[Federal Register Volume 70, Number 232 (Monday, December 5, 2005)]
[Notices]
[Pages 72437-72442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-6808]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers For Medicare & Medicaid Services


Privacy Act of 1974; Report of a New System of Records

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Notice of a 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 title, 
``Implantable Cardioverter-Defibrillator (ICD) System, System No. 09-
70-0548.'' National coverage determinations (NCDs) are determinations 
by the Secretary with respect to whether or not a particular item or 
service is covered nationally under title XVIII of the Social Security 
Act (the Act) Sec.  1869(f)(1)(B). In order to be covered by Medicare, 
an item or service must fall within one or more benefit categories 
contained within Part A or Part B, and must not be otherwise excluded 
from coverage. Moreover, with limited exceptions, the expenses incurred 
for items or services must be ``reasonable and necessary for the 
diagnosis or treatment of illness or injury or to improve the 
functioning of a malformed body member,'' Sec.  1862(a)(1)(A). CMS has 
determined that the evidence is adequate to conclude that an 
implantable cardioverter-defibrillator (ICD) is reasonable and 
necessary in several patient groups where certain criteria for these 
patients have been met. The reasonable and necessary determination 
requires that patients meet the ICD implantation criteria set forth in 
the decision memorandum and are consistent with the trials discussed. 
Collection of these data elements allows that determination to be made.
    The purpose of this system is to provide reimbursement for ICDs and 
assist in the collection of data on patients receiving an ICD for 
primary prevention to a data collection process to assure patient 
safety and protection and to determine that the ICD is reasonable and 
necessary. Information retrieved from 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 or state agency with information to enable 
such agency to administer a Federal health benefits program, or to 
enable such agency to fulfill a requirement of Federal statute or 
regulation that implements a health benefits program funded in whole or 
in part with Federal funds; (3) to an individual or organization for a 
research project or in support of an evaluation project related to the 
prevention of disease or disability, the restoration or maintenance of 
health, or payment related projects; (4) support constituent requests 
made to a congressional representative; (5) support litigation 
involving the agency; and (6) combat fraud and abuse in certain health 
benefits programs. We have provided background information about the 
modified system in the ``Supplementary Information'' section below. 
Although the Privacy Act requires only that CMS provide an opportunity 
for interested persons to comment on the proposed routine uses, CMS 
invites comments on all portions of this notice. See Effective Dates 
section for comment period.

EFFECTIVE DATE: CMS filed a new SOR report with the Chair of the House 
Committee on Government Reform and

[[Page 72438]]

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 28, 2005 . We will 
not disclose any information under a routine use until 30 days after 
publication. 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 comment to the CMS Privacy 
Officer, Mail Stop 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: Rosemarie Hakim, Epidemiologist, 
Office of Clinical Standards and Quality, CMS, Mail Stop C1-09-06, 7500 
Security Boulevard, Baltimore, Maryland 21244-1849, Telephone Number 
(410) 786-3934, [email protected].

SUPPLEMENTARY INFORMATION: We desire to ensure that defibrillator 
implantation only occurs in those patients who are most likely to 
benefit and that the procedures are done only by competent providers in 
facilities with a history of good outcomes and a quality assessment/
improvement program to identify providers with poor outcomes and other 
areas for improvement. As mentioned above, we are concerned that the 
available evidence does not allow providers to target these devices to 
patients who will clearly derive benefit. In order to provide maximum 
protection to our beneficiaries, CMS will require that reimbursement 
for ICDs for primary prevention of sudden cardiac death occur only if 
the beneficiary receiving the defibrillator implantation is enrolled in 
either a FDA approved category B IDE clinical trial, a trial under the 
CMS Clinical Trial Policy or a qualifying data collection system 
including approved clinical trials and registries.
    The submission of data on patients receiving an ICD for primary 
prevention to a data collection process is needed to assure patient 
safety and protection and to determine that the ICD is reasonable and 
necessary. These patient protections and safeguards require that data 
be made available in some form to providers and practitioners to inform 
their decisions, monitor performance quality, benchmark and identify 
best practices. The reasonable and necessary determination requires 
that patients meet the ICD implantation criteria set forth in this 
decision memorandum and are consistent with the trials discussed. 
Collection of these data elements allows that determination to be made. 
We will also ensure that any future data collection system are 
consistent with the Standards for Privacy of Individually Identifiable 
Health Information and that all issues related to patient 
confidentiality, privacy, and compliance with other Federal laws will 
be resolved prior to the collection of any data.
    There will be an initial ICD registry so that data collection can 
begin with the posting of this decision. A data submission mechanism 
will be used that is already in use by Medicare participating hospitals 
to submit quality data. Initial hypotheses to be addressed by the 
registry will include the following:
    1. The clinical characteristics of the registry patients receiving 
ICDs are similar to those of patients involved in the primary 
prevention randomized clinical trials.
    2. The indications for ICD implantation in registry patients are 
similar to those in the primary prevention randomized clinical trials.
    3. The in-hospital procedure related complications for registry 
patients is similar to those in the primary prevention randomized 
clinical trials.
    4. Certified providers competent in ICD implantation are implanting 
ICD devices in registry patients.
    5. Registry patients who receive an ICD represent patients for 
which current clinical guidelines and the evidence base recommend 
implantation.
    6. The clinical characteristics and indications for ICD 
implantation in registry patients do not differ significantly among 
facilities.
    7. The clinical characteristics and indications for ICD 
implantation in registry patients do not differ significantly among 
providers.
    8. The in-hospital procedure related complications for ICD 
implantation in registry patients does not differ significantly among 
facilities.
    9. The in-hospital procedure related complications for ICD 
implantation in registry patients does not differ significantly among 
providers.
    10. The in-hospital procedure related complications for ICD 
implantation in registry patients does not differ significantly among 
device manufacturer, types, and/or programming.
    Data elements necessary to address these hypotheses are the minimum 
necessary to determine that the ICD is reasonable and necessary. CMS 
reserves the right to modify these hypotheses and elements as other 
evidence becomes available. Initially, an ICD registry will be 
maintained using a data submission mechanism that is already in use by 
Medicare participating hospitals to submit quality data. Data 
collection will be completed using the ICDA (ICD Abstraction Tool) and 
transmitted via Quality Network Exchange (QNET) to the Iowa Foundation 
for Medical Care (IFMC) who will collect and maintain registry data. 
CMS will post additional information on data submission on its coverage 
website, through the MedLearn system, and through the QNET education 
program.
    This registry is only an initial data collection process. A follow-
on registry that will replace the QNET registry and address additional 
hypotheses is currently being explored with specialty societies, 
industry, health plans and hospital associations. Industry has 
committed to developing a system to more closely evaluate the benefit 
in patients with LVEF 30-35%, NYHA Class IV in CRT-D, or NIDCM of 3-9 
months duration. Specialty societies have indicated interest in more 
clearly defining appropriate facility and provider standards. CMS will 
continue to encourage the public discussion of the appropriate 
replacement registry. We will also ensure that any future data 
collection system is consistent with the Standards for Privacy of 
Individually Identifiable Health Information and that all issues 
related to patient confidentiality, privacy, and compliance with other 
Federal laws will be resolved prior to the collection of any data.
    Finally, technology exists to easily capture the type of data 
collected in our initial registry and to prevent repeated entry of 
identical data into the several trials or registries in which hospitals 
participate. CMS is interested in public input into how the Agency 
might assist the healthcare community in creating a single data entry 
system.

I. Description of the Proposed System of Records

 A. Statutory and Regulatory Basis for SOR

    The statutory authority for linking coverage decisions to the 
collection of additional data is derived from Sec. 1862(a)(1)(A) of the 
Act, which states that Medicare may not provide payment for items and 
services unless they are ``reasonable and necessary'' for the treatment 
of illness or injury. In some cases, CMS will determine that an item or 
service is only reasonable and necessary when specific data collections 
accompany the provisions of the

[[Page 72439]]

service. In these cases, the collection of data is required to ensure 
that the care provided to individual patients will improve health 
outcomes.

B. Collection and Maintenance of Data in the System

    CMS has determined that the evidence is adequate to conclude that 
an implantable cardioverter-defibrillator (ICD) is reasonable and 
necessary for the following:
     Patients with ischemic dilated cardio-myopathy, documented 
prior myocardial infarction (MI), New York Heart Association (NYHA) 
Class II and III heart failure, and measured left ventricular ejection 
fraction (LVEF) <= 35%;
     Patients with nonischemic dilated cardiomyopathy > 9 
months, NYHA Class II and III heart failure, and measured LVEF <= 35%;
     Patients who meet all current CMS coverage requirements 
for a cardiac resynchronization therapy device and have NYHA Class IV 
heart failure.
    The collected information will contain name, address, telephone 
number, Health Insurance Claim Number (HICN), geographic location, 
race/ethnicity, gender, and date of birth, as well as, background 
information relating to Medicare or Medicaid issues.

II. Agency Policies, Procedures, and Restrictions on the Routine Use

 A. 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 ICD information that can be associated 
with an individual as provided for under ``Section III. Proposed 
Routine Use Disclosures of Data in the System.'' Both identifiable and 
non-identifiable data may be disclosed under a routine use.
    We will only collect the minimum personal data necessary to achieve 
the purpose of ICD. CMS has the following policies and procedures 
concerning disclosures of information that will be maintained in the 
system. Disclosure of information from the SOR will be approved only to 
the extent necessary to accomplish the purpose of the disclosure and 
only after CMS:
    1. Determines that the use or disclosure is consistent with the 
reason that the data is being collected, e.g., to provide reimbursement 
for ICDs and assist in the collection of data on patients receiving an 
ICD for primary prevention to a data collection process to assure 
patient safety and protection and to determine that the ICD is 
reasonable and necessary.
    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 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.
    4. Determines that the data are valid and reliable.

 III. Proposed Routine Use Disclosures of Data in the System

    A. The Privacy Act allows 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 compatible use of data is known as a ``routine 
use.'' The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. 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 engaged by 
the agency to assist in the performance of a service related to this 
system of records and who need to have access to the records in order 
to perform the activity.
    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 CMS function 
relating to purposes for this system.
    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 to:
    a. To provide reimbursement for ICDs and assist in the collection 
of data on patients receiving an ICD for primary prevention to a data 
collection process to assure patient safety and protection and to 
determine that the ICD is reasonable and necessary,
    b. Contribute to the accuracy of CMS's proper payment of Medicare 
benefits, and/or
    c. 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.
    Other Federal or state agencies in their administration of a 
Federal health program may require ICD information in order to provide 
reimbursement for ICDs and assist in the collection of data on patients 
receiving an ICD for primary prevention to a data collection process to 
assure patient safety and protection and to determine that the ICD is 
reasonable and necessary.
    3. To an individual or organization for a research project or in 
support of an evaluation project related to the prevention of disease 
or disability, the restoration or maintenance of health, or payment 
related projects.
    The ICD data will provide for research or in support of evaluation 
projects, a broader, longitudinal, national perspective of the status 
of Medicare beneficiaries. CMS anticipates that many researchers will 
have legitimate requests to use these data in projects that could 
ultimately improve the care provided to Medicare beneficiaries and the 
policy that governs the care.
    4. 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 an 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.

[[Page 72440]]

    5. 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 that 
the use of such records by the DOJ, court or adjudicatory body is 
compatible with the purpose for which the agency collected the records.
    Whenever CMS is involved in litigation, and occasionally when 
another party is involved in litigation and CMS' 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.
    6. 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.
    7. 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 ICD 
information for the purpose of combating fraud and abuse in such 
Federally funded programs.
    B. Additional Provisions Affecting Routine Use Disclosures. This 
system contains Protected Health Information (PHI) as defined by HHS 
regulation ``Standards for Privacy of Individually Identifiable Health 
Information'' (45 Code of Federal Regulations (CFR) Parts 160 and 164, 
65 Fed. Reg. 82462 (12-28-00), Subparts A and E.) Disclosures of PHI 
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.''
    In addition, our policy will be to prohibit release even if not 
directly identifiable information, except pursuant to one of the 
routine uses or if required by law, if we determine 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

    CMS has safeguards in place 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 
information security requirements. Employees who maintain records in 
this system are instructed not to release data until the intended 
recipient agrees to implement appropriate management, operational and 
technical safeguards sufficient to protect the confidentiality, 
integrity and availability of the information and information systems 
and to prevent unauthorized access.
    This system will conform to all applicable Federal laws and 
regulations and Federal, HHS, and CMS policies and standards as they 
relate to information security and data privacy. These laws and 
regulations include but are not limited to: the Privacy Act of 1974; 
the Federal Information Security Management Act of 2002; the Computer 
Fraud and Abuse Act of 1986; the Health Insurance Portability and 
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the 
corresponding implementing regulations. OMB Circular A-130, Management 
of Federal Resources, Appendix III, Security of Federal Automated 
Information Resources also applies. Federal, HHS, and CMS policies and 
standards include but are not limited to: all pertinent National 
Institute of Standards and Technology publications; HHS Information 
Systems Program Handbook and the CMS Information Security Handbook.

V. Effects of the Proposed System of Records 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 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 are 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 information relating to 
individuals.

Lori Davis,
Acting Chief Operating Officer, Centers for Medicare & Medicaid 
Services.
SYSTEM NO. 09-70-0548

SYSTEM NAME:
    ``Implantable Cardioverter-Defibrillator (ICD) System;'' HHS/CMS/
OCSQ.

SECURITY CLASSIFICATION:
    Level Three Privacy Act Sensitive Data.

SYSTEM LOCATION:
    Centers for Medicare & Medicaid Services (CMS) Data Center, 7500 
Security Boulevard, North Building, First Floor, Baltimore, Maryland 
21244-1850 and at various co-locations of CMS contractors.

[[Page 72441]]

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    CMS has determined that the evidence is adequate to conclude that 
an implantable cardioverter-defibrillator (ICD) is reasonable and 
necessary for the following:
     Patients with ischemic dilated cardio-myopathy, documented 
prior myocardial infarction (MI), New York Heart Association (NYHA) 
Class II and III heart failure, and measured left ventricular ejection 
fraction (LVEF) <= 35%;
     Patients with nonischemic dilated cardiomyopathy > 9 
months, NYHA Class II and III heart failure, and measured LVEF <= 35%;
     Patients who meet all current CMS coverage requirements 
for a cardiac resynchronization therapy device and have NYHA Class IV 
heart failure.

CATEGORIES OF RECORDS IN THE SYSTEM:
    The data collection should include baseline patient 
characteristics. The collected information will contain name, address, 
telephone number, Health Insurance Claim Number (HICN), geographic 
location, race/ethnicity, gender, and date of birth, as well as, 
background information relating to Medicare or Medicaid issues.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    The statutory authority for linking coverage decisions to the 
collection of additional data is derived from Sec. 1862 (a) (1) (A) of 
the Social Security Act (the Act), which states that Medicare may not 
provide payment for items and services unless they are ``reasonable and 
necessary'' for the treatment of illness or injury. In some cases, CMS 
will determine that an item or service is only reasonable and necessary 
when specific data collections accompany the provision of the service. 
In these cases, the collection of data is required to ensure that the 
care provided to individual patients will improve health outcomes.

PURPOSE(S) OF THE SYSTEM:
    The purpose of this system is to provide reimbursement for ICDs and 
assist in the collection of data on patients receiving an ICD for 
primary prevention to a data collection process to assure patient 
safety and protection and to determine that the ICD is reasonable and 
necessary. Information retrieved from 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 or state agency with information to enable 
such agency to administer a Federal health benefits program, or to 
enable such agency to fulfill a requirement of Federal statute or 
regulation that implements a health benefits program funded in whole or 
in part with Federal funds; (3) to an individual or organization for a 
research project or in support of an evaluation project related to the 
prevention of disease or disability, the restoration or maintenance of 
health, or payment related projects; (4) support constituent requests 
made to a congressional representative; (5) support litigation 
involving the agency; and (6) combat fraud and abuse in certain health 
benefits programs.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OR USERS AND THE PURPOSES OF SUCH USES:
    A. The Privacy Act allows 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 compatible use of data is known as a ``routine 
use.'' The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. 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 engaged by 
the agency to assist in the performance of a service related to this 
system of records and who need to have access to the records in order 
to perform the activity.
    2. To another Federal or state agency to:
    a. Provide reimbursement for ICDs and assist in the collection of 
data on patients receiving an ICD for primary prevention to a data 
collection process to assure patient safety and protection and to 
determine that the ICD is reasonable and necessary,
    b. Contribute to the accuracy of CMS's proper payment of Medicare 
benefits, and/or
    c. 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.
    3. To an individual or organization for a research project or in 
support of an evaluation project related to the prevention of disease 
or disability, the restoration or maintenance of health, or payment 
related projects.
    4. 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.
    5. 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 that 
the use of such records by the DOJ, court or adjudicatory body is 
compatible with the purpose for which the agency collected the records.
    6. 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.
    7. 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.
    B. Additional Provisions Affecting Routine Use Disclosures. This 
system contains Protected Health Information (PHI) as defined by the 
Department of Health and Human Services (HHS) regulation ``Standards 
for Privacy of Individually Identifiable Health Information'' (45 Code 
of Federal Regulations (CFR) Parts 160 and 164, 65 Fed. Reg. 82462 (12-
28-00), Subparts A and E.) Disclosures of PHI 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.''
    In addition, our policy will be to prohibit release even of not 
directly identifiable information, except

[[Page 72442]]

pursuant to one of the routine uses or if required by law, if we 
determine 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).

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    All records are stored electronically.

RETRIEVABILITY:
    The data are retrieved by an individual identifier i.e., name of 
beneficiary or provider.

SAFEGUARDS:
    CMS has safeguards in place 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 
information security requirements. Employees who maintain records in 
this system are instructed not to release data until the intended 
recipient agrees to implements appropriate management, operational and 
technical safeguards sufficient to protect the confidentiality, 
integrity and availability of the information and information systems 
and to prevent unauthorized access.
    This system will conform to all applicable Federal laws and 
regulations and Federal, HHS, and CMS policies and standards as they 
relate to information security and data privacy. These laws and 
regulations include but are not limited to: the Privacy Act of 1974; 
the Federal Information Security Management Act of 2002; the Computer 
Fraud and Abuse Act of 1986; the Health Insurance Portability and 
Accountability Act of 1996; the E-Government Act of 2002; the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the 
corresponding implementing regulations. OMB Circular A-130, Management 
of Federal Resources, Appendix III, Security of Federal Automated 
Information Resources also applies. Federal, HHS, and CMS policies and 
standards include but are not limited to: all pertinent National 
Institute of Standards and Technology publications; HHS Information 
Systems Program Handbook and the CMS Information Security Handbook.

RETENTION AND DISPOSAL:
    CMS will retain information for a total period of 10 years. All 
claims-related records are encompassed by the document preservation 
order and will be retained until notification is received from DOJ.

SYSTEM MANAGER AND ADDRESS:
    Director, Office of Clinical Standards and Quality, CMS, Room S2-
26-17, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

NOTIFICATION PROCEDURE:
    For the purpose of access, the subject individual should write to 
the system manager who will require the system name, address, age, 
gender, and for verification purposes, the subject individual's name 
(woman's maiden name, if applicable).

RECORD ACCESS PROCEDURE:
    For the purpose of access, use the same procedures outlines 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).

CONTESTING RECORDS PROCEDURES:
    The subject individual should contact the system manager named 
above and reasonable identify the records 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:
    Records maintained in this system are derived from Carrier and 
Fiscal Intermediary Systems of Records, Common Working File System of 
Records, clinics, institutions, hospitals and group practices 
performing the procedures, and outside registries and professional 
interest groups.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

[FR Doc. E5-6808 Filed 12-2-05; 8:45 am]
BILLING CODE 4120-03-P