[Federal Register Volume 69, Number 112 (Thursday, June 10, 2004)]
[Notices]
[Pages 32587-32592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13240]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of New System

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

ACTION: Notice of 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 ``MMA Section 641 
Prescription Drug Benefit Demonstration'' (MMA641) System NO. 09-70-
0545, HHS/CMS/ORDI. The primary purposes of the system of records are 
to maintain information on individual Medicare beneficiaries who 
voluntarily enroll in a demonstration project for coverage of certain 
prescription drugs and biologicals. This demonstration project is 
mandated in the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 under section 641. The system of records will 
enable CMS to: Enroll and communicate with eligible Medicare 
beneficiaries who volunteer to participate in the demonstration 
project, communicate with clinicians and other providers and suppliers 
who submit claims payable under the demonstration project, review 
submitted claims and pay those conforming to applicable payment 
criteria and federal law, and develop, maintain, and analyze research 
information showing the potential impact of providing certain 
prescription drugs and biologicals.
    Information retrieved from this system of records will also be 
disclosed to support regulatory, reimbursement, and policy functions 
performed within the agency or by a contractor or consultant; support 
constituent requests made to a Congressional representative; support 
litigation involving the agency; support activities reasonably 
necessary to fulfill the provisions of the demonstration project and 
ensure appropriate use of Medicare trust fund and program funds; and 
third parties where the contact is expected to have information 
relating to the individual's capacity to manage his or her own affairs.
    We have provided background information about the proposed system 
in the ``Supplementary Information'' section, below. 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 June 4, 2004. In any event, we will not disclose any 
information under a routine use until forty (40) calendar days after 
publication. We may defer implementation of this system of records or 
one or more of the routine use statements listed below if we receive 
comments that persuade us to defer implementation.

ADDRESSES: The public should address comments to: Director, Division of 
Privacy Compliance Data Development (DPCDD), 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: James Coan, Division of Health 
Promotion and Disease Prevention Demonstrations (DHPDPD), Office of 
Research, Development, and Information, CMS, MS-S3-02-01, 7500 Security 
Boulevard, Baltimore,

[[Page 32588]]

Maryland 21244-1850. The telephone number is (410) 786-9168.

SUPPLEMENTARY INFORMATION:

I. Description of the New System of Records

A. Statutory and Regulatory Basis for System of Records

    The authority for this system of records is Section 641 of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
(MMA) (Pub. L. 108-173).

B. Background

    Section 641 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) (Pub. L. 108-173) provides for a 
demonstration that would pay for drugs and biologicals that are 
prescribed as replacements for drugs currently covered under Medicare 
Part B. The legislation specifies that no more than 50,000 
beneficiaries be covered under the demonstration and that funding is 
limited to $500 million.
    The demonstration will apply to the 50 United States and the 
District of Columbia and will provide this coverage for the period up 
to December 31, 2005, or until legislated limitations have been 
reached. Provisions under the demonstration include enhanced low-income 
benefits for those unable to afford deductibles and cost sharing. 
Interested beneficiaries will be screened for eligibility and asked for 
basic information about diagnosis, treatment, and income. Once they are 
determined to be eligible, they will be assigned to a national pharmacy 
benefits manager where their individual prescription plan will be 
established.
    Prescription drug and biological coverage will follow the 
conditions outlined in MMA for the new Part D prescription drug plan, 
including all deductibles, cost sharing percentages, and out-of-pocket 
expense limitations.

II. Collection and Maintenance of Data in the System

A. Scope of the Data Collected

    MMA641 includes standard data for identification such as Name, 
Medicare Health Insurance Claim (HIC) Number, sex, race, date of birth, 
zip code, state and county for Medicare beneficiaries who are 
voluntarily participating in the Section 641 Demonstration. All of the 
included data is necessary to employ proper research methods and to 
verify eligibility criteria. It also includes claims information 
related to prescription drug claims, supplemental prescription drug 
coverage plans, income attestation, physician certification, answers to 
eligibility questions, answers to enrollment questionnaires and other 
information needed to confirm the beneficiaries eligibility for 
enrollment and ongoing participation in the demonstration, as well as 
other survey and research information needed to pay claims, administer 
the demonstration project, and develop research reports on the study's 
findings. Information collected is critical to implementing the 
demonstration as mandated in the legislation. Specifically, the 
demonstration must follow the new Part D Prescription Drug Benefit 
rules for participation, low-income subsidies, use of supplemental drug 
coverage plans, and enrollment. Furthermore, because this is a research 
demonstration project and a Report to Congress is required, evaluation 
of the effects of the demonstration must include scientifically 
relevant data and controls for comparative analysis.

B. 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 MMA641 information that can be 
associated with an individual as provided for under ``Section III. 
Entities Who May Receive Disclosures Under Routine Use.'' Both 
identifiable and non-identifiable data may be disclosed under a routine 
use. Identifiable data includes individual records with MMA641 
information and identifiers. Non-identifiable data includes individual 
records with MMA641 information and masked identifiers or MMA641 
information with identifiers stripped out of the file.
    CMS will only disclose the minimum personal data necessary to 
achieve the purpose of the MMA641. 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 SOR will be approved only for the minimum information necessary to 
accomplish the purpose of the disclosure after CMS:
    1. Determines that the use or disclosure is consistent with the 
reason that the data are being collected; e.g., to maintain information 
on individual Medicare beneficiaries who voluntarily enroll in a 
demonstration project for coverage of certain prescription drugs and 
biologicals.
    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 That 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 MMA641 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. CMS proposes to 
establish the following routine use disclosures of information 
maintained in the system:
    1. To agency contractors, or consultants that have been contracted 
by the agency to assist in the performance of a service related to this 
system of records and that need to have access to the records in order 
to perform the activity.
    CMS contemplates 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 agency business 
functions relating to purposes for this system of records.
    CMS occasionally contracts out certain of its functions when doing 
so would contribute to effective and

[[Page 32589]]

efficient operations. CMS must be able to give a contractor whatever 
information is necessary for the contractor to fulfill its duties. In 
these situations, safeguards are provided in the contract prohibiting 
the contractor from using or disclosing the information for any purpose 
other than, that described in the contract and requires the contractor 
to return or destroy all information at the completion of the contract.
    2. 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.
    Individuals sometimes request the help of a Member of Congress in 
resolving some 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.
    3. 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. A determination would be made in each instance that, 
under the circumstances involved, the purposes served by the use of the 
information in the particular litigation is compatible with a purpose 
for which CMS collects the information.
    4. To an individual or organization engaged in, or assisting in: 
the appropriate submission of claims payments payable under the 
demonstration project; the screening, enrollment, communications, and 
research efforts related to beneficiary participation in the 
demonstration project (including summary analyses demonstrating the 
impact of the demonstration project); the inter-relationship of the 
demonstration claims processing system with other Medicare systems of 
records to beneficiary information and claims payment; and, other 
activities reasonably necessary to fulfill the provisions of the 
demonstration project and ensure appropriate use of Medicare trust fund 
and program funds.
    5. To third party contacts in situations where the party to be 
contacted has, or is expected to have information relating to the 
individual's capacity to manage his or her affairs or to his or her 
eligibility for, or an entitlement to, benefits under the Medicare 
program and,
    a. The individual is unable to provide the information being sought 
(an individual is considered to be unable to provide certain types of 
information when any of the following conditions exists: the individual 
is confined to a mental institution, a court of competent jurisdiction 
has appointed a guardian to manage the affairs of that individual, a 
court of competent jurisdiction has declared the individual to be 
mentally incompetent, or the individual's attending physician has 
certified that the individual is not sufficiently mentally competent to 
manage his or her own affairs or to provide the information being 
sought, the individual cannot read or write, cannot afford the cost of 
obtaining the information, a language barrier exist, or the custodian 
of the information will not, as a matter of policy, provide it to the 
individual), or
    b. The data are needed to establish the validity of evidence or to 
verify the accuracy of information presented by the individual, and it 
concerns one or more of the following: the individual's entitlement to 
benefits under the Medicare program, the amount of reimbursement, and 
in cases in which the evidence is being reviewed as a result of 
suspected fraud and abuse, program integrity, quality appraisal, or 
evaluation and measurement of activities.
    Third party contacts require MMA641 information in order to provide 
support for the individual's entitlement to benefits under the Medicare 
program; to establish the validity of evidence or to verify the 
accuracy of information presented by the individual, and assist in the 
monitoring of Medicare claims information of beneficiaries, including 
proper reimbursement of services provided.

B. Additional Provisions Affecting Routine Use Disclosures

    In addition, CMS policy will be to prohibit release even of non-
identifiable data, 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 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 individual).
    This System of Records contains Protected Health Information as 
defined by the Department of Health and Human Services' regulation 
``Standards for Privacy of Individually Identifiable Health 
Information'' (45 CFR Parts 160 and 164, 65 Federal Register 82462 as 
amended by 66 Federal Register 12434). 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.''

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, DHHS, 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, DHHS, and CMS policies and 
standards include but are not limited to: all pertinent NIST 
publications; the DHHS Automated Information Systems Security Handbook 
and the CMS Information Security Handbook.

[[Page 32590]]

V. Effects of the New 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. 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 monitor the collection and reporting of MMA641 data. 
MMA641 information is submitted to CMS through standard systems. CMS 
will use a variety of onsite and offsite edits and audits to increase 
the accuracy of MMA641 data.
    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 maintaining this system of records.

    Dated: June 4, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0545

SYSTEM NAME:
    ``MMA Section 641 Prescription Drug Benefit Demonstration'' 
(MMA641) System No. 09-70-0545, HHS/CMS/ORDI.

SECURITY CLASSIFICATION:
    Level 3, Privacy Act Sensitive.

SYSTEM LOCATION:
    Records are stored at the Office of Information System and the 
Office of Operations Management, CMS, 7500 Security Boulevard, 
Baltimore, Maryland 21244 and Trailblazer Health Enterprises, LLC, 1954 
Greenspring Drive, Timonium, MD 21093.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    This system will contain claims and demographic information on 
Medicare beneficiaries who are voluntarily participating in the MMA641.

CATEGORIES OF RECORDS IN THE SYSTEM:
    The MMA641 will contain information on Medicare beneficiaries who 
are voluntarily participating in the project including, standard data 
for identification such as Name, Medicare Health Insurance Claim (HIC) 
Number, sex, race, date of birth, zip code, state and county for 
Medicare beneficiaries who are voluntarily participating in the Section 
641 Demonstration. It also includes claims information related to 
prescription drug claims, supplemental prescription drug coverage 
plans, income attestation, physician certification, answers to 
eligibility questions, answers to enrollment questionnaires and other 
information needed to confirm the beneficiaries eligibility for 
enrollment and ongoing participation in the demonstration, as well as 
other survey and research information needed to pay claims, administer 
the demonstration project, and develop research reports on the study's 
findings.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Authority for this system of records comes from the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), 
(Pub. L. 108-173) Title XVIII of the Social Security Act, Section 
1860D, Subtitle D-Additional Demonstrations, Studies, and Other 
Provisions, Sec 641(a).

PURPOSE (S) OF THE SYSTEM:
    The primary purposes of the system of records are to maintain 
information on individual Medicare beneficiaries who voluntarily enroll 
in a demonstration project for coverage of certain prescription drugs 
and biologicals. This demonstration project is mandated in the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 under 
section 641. The system of records will enable CMS to: Enroll and 
communicate with eligible Medicare beneficiaries who volunteer to 
participate in the demonstration project, communicate with clinicians 
and other providers and suppliers who submit claims payable under the 
demonstration project, review submitted claims and pay those conforming 
to applicable payment criteria and federal law, and develop, maintain, 
and analyze research information showing the potential impact of 
providing certain prescription drugs and biologicals.
    Information retrieved from this system of records will also be 
disclosed to support regulatory, reimbursement, and policy functions 
performed within the agency or by a contractor or consultant; support 
constituent requests made to a Congressional representative; support 
litigation involving the agency; and to support activities reasonably 
necessary to fulfill the provisions of the demonstration project and 
ensure appropriate use of Medicare trust fund and program funds; and 
third parties where the contact is expected to have information 
relating to the individual's capacity to manage his or her own affairs.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OR USERS AND THE PURPOSES OF SUCH USES:
    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 MMA641 System 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. In addition, CMS 
policy will be to prohibit release even of non-identifiable data, 
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 population is so small that 
individuals who are familiar with the enrollees could, because of the 
small size, use this information to deduce personal identity).
    1. To agency contractors, or consultants that have been contracted 
by the agency to assist in the performance of a service related to this 
system of records and that need to have access to the records in order 
to perform the activity.
    2. 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.
    3. 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.

[[Page 32591]]

    4. To an individual or organization engaged in, or assisting in: 
The appropriate submission of claims payments payable under the 
demonstration project; the screening, enrollment, maintenance, 
communications, and research efforts related to beneficiary 
participation in the demonstration project (including summary analyses 
demonstrating the impact of the demonstration project); the inter-
relationship of the demonstration claims processing system with other 
Medicare systems of records to beneficiary information and claims 
payment; and, other activities reasonably necessary to fulfill the 
provisions of the demonstration project and ensure appropriate use of 
Medicare trust fund and program funds.
    5. To third party contacts in situations where the party to be 
contacted has, or is expected to have information relating to the 
individual's capacity to manage his or her affairs or to his or her 
eligibility for, or an entitlement to, benefits under the Medicare 
program and,
    a. The individual is unable to provide the information being sought 
(an individual is considered to be unable to provide certain types of 
information when any of the following conditions exists: The individual 
is confined to a mental institution, a court of competent jurisdiction 
has appointed a guardian to manage the affairs of that individual, a 
court of competent jurisdiction has declared the individual to be 
mentally incompetent, or the individual's attending physician has 
certified that the individual is not sufficiently mentally competent to 
manage his or her own affairs or to provide the information being 
sought, the individual cannot read or write, cannot afford the cost of 
obtaining the information, a language barrier exist, or the custodian 
of the information will not, as a matter of policy, provide it to the 
individual), or
    b. The data are needed to establish the validity of evidence or to 
verify the accuracy of information presented by the individual, and it 
concerns one or more of the following: The individual's entitlement to 
benefits under the Medicare program, the amount of reimbursement, and 
in cases in which the evidence is being reviewed as a result of 
suspected fraud and abuse, program integrity, quality appraisal, or 
evaluation and measurement of activities.
    Third party contacts require MMA641 information in order to provide 
support for the individual's entitlement to benefits under the Medicare 
program; to establish the validity of evidence or to verify the 
accuracy of information presented by the individual, and assist in the 
monitoring of Medicare claims information of beneficiaries, including 
proper reimbursement of services provided.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    All records are stored on magnetic media. Some input data may 
arrive as paper enrollment applications as in the case of income 
attestations and physician certifications before transcription to 
magnetic media.

RETRIEVABILITY:
    The Medicare records are retrieved by health insurance claim (HIC) 
number of the beneficiary.

SAFEGUARDS:
    CMS has safeguards in place for authorized users and monitors such 
users to ensure against excessive or unauthorized use. Personnel having 
access to the system have been trained in the Privacy Act and 
information security requirements. Employees who maintain records in 
this system are instructed not to release data until the intended 
recipient agrees to 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, DHHS, 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, DHHS, and CMS policies and 
standards include but are not limited to: all pertinent NIST 
publications; the DHHS Automated Information Systems Security Handbook 
and the CMS Information Security Handbook.

RETENTION AND DISPOSAL:
    CMS will retain identifiable MMA641 data for a total period not to 
exceed 25 years. Data residing with the designated enrollment and 
claims payment contractor shall be returned to CMS at the end of the 
contract period, with all data then being the responsibility of CMS for 
adequate storage and security.

SYSTEM MANAGER AND ADDRESS:
    Director, Office of Research, Development, and Information, CMS, 
Room C3-20-11, 7500 Security Boulevard, Baltimore, Maryland, 21244-
1850.

NOTIFICATION PROCEDURE:
    For purpose of access, the subject individual should write to the 
system manager, who will require the system name, the subject 
individual's name (woman's maiden name, if applicable), social security 
number (SSN) (furnishing the SSN is voluntary, but it may make 
searching for a record easier and prevent delay), phone no., if known, 
address, date of correspondence and control number.

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:
    1. Eligibility data on Medicare beneficiaries volunteering to 
participate in the MMA Prescription Drug Benefit Demonstration will 
come from input from beneficiaries who report to CMS officials or 
contractors, pursuant to information collection activities approved at 
the Office of Management and Budget and through an Institutional Review 
Board as required by law. Eligibility will be and crosschecked with 
information contained in the Common Working File (CWF). Enrollment 
application information and questionnaires for participants will also 
come directly from beneficiaries' voluntary reporting.

[[Page 32592]]

    2. Income attestation information will come from beneficiaries who 
voluntarily report this information in an approved format and pursuant 
to information collection activities approved at the Office of 
Management and Budget and through an Institutional Review Board as 
required by law.
    3. Physician certification information will come through voluntary 
submission of physicians or other health care providers who have the 
legal authority to provide such information.
    4. Claims data will come through submissions provided by a pharmacy 
benefits manager who will be providing coverage for specified drugs and 
biologicals as discussed in the MMA legislation (section 641) in 
accordance with the provisions of the demonstration and the conditions 
of participation in the Medicare program.
    5. Eligibility information as well as financial or quality 
reporting related to program integrity or other matters may also 
interact with existing CMS registries such as those relating to 
Medicare claims, provider registries, beneficiary enrollment databases, 
and national claims histories.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

[FR Doc. 04-13240 Filed 6-9-04; 8:45 am]
BILLING CODE 4120-03-P