[Federal Register: September 20, 2005 (Volume 70, Number 181)]
[Notices]
[Page 55133-55137]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se05-64]
[[Page 55133]]
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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: Department of Health and Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
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 SOR titled, ``Anti-Cancer
Chemotherapy for Colorectal Cancer (CRC) System, System No. 09-70-
0554.'' National Coverage Determinations (NCD) 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) section 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'' (section 1862(a)(1)(A).
Under authority of section 1861(t)(2) of the statute, Medicare
provides coverage for Food and Drug Administration (FDA) approved
indications for anticancer chemotherapeutic agents and for other
indications that are in the specific approved compendia listed below.
Increased understanding of the biology of cancer and emerging
technologies is making possible new approaches in treating cancer. To
ensure that beneficiaries have access to the most appropriate cancer
treatments, it is imperative that adequate clinical trial data for off-
label uses be made available to patients and providers for clinical
decision-making and to policy-making. CMS has determined that Medicare
will cover the use of oxaliplatin (Eloxatin[reg]), irinotecan
(Camptosar[reg]), cetuximab (ErbituxTM), or bevacizumab
(AvastinTM), in clinical trials identified by CMS and
sponsored by the National Cancer Institute (NCI).
The purpose of this system is to provide reimbursement for CRCs and
assist in the collection of data on patients receiving CRC as a new or
emerging cancer treatment regimen to a data collection process to
assure patient safety and protection and to determine that the CRC 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 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 September 13, 2005. We will not disclose any information under
a routine use until 30 days after publication. We may defer
implementation of this system 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. to 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. Her telephone
number is (410) 786-3934, she can also be reached via e-mail at
rhakim@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: CMS has determined that oxaliplatin,
irinotecan, cetuximab, and bevacizumab are Medicare covered for the
FDA-approved and compendia-supported use in 1st and/or 2nd line
treatment of advanced colorectal cancer. The off-label use of
irinotecan for the treatment of non-small cell lung cancer is supported
in one of the approved drug compendia; therefore this off-label use is
covered by Medicare. No other off-label use for irinotecan,
oxaliplatin, cetuximab, or bevacizumab appears as supported in the
approved drug compendia. Off-label coverage of these agents is
therefore determined by the Medicare contractors based on their review
of the medical literature. During our NCD review of the medical
literature, we found studies of off-label indications for these agents
that varied widely in quality.
At the request of CMS, NCI identified high priority clinical trials
studying off-label uses of the four agents that are the subject of this
national coverage determination review. It was agreed that the selected
trials should address questions likely to lead to important changes in
therapy and that by covering the use of these agents in selected
trials; we will:
Offer consistent national coverage for these specific
trials,
Ensure continued advancement in knowledge for the
appropriate use of these agents,
Accelerate the development of evidence for new or emerging
cancer treatment regimens for these agents,
Ensure beneficiaries rapid access to promising new uses of
approved technologies under controlled clinical trial conditions,
Serve as a potential model for additional coverage
expansions in clinical trials for other anti-cancer chemotherapeutic
agents,
Encourage industry to invest in studies that will expand
knowledge base for patient and doctor discussions.
Although we did not find sufficient evidence to support coverage of
off-label use of cancer chemotherapy for all persons who have cancer, a
sufficient inference of benefit can be drawn to support limited
coverage in the context of an NCI-sponsored clinical trial that
provides rigorous safeguards for patients. We base this inference on
the evidence discussed above regarding the benefits of chemotherapy for
labeled uses. We further believe that NCI-sponsored clinical trials
offer safeguards for patients to ensure appropriate patient evaluation
and selection and
[[Page 55134]]
reasonable use of cancer chemotherapy. We conclude that coverage for
the off-label use of cancer chemotherapy could provide clinical
benefits to Medicare beneficiaries with cancer, and that those benefits
are likely to be present in the context of a clinical trial that
assures informed individualized analysis and evaluation of the response
to chemotherapy and patient health status, as well as an adequate plan
for data and safety monitoring.
The proposed policy does not obviate the need for contractors to
continue to review the medical literature and determine the conditions
under which off-label indications of FDA-approved drugs and biologicals
used in anti-cancer chemotherapeutic regimens for medically accepted
indications are reasonable and necessary (Sec. 1861(t)(2)(B)(ii)(II)).
Contractors will not infer from this NCD that any other uses of these
drugs should not be approved.
This policy also does not withdraw Medicare coverage for items and
services that may be covered according to the existing national
coverage policy for Routine Costs in a Clinical Trial (National
Coverage Determination Manual, section 310.1). Routine costs will
continue to be covered as well as other items and services provided as
a result of coverage of these specific trials in this NCD. Specific
reimbursements will be determined as the protocols are completed and
the trials begin.
In addition to covering these specific NCI trials, we are
interested in establishing other processes to identify appropriate
trials for which we may provide coverage. We are also interested in
identifying additional means of gathering evidence outside of a
clinical trial setting for use in decision-making such as registries
and analyses of routinely collected electronic data. Therefore, we will
shortly begin a process to develop appropriate guidance (Medicare
Prescription Drug Improvement, Modernization Act of 2003 section 731)
that will include an Open Door Forum and an expert panel convened by
the Institute of Medicine and will result in the publication of a draft
guidance document. We encourage broad public participation in this
process.
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 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
The data collection should include baseline patient
characteristics. The collected information will also contain, but is
not limited to, 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 CRC 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 CRC. 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 CRCs and assist in the collection of data on patients receiving CRC
as a new or emerging cancer treatment regimens to a data collection
process to assure patient safety and protection and to determine that
the CRC 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 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.
[[Page 55135]]
2. To another Federal or state agency to:
a. Provide reimbursement for CRCs and assist in the collection of
data on patients receiving CRC as a new or emerging cancer treatment
regimens to a data collection process to assure patient safety and
protection and to determine that the CRC 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 CRC information in order to provide
reimbursement for CRCs and assist in the collection of data on patients
receiving CRC as a new or emerging cancer treatment regimens to a data
collection process to assure patient safety and protection and to
determine that the CRC 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 CRC 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 this 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.
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 CRC 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 Parts 160 and 164,
65 FR 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 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,
[[Page 55136]]
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. 09-70-0554
SYSTEM NAME:
``Anti-Cancer Chemotherapy for Colorectal Cancer (CRC) 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.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
CMS will cover the use of oxaliplatin (Eloxatin[supreg]),
irinotecan (Camptosar[supreg]), cetuximab (ErbituxTM), or
bevacizumab (AvastinTM), on all Medicare beneficiaries who
are in clinical trials identified by CMS and sponsored by the National
Cancer Institute.
CATEGORIES OF RECORDS IN THE SYSTEM:
The data collection should include baseline patient
characteristics. The collected information will also contain, but is
not limited to, 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 section 1862(a)(1)(A) of
the Social Security 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 CRCs and
assist in the collection of data on patients receiving CRC as a new or
emerging cancer treatment regimens to a data collection process to
assure patient safety and protection and to determine that the CRC 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 CRCs and assist in the collection of
data on patients receiving CRC as a new or emerging cancer treatment
regimens to a data collection process to assure patient safety and
protection and to determine that the CRC 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
[[Page 55137]]
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
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 FR 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 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 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.
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. 05-18488 Filed 9-19-05; 8:45 am]
BILLING CODE 4120-03-P