[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
[[Page 32993]]
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
[[Page 32994]]
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
[[Page 32995]]
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.
[[Page 32996]]
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
