Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Notices 66903

facilities, workers at DOE facilities, and

other persons potentially exposed to

radiation or to potential hazards from

non-nuclear energy production use.

HHS delegated program responsibility

to CDC.

In addition, a memo was signed in

October 1990 and renewed in November

1992, 1996, and in 2000, between

ATSDR and DOE. The MOU delineates

the responsibilities and procedures for

ATSDR’s public health activities at DOE

sites required under sections 104, 105,

107, and 120 of the Comprehensive

Environmental Response,

Compensation, and Liability Act

(CERCLA or ‘‘Superfund’’). These

activities include health consultations

and public health assessments at DOE

sites listed on, or proposed for, the

Superfund National Priorities List and

at sites that are the subject of petitions

from the public; and other healthrelated activities such as epidemiologic

studies, health surveillance, exposure

and disease registries, health education,

substance-specific applied research,

emergency response, and preparation of

toxicological profiles.

Purpose: This subcommittee is

charged with providing advice and

recommendations to the Director, CDC,

and the Administrator ATSDR,

regarding community concerns

pertaining to CDC’s and ATSDR’s public

health activities and research at this

DOE site. The purpose of this meeting

is to provide a forum for community

interaction and serve as a vehicle for

community concerns to be expressed as

advice and recommendations to CDC

and ATSDR.

Matters to be Discussed: Agenda items

include an update from the National

Institute for Occupational Safety and

Health (NIOSH); a presentation on

toxicity of heavy metals and

radionuclides; an update on screening

methods for Savannah River Site

production workers; and status reports

from the SRSHES working groups on

Epidemiologic Data, Scenario Screening,

and Phase II—Community Summary.

Agenda items are subject to change as

priorities dictate.

An administrative delay prevented

meeting the 15-day publication

requirement.

Contact Person for More Information:

Phillip Green, Executive Secretary,

SRSHES, Radiation Studies Branch,

Division of Environmental Hazards and

Health Effects, NCEH, CDC, 1600 Clifton

Road, N.E. (E–39), Atlanta, GA 30333,

telephone 404/498–1800, fax 404/498–

1811.

The Director, Management Analysis

and Services Office, has been delegated

the authority to sign Federal Register

notices pertaining to announcements of

meetings and other committee

management activities for both CDC and

ATSDR.

Dated: December 19, 2001.

John Burckhardt,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention.

[FR Doc. 01–31733 Filed 12–26–01; 8:45 am]

BILLING CODE 4163–18–P

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).

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.

66904 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Notices

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 nonpatient 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 nonpatient 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, nonmaternity 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 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. 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 nonMedicaid 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 nonidentifiable data may be disclosed under

a routine use. Identifiable data includes

individual records with OASIS

information and identifiers. Nonidentifiable 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.

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Notices 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

66906 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Notices

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:

• 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;

• Quality Index 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

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Notices 66907

• 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:

• 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.

• 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

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 nonMedicare 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;

66908 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Notices

(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 individuallevel 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, nonmaternity 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 nonidentifiable 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

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Notices 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