[Federal Register: September 9, 2005 (Volume 70, Number 174)]
[Notices]
[Page 53667-53672]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se05-91]
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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 create a new SOR titled, ``Data Collection
Secondary to Coverage Decision (DCSCD) System, HHS/CMS/OCSQ, System No.
09-70-0547.'' 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 certain identified diagnoses are 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 criteria and are consistent with the trials
discussed. Collection of these data elements allows that determination
to be made. We are particularly
[[Page 53668]]
interested in seeing evidence that would permit us to make a coverage
or non-coverage decision, i.e., to move a diagnostic indication from
coverage under a clinical trial or study to coverage or non-coverage
based on definitive evidence of benefit, no benefit, or harm. If
adequate new evidence is available, the decision may be changed to
either ``coverage based on evidence of benefit,'' ``limited coverage''
or ``non-coverage based on evidence of harm or no benefit.''
The purpose of this system is to collect and maintain data on
patients to review determinations of ``reasonable and necessary'' with
respect to whether or not a particular item or service is covered
nationally under title XVIII of the Act Sec. 1869(f)(1)(B).
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
new 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 DATES: 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 09/01/2005. 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 comments 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. Her telephone
number is (410) 786-3934, or she can be reached via e-mail at
rhakim@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: In the case of ``limited coverage'', in NCDs
for which additional evidence is required, CMS has determined that the
evidence is adequate to conclude that the item or service improves net
health outcomes only under specific circumstances. One of these
circumstances is that the service is delivered in the context of
specific data being collected. Coverage may be limited to providers who
participate in and beneficiaries who are enrolled in a defined
prospective data collection activity, when this data collection
activity constitutes part of the evidence required to ensure that the
item or service provided to that patient is reasonable and necessary.
CMS is committed to ensuring that advances in medical technology
are available for its Medicare beneficiaries while ensuring the care
they receive is reasonable and necessary, which is a necessary
condition for payment. The coverage with evidence development
initiative is intended to enable Medicare to provide payment for items
and services under conditions that help assure significant net benefits
of the treatment for beneficiaries, and to give rise to additional
information. This evidence will also assist doctors and patients in
better understanding the risks, benefits and costs of alternative
diagnostic and treatment options. Consequently, the linkage of coverage
to data collection will also help to ensure that individual patients
are receiving care that is reasonable and necessary given their
specific clinical situation; systematic, protocol-driven data has the
potential to increase the likelihood of improved health outcomes. Care
provided under these protocols may lead to greater attention to
appropriate patient evaluation and selection, as well as the
appropriate application of the technology. These additional data may
alter the course of patient treatment based on the best available
evidence, and may lead a physician to reconsider the use of the item or
service or otherwise alter a patient's management plan, potentially
improving health outcomes. In addition, these additional data will be
made available in some form to providers and practitioners to inform
their decisions, monitor performance quality, benchmark and identify
best practices. Collection of these data elements allows that
determination to be made. 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.
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 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.
B. Collection and Maintenance of Data in the System
Information will be collected on individuals where CMS has
determined that the evidence is adequate to conclude that certain
identified diagnoses are reasonable and necessary in several patient
groups where certain criteria for these patients have been met and the
criteria are consistent with the trials reviewed. The collected
information will contain, but is not limited to, name, address,
telephone number, health insurance claim (HIC) number, geographic
location, race/ethnicity, gender, and date of birth, as well as,
background information relating to Medicare or Medicaid issues.
[[Page 53669]]
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 DCSCD 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 DCSCD. CMS has the following policies and procedures
concerning disclosures of information that will be maintained in the
system. Disclosure of information from the system 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 NCDs and assist in the collection of data on patients receiving an
NCD for primary prevention to a data collection process to assure
patient safety and protection and to determine that the NCD 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 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 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. Assist in the review determinations of ``reasonable and
necessary'' with respect to whether or not a particular item or service
is covered nationally under title XVIII of the Act Sec. 1869(f)(1)(B).
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 DCSCD information in order to assist
in the review determinations of ``reasonable and necessary'' with
respect to whether or not a particular item or service is covered
nationally under title XVIII of the Act Sec. 1869(f)(1)(B).
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 DCSCD 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
[[Page 53670]]
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 DCSCD 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 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).
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 Prescription Drug
Improvement, and Modernization Act (MMA) 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 System 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.
John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0547
SYSTEM NAME:
``Data Collection Secondary to Coverage Decision (DCSCD) 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:
Individuals where CMS has determined that the evidence is adequate
to conclude that certain identified diagnoses are reasonable and
necessary in several patient groups where certain criteria for these
patients have been met and the criteria are consistent with the trials
reviewed.
CATEGORIES OF RECORDS IN THE SYSTEM:
The data collection should include baseline patient
characteristics. The collected information will contain, but is not
limited to, name, address, telephone number, health insurance claim
(HIC) number, 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
[[Page 53671]]
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 collect and maintain data on
patients to review determinations of ``reasonable and necessary'' with
respect to whether or not a particular item or service is covered
nationally under title XVIII of the Act Sec. 1869(f)(1)(B).
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:
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.'' We are proposing to establish the following routine use
disclosures of information maintained in the system. Information will
be disclosed:
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. Assist in the review determinations of ``reasonable and
necessary'' with re spect to whether or not a particular item or
service is covered nationally under title XVIII of the Act Sec.
1869(f)(1)(B).
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.
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 complaint
population is so small that individuals who are familiar with the
complainants could, because of the small size, use this information to
deduce the identity of the complainant).
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
All records are stored electronically.
RETRIEVABILITY:
The data is retrieved by an individual identifier i.e., name of
beneficiary.
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
[[Page 53672]]
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 Prescription Drug Improvement,
Modernization Act (MMA) 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 the
Department of Justice.
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. 05-17845 Filed 9-8-05; 8:45 am]
BILLING CODE 4120-03-P