[Federal Register Volume 67, Number 11 (Wednesday, January 16, 2002)]
[Notices]
[Pages 2216-2222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-1063]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of New System

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

[[Page 2217]]


ACTION: Notice of new system of records (SOR).

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to establish a new system of records (SOR), 
called the ``Evaluations of The Medicaid Reform Demonstrations 
(EMRD),'' HHS/CMS/OSP No. 09-70-0068. The primary purpose of this SOR 
is to collect and provide data necessary to evaluate a series of 
Medicaid Reform Demonstrations that rely on waivers of section 1115 of 
the Social Security Act. This system will allow measurement of the 
effects of the demonstration on beneficiaries eligibility, access to 
care, utilization, health care costs, satisfaction with care, quality 
of care and health status. The information retrieved from this SOR will 
be used: (1) To support program administration, reporting, and 
regulatory, reimbursement, and policy functions performed within the 
CMS or by a contractor or consultant; (2) to enable another Federal or 
State Agency to contribute to the accuracy of the CMS's proper payment 
of Medicaid, State Children's Health Insurance Program and Medicare 
benefits; (3) to enable CMS to administer a Federal health benefits 
program or to enable CMS 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; (4) to support constituent requests made 
by a Congressional representative; (5) to support litigation involving 
the Agency; (6) to support program administration, reporting, research, 
evaluation, and related issues; (7) and to disclose individual-specific 
information for the purpose of combating fraud and abuse in health 
benefits programs administered by CMS. 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.

EFFECTIVE DATES: CMS filed a new system 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 January 4, 2002. In any event, we will not disclose any 
information under a routine use until 40 days after publication. We may 
defer implementation of this system of records or one or more of the 
routine use statements listed below if we receive comments that 
persuade us to defer implementation.

ADDRESSES: The public should address comments to: Director, Division of 
Data Liaison and Distribution (DDLD), 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 time 
zone.

FOR FURTHER INFORMATION CONTACT: Sydney Galloway, Office of Strategic 
Planning, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, Maryland 21244-1850. The telephone number is 410-
786-6645.

SUPPLEMENTARY INFORMATION:   

I. Description of the New System of Records

A. Statutory and Regulatory Basis for System of Records

    CMS proposes to initiate a new SORs collecting data under the 
authority of section 1875(a) (42 U.S.C. 1395ll) and section 1115 (42 
U.S.C. 1315) of the Social Security Act. The EMRD SOR will provide data 
necessary to evaluate CMS's Evaluations of the Medicaid Reform 
Demonstrations. As part of this effort, individually identifiable data 
will be used to analyze the effects of the demonstration on beneficiary 
eligibility, access to care, utilization, health care costs, 
satisfaction with care, quality of care, and health status. The 
information retrieved from this SOR will be used: (1) To support 
program administration, reporting, and regulatory, reimbursement, and 
policy functions performed within the Centers for Medicare & Medicaid 
Services (CMS) or by a contractor or consultant; (2) to enable another 
Federal or State agency to contribute to the accuracy of the CMS's 
proper payment of Medicaid, State Children's Health Insurance Program 
and Medicare benefits; (3) to enable CMS to administer a Federal health 
benefits program or to enable CMS 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; (4) to support constituent 
requests made by a Congressional representative; (5) to support 
litigation involving the Agency; (6) to support program administration, 
reporting, research, evaluation, and related issues; (7) and to 
disclose individual-specific information for the purpose of combating 
fraud and abuse in health benefits programs administered by CMS.

B. Background

    As of September 1, 1999, 21 section 1115 waivers for demonstrations 
in the following States have been approved and implemented: Alabama 
(Mobile County only), Arizona, Arkansas, California (Los Angeles County 
only), Delaware, District of Columbia, Florida, Hawaii, Kentucky, 
Maryland, Massachusetts, Minnesota, New Jersey, New York, Ohio, 
Oklahoma, Oregon, Rhode Island, Tennessee, Vermont and Wisconsin.
    CMS has awarded a number of contracts to independent evaluators to 
assess the demonstrations thus far. These evaluations include:
    Evaluation of the State Health Reform Demonstrations (Contract 
Number 500-94-0047)--Awarded to prime contractor Mathematica Policy 
Research, Inc. and subcontractors.
    Examines the impact of five State Medicaid reform demonstrations 
(Hawaii, Maryland, Oklahoma, Rhode Island, and Tennessee).
    Evaluation of the Medicaid Health Reform Demonstrations (Contract 
Number 500-95-0040) Awarded to Urban Institute and its subcontractors.
    Examines five health reform demonstrations (California (Los Angeles 
County only), Kentucky, Minnesota, New York, and Vermont).
    Evaluation of the Oregon Medicaid Reform Demonstration (Contract 
Number 500-94-0056)--Awarded to Health Economics Research, Inc. and 
subcontractors.
    Examines the impacts of the Oregon Medicaid Reform Demonstration.
    Evaluation of Delaware's Diamond State Health Plan (500-92-0033 
Delivery Order Nos. 1 and 4)--Awarded to Research Triangle Institute 
and subcontractors.
    Examines the impacts of the Delaware demonstration, with particular 
emphasis on children, including children with special health care 
needs.
    Evaluation of Mass Health Quality Improvement Plan and Insurance 
Reimbursement Program (Contract Number 500-95-0058/T.O. #9)--Awarded to 
Health Economics Research, Inc. and subcontractors.
    The evaluation will consist of two parts: (1) A case study of the 
quality improvement process in Medicaid MCOs and PCCs; (2) A case study 
of the implementation of the Insurance Reimbursement Program for low-
income families.
    Evaluation of the District of Columbia's Demonstration Project, 
``Managed Care System for Disabled and

[[Page 2218]]

Special Needs Children'' (Contract Number 500-96-0003)--Awarded to Abt 
Associates, Inc. and subcontractors.
    The goal of this project is to document and analyze the experiences 
of the District of Columbia's managed care system for children and 
adolescents under the age of 22 who are eligible for Medicaid and who 
are considered disabled according to Supplemental Security Income (SSI) 
Program guidelines.
    Focused Evaluation of Ohio Section 1115 State Health Reform 
Demonstration: Behavioral Health (Contract Number 500-97-0022)--Awarded 
to Heath Economics Research, Inc. and subcontractors.
    This evaluation will consist of the following two components: (1) A 
focused evaluation of the behavioral health component of OhioCare, 
Ohio's section 1115 State health reform demonstration; and (2) A case 
study of the implementation of OhioCare.
    Additional contracts will be awarded to evaluate other 
demonstrations as they are approved.
    1. Each evaluation conducts analyses to answer the following broad 
questions for participants, individuals, employers or other relevant 
parties; or nonparticipant comparison populations from the pre-
demonstration period, during the demonstration, and post-demonstration 
period.
    2. How were the demonstrations implemented, and what processes were 
put in place to administer them. Are these processes effective?
    3. What are the impacts of the demonstrations on eligibility and 
access to care?
    4. What are the demonstrations' impacts on quality, including 
health status impacts, the process of care delivered, and satisfaction 
with care received?
    5. What are the impacts of the demonstrations on the utilization of 
services?
    6. What are the impacts of the demonstrations on cost, from 
Federal, State, provider, employer, and beneficiary perspectives?
    As part of these efforts, the contractors will use individually 
identifiable data from state administrative data bases (including, but 
not, limited to, Medicaid eligibility, claims and encounter data), CMS 
data bases, data from other Federal and State agencies (including, but 
not limited to, the Social Security Administration), and other relevant 
data bases, surveys and vital records to analyze the effects of the 
demonstration on beneficiary eligibility, access to care, health care 
costs, satisfaction with care, and health status. CMS and the 
contractor will collect only that information necessary to perform the 
system's function.

II. Collection and Maintenance of Data in the System

A. Scope of the Data Collected

    The SOR is expected to include data on the number and type of 
services used by demonstration participants and comparison group 
members and their experiences in accessing health care before, during, 
and after the demonstration period. Sources of information contained in 
this records system are expected to include: State Medicaid Management 
Information Systems, managed care organizations (i.e., encounter data), 
fee-for-service providers, surveys of demonstration participants or 
providers and comparison group members, medical records, Social 
Security Administration data bases, vital statistics, and other 
relevant data systems.

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 EMRD information that can be 
associated with an individual 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 EMRD 
information and identifiers. Non-identifiable data includes individual 
records with EMRD information and masked identifiers or EMRD 
information with identifiers stripped out of the file.
    We will only disclose the minimum personal data necessary to 
achieve the purpose of the EMRD. CMS has the following policies and 
procedures concerning disclosures of information that will be 
maintained in the system. 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:
    1. Determines that the use or disclosure is consistent with the 
reason that the data is being collected; e.g., to evaluate the effects 
of the demonstration on beneficiaries eligibility, access to care, 
utilization, health care costs, satisfaction with care; quality of 
care, and health status.
    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).
    3. Requires the information recipient to:
    a. Establish administrative, technical, and physical safeguards to 
prevent
    b. Unauthorized use of disclosure of the record;
    c. Remove or destroy at the earliest time all patient-identifiable 
information; and
    d. Agree to not use or disclose the information for any purpose 
other than the stated purpose under which the information was 
disclosed.
    4. 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 EMRD 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 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 the performance of a service related to this 
system of records and who need to have access to the records in order 
to perform the activity.
    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 agency business 
functions relating to purposes for this system of records.
    CMS occasionally contracts out certain of its functions when doing 
so

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would contribute to effective and efficient operations. CMS must be 
able to give a contractor whatever information is necessary for the 
contractor to fulfill its duties. In these situations, safeguards are 
provided in the contract prohibiting the contractor from using or 
disclosing the information for any purpose other than that described in 
the contract and requires the contractor to return or destroy all 
information at the completion of the contract.
    2. To the Agency of a state or local government, or established by 
state law, for purposes of ensuring that no payments are made with 
respect to any item or service furnished by an individual or entity 
during the period when such individual or entity is excluded from 
participation in Medicaid, SCHIP, Medicare or other Federal and State 
health care programs. Data will be released to the State only on those 
individuals who are either individuals or entities excluded from 
participation in Medicaid, SCHIP, Medicare, or other Federal and State 
health care programs, or employers of excluded individuals or entities, 
or are legal residents of the State, irrespective of the location of a 
provider or supplier furnishing items or services.
    Program evaluation relies, in large part, on program integrity and 
the integrity of collected data, the routine use proposed in this 
paragraph is a necessary requirement for this database, and is 
therefore, compatible with the purpose for which the information is 
being collected.
    3. To another Federal or state agency:
    a. To contribute to the accuracy of CMS's proper payment of 
Medicaid, SCHIP, or Medicare benefits,
    b. To 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, or
    c. To fulfill reporting requirements, research, evaluation, or 
other policy or epidemiological considerations.
    CMS, and other Federal or state and local agencies, all contribute 
data to the databases included in this SOR, and (both separately and 
jointly) have an interest in performing program evaluation, conducting 
research and maintaining program integrity. Therefore, the routine uses 
described herein are compatible with the purpose for which the data are 
being collected.
    4. To an individual or other private or public entity for research, 
evaluation or epidemiological projects related to the prevention of 
disease or disability, the restoration or maintenance of health, or for 
projects designed to increase the efficiency and economy of care 
provision.
    The EMRD data will provide an opportunity for comprehensive 
research, evaluation and epidemiological projects regarding EMRD 
patients. CMS anticipates that many researchers will have legitimate 
requests to use these data in projects that could ultimately improve 
the care provided to Medicaid, SCHIP and Medicare beneficiaries and the 
policy that governs the care.
    5. 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.
    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. A determination would be made in each instance that, 
under the circumstances involved, the purposes served by the use of the 
information in the particular litigation is compatible with a purpose 
for which CMS collects the information.
    7. To CMS or State contractors, to administer some aspect of the 
health benefits programs, or to a CMS grantee or program which is or 
could be affected by fraud and abuse, for the purpose of preventing, 
deterring, discovering, detecting, investigating, examining, 
prosecuting, suing with respect to, defending against, correcting, 
remedying, or otherwise combating such fraud and abuse in such 
programs.
    CMS contemplates 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 CMS functions 
relating to purposes for this SORs.
    CMS occasionally contracts out certain of its functions when this 
would contribute to effective and efficient operations. CMS must be 
able to give a contractor whatever information is necessary for the 
contractor to fulfill its duties. In these situations, safeguards (like 
ensuring that the purpose for which the disclosure is to be made is of 
sufficient importance to warrant the effect and/or risk on the privacy 
of the individual that additional exposure of the record might bring 
and those stated in II.B above), are provided in the contract 
prohibiting the contractor from using or disclosing the information for 
any purpose other than that described in the contract and to return or 
destroy all information.
    Program evaluation relies, in large part, on program integrity and 
the integrity of collected data, the routine use proposed in this 
paragraph is a necessary requirement for this database, and is 
therefore, compatible with the purpose for which the information is 
being collected.
    8. 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 government agency, for the purpose 
of preventing, deterring, discovering, detecting, investigating, 
examining, prosecuting, suing with respect to, defending against, 
correcting, remedying, or otherwise combating such fraud and abuse in 
health benefits program funded in whole or in part by Federal funds.
    Other State or local agencies in their administration of a Federal 
health program may require EMRD information for the purpose of 
preventing, deterring, discovering, detecting, investigating, 
examining, prosecuting, suing with respect to, defending against, 
correcting, remedying, or otherwise combating such fraud and abuse in 
such programs. 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.
    Program evaluation relies, in large part, on program integrity and 
the integrity of collected data, the routine use proposed in this 
paragraph is a necessary requirement for this database, and is 
therefore, compatible with the

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purpose for which the information is being collected.

B. Additional Provisions Affecting Routine Use Disclosures

    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 System of Records contains Protected Health Information as 
defined by the Department of Health and Human Services' regulation 
``Standards for Privacy of Individually Identifiable Health 
Information'' (45 CFR parts 160 and 164, 65 FR 82462 as amended by 66 
FR 12434). Disclosures of Protected Health Information authorized by 
these routine uses may only be made if, and as, permitted or required 
by the ``Standards for Privacy of Individually Identifiable Health 
Information.''

IV. Safeguards

    The HHS EMRD 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 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. Records are used 
in a designated work area and system location is attended at all times 
during working hours.
    To ensure security of the data, the proper level of class user is 
assigned for each individual user 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
     Submitter class has read and write access to database 
objects, but no database administration privileges.

A. Physical Safeguards

    All server sites will implement 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 CMS system:
    Access to all servers is to be 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 is to require a 
specific log-on process. All entrance doors are identified and marked. 
A log is kept of all personnel who were issued a security card, key 
and/or combination, which grants access to the room housing the server, 
and all visitors are escorted while in this room. All servers are 
housed in an area where appropriate environmental security controls are 
implemented, which include measures implemented to mitigate damage to 
Automated Information Systems (AIS) resources caused by fire, 
electricity, water and inadequate climate controls.
    Protection applied to the workstations, servers and databases 
include:
     User Log-on--Authentication is to be 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 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 to be determined and 
implemented at the agency level.
     Inactivity Lockout--Access to the NT workstation is to be 
automatically locked after a specified period of inactivity.
     Warnings--Legal notices and security warnings are to be 
displayed on all servers and workstations.
     Remote Access Security--Windows NT Remote Access Service 
(RAS) security handles resource access control. Access to NT resources 
is to be 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.

A. Procedural Safeguards

    All automated systems must comply with Federal laws, guidance, and 
policies for information systems security. These include, but are not 
limited to: the Privacy Act of 1974; the Computer Security Act of 1987; 
OMB Circular A-130, revised; Information Resource Management (IRM) 
Circular #10; HHS Automated Information Systems Security Program; the 
CMS Information Systems Security Policy, Standards, and Guidelines 
Handbook; and other CMS systems security policies. 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.

II. Effects of the New System On Individual Rights

    CMS proposes to establish this system in accordance with the 
principles and requirements of the Privacy Act and will collect, use, 
and disseminate information only as prescribed therein. Data in this 
system will be subject to the authorized releases in accordance with 
the routine uses identified in this system of records.
    CMS will monitor the collection and reporting of EMRD data. EMRD 
information on patients is submitted to CMS through standard systems. 
Accuracy of the data is important since incorrect information could 
result in the wrong payment for services and a less

[[Page 2221]]

effective process for assuring quality of services. CMS will utilize a 
variety of onsite and offsite edits and audits to increase the accuracy 
of EMRD 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 of patients whose data is maintained in the system. CMS will 
collect only that information necessary to perform the system's 
functions. In addition, CMS will make disclosure 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.
    CMS, therefore, does not anticipate an unfavorable effect on 
individual privacy as a result of maintaining this system of records.

    Dated: January 4, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
09-70-0068

SYSTEM NAME:
    ``Evaluations of the Medicaid Reform Demonstrations,'' (EMRD).

SECURITY CLASSIFICATION:
    Level 3, Privacy Act Sensitive.

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

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Individuals eligible for Medicaid under the demonstrations 
(eligibility requirements vary by State) and individuals selected as 
comparison group members for the evaluations.

CATEGORIES OF RECORDS IN THE SYSTEM:
    The system will contain information concerning individual 
identifiers, demographics, employment, health care coverage, diagnostic 
and health status information, utilization and cost of health care 
services, and responses to survey or, other types of data collection 
methods.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Section 1875(a) (42 U.S.C. 1395ll) and section 1115 (42 U.S.C. 
1315) of the Social Security Act.

PURPOSE(S) OF THE SYSTEM:
    The primary purpose of this system of records (SOR) is to collect 
and provide data necessary to evaluate a series of Medicaid Reform 
Demonstrations that rely on waivers of section 1115 of the Social 
Security Act. This system will allow measurement of the effects of the 
demonstration on beneficiaries eligibility, access to care, 
utilization, health care costs, satisfaction with care, quality of care 
and health status. The information retrieved from this SOR will be 
used: (1) To support program administration, reporting, and regulatory, 
reimbursement, and policy functions performed within the Health Care 
Financing Administration (CMS) or by a contractor or consultant; (2) to 
enable another Federal or State agency to contribute to the accuracy of 
the CMS's proper payment of Medicaid, State Children's Health Insurance 
Program and Medicare benefits; (3) to enable CMS to administer a 
Federal health benefits program or to enable CMS 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; (4) to 
support constituent requests made by a Congressional representative; 
(5) to support litigation involving the agency; (6) to support program 
administration, reporting, research, evaluation, and related issues; 
(7) and to disclose individual-specific information for the purpose of 
combating fraud and abuse in health benefits programs administered by 
CMS.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OR USERS AND THE PURPOSES OF SUCH USES:
    These routine uses specify circumstances, in addition to those 
provided by statute in the Privacy Act of 1974, under which CMS may 
release information from the EMRD 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). Be advised, this System of Records contains Protected 
Health Information as defined by the Department of Health and Human 
Services' regulation ``Standards for Privacy of Individually 
Identifiable Health Information'' (45 CFR parts 160 and 164, 65 FR 8462 
as amended by 66 FR 12434). Disclosures of Protected Health Information 
authorized by these routine uses may only be made if, and as, permitted 
or required by the ``Standards for Privacy of Individually Identifiable 
Health Information.''
    1. To agency contractors or consultants who have been contracted by 
the agency to assist in the performance of a service related to this 
system of records and who need to have access to the records in order 
to perform the activity.
    2. To the Agency of a state or local government, or established by 
state law, for purposes of ensuring that no payments are made with 
respect to any item or service furnished by an individual or entity 
during the period when such individual or entity is excluded from 
participation in Medicaid, SCHIP, Medicare or other Federal and state 
health care programs. Data will be released to the State only on those 
individuals who are either individuals or entities excluded from 
participation in Medicaid, SCHIP, Medicare, or other Federal and state 
health care programs, or employers of excluded individuals or entities, 
or are legal residents of the State, irrespective of the location of a 
provider or supplier furnishing items or services.
    3. To another Federal or state agency:
    a. To contribute to the accuracy of CMS's proper payment of 
Medicaid, SCHIP, or Medicare benefits,
    b. To 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, or
    c. To fulfill reporting requirements, research, evaluation, or 
other policy or epidemiological considerations.
    4. To an individual or other private or public entity for research, 
evaluation or epidemiological projects related to the prevention of 
disease or disability, the restoration or maintenance of health, or for 
projects designed to increase the efficiency and economy of care 
provision.
    5. 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.
    6. To the Department of Justice (DOJ), court or adjudicatory body 
when:

[[Page 2222]]

    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 and the 
use of such records by the DOJ, court or adjudicatory body is 
compatible with the purpose for which the agency collected the records.
    7. To CMS or state contractors, to administer some aspect of the 
health benefits programs, or to a CMS grantee or program which is or 
could be affected by fraud and abuse, for the purpose of preventing, 
deterring, discovering, detecting, investigating, examining, 
prosecuting, suing with respect to, defending against, correcting, 
remedying, or otherwise combating such fraud and abuse in such 
programs.
    8. 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 government agency, for the purpose 
of preventing, deterring, discovering, detecting, investigating, 
examining, prosecuting, suing with respect to, defending against, 
correcting, remedying, or otherwise combating such fraud and abuse in 
health benefits program funded in whole or in part by Federal funds.

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

RETRIEVABILITY:
    Beneficiary's name, Medicaid identification number, Health 
Insurance Claim Number, Social Security Number or other identifying 
variables retrieve the records.

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 CMS system. For computerized records, 
safeguards have been established in accordance with HHS standards and 
National Institute of Standards and Technology guidelines; e.g., 
security codes will be used, limiting access to authorized personnel. 
System securities are established in accordance with HHS, Information 
Resource Management (IRM) Circular #10, Automated Information Systems 
Security Program; CMS Information Systems Security, Standards 
Guidelines Handbook and OMB Circular No. A-130 (revised) Appendix III.

RETENTION AND DISPOSAL:
    CMS and the repository of the National Archive and Records 
Administration (NARA) will retain identifiable EMRD data permanently, 
or as an indefinite retention.

SYSTEM MANAGER AND ADDRESS:
    CMS, Director, Office of Strategic Planning, Health Care Financing 
Administration, 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), address, age, and sex, and social 
security number (SSN) (furnishing the SSN is voluntary, but it may make 
searching for a record easier and prevent delay).

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 part 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 part 5b.7.)

Record Source Categories:
    Sources of information contained in this records system are 
expected to include: State Medicaid Management Information Systems, 
managed care organizations (i.e., encounter data), fee-for-service 
providers, surveys of demonstration participants or providers and 
comparison group members, medical records, Social Security 
Administration data bases, vital statistics and other relevant data 
systems.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

[FR Doc. 02-1063 Filed 1-15-02; 8:45 am]
BILLING CODE 4120-03-P