[Federal Register Volume 70, Number 193 (Thursday, October 6, 2005)]
[Notices]
[Pages 58436-58441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19905]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of 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.

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, CMS is proposing to establish a new system of records (SOR) 
titled ``Medicare Drug Data Processing System (DDPS),'' System No. 09-
70-0553. On December 8, 2003, Congress passed the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 
(Pub. L.) 108-173). MMA amends the Social Security Act (the Act) by 
adding the Medicare Part D Program under Title XVIII and mandate that 
CMS establish a voluntary Medicare prescription drug benefit program 
effective January 1, 2006. Under the new Medicare Part D benefit, the 
Act allows Medicare payment to plans that contract with CMS to provide 
qualified Part D prescription drug coverage as described in 42 Code of 
Federal Regulations (CFR) Sec.  423.401. As a condition of payment, all 
Part D plans must submit data and information necessary for CMS to 
carry out payment provisions (Sec.  1860D-15(c)(1)(C) and (d)(2) of the 
Act, and 42 CFR 423.322).
    The primary purpose of this system is to collect, maintain, and 
process information on all Medicare covered and non-covered drug 
events, including non-Medicare drug events, for Medicare beneficiaries 
participating in the Part D voluntary prescription drug coverage under 
the Medicare program. The system will process drug event transactions 
and other drug events as necessary for CMS to help determine 
appropriate payment of covered drugs. The DDPS will consist of the 
transaction validation processing, storing and maintaining the drug 
event data in a large-scale database, and staging the data into data 
marts to support beneficiary and plan analysis of incurred payment. 
Information in this system will also be disclosed to: (1)

[[Page 58437]]

Support regulatory, reimbursement, and policy functions performed 
within the agency or by a contractor or consultant; (2) assist Quality 
Improvement Organizations; (3) assist Part D prescription drug plans; 
(4) support an individual or organization for a research, evaluation or 
epidemiological project; (5) support constituent requests made to a 
congressional representative; (6) support litigation involving the 
agency; and (7) 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 system 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 28, 2005. To ensure that all parties have adequate 
time in which to comment, the new system will become effective 30 days 
from the publication of the notice, or from the date it was submitted 
to OMB and the Congress, whichever is later, unless CMS receives 
comments that require alterations to this notice.

ADDRESSES: The public should address comments to the CMS Privacy 
Officer, Division of Privacy Compliance Data Development, 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 daylight time.

FOR FURTHER INFORMATION CONTACT: Harvey Hull, Health Insurance 
Specialist Division of Program Analysis and Performance, Medicare Drug 
Benefit Group, Centers for Beneficiary Choices, CMS, Room C1-25-05, 
7500 Security Boulevard, Baltimore, Maryland 21244-1850. The telephone 
number is 410-786-4036 or contact <a href="/cdn-cgi/l/email-protection#ddb5bcafabb8a4f3b5a8b1b19dbeb0aef3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="6c040d1e1a091542041900002c0f011f4204041f420b031a">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In December 2003, Congress passed the 
Medicare Prescription Drug, Improvement, and Modernization Act, 
amending the Act by adding Part D under Title XVIII. Under the new 
Medicare benefit, the Act allows Medicare payment to plans that 
contract with CMS to provide qualified Part D prescription drug 
coverage as described in 42 CFR 423.401. For simplicity, we use the 
term ``plans'' to refer to these entities that provide Part D 
prescription drug benefits and that must submit claims data to CMS for 
payment calculations. The Act provides four summary mechanisms for 
paying plans: 1. Direct subsidies; 2. premium and cost-sharing 
subsidies for qualifying low-income individuals (low-income subsidy); 
3. federal reinsurance subsidies; and 4. risk-sharing.
    As a condition of payment, all Part D plans must submit data and 
information necessary for CMS to carry out payment provisions (Sec.  
1860D-15(c) (1) (C) and (d) (2) of the Act, and 42 CFR Sec.  423.322). 
This document describes how CMS will implement the statutory payment 
mechanisms by collecting a limited subset of data elements on 100 
percent of prescription drug ``claims'' or events. Much of the data, 
especially dollar fields, will be used primarily for payment. However, 
some of the other data elements such as pharmacy and prescriber 
identifiers will be used for validation of the claims as well as for 
other legislated functions such as quality monitoring, program 
integrity, and oversight. In addition, we note that this paper only 
covers data collected on claims and does not cover data CMS may collect 
from plans through other mechanisms, for example monitoring plan 
formularies and beneficiary appeals.
    Every time a beneficiary fills a prescription covered under Part D, 
plans must submit a summary record called the prescription drug event 
(PDE) record to CMS. The PDE record contains prescription drug cost and 
payment data that will enable CMS to make payment to plans and 
otherwise administer the Part D benefit. Specifically, the PDE record 
will include covered drug costs above and below the out-of-pocket 
threshold; distinguish enhanced alternative costs from the costs of 
drugs provided under the standard benefit; and will record payments 
made by Part D plan sponsors, other payers, and by or on behalf of 
beneficiaries. Plans must also identify costs that contribute towards a 
beneficiary's true-out-of-pocket or TrOOP limit, separated into three 
categories: low-income cost-sharing subsidy amounts paid by the plan at 
the point of sale (POS), beneficiary payments, and all TrOOP-eligible 
payments made by qualified entities on behalf of a beneficiary. Much of 
the data, especially dollar fields, will be used primarily for payment. 
However, some of the other data elements such as pharmacy and 
prescriber identifiers will be used for validation of the claims as 
well as for other legislated functions such as quality monitoring, 
program integrity, and oversight.

I. Description of the Proposed System of Records

A. Statutory and Regulatory Basis for System

    Authority for maintenance of this system is given under provisions 
of the Medicare Prescription Drug, Improvement, and Modernization Act, 
amending the Social Security Act (the Act) by adding Part D under Title 
XVIII (Sec.  1860D-15(c)(1)(C) and (d)(2), as described in 42 Code of 
Federal Regulation (CFR) 423.401.

B. Collection and Maintenance of Data in the System

    The system contains summary prescription drug claim information on 
all Medicare covered and non-covered drug events, including non-
Medicare drug events, for Medicare beneficiaries of the Medicare 
program. This system contains summary prescription drug claim data, 
health insurance claim number, card holder identification number, date 
of service, gender, and optionally, the date of birth. The system 
contains provider characteristics, prescriber identification number, 
assigned provider number (facility, referring/servicing physician), and 
national drug code, total charges, Medicare payment amount, and 
beneficiary's liability.

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

    A. 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 DDPS 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 disclose the minimum personal data necessary to 
achieve the purpose of DDPS. CMS has the following policies and 
procedures concerning disclosures of information that will be 
maintained in the system. In general, disclosure of information from 
the system will be approved only for the minimum information necessary

[[Page 58438]]

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 assist in a variety 
of health care initiatives with other entities related to the 
evaluation and study of the operation and effectiveness of 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 of 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. Entities Who May Receive Disclosures Under Routine Use

    These routine uses specify circumstances, in addition to those 
provided by statute in the Privacy Act of 1974, under which CMS may 
release information from the DDPS without the consent of the individual 
to whom such information pertains. Each proposed disclosure of 
information under these routine uses will be evaluated to ensure that 
the disclosure is legally permissible, including but not limited to 
ensuring that the purpose of the disclosure is compatible with the 
purpose for which the information was collected. We propose to 
establish or modify the following routine use disclosures of 
information maintained in the system:
    1. To Agency contractors or consultants who have been contracted by 
the Agency to assist in accomplishment of a CMS function relating to 
the purposes for this system and who need to have 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 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 Quality Improvement Organization (QIO) in connection with 
review of claims, or in connection with studies or other review 
activities conducted pursuant to Part B of Title XI of the Act and in 
performing affirmative outreach activities to individuals for the 
purpose of establishing and maintaining their entitlement to Medicare 
benefits or health insurance plans.
    QIOs will work to implement quality improvement programs, provide 
consultation to CMS, its contractors, and to state agencies. QIOs will 
assist the state agencies in related monitoring and enforcement 
efforts, assist CMS and intermediaries in program integrity assessment, 
and prepare summary information for release to CMS.
    3. To Part D Prescription Drug Plans and their Prescription Drug 
Event submitters, providing protection against medical expenses of 
their enrollees without the beneficiary's authorization, and having 
knowledge of the occurrence of any event affecting (a) an individual's 
right to any such benefit or payment, or (b) the initial right to any 
such benefit or payment, for the purpose of coordination of benefits 
with the Medicare program and implementation of the Medicare Secondary 
Payer provision at 42 U.S.C. 1395y (b). Information to be disclosed 
shall be limited to Medicare utilization data necessary to perform that 
specific function. In order to receive the information, they must agree 
to:
    a. Certify that the individual about whom the information is being 
provided is one of its insured or employees, or is insured and/or 
employed by another entity for whom they serve as a Third Party 
Administrator;
    b. Utilize the information solely for the purpose of processing the 
individual's insurance claims; and
    c. Safeguard the confidentiality of the data and prevent 
unauthorized access.
    Other insurers may require DDPS information in order to support 
evaluations and monitoring of Medicare claims information of 
beneficiaries, including proper reimbursement for services provided.
    4. To an individual or organization for a research, evaluation, or 
epidemiological project related to the prevention of disease or 
disability, the restoration or maintenance of health, or payment-
related projects.
    DDPS data will provide for research, evaluation, and 
epidemiological projects, a broader, longitudinal, national perspective 
of the status of Medicare beneficiaries. CMS anticipates that many 
researchers will have legitimate requests to use these data in projects 
that could ultimately improve the care provided to Medicare 
beneficiaries and the policy that governs the care.
    5. To a Member of Congress or 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 often 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.
    6. 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.
    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.
    7. To a CMS contractor (including, but not limited to fiscal 
intermediaries and carriers) that assists in the administration of a 
CMS-administered

[[Page 58439]]

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 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.
    8. 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 DDPS information for the purpose of 
combating fraud and abuse in such Federally funded programs.

B. Additional Circumstances Affecting Routine Use Disclosures

    This system contains Protected Health Information as defined by HHS 
regulation ``Standards for Privacy of Individually Identifiable Health 
Information'' (45 CFR Parts 160 and 164, 65 FR 82462 (Dec. 28, 00), as 
amended by 66 FR 12434 (Feb. 26, 01)). Disclosures of Protected Health 
Information 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 non-
identifiable information, except pursuant to one of the routine uses, 
if there is a possibility that an individual can be identified through 
implicit deduction based on small cell sizes (instances where the 
patient population is so small that individuals who are familiar with 
the enrollees could, because of the small size, use this information to 
deduce the identity of the beneficiary).

IV. Safeguards

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

V. Effect of the Modified System 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. We will only 
disclose the minimum personal data necessary to achieve the purpose of 
DDPS. Disclosure of information from the system will be approved only 
to the extent necessary to accomplish the purpose of the disclosure. 
CMS has assigned a higher level of security clearance for the 
information maintained in this system in an effort to provide added 
security and protection of data in this system.
    CMS will take precautionary measures to minimize the risks of 
unauthorized access to the records and the potential harm to individual 
privacy or other personal or property rights. 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 the disclosure of information 
relating to individuals.

    Dated: September 28, 2005.
John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
System No. 09-70-0553

SYSTEM NAME:
    Medicare Drug Data Processing System (DDPS), HHS/CMS/CBC.

SECURITY CLASSIFICATION:
    Level Three Privacy Act Sensitive.

SYSTEM LOCATION:
    CMS Data Center, 7500 Security Boulevard, North Building, First 
Floor, Baltimore, Maryland 21244-1850 and at various contractor sites.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    The system contains summary prescription drug claim information on 
all Medicare covered and non-covered drug events, including non-
Medicare drug events, for Medicare beneficiaries of the Medicare 
program.

CATEGORIES OF RECORDS IN THE SYSTEM:
    This system contains summary prescription drug claim data, health 
insurance claim number (HICN), card holder identification number, date 
of service, gender, and optionally, the date of birth. The system 
contains provider characteristics, prescriber identification number, 
assigned provider number (facility, referring/servicing physician), and 
national drug code, total charges, Medicare payment amount, and 
beneficiary's liability.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Authority for maintenance of this system is given under provisions 
of the Medicare Prescription Drug, Improvement, and Modernization Act, 
amending the Social Security Act (the

[[Page 58440]]

Act) by adding Part D under Title XVIII (Sec.  1860D-15(c)(1)(C) and 
(d)(2), as described in 42 Code of Federal Regulation (CFR) Sec.  
423.401.

PURPOSE(S) OF THE SYSTEM:
    The primary purpose of this system is to collect, maintain, and 
process information on all Medicare covered and non-covered drug 
events, including non-Medicare drug events, for Medicare beneficiaries 
participating in the Part D voluntary prescription drug coverage under 
the Medicare program. The system will process drug event transactions 
and other drug events as necessary for CMS to help determine 
appropriate payment of covered drugs. The DDPS will consist of the 
transaction validation processing, storing and maintaining the drug 
event data in a large-scale database, and staging the data into data 
marts to support beneficiary and plan analysis of incurred payment. 
Information in 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 Quality Improvement 
Organizations; (3) assist Part D prescription drug plans; (4) support 
an individual or organization for a research, evaluation or 
epidemiological project; (5) support constituent requests made to a 
congressional representative; (6) support litigation involving the 
agency; and (7) 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. Entities Who May Receive Disclosures Under Routine Use
    These routine uses specify circumstances, in addition to those 
provided by statute in the Privacy Act of 1974, under which CMS may 
release information from the DDPS without the consent of the individual 
to whom such information pertains. Each proposed disclosure of 
information under these routine uses will be evaluated to ensure that 
the disclosure is legally permissible, including but not limited to 
ensuring that the purpose of the disclosure is compatible with the 
purpose for which the information was collected. We propose to 
establish or modify the following routine use disclosures of 
information maintained in the system:
    1. To Agency contractors or consultants who have been contracted by 
the Agency to assist in accomplishment of a CMS function relating to 
the purposes for this system and who need to have access to the records 
in order to assist CMS.
    2. To Quality Improvement Organization (QIO) in connection with 
review of claims, or in connection with studies or other review 
activities conducted pursuant to Part B of Title XI of the Act and in 
performing affirmative outreach activities to individuals for the 
purpose of establishing and maintaining their entitlement to Medicare 
benefits or health insurance plans.
    3. To Part D Prescription Drug Plans and their Prescription Drug 
Event submitters, providing protection against medical expenses of 
their enrollees without the beneficiary's authorization, and having 
knowledge of the occurrence of any event affecting (a) an individual's 
right to any such benefit or payment, or (b) the initial right to any 
such benefit or payment, for the purpose of coordination of benefits 
with the Medicare program and implementation of the Medicare Secondary 
Payer provision at 42 U.S.C. 1395y (b). Information to be disclosed 
shall be limited to Medicare utilization data necessary to perform that 
specific function. In order to receive the information, they must agree 
to:
    a. Certify that the individual about whom the information is being 
provided is one of its insured or employees, or is insured and/or 
employed by another entity for whom they serve as a Third Party 
Administrator;
    b. Utilize the information solely for the purpose of processing the 
individual's insurance claims; and
    c. Safeguard the confidentiality of the data and prevent 
unauthorized access.
    4. To an individual or organization for a research, evaluation, or 
epidemiological project related to the prevention of disease or 
disability, the restoration or maintenance of health, or payment-
related projects.
    5. To a Member of Congress or 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.
    6. 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.
    7. To a CMS contractor (including, but not 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.
    8. 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 Circumstances Affecting Routine Use Disclosures
    This system contains Protected Health Information as defined by HHS 
regulation ``Standards for Privacy of Individually Identifiable Health 
Information'' (45 CFR Parts 160 and 164, 65 FR 82462 (Dec. 28, 00), as 
amended by 66 FR 12434 (Feb. 26, 01)). Disclosures of Protected Health 
Information 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 non-
identifiable information, except pursuant to one of the routine uses, 
if 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:
    Records are stored on both tape cartridges (magnetic storage media) 
and in a DB2 relational database management environment (DASD data 
storage media).

[[Page 58441]]

RETRIEVABILITY:
    Information is most frequently retrieved by HICN, provider number 
(facility, physician, IDs), service dates, and beneficiary state code.

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

RETENTION AND DISPOSAL:
    Records are maintained with identifiers for all transactions after 
they are entered into the system for a period of 20 years. Records are 
housed in both active and archival files. 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, Division of Program Analysis and Performance, Medicare 
Drug Benefit Group, Centers for Beneficiary Choices, CMS, Room S1-06-
14, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

NOTIFICATION PROCEDURE:
    For purpose of notification, the subject individual should write to 
the system manager who will require the system name, and the retrieval 
selection criteria (e.g., HICN, facility/pharmacy number, service 
dates, etc.).

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 should contact the system manager named 
above, and 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:
    Summary prescription drug claim information contained in this 
system is obtained from the Prescription Benefit Package (PBP) Plans 
and Medicare Advantage (MA-PBP) Plans daily and monthly drug event 
transaction reports, Medicare Beneficiary Database (09-70-0530), and 
other payer information to be provided by the TROOP Facilitator.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

[FR Doc. 05-19905 Filed 10-5-05; 8:45 am]
BILLING CODE 4120-03-P


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