[Federal Register Volume 66, Number 248 (Thursday, December 27, 2001)]
[Notices]
[Pages 66903-66909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31546]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of a Modified or Altered System

AGENCY: Department of Health and Human Services (HHS), Centers for 
Medicare & Medicaid Services (CMS) (formerly the Health Care Financing 
Administration).

ACTION: Notice of modified or altered System of Records (SOR).

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to modify or alter an SOR titled ``Home Health 
Agency Outcome and Assessment Information Set (HHA OASIS),'' System No. 
09-70-9002. CMS proposes to add a new routine use authorizing 
disclosure to national accrediting organizations that have been 
approved by CMS for deeming authority for Medicare requirements for 
home health services. Information will be released to these 
organizations upon specific request, and only for those facilities that 
they accredit and that participate in the Medicare program by virtue of 
their accreditation status, i.e., facilities with deemed status. 
Additionally, disclosures authorized by published routine uses numbers 
3 and 4 are similar in scope and as such will be combined into one 
routine use to allow release of information to ``another Federal and/or 
state agency, agency of a state government, an agency established by 
state law, or its fiscal agent, for evaluating and monitoring the 
quality of home health care and contribute to the accuracy of health 
insurance operations.'' CMS will also add 2 new routine uses that will 
permit disclosure of information in this system to combat fraud and 
abuse in certain Federally funded health care programs.
    In addition, the security classification previously reported as 
``None'' will be modified to reflect that the data in this system are 
considered to be ``Level Three Privacy Act Sensitive.'' We are 
modifying the language in the remaining routine uses to provide clarity 
to CMS's intention to disclose individual-specific information 
contained in this system. The routine uses will then be prioritized and 
reordered according to their usage. We will also take the opportunity 
to update any sections of the system that were affected by the recent 
reorganization and to update language in the administrative sections to 
correspond with language used in other CMS SORs.
    The primary purposes of the SOR are to: (1) Study and help ensure 
the quality of care provided by home health agencies (HHA); (2) aid in 
administration of the survey and certification of Medicare/Medicaid 
HHAs; (3) enable regulators to provide HHAs with data for their 
internal quality improvement activities; (4) support agencies of the 
state government to determine, evaluate and assess overall 
effectiveness and quality of HHA services provided in the state; (5) 
provide for the validation, and refinements of the Medicare Prospective 
Payment System; (6) aid in the administration of Federal and state HHA 
programs within the state; and (7) monitor the continuity of care for 
patients who reside temporarily outside of the state. Information 
maintained in this system will also be disclosed to: (1) Support 
regulatory, reimbursement, and policy functions performed within the 
Agency or by a contractor or consultant; (2) assist another Federal 
and/or state agency, agency of a state government, an agency 
established by state law, or its fiscal agent, for evaluating and 
monitoring the quality of home health care and contribute to the 
accuracy of health insurance operations; (3) support research, 
evaluation, or epidemiological projects related to the prevention of 
disease or disability, or the restoration or maintenance of health, and 
for payment related projects; (4) support the functions of Peer Review 
Organizations (PRO); (5) support the functions of national accrediting 
organizations; (6) support litigation involving the Agency; (7) support 
constituent requests made to a Congressional representative; and (8) 
combat fraud and abuse in certain health care programs. 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, CMS invites comments on all portions of this 
notice. See Effective Dates section for comment period.

[[Page 66904]]


EFFECTIVE DATES: CMS filed a modified SOR 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 December 18, 2001. The modified SOR, including routine uses, 
will become effective 40 days from the publication of this notice, or 
from the date it was submitted to OMB and the Congress, whichever is 
later. We may defer implementation of this SOR 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), CMS, Room N2-04-27, 7500 Security 
Boulevard, Baltimore, Maryland 21244-1850. Comments received will be 
available for review at this location, by appointment, during regular 
business hours, Monday through Friday from 9 a.m.-3 p.m., eastern 
daylight time.

FOR FURTHER INFORMATION CONTACT: Helene Fredeking, Technical Director, 
Division of Nursing Homes and Continuing Care Services, Center for 
Medicaid and State Operations, CMS, 7500 Security Boulevard, S2-12-25, 
Baltimore, Maryland 21244-1850. The telephone number is (410) 786-7304.

SUPPLEMENTARY INFORMATION:

I. Description of the Modified System

A. Background

    CMS established a new SOR in 1999 containing data on the physical, 
mental, functional, and psychosocial status of all patients receiving 
the services of 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. Notice of this system was 
published in the Federal Register at 64 Federal Register (FR) 32992 
(June 18, 1999). We published in the Federal Register, at 62 FR 11035 
(March 10, 1997), 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.'' 
Some provisions of this rule were published as a Final Rule in the 
Federal Register at 64 FR 3764 (January 25, 1999) titled ``Medicare and 
Medicaid Program: 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 section 484.55 of the Conditions of Participation. Also 
published in the Federal Register at 64 FR 3748 (January 25, 1999) was 
an interim final rule with comment titled ``Medicare and Medicaid: 
Reporting Outcome and Assessment Information Set (OASIS) Data as Part 
of the Conditions of Participation for Home Health Agencies.'' 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.

B.Statutory and Regulatory Basis for SOR

    Sections 1102(a), 1154, 1861(m), 1861(o), 1861(z), 1863, 1864, 
1865, 1866, 1871, 1891, and 1902 of the Social Security Act (the Act) 
authorize the Administrator of CMS to require HHAs participating in the 
Medicare and Medicaid programs to complete a standard, valid, patient 
assessment data set; i.e., the OASIS, as part of their comprehensive 
assessments and updates when evaluating adult, non-maternity patients 
as required by section 484.55 of the Conditions of Participation.

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: (1) Patient History, (2) Living Arrangements, (3) 
Supportive Assistance, (4) Sensory Status, (5) Integumentary Status, 
(6) Respiratory Status, (7) Elimination Status, (8) Neuro/Emotional/
Behavioral Status, (9) Activities of Daily Living/Instrumental 
Activities of Daily Living (ADL/IADL), (10) Medications, (11) Equipment 
Management, (12) Emergent Care, and (13) Discharge. Identifiers are 
patient name, social security number, Medicare number and Medicaid 
number. A masked identifier is one in which an encrypted value is 
permanently substituted for an identifier to prevent recipients of the 
information from identifying the individual.
    The OASIS information will be submitted by the HHA to the 
government for all patients, except pre-partum and postpartum patients, 
patients under 18 years of age, and patients receiving other than 
personal care or health care services; i.e., housekeeping services and 
chore services. Identifiers will be included for all patients receiving 
services paid for by Medicare traditional fee-for-service, Medicaid 
traditional fee-for-service, Medicare HMO/managed care or Medicaid HMO/
managed care. For patients with only a non-Medicare or non-Medicaid 
payment source, the HHA will submit OASIS information with masked 
identifiers and will retain the identifier and masked identifier at the 
HHA. In other words, the patient identifier for non-Medicare and non-
Medicaid patients will only be known and retained by the HHA and not by 
the government.

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 
that is compatible with the purpose(s) for which the information was 
collected. Any such disclosure of data is known as a ``routine use.'' 
The government will only release OASIS information that can be 
associated with an individual HHA patient as provided for under 
``Section III. 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. CMS has the following policies and 
procedures concerning disclosures of information that will be 
maintained in the system.

[[Page 66905]]

In general, disclosure of information from the SOR will be approved 
only for the minimum information necessary to accomplish the purpose of 
the disclosure after CMS:
    Determines that the use or disclosure is consistent with the reason 
that the data is being collected; e.g., study and help ensure the 
quality of care provided by HHAs, developing and refining payment 
systems, and monitoring the quality of care provided to patients.
    1. Determines that:
    a. The purpose for which the disclosure is to be made can only be 
accomplished if the record is provided in individually identifiable 
form;
    b. 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
    c. there is a strong probability that the proposed use of the data 
would in fact accomplish the stated purpose(s).
    2. Requires the information recipient to:
    a. Establish administrative, technical, and physical safeguards to 
prevent unauthorized use of disclosure of the record;
    b. remove or destroy at the earliest time all patient-identifiable 
information; and
    c. agree to not use or disclose the information for any purpose 
other than the stated purpose under which the information was 
disclosed.
    3. 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

    These routine uses specify circumstances, in addition to those 
provided by statute in the Privacy Act of 1974, under which CMS may 
release information from the 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. We are proposing to 
establish or modify the following routine use disclosures of 
information maintained in the system:
    1. To Agency contractors, or consultants who have been contracted 
by the Agency to assist in accomplishment of a CMS function relating to 
the purposes for this system and who need to have access to the records 
in order to assist CMS.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual or similar 
agreement with a third party to assist in accomplishing a CMS function 
relating to purposes for this SOR.
    CMS occasionally contracts out certain of its functions when doing 
so would contribute to effective and efficient operations. CMS must be 
able to give a contractor or consultant whatever information is 
necessary for the contractor or consultant to fulfill its duties. In 
these situations, safeguards are provided in the contract prohibiting 
the contractor or consultant from using or disclosing the information 
for any purpose other than that described in the contract and requires 
the contractor or consultant to return or destroy all information at 
the completion of the contract.
    2. To another Federal or state agency, agency of a state 
government, an agency established by state law, or its fiscal agent, 
for evaluating and monitoring the quality of home health care and 
contribute to the accuracy of health insurance operations to:
    a. Contribute to the accuracy of CMS's proper payment of Medicare 
benefits,
    b. enable such agency to administer a Federal health benefits 
program, or as necessary to enable such agency to fulfill a requirement 
of a Federal statute or regulation that implements a health benefits 
program funded in whole or in part with Federal funds, and/or
    c. assist Federal/state Medicaid programs within the state.
    Other Federal or state agencies (e.g., state survey agencies and 
state Medicaid agencies) may require OASIS data to contribute to the 
accuracy of CMS'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 may require OASIS data for purposes 
of determining, evaluating and/or assessing overall or aggregate cost, 
effectiveness, and/or the quality of HHA services provided in the 
state;
    Other Federal or state agencies may require OASIS data 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 an 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 CMS 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.
    Other state agencies in their administration of a Federal health 
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 CMS collects 
the information.
    3. 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. CMS 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.
    4. To PROs 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 CMS, 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 CMS and 
help regional home health intermediaries in home health program 
integrity assessment; and prepare summary information about the 
nation's home health care for release to beneficiaries.
    5. To national accrediting organizations with approval for deeming 
authority for Medicare requirements for

[[Page 66906]]

home health services (i.e., the Joint Commission on Accreditation of 
Healthcare Organizations, or the Community Health Accreditation 
Program). Information will be released to these organizations upon 
specific request, and only for those facilities that they accredit, and 
that participate in the Medicare program by virtue of their 
accreditation (deemed) status.
    CMS anticipates providing these national accrediting organizations 
with OASIS information to enable them to target potential or identified 
problems during the organization's accreditation review process of that 
facility.
    6. To the Department of Justice (DOJ), court, or adjudicatory body 
when:
    a. The Agency or any component thereof; or
    b. any employee of the Agency in his or her official capacity; or
    c. any employee of the Agency in his or her individual capacity 
where the DOJ has agreed to represent the employee; or
    d. the United States Government;

is a party to litigation or has an interest in such litigation, and by 
careful review, CMS determines that the records are both relevant and 
necessary to the litigation.
    Whenever CMS is involved in litigation, or occasionally when 
another party is involved in litigation and CMS's policies or 
operations could be affected by the outcome of the litigation, CMS 
would be able to disclose information to the DOJ, court, or 
adjudicatory body involved.
    7. To 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 CMS. The Member of 
Congress then writes CMS, and CMS must be able to give sufficient 
information to be responsive to the inquiry.
    8. To a CMS contractor (including, but not limited to Fiscal 
Intermediaries and carriers) that assists in the administration of a 
CMS-administered health benefits program, or to a grantee of a CMS-
administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud or abuse in such programs.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contract or grant with a 
third party to assist in accomplishing CMS functions relating to the 
purpose of combating fraud and abuse;
    CMS occasionally contracts out certain of its functions when doing 
so would contribute to effective and efficient operations. CMS must be 
able to give a contractor or grantee whatever information is necessary 
for the contractor or grantee to fulfill its duties. In these 
situations, safeguards are provided in the contract prohibiting the 
contractor or grantee from using or disclosing the information for any 
purpose other than that described in the contract and requiring the 
contractor or grantee to return or destroy all information.
    9. To another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any state or local governmental agency), that 
administers, or that has the authority to investigate potential fraud 
or abuse in, a health benefits program funded in whole or in part by 
Federal funds, when disclosure is deemed reasonably necessary by CMS to 
prevent, deter, discover, detect, investigate, examine, prosecute, sue 
with respect to, defend against, correct, remedy, or otherwise combat 
fraud or abuse in such programs.
    Other agencies may require OASIS information for the purpose of 
combating fraud and abuse in such Federally funded programs.

B. Additional Circumstances Affecting Routine Use Disclosure

    This SOR contains Protected Health Information as defined by HHS 
regulation ``Standards for Privacy of Individually Identifiable Health 
Information'' (45 CFR parts 160 and 164, 65 Federal Register FR 82462 
(12-28-00), as amended by 66 FR 12434 (2-26-01)). Disclosures of 
Protected Health Information authorized by these routine uses may only 
be made if, and as permitted or required by this HHS regulation 
``Standards for Privacy of Individually Identifiable Health 
Information''
    In addition, our policy will be to prohibit release even of non-
identifiable data, except pursuant to one of the routine uses, 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 
enrollees could, because of the small size, use this information to 
deduce the identity of the beneficiary).

IV. Safeguards

    The HHA OASIS system will conform to 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.'' CMS 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 CMS 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, CMS is monitoring the authorized users to ensure 
against excessive or unauthorized use. Records are used in a designated 
work area or workstation 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:
    <bullet> Database Administrator class owns the database objects; 
e.g., tables, triggers, indexes, stored procedures, packages, and has 
database administration privileges to these objects;
    <bullet> Quality Control Administrator class has read and write 
access to key fields in the database;
    <bullet> Quality Index Report Generator class has read-only access 
to all fields and tables;
    <bullet> Policy Research class has query access to tables, but are 
not allowed to access confidential patient identification information; 
and

[[Page 66907]]

    <bullet> 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 
that 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 resources caused by fire, electricity, water and 
inadequate climate controls.
    Protection applied to the workstations, servers and databases 
include:
    <bullet> User Log ons--Authentication is performed by the Primary 
Domain Controller/Backup Domain Controller of the log on domain.
    <bullet> Workstation Names--Workstation naming conventions may be 
defined and implemented at the state agency level.
    <bullet> 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.
    <bullet> Inactivity Lockout--Access to the NT workstation is 
automatically locked after a specified period of inactivity.
    <bullet> Warnings--Legal notices and security warnings display on 
all servers and when servers are accessed by workstations.
    <bullet> 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 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.

V. Effect of the Modified System on Individual Rights

    CMS established 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. CMS has assigned a higher level of security 
clearance for the information in this system to provide added security 
and protection of data in this system.
    CMS will monitor the collection and reporting of OASIS data. OASIS 
information on patients is completed by the HHA and submitted to CMS 
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. CMS will utilize a variety of onsite and offsite 
edits and audits to increase the accuracy of OASIS data. CMS will take 
precautionary measures (see item IV. above) to minimize the risks of 
unauthorized access to the records and the potential harm to individual 
privacy or other personal or property rights including not collecting 
patient identifiable data for non-Medicare and non-Medicaid patients. 
Therefore, CMS anticipates no adverse effect on any of these rights. 
CMS will collect only that information necessary to perform the 
system's functions. In addition, CMS 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 CMS Privacy Act SOR; to ensure the 
integrity, security, and confidentiality of information maintained by 
CMS; and to permit appropriate disclosure and use of such data as 
permitted by law, CMS and the non-CMS 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 CMS will disclose and the User will obtain and use the 
information contained in the system. The parties mutually agree that 
CMS 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 
CMS. The User represents and warrants further that the facts and 
statements made in any study or research protocol or project plan 
submitted to CMS 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 SOR 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 CMS determines or has reasonable belief that the User has made an 
unauthorized disclosure of the data, CMS in its sole discretion may 
require the User to: (a) Promptly investigate and report to CMS 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;

[[Page 66908]]

(d) submit a corrective action plan with steps to prevent any future 
unauthorized disclosures; and (e) return data files to CMS. If CMS 
determines or has reasonable belief that unauthorized disclosures have 
taken place; CMS may refuse to release further CMS data to the User for 
a period of time to be determined by CMS.
    The Privacy Act provides criminal penalties for certain violations. 
The Act provides that ``[a]ny 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 any 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 ``[a]ny 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 contractor's 
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.
    CMS, therefore, does not anticipate an unfavorable effect on 
individual privacy as a result of the disclosure of information 
relating to individuals.

    Dated: December 4, 2001.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
09-70-9002

System Name:
    Home Health Agency Outcome and Assessment Information Set (HHA 
OASIS)

Security Classification:
    Level Three Privacy Act Sensitive

System Location:
    CMS Data Center, 7500 Security Boulevard, North Building, First 
Floor, Baltimore, Maryland 21244-1850. CMS contractors and agents at 
various locations.

Categories of Individuals Covered by the System:
    The system of records (SOR) will contain clinical assessment 
information (OASIS) for all patients receiving the services of a 
Medicare and/or Medicaid approved HHA, except 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 maintained in the 
SOR only for those individuals whose payments come from Medicare or 
Medicaid.

Categories of Records in the System:
    This SOR will contain individual-level demographic and identifying 
data, as well as clinical status data for patients with the payment 
sources of Medicare traditional fee for service, Medicaid traditional 
fee for service, Medicare HMO/managed care or Medicaid HMO/managed 
care.

Authority for Maintenance of the System:
    Sections 1102(a), 1154, 1861(m), 1861(o), 1861(z), 1863, 1864, 
1865, 1866, 1871, 1891, and 1902 of the Social Security Act (the Act) 
authorize the Administrator of CMS to require HHAs participating in the 
Medicare and Medicaid programs to complete a standard, valid, patient 
assessment data set; i.e., the OASIS, as part of their comprehensive 
assessments and updates when evaluating adult, non-maternity patients 
as required by section 484.55 of the Conditions of Participation.

Purpose(s) of the System:
    The primary purposes of the SOR are to: (1) Study and help ensure 
the quality of care provided by home health agencies (HHA); (2) aid in 
administration of the survey and certification of Medicare/Medicaid 
HHAs; (3) enable regulators to provide HHAs with data for their 
internal quality improvement activities; (4) support agencies of the 
state government to determine, evaluate and assess overall 
effectiveness and quality of HHA services provided in the state; (5) 
provide for the validation, and refinements of the Medicare Prospective 
Payment System; (6) aid in the administration of Federal and state HHA 
programs within the state; and (7) monitor the continuity of care for 
patients who reside temporarily outside of the state. Information 
maintained in this system will also be disclosed to: (1) Support 
regulatory, reimbursement, and policy functions performed within the 
Agency or by a contractor or consultant; (2) assist another Federal 
and/or state agency, agency of a state government, an agency 
established by state law, or its fiscal agent, for evaluating and 
monitoring the quality of home health care and contribute to the 
accuracy of health insurance operations; (3) support research, 
evaluation, or epidemiological projects related to the prevention of 
disease or disability, or the restoration or maintenance of health, and 
for payment related projects; (4) support the functions of Peer Review 
Organizations (PRO); (5) support the functions of national accrediting 
organizations; (6) support litigation involving the Agency; (7) support 
constituent requests made to a Congressional representative; and (8) 
combat fraud and abuse in certain health care programs.

Routine Uses of Records Maintained in the System, Including Categories 
of 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 CMS may 
release information from the 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. In addition, our 
policy will be to prohibit release even of non-identifiable data, 
except pursuant to one of the routine uses, 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 enrollees could, because of 
the small size, use this information to deduce the identity of the 
beneficiary).
    This SOR contains Protected Health Information as defined by HHS 
regulation ``Standards for Privacy of Individually Identifiable Health 
Information'' (45 CFR Parts 160 and 164, 65 Federal Register (FR) 82462 
(12-28-00), as amended by 66 FR 12434 (2-26-01)). Disclosures of 
Protected Health Information authorized by these routine uses may only 
be made if, and as permitted or required by this HHS regulation 
``Standards for Privacy of Individually Identifiable Health 
Information.'' We are proposing to establish or modify the following 
routine use disclosures of information maintained in the system:
    1. To Agency contractors, or consultants who have been contracted 
by the Agency to assist in accomplishment of a CMS function relating to 
the purposes for this system and who need to have access to the records 
in order to assist CMS.
    2. To another Federal or state agency, agency of a state 
government, an agency

[[Page 66909]]

established by state law, or its fiscal agent, for evaluating and 
monitoring the quality of home health care and contribute to the 
accuracy of health insurance operations to:
    a. Contribute to the accuracy of CMS's proper payment of Medicare 
benefits,
    b. Enable such agency to administer a Federal health benefits 
program, or as necessary to enable such agency to fulfill a requirement 
of a Federal statute or regulation that implements a health benefits 
program funded in whole or in part with Federal funds, and/or
    c. Assist Federal/state Medicaid programs within the state.
    3. 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.
    4. To Peer Review Organizations (PRO) in order to assist the PRO to 
perform Title XI and Title XVIII functions relating to assessing and 
improving HHA quality of care.
    5. To national accrediting organizations with approval for deeming 
authority for Medicare requirements for home health services (i.e., the 
Joint Commission on Accreditation of Healthcare Organizations, or the 
Community Health Accreditation Program). Information will be released 
to these organizations only for those facilities that they accredit, 
and that participate in the Medicare program by virtue of their 
accreditation (deemed) status.
    6. 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, CMS determines that 
the records are both relevant and necessary to the litigation.
    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.
    8. To a CMS contractor (including, but not limited to Fiscal 
Intermediaries and carriers) that assists in the administration of a 
CMS-administered health benefits program, or to a grantee of a CMS-
administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud or abuse in such programs.
    9. To another Federal agency or to an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any state or local governmental agency), that 
administers, or that has the authority to investigate potential fraud 
or abuse in, a health benefits program funded in whole or in part by 
Federal funds, when disclosure is deemed reasonably necessary by CMS to 
prevent, deter, discover, detect, investigate, examine, prosecute, sue 
with respect to, defend against, correct, remedy, or otherwise combat 
fraud or abuse in such programs.

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 (SSN) or by state assigned 
Medicaid number.

Safeguards:
    CMS 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, CMS has physical safeguards in place to reduce the 
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 Circular #10, Automated 
Information Systems Security Program; CMS's Information System Security 
Policy and Program Handbook; and OMB Circular No. A-130 (revised) 
Appendix III.

Retention and Disposal:
    CMS and the repository of the National Archive and Records 
Administration will retain identifiable OASIS assessment data for a 
total period not to exceed fifteen (15) years.

System Manager and Address:
    Director, Center for Medicaid and State Operations, CMS, 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), 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. 01-31546 Filed 12-26-01; 8:45 am]
BILLING CODE 4120-03-P