to the records and the 
potential harm to individual privacy or other personal or property 
rights including not collecting patient identifiable data for non-
Medicare and non-Medicaid patients. Therefore, HCFA anticipates no 
adverse effect on any of these rights. HCFA will collect only that 
information necessary to perform the system's functions. In addition, 
HCFA will make disclosure of identifiable data 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.
    To secure data that resides in a HCFA Privacy Act System of 
Records; to ensure the integrity, security, and confidentiality of 
information maintained by HCFA; and to permit appropriate disclosure 
and use of such data as permitted by law, HCFA and the non-HCFA 
recipient of the data, hereafter termed ``User,'' enter into an 
agreement to comply with the following specific requirements. The 
agreement addresses the conditions under which HCFA will disclose and 
the user will obtain and use the information contained in the system of 
records. The parties mutually agree that HCFA retains ownership rights 
to the data and that the user does not obtain any right, title, or 
interest in any of the data furnished by HCFA. The user represents and 
warrants further that the facts and statements made in any study or 
research protocol or project plan submitted to HCFA for each purpose 
are complete and accurate. The user shall not disclose, release, 
reveal, show, sell, rent, lease, loan, or otherwise grant access to the 
data disclosed from the system of records to any person. The user 
agrees that access to the data shall be limited to the minimum number 
of individuals necessary to achieve the purpose stated in the protocol 
and to those individuals on a need to know basis only. If HCFA 
determines or has reasonable belief that the user has made an 
unauthorized disclosure of the data, HCFA in its sole discretion may 
require the user to: (a) Promptly investigate and report to HCFA any 
alleged or actual unauthorized disclosures; (b) promptly resolve any 
problems identified by the investigation; (c) submit a formal response 
to any allegation of unauthorized disclosures; (d) submit a corrective 
action plan with steps to prevent any future unauthorized disclosures; 
and (e) return data files to HCFA. If HCFA determines or has reasonable 
belief that unauthorized disclosures have taken place, HCFA may refuse 
to release further HCFA data to the user for a period of time to be 
determined by HCFA.
    The Privacy Act provides criminal penalties for certain violations. 
The Act provides that ``Any officer or employee of an agency, who by 
virtue of his [or her] employment or official position, has possession 
of, or access to, agency records which contain individually 
identifiable information the disclosure of which is prohibited by this 
section or by rules or regulations established thereunder, and who 
knowing that disclosure of the specific materials is so prohibited, 
willfully discloses the material in any manner to a person or agency 
not entitled to receive it, shall be guilty of a misdemeanor and fined 
not more than $5,000.'' (5 U.S.C. 552a(i)(1). The Act also provides 
that ``Any person who knowingly and willfully requests or obtains any 
record concerning an individual from an agency under false pretenses 
shall be guilty of a misdemeanor and fined not more than $5,000.'' (5 
U.S.C. 552a(i)(3). The agency's contractor and any contractors' 
employees who are covered by 5 U.S.C. 552a(m)(1) are considered 
employees of the agency for the purposes of these criminal penalties.
    HCFA, therefore, does not anticipate an unfavorable effect on 
individual privacy as a result of the disclosure of information 
relating to individuals.

    Dated: June 11, 1999.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
09-70-9002

SYSTEM NAME:
    Home Health Agency Outcome and Assessment Information Set (HHA 
OASIS).

SECURITY CLASSIFICATION
    None.

[[Page 32997]]

SYSTEM LOCATION:
    HCFA Data Center, 7500 Security Boulevard, North Building, First 
Floor, Baltimore, Maryland 21244-1850. HCFA contractors and agents at 
various locations.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    The system of records will contain clinical assessment information 
(OASIS records) for all patients receiving the services of a Medicare 
and/or Medicaid approved Home Health Agency (HHA), 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. Identifiable information will 
be retained in the system of records only for those individuals whose 
payments come from Medicare or Medicaid.

CATEGORIES OF RECORDS IN THE SYSTEM:
    This system of records 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:
    Secs. 1102(a), 1154, 1861(o), 1861(z), 1863, 1864, 1865, 1866, 
1871, 1891(b) of the Social Security Act.

PURPOSE(S):
    In 1987, Congress changed the Social Security Act to require HCFA 
to survey the quality of care furnished by HHAs using a ``standardized, 
reproducible assessment instrument.'' Through a contract with the 
University of Colorado, the OASIS was developed by researchers, 
doctors, and clinicians as the standardized, reliable assessment 
instrument. OASIS represents a significant advancement in home health 
care. Home health patients are one of the more vulnerable populations 
because services are provided in the homes where it is difficult to 
oversee the quality of services provided. OASIS will ensure accurate 
payments to HHAs under the prospective payment system, improve quality 
of patient care, and allow HCFA to monitor the quality of care that it 
purchases for its beneficiaries.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OR USERS AND THE PURPOSES OF SUCH USES:
    These routine uses specify circumstances, in addition to those 
provided by statute in the Privacy Act of 1974, under which HCFA may 
release information from the HHA OASIS without the consent of the 
individual to whom such information pertains. Each proposed disclosure 
of information under these routine uses will be evaluated to ensure 
that the disclosure is legally permissible, including but not limited 
to ensuring that the purpose of the disclosure is compatible with the 
purpose for which the information was collected. Also, HCFA will 
require each prospective recipient of such information, except those 
otherwise covered by the Privacy Act, to agree in writing to certain 
conditions to ensure the continuing confidentiality and security, 
including physical safeguards of the information.

Disclosures may be made:
    1. To the Department of Justice (DOJ), court or adjudicatory body 
when:
    (a) The agency or any component thereof; or
    (b) Any employee of the agency in his or her official capacity; or
    (c) Any employee of the agency in his or her individual capacity 
where the DOJ has agreed to represent the employee; or
    (d) The United States Government;

is a party to litigation or has an interest in such litigation, and by 
careful review, HCFA determines that the records are both relevant and 
necessary to the litigation and the use of such records by the DOJ, 
court or adjudicatory body is therefore deemed by the agency to be for 
a purpose that is compatible with the purpose for which the agency 
collected the records.
    2. To agency contractors, or consultants who have been engaged by 
the agency to assist in the performance of a service related to this 
system of records and who need to have access to the records in order 
to perform the activity. Recipients shall be required to comply with 
the requirements of the Privacy Act of 1974, as amended, pursuant to 5 
U.S.C. 552a(m).
    3. To the agency of a State Government, or established by State 
law, for purposes of determining, evaluating and/or assessing overall 
or aggregate cost, effectiveness, and/or the quality of HHA services 
provided in the State; for developing and operating Medicaid 
reimbursement systems; or for the purpose of administration of Federal/
State HHA programs within the State. Data will be released to the State 
only on those individuals who are either patients under the services of 
a HHA within the State, or are legal residents of the State, regardless 
of the location of the HHA in which the patient is receiving services.
    4. To another Federal or State agency (e.g. Department of Defense, 
Veterans Administration, state survey agencies and state Medicaid 
agencies) to contribute to the accuracy of HCFA's health insurance 
operations (payment, treatment and coverage) and/or to support state 
agencies in the evaluations and monitoring of care provided by HHAs.
     Other Federal or State agencies in their administration of a 
Federal health program may require OASIS information in order to 
support payment evaluations, and monitoring quality of care for special 
populations or special care area, including proper reimbursement for 
services provided. Releases of information would be allowed if the 
proposed use(s) for the information proved compatible with the purpose 
for which HCFA collects the information.
    5. To a Peer Review Organization (PRO) in order to assist the PRO 
to perform Title XI and Title XVIII functions relating to assessing and 
improving HHA quality of care.
    6. To an individual or organization for a research, evaluation, or 
epidemiological project related to the prevention of disease or 
disability, the restoration or maintenance of health, or payment 
related projects.
    7. To a member of Congress or to a Congressional staff member in 
response to an inquiry of the Congressional Office made at the written 
request of the constituent about whom the record is maintained.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
     All records are stored on magnetic media.

RETRIEVABILITY:
    The Medicare and Medicaid records are retrieved by health insurance 
claim number, social security number or by State assigned Medicaid 
number.

SAFEGUARDS:
    HCFA has safeguards for authorized users and monitors such users to 
ensure against excessive or unauthorized use. Personnel having access 
to the system have been trained in the Privacy Act and systems security 
requirements. Employees who maintain records in the system are 
instructed not to release any data until the intended recipient agrees 
to implement appropriate administrative, technical, procedural, and 
physical safeguards sufficient to protect the confidentiality of the 
data and to prevent unauthorized access to the data.
    In addition, HCFA has physical safeguards in place to reduce the

[[Page 32998]]

exposure of computer equipment and thus achieve an optimum level of 
protection and security for the HHA OASIS system. For computerized 
records, safeguards have been established in accordance with HHS 
standards and National Institute of Standards and Technology 
guidelines; e.g., security codes will be used, limiting access to 
authorized personnel. System securities are established in accordance 
with HHS, Information Resource Management (IRM) Circular #10, Automated 
Information Systems Security Program; HCFA Automated Information 
Systems (AIS) Guide, Systems Securities Policies; and OMB Circular No. 
A-130 (revised), Appendix III.

RETENTION AND DISPOSAL:
    HCFA and the repository of the National Archive and Records 
Administration (NARA) will retain identifiable OASIS assessment data 
for a total period not to exceed fifteen (15) years.

5SYSTEM MANAGER(S) AND ADDRESS:
    Director, Center for Medicaid and State Operations, HCFA, 7500 
Security Boulevard, 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), social security number (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 reasonably 
specify the record contents being sought. (These procedures are in 
accordance with Department regulation 45 CFR 5b.5(a)(2).)

CONTESTING RECORD PROCEDURES:
    The subject individual should contact the system manager named 
above, and reasonably identify the record and specify the information 
to be contested. State the corrective action sought and the reasons for 
the correction with supporting justification. (These procedures are in 
accordance with Department regulation 45 CFR 5b.7.)

RECORD SOURCE CATEGORIES:
    The Outcome and Assessment Information Set.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.
[FR Doc. 99-15530 Filed 6-16-99; 9:00 am]
BILLING CODE 4120-03-P