[Federal Register Volume 71, Number 235 (Thursday, December 7, 2006)]
[Notices]
[Pages 70967-70971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20718]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of a Modified or Altered System of 
Records

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

ACTION: Notice of a Modified or Altered System of Records (SOR).

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, CMS is proposing to modify or alter existing system of records 
titled ``Medicare Exclusion Database'' (MED), System No. 09-70-0534,'' 
established at 67 Federal Register 8810 (February 26, 2002). We propose 
to modify existing routine use number 1 that permits disclosure to 
agency contractors and consultants to include disclosure to CMS 
grantees who perform a task for the agency. CMS grantees, charged with 
completing projects or activities that require CMS data to carry out 
that activity, are classified separate from CMS contractors and/or 
consultants. The modified routine use will remain as routine use number 
1.
    Published routine use number 2 and 3 will be combined as one 
because both are written to complete the same or similar purpose. 
Disclosures allowed by published routine uses numbers 2, and 3 will be 
covered by a new routine use numbered 2 to permit release of 
information to ``another Federal and/or State agency, agency of a State 
government, an agency established by State law, or its fiscal agent.'' 
The scope of this routine use has been broadened to include State 
Medicaid agencies when disclosure of the information proved compatible 
with the purpose for which CMS collects the information. We will delete 
routine use number 5 authorizing disclosure to support constituent 
requests made to a congressional representative. If an authorization 
for the disclosure has been obtained from the data subject, then no 
routine use is needed. The Privacy Act allows for disclosures with the 
``prior written consent'' of the data subject.
    Finally, we will delete the section titled ``Additional 
Circumstances Affecting Routine Use Disclosures,'' that addresses 
``Protected Health Information (PHI)'' and ``small cell size.'' The 
requirement for compliance with HHS regulation ``Standards for Privacy 
of Individually Identifiable Health Information'' does not apply 
because this system does not collect or maintain PHI. In addition, our 
policy to prohibit release if there is a possibility that an individual 
can be identified through ``small cell size'' is not applicable to the 
data maintained in this system.
    We are modifying the language in the remaining routine uses to 
provide a proper explanation as to the need for the routine use and to 
provide clarity to CMS's intention to disclose individual-specific 
information contained in this system. The routine uses will then be 
prioritized and reordered according to their usage. We will also take 
the opportunity to update any sections of the system that were affected 
by the recent reorganization or because of the impact of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) 
(Public Law 108-173) provisions and to update language in the 
administrative sections to correspond with language used in other CMS 
SORs.
    The primary purpose of this system of records is to collect and 
maintain information on individuals that have been excluded from 
receiving Medicare payments for any item or service furnished during 
the period when excluded from participation in the Medicare program. 
Information maintained in this system will also be disclosed to: (1) 
Support regulatory, reimbursement, and policy functions performed 
within the Agency or by a contractor, consultant or CMS grantee; (2) 
assist another Federal or State agency, agency of a State government, 
an agency established by State law, or its fiscal agent; (3) facilitate 
research on the quality and effectiveness of care

[[Page 70968]]

provided, as well as epidemiological projects; (4) support litigation 
involving the Agency; and (5) combat fraud, waste 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 DATES: CMS filed a new system report with the Chair of the 
House Committee on Government Reform and Oversight, the Chair of the 
Senate Committee on Homeland Security and Governmental Affairs, and the 
Administrator, Office of Information and Regulatory Affairs, Office of 
Management and Budget (OMB) on November 30, 2006. In any event, we will 
not disclose any information under a routine use until 30 days after 
publication in the Federal Register or 40 days after mailings to 
Congress, which ever is later. We may defer implementation of this 
system or on one or more of the routine uses listed below if we receive 
comments that persuade us to defer implementation.

ADDRESSES: The public should address comments to: CMS Privacy Officer, 
Division of Privacy Compliance, Enterprise Architecture and Strategy 
Group, Office of Information Services, CMS, Room N2-04-27, 7500 
Security Boulevard, Baltimore, Maryland 21244-1850. Comments received 
will be available for review at this location, by appointment, during 
regular business hours, Monday through Friday from 9 a.m.-3 p.m., 
Eastern Time zone.

FOR FURTHER INFORMATION CONTACT: Lisa Eggleston, Health Insurance 
Specialist, Program Integrity Group, Office of Financial Management, 
CMS, Mail Stop C3-02-16, 7500 Security Boulevard, Baltimore, Maryland 
21244-1850. The telephone number is (410) 786-6130 or e-mail 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Description of the Modified or Altered System of Records

A. Statutory and Regulatory Basis for SOR

    Authority for maintenance of this system is given under Sec. Sec.  
1128 A and B, and 1156 of the Social Security Act.

B. Collection and Maintenance of Data in the System

    For purposes of this SOR, the system contains information related 
to individual health care providers who have been excluded from 
participation in Medicare and other Federal and State health care 
programs. The system contains information such as other provider 
identifiers used by those individuals, names, demographic information, 
including, but not limited to gender and date of birth, provider 
taxonomy information, address data, contact information, and taxpayers 
identifying number.

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 MED information that can be associated 
with an individual as provided for under ``Section III. Proposed 
Routine Use Disclosures of Data in the System.'' Both individually 
identifiable and non-individually-identifiable data may be disclosed 
under a routine use.
    We will only disclose the minimum personal data necessary to 
achieve the purpose of MED. 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 the data are being collected; e.g., is to collect and maintain 
information on individuals that have been excluded from receiving 
Medicare payments for any item or service furnished during the period 
when excluded from participation in the Medicare program.
    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 or disclosure of the record;
    b. remove or destroy at the earliest time all individually-
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 support Agency contractors, consultants, or grantees that 
have been contracted by the Agency to assist in accomplishment of a CMS 
function relating to the purposes for this system and who need access 
to the records in order to assist CMS.
    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 a 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, consultant, or grantee whatever information 
is necessary for the contractor, consultant, or grantee to fulfill its 
duties. In these situations, safeguards are provided in the contract 
prohibiting the contractor, consultant, or grantee 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 assist another Federal or State agency, agency of a State 
government, an agency established by State law, or its fiscal agent to:
    a. Contribute to the accuracy of CMS's proper payment of Medicare 
benefits,
    b. 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

[[Page 70969]]

benefits program funded in whole or in part with Federal funds, and/or
    c. assist Federal/State Medicaid programs within the State.
    Other Federal or State agencies in their administration of a 
Federal health program may require MED information in order to support 
evaluations and monitoring of Medicare claims information of 
beneficiaries, including proper payment for services provided.
    MED data may be disclosed to a State agency, agency of a State 
government, an agency established by State law, or its fiscal agent for 
purposes of ensuring that no payments are made with respect to any item 
or service furnished by an individual during the period when excluded 
from participation in Medicare and other Federal and State health care 
programs.
    MED data may potentially be released to the State only on those 
individuals who are either individuals excluded from participation in 
the Medicare and other Federal and State health care programs, or 
employers of excluded individuals, or are legal residents of the State, 
irrespective of the location of provider or supplier furnishing items 
or services.
    3. To support an individual or organization for a research, 
evaluation, or epidemiological project related to the prevention of 
disease or disability or the restoration or maintenance of health.
    MED data may be able to provide for research, evaluation, and 
epidemiological projects a broader longitudinal national perspective of 
the status of health care patients. CMS anticipates that many 
researchers will have legitimate requests to use these data in projects 
that could ultimately improve the care provided to patients and the 
policy that governs the care.
    4. To assist 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, or occasionally when 
another party is involved in litigation and CMS's policies or 
operations could be affected by the outcome of the litigation, CMS 
would be able to disclose information to the DOJ, court, or 
adjudicatory body involved.
    5. To support a CMS contractor 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, waste or abuse in such programs.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contract 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 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.
    6. To support 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, 
waste or abuse in a 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, waste or abuse in such programs.
    Other agencies may require MED information for the purpose of 
combating fraud, waste or abuse in such Federally-funded programs.

IV. Safeguards

    CMS has safeguards in place for authorized users and monitors such 
users to ensure against 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 Modified System of Records on Individual Rights

    CMS proposes to modify 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.


[[Page 70970]]


    Dated: November 28, 2006.
John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
System Number: 09-70-0534

SYSTEM NAME:
    ``Medicare Exclusion Database (MED), HHS/CMS/OFM.

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 other remote locations.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    For purposes of this SOR, the system contains information related 
to individual health care providers who have been excluded from 
participation in Medicare and other Federal and State health care 
programs.

CATEGORIES OF RECORDS IN THE SYSTEM:
    The system contains information such as other provider identifiers 
used by those individuals, names, demographic information, including, 
but not limited to gender and date of birth, provider taxonomy 
information, address data, contact information, and taxpayers 
identifying number.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Authority for maintenance of this system is given under Sec. Sec.  
1128 A and B, and 1156 of the Social Security Act.

PURPOSE(S) OF THE SYSTEM:
    The primary purpose of this system of records is to collect and 
maintain information on individuals that have been excluded from 
receiving Medicare payments for any item or service furnished during 
the period when excluded from participation in the Medicare program. 
Information maintained in this system will also be disclosed to: (1) 
Support regulatory, reimbursement, and policy functions performed 
within the Agency or by a contractor, consultant or CMS grantee; (2) 
assist another Federal or State agency, agency of a State government, 
an agency established by State law, or its fiscal agent; (3) facilitate 
research on the quality and effectiveness of care provided, as well as 
epidemiological projects; (4) support litigation involving the Agency; 
and (5) combat fraud, waste 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.'' 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:
    To support Agency contractors, consultants, or CMS grantees that 
have been contracted by the Agency to assist in accomplishment of a CMS 
function relating to the purposes for this system and who need access 
to the records in order to assist CMS.
    To assist another Federal or State agency, agency of a State 
government, an agency established by State law, or its fiscal agent to: 
Contribute to the accuracy of CMS's proper payment of Medicare 
benefits, 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, and/or assist 
Federal/State Medicaid programs within the State.
    To support an individual or organization for a research, 
evaluation, or epidemiological project related to the prevention of 
disease or disability or the restoration or maintenance of health.
    To assist the Department of Justice (DOJ), court or adjudicatory 
body when:
    The Agency or any component thereof, or any employee of the Agency 
in his or her official capacity, or any employee of the Agency in his 
or her individual capacity where the DOJ has agreed to represent the 
employee, or 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.
    To support a CMS contractor 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, waste or abuse in such programs.
    To support 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 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, waste or 
abuse in such programs.

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

RETRIEVABILITY:
    All records are accessible by UPIN/NPI or alpha (name) search. This 
system supports both on-line and batch access.

SAFEGUARDS:
    CMS has safeguards in place for authorized users and monitors such 
users to ensure against 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

[[Page 70971]]

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:
    Records are maintained for a period of 15 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, Program Integrity Group, Office of Financial Management, 
CMS, Mail Stop C3-02-16, 7500 Security Boulevard, Baltimore, Maryland 
21244-1850.

NOTIFICATION PROCEDURE:
    For purpose of access, the subject individual health care provider 
should write to the system manager who will require the system name, 
National Provider Identifier, address, date of birth, and gender, and 
for verification purposes, the subject individual health care 
provider's name (woman's maiden name, if applicable), and social 
security number (SSN). Furnishing the SSN is voluntary, but it may make 
searching for a record easier and prevent delay.

RECORD ACCESS PROCEDURE:
    For purpose of access, use the same procedures outlined in 
Notification Procedures above. Requestors should also reasonably 
specify the record contents being sought. (These procedures are in 
accordance with department regulation 45 CFR 5b.5(a)(2)).

CONTESTING RECORD PROCEDURES:
    The subject individual health care provider should contact the 
systems manager named above, reasonably identify the record and specify 
the information to be contested, state the corrective action sought, 
and the reasons for the correction with supporting justification. 
(These procedures are in accordance with department regulation 45 CFR 
5b.7).

RECORD SOURCE CATEGORIES:
    The Office of the Inspector General Exclusion file, Online Survey 
Certification and Reporting System file, National Supplier Clearing 
House file, Unique Physician Identification Number Registry, Medicare 
Contractor Provider Files, and Social Security Administration records 
to assist in a determination of the excluded individual's employers.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

 [FR Doc. E6-20718 Filed 12-6-06; 8:45 am]
BILLING CODE 4120-03-P