[Federal Register Volume 66, Number 218 (Friday, November 9, 2001)]
[Notices]
[Pages 56681-56687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28219]


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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).

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. The 
proposed system is titled ``Inpatient Rehabilitation Facilities Patient 
Assessment Instrument (IRF-PAI), HHS/CMS/CMSO, 09-70-1518.'' CMS 
proposes to establish a new system of records containing data on the 
physical, cognitive, functional, and psychosocial status of all 
patients receiving the services of Inpatient Rehabilitation Facilities 
(IRF) that are approved to participate in the Medicare program. 
Information will not be retained in this system for those individuals 
who have non-Medicare payment sources.
    The primary purpose of the IRF system of records is to support the 
IRF prospective payment system (PPS) for payment of the IRF Medicare 
Part A fee-for-services furnished by the IRF to Medicare beneficiaries. 
Other purposes for the system of records are to: (1) Help validate and 
refine the Medicare IRF-PPS; (2) study and help ensure the quality of 
care provided by IRFs; (3) enable CMS and its agents to provide IRFs 
with data for their own quality assurance and, (4) ultimately, quality 
improvement activities; (5) support agencies of the State government, 
deeming organizations or accrediting agencies to determine, evaluate 
and assess overall effectiveness and quality of IRF services provided 
in the State; (6) provide information to consumers to allow them to 
make better informed selections of providers; (7) support regulatory 
and policy functions performed within the IRF or by a contractor or 
consultant; (8) support constituent requests made to a Congressional 
representative; (9) support litigation involving the facility; and (10) 
support research on the utilization and quality of inpatient 
rehabilitation services; as well as, evaluation, or epidemiological 
projects related to the prevention of disease or disability, or the 
restoration or maintenance of health for understanding and improving 
payment systems. 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 November 2, 2001. 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.

[[Page 56682]]


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: Centers for Medicare & Medicaid 
Services (CMS), Director, Survey and Certification Group, 7500 Security 
Boulevard, S2-12-25, Baltimore, Maryland 21244-1850.

SUPPLEMENTARY INFORMATION:

I. Description of The New System of Records

A.Glossary of IRF-PAI Terms

    1. IRF-PAI Data Set--The IRF-PAI data set is the patient assessment 
instrument that contains the sum of the identifiers and information.
    2. Identifiers--Identifiers are the data elements that can be used 
to determine a patient's identity. These are: patient's name, social 
security number, Medicaid number, Medicare number, and patient 
identification number.
    3. IRF-PAI Information IRF-PAI information includes the clinical 
items listed below and case mix adjusters.
Patient History
Social Cognition
Functional Status
Bowel/Bladder Management
Diagnoses
Medical Complexities
Pain Status
Oral/Nutrition Status
Functional Prognosis
Safety
Resources for Discharge

B. Statutory and Regulatory Basis For System of Records

    Section 1886 (j) (2) (D) of the Social Security Act authorizes the 
Secretary to collect the data necessary to establish and administer the 
payment system.

C. Data/Information

    The IRF-PAI information may contribute to development of the 
patient care plan by identifying patients at risk for adverse outcomes, 
such as weight loss, aspiration, or pressure ulcers, and ensure that 
these patients are monitored to prevent such outcomes which might 
negatively impact patients' likelihood of optimal rehabilitation. The 
data collected will generate quality indicators that would allow 
providers to assess their performance, and to compare it against 
benchmarks derived from standards of care or the performance of peers. 
The detection of quality of care problems will guide CMS, the State 
survey agencies and accrediting agencies in surveying IRFs. This 
information will be valuable to CMS in fulfilling its responsibility 
for validating surveys conducted by accrediting agencies. Also, IRF-PAI 
items may be useful in developing core measures that provide meaningful 
information on patient characteristics and outcomes across post-acute 
care settings. We will monitor the data obtained from the IRF-PAI to 
assess the effects of implementing the changes in the payment system on 
the quality of care provided in post-acute care settings.
    The system of records will contain clinical assessment information 
(IRF-PAI records) for all Medicare Part A fee-for-service patients 
receiving the services of a Medicare approved IRF.

II. Collection and Maintenance of Data in the System

A. Scope of the Data Collected

    The IRF-PAI will be completed on all Medicare Part A fee-for-
service patients who receive services under Part A from an IRF. The 
IRF-PAI may be completed on Medicare+Choice enrollees, but it is not a 
requirement. The IRF-PAI data set includes identifiers and information 
(the specific areas have already been identified in the SUPPLEMENTARY 
INFORMATION section IA).

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 IRF-PAI 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 IRF-PAI 
information and identifiers. Non-identifiable data includes individual 
records with IRF-PAI information and masked identifiers or IRF-PAI 
information with identifiers stripped out of the file.
    We will only disclose the minimum personal data necessary to 
achieve the purpose of the IRF-PAI. 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., developing and refining 
payment systems and monitoring the quality of care provided to 
patients.
    2. 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 IRF-PAI 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.

[[Page 56683]]

    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 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 a Peer Review Organization (PRO) in order to assist the PRO 
to perform Title XI and Title XVIII functions relating to assessing and 
improving IRF quality of care. PROs will work with IRFs to implement 
quality improvement programs, provide consultation to CMS, its 
contractors, and to State agencies.
    The PROs may use these data to support quality improvement 
activities and other PRO responsibilities as detailed in Title XI, 
Sections 1151-1164.
    3. To another Federal or State agency:
    a. To contribute to the accuracy of CMS's proper payment of 
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 improve the state survey process for investigation of 
complaints related to health and safety or quality of care and to 
implement a more outcome oriented survey and certification program.
    Other Federal or State agencies in their administration of a 
Federal health program may require IRF-PAI information in order to 
support evaluations and monitoring of quality of care for special 
populations or special care areas, including proper payment 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.
    4. To an individual or organization for research on the utilization 
of inpatient rehabilitation services as well as evaluation or 
epidemiological projects related to the prevention of disease or 
disability, the restoration or maintenance of health, or for 
understanding and improving payment projects.
    The IRF-PAI data will provide an opportunity for comprehensive 
research, evaluation and epidemiological projects regarding IRF 
patients. CMS anticipates that many researchers will have legitimate 
requests to use these data in projects that could ultimately improve 
the care provided to IRF patients 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 a CMS contractor (including, but not necessarily 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 program.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual relationship 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 and makes 
grants 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.
    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 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 IRF-PAI information for the purpose of 
combating fraud and abuse in such Federally funded programs. Releases 
of information would be allowed if the proposed use(s) for the 
information proved compatible with the purposes of collecting the 
information.
    9. To a national accrediting organization whose accredited 
facilities are presumed to meet certain Medicare requirements for 
inpatient hospital rehabilitation services (e.g., the Joint Commission 
for the Accreditation of Healthcare Organizations (JCAHO), the American 
Osteopathic Association (AOA) or the Commission on Accreditation of 
Rehabilitation Facilities (CARF)). Information will be released to 
these organizations only for those facilities that they accredit and 
that participate in Medicare.
    At this time, CMS anticipates providing accrediting organizations 
with IRF-PAI information to enable them to target potential or 
identified problems during the organization's

[[Page 56684]]

accreditation review process of the facility.
    10. To insurance companies, third party administrators (TPA), 
employers, self-insurers, managed care organizations, other 
supplemental insurers, non-coordinating insurers, multiple employer 
trusts, group health plans (i.e., health maintenance organizations 
(HMO) or a competitive medical plan (CMP)) with a Medicare contract, or 
a Medicare-approved health care prepayment plan (HCPP), directly or 
through a contractor, and other groups providing protection for their 
enrollees. Information to be disclosed shall be limited to Medicare 
entitlement data. In order to receive the information, they must agree 
to:
    a. Certify that the individual about whom the information is being 
provided is one of its insured or employees, or is insured and/or 
employed by another entity for whom they serve as a third party 
administrator;utilize the information solely for the purpose of 
processing the individual's insurance claims; and
    b. Safeguard the confidentiality of the data and prevent 
unauthorized access. Other insurers, CMP, HMO, and HCPP may require 
IRF-PAI information in order to support evaluations and monitoring of 
Medicare claims information of beneficiaries, including proper payment 
for services provided.

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 IRF-PAI 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.'' HCFA has 
prepared a comprehensive system security plan as required by OMB 
Circular A-130, Appendix III. This plan conforms fully to guidance 
issued by the National Institute for Standards and Technology (NIST) in 
NIST Special Publication 800-18, ``Guide for Developing Security Plans 
for Information Technology Systems.'' Paragraphs A-C of this section 
highlight some of the specific methods that HCFA is using to ensure the 
security of this system and the information within it.

A. Authorized Users

    Personnel having access to the system have been trained in Privacy 
Act 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.

B. 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.

C. 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

[[Page 56685]]

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.

V. 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 IRF-PAI data. IRF-
PAI information on patients is completed by the IRF and 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 effective process for assuring quality of services. CMS will 
utilize a variety of onsite and offsite edits and audits to increase 
the accuracy of IRF-PAI 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: November 2, 2001.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
09-70-1518.

System Name:
    Inpatient Rehabilitation Facilities Patient Assessment Instrument 
(IRF PAI), HHS/CMS/CMSO.

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:
    The system of records will contain clinical assessment information 
(IRF-PAI records) for all Medicare Part A fee-for-service patients 
receiving the services of a Medicare approved Inpatient Rehabilitation 
Facility (IRF). Information will be retained in the system of records 
only for those individuals whose payments come from Medicare.

Categories of Records in the System:
    This system of records will contain individual-level demographic 
and identifying data, as well as clinical status data for patients with 
the payment source of traditional Medicare Part A fee-for-service and 
Medicare+Choice Enrollees.

Authority for Maintenance of the System:
    Section 1886 (j) (2) (D) of the Social Security Act authorizes the 
Secretary to collect the data necessary to establish and administer the 
payments system

Purpose(s) of the System:
    The primary purpose of the IRF system of records is to support the 
IRF prospective payment system (PPS) for payment of the IRF Medicare 
Part A fee-for-services furnished by the IRF to Medicare beneficiaries. 
Other purposes for the system of records are to: (1) Help validate and 
refine the Medicare IRF-PPS; (2) study and help ensure the quality of 
care provided by IRFs; (3) enable CMS and its agents to provide IRFs 
with data for their own quality assurance and, (4) ultimately, quality 
improvement activities; (5) support agencies of the State government, 
deeming organizations or accrediting agencies to determine, evaluate 
and assess overall effectiveness and quality of IRF services provided 
in the State; (6) provide information to consumers to allow them to 
make better informed selections of providers; (7) support regulatory 
and policy functions performed within the IRF or by a contractor or 
consultant; (8) support constituent requests made to a Congressional 
representative; (9) support litigation involving the facility; and (10) 
support research on the utilization and quality of inpatient 
rehabilitation services; as well as, evaluation, or epidemiological 
projects related to the prevention of disease or disability, or the 
restoration or maintenance of health for understanding and improving 
payment systems.

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 IRF-PAI 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 a Peer Review Organization (PRO) in order to assist the PRO 
to

[[Page 56686]]

perform Title XI and Title XVIII functions relating to assessing and 
improving IRF quality of care. PROs will work with IRFs to implement 
quality improvement programs, provide consultation to CMS, its 
contractors, and to State agencies.
    3. To another Federal or State agency:
    a. To contribute to the accuracy of CMS's proper payment of 
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 improve the state survey process for investigation of 
complaints related to health and safety or quality of care and to 
implement a more outcome oriented survey and certification program.
    4. To an individual or organization for research on the utilization 
of inpatient rehabilitation services as well as evaluation or 
epidemiological projects related to the prevention of disease or 
disability, or the restoration or maintenance of health 
epidemiological, or for understanding and improving payment projects.
    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:
    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 a CMS contractor (including, but not necessarily 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 program.
    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 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.
    9. To a national accrediting organization that has been approved 
for deeming authority for Medicare requirements for inpatient 
rehabilitation services (i.e., the Joint Commission for the 
Accreditation of Healthcare Organizations, the American Osteopathic 
Association and the Commission on Accreditation of Rehabilitation 
Facilities). Data will be released to these organizations only for 
those facilities that participate in Medicare by virtue of their 
accreditation status.
    10. To insurance companies, third party administrators (TPA), 
employers, self-insurers, managed care organizations, other 
supplemental insurers, non-coordinating insurers, multiple employer 
trusts, group health plans (i.e., health maintenance organizations 
(HMO) or a competitive medical plan (CMP)) with a Medicare contract, or 
a Medicare-approved health care prepayment plan (HCPP), directly or 
through a contractor, and other groups providing protection for their 
enrollees. Information to be disclosed shall be limited to Medicare 
entitlement data. In order to receive the information, they must agree 
to:
    a. Certify that the individual about whom the information is being 
provided is one of its insured or employees, or is insured and/or 
employed by another entity for whom they serve as a third party 
administrator;
    b. Utilize the information solely for the purpose of processing the 
individual's insurance claims; and
    c. Safeguard the confidentiality of the data and prevent 
unauthorized access

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 records are retrieved by health insurance claim (HIC) 
number, social security 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 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 will retain identifiable IRF-PAI data for a total period of 15 
years.

SYSTEM MANAGER AND ADDRESSES:
    Health Care Financing Administration, Center for Medicaid and State 
Operations, Director, Survey and Certification Group, 7500 Security 
Boulevard, S2-12-25, Baltimore, Maryland 2124-1850.

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

[[Page 56687]]

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:
    Inpatient Rehabilitation Facilities--Patient Assessment Instrument.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

[FR Doc. 01-28219 Filed 11-8-01; 8:45 am]
BILLING CODE 4120-03-P