[Federal Register: June 10, 2004 (Volume 69, Number 112)]
[Notices]
[Page 32587-32592]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jn04-108]
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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