[Federal Register Volume 71, Number 4 (Friday, January 6, 2006)]
[Notices]
[Pages 937-941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-8331]


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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, ``Medicare 
Bariatric Surgery System (MBSS), System No. 09-70-0570.'' National 
coverage determinations (NCDs) are determinations made by the Secretary 
of HHS 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). CMS has determined that 
the evidence is adequate to conclude that bariatric surgery 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 MBSS criteria set forth 
in the decision memorandum and are consistent with the trials 
discussed. Bariatric surgery is reasonable and necessary only when 
facilities performing the surgery have full accreditation based on 
standards equivalent to or exceeding the CMS minimum standards. 
Collection of data elements related to bariatric surgery allows that 
determination to be made.
    The purpose of this system is to provide reimbursement for 
bariatric surgery, and assist in the collection of data on patients 
receiving bariatric surgery, for a data collection process to assure 
patient safety and protection, and to determine that the bariatric 
surgery 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) assist 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 Federally-funded 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 12/29/2005. 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.-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. She may be 
contacted via telephone at (410) 786-3934, or via e-mail at 
[email protected].

SUPPLEMENTARY INFORMATION: Obesity is a growing epidemic in the United 
States with over 60% of the population classified as overweight or 
obese. One form of treatment for obesity is bariatric surgery. In May 
2005 CMS began a reconsideration of the NCD on BS for Medicare 
beneficiaries submitted by the American Society for bariatric surgery, 
the American Obesity Association, and others. The requestors included 
the following bariatric surgery procedures in their request for 
reconsideration: (1) Roux-en-y Gastric Bypass, (2) Biliopancreatic 
Diversion, (3) Laparoscopic Adjustable Gastric Banding, and (4) 
Vertical Gastric Banding. CMS has determined that the evidence is 
adequate to conclude that bariatric surgery is reasonable and necessary 
for Medicare beneficiaries who have a Body Mass Index >= 35, at least 
one co-morbidity related to morbid obesity, and have been unsuccessful 
with medical treatment for obesity.

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 section 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.

[[Page 938]]

B. Collection and Maintenance of Data in the System

    The data collection should include baseline patient 
characteristics. The information collected will include 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 MBSS 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 MBSS. 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 bariatric surgery, and assist in the collection of data on patients 
receiving bariatric surgery, for a data collection process to assure 
patient safety and protection, and to determine that the bariatric 
surgery 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.
    2. To another Federal or state agency to:
    a. Provide reimbursement for bariatric surgery, and assist in the 
collection of data on patients receiving bariatric surgery for a data 
collection process to assure patient safety and protection, and to 
determine that the bariatric surgery 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 MBSS information in order to provide 
reimbursement for bariatric surgery, and assist in the collection of 
data on patients receiving bariatric surgery for a data collection 
process to assure patient safety and protection, and to determine that 
the bariatric surgery 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 MBSS data will provide for research or in support of evaluation 
projects, a broader, 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.
    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

[[Page 939]]

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 MBSS information for the purpose of 
combating fraud and abuse in such Federally-funded programs.

B. Additional Provisions Affecting Routine Use Disclosures

    To the extent 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 such PHI 
that are otherwise 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 data 
not directly identifiable, 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 may apply 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; the 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.

    Dated: December 27, 2005.
Lori Davis,
Acting Chief Operating Officer, Centers for Medicare & Medicaid 
Services.
System No. 09-70-0570

System Name:
    ``Medicare Bariatric Surgery System (MBSS);'' 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 has determined that the evidence is adequate to conclude that 
bariatric surgery is reasonable and necessary for Medicare 
beneficiaries who have a Body Mass Index >= 35, at least one co-
morbidity related to morbid obesity, and have been unsuccessful with 
medical treatment for obesity.

[[Page 940]]

Categories of Records in the System:
    The data collection should include baseline patient 
characteristics. The information collected will include 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 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 
bariatric surgery, and assist in the collection of data on patients 
receiving bariatric surgery, for a data collection process to assure 
patient safety and protection, and to determine that the bariatric 
surgery 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) assist 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 Federally-funded health benefits programs.

Routine Uses of Records Maintained in the System, Including Categories 
of 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 bariatric surgery, and assist in the 
collection of data on patients receiving bariatric surgery, for a data 
collection process to assure patient safety and protection, and to 
determine that the bariatric surgery 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.
    To the extent 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 such PHI 
that are otherwise 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 data 
not directly identifiable, 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.

[[Page 941]]

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 may apply 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; the HHS Information 
Systems Program Handbook and the CMS Information Security Handbook.

Retention and Disposal:
    CMS will retain information for a total period of 6 years and 3 
months. 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. E5-8331 Filed 1-5-06; 8:45 am]
BILLING CODE 4120-03-P