Privacy Act of 1974; Report of New System

Federal RegisterJun 18, 1999

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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:

[[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

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).

(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

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.

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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: