Privacy Act of 1974; Report of a New System of Records, 58442-58446 [05-19907]
Download as PDF
58442
Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Notices
Title
System
manager
Evaluation of the Medicaid Demonstration for Improving Access to Care for Substance Abusing Pregnant
Women.
Evaluation of and External Quality Assurance for the Community Nursing Organization Demonstration .........
HHS/CMS/ORDI
System No.
09–70–0063
09–70–0066
Dated: September 27, 2005.
Charlene Brown,
Acting Chief Operating Officer, Centers for
Medicare & Medicaid Services.
[FR Doc. 05–19906 Filed 10–5–05; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Privacy Act of 1974; Report of a New
System of Records
Department of Health and
Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a new System of
Records (SOR).
AGENCY:
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
we are proposing to establish a new
SOR titled ‘‘Medicare Care Management
Performance Demonstration (MCMP),’’
System No. 09–70–0562. MCMP
demonstration tests a payment
methodology for physician practices
that combines Medicare fee-for-service
payments with performance-based
payments for improvements in
information technology systems, patient
education, care management, and
quality of care. Improvements in these
areas are expected to generate savings to
the Medicare program to offset the costs
of the performance payments. Mandated
by Section 649 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA), the
MCMP Demonstration seeks to provide
incentives for physicians to adopt and
integrate information technology
systems into their practices, and to
improve quality as defined by key
measurable outcomes.
The primary purpose of the system is
to establish a pay-for-performance three
year pilot with physicians to promote
the adoption and use of health
information technology to improve the
quality of patient care for chronically ill
Medicare patients. Information retrieved
from this system will also be disclosed
to: (1) Support regulatory,
reimbursement, and policy functions
performed within the agency or by a
contractor or consultant; (2) assist
another Federal or state agency with
VerDate Aug<31>2005
19:52 Oct 05, 2005
Jkt 208001
information to enable such agency to
administer a Federal health benefits
program, or to enable such agency to
fulfill a requirement of Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal funds; (3) assist an
individual or organization for a research
project or in support of an evaluation
project related to the prevention of
disease or disability, the restoration or
maintenance of health, or payment
related projects; (4) support constituent
requests made to a congressional
representative; (5) support litigation
involving the agency; and (6) combat
fraud and abuse in certain 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 27, 2005. In any
event, we will not disclose any
information under a routine use until 40
days after publication. We may defer
implementation of this system or one or
more of the routine use statements listed
below if we receive comments that
persuade us to defer implementation.
ADDRESSES: The public should address
comments to: CMS Privacy Officer,
Division of Privacy Compliance Data
Development, CMS, Mail Stop N2–04–
27, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850. Comments
received will be available for review at
this location, by appointment, during
regular business hours, Monday through
Friday from 9 a.m.–3 p.m., eastern time
zone.
FOR FURTHER INFORMATION CONTACT: Jody
Blatt, Research Analyst, Division of
Payment Policy, Medicare
Demonstration Programs Group, Office
of Research Development and
Information, CMS, Mail Stop C4–17–27,
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
HHS/CMS/ORDI
7500 Security Boulevard, Baltimore,
Maryland 21244–1850. The telephone
number is (410) 786–6921 or e-mail
jody.blatt@cms.hhs.gov.
Section
649 of (MMA) requires the Secretary of
Health and Human Services to
‘‘establish a pay-for-performance
demonstration program with physicians
to meet the needs of eligible
beneficiaries through the adoption and
use of health information technology
and evidence-based outcomes
measures.’’ The resulting
demonstration, known as MCMP
Demonstration, provides incentives to
primary care physician practices for (1)
clinical systems, which encompasses
the implementation and use of
information technology, patient
education, and care management, and
(2) clinical quality, which encompasses
using evidence-based outcome
measures. The objectives of the
demonstration are to: (1) Promote
continuity of care, (2) stabilize medical
conditions, (3) reduce adverse health
outcomes, and (4) prevent or minimize
acute episodes of chronic conditions
that require an emergency room visit or
hospitalization.
In the demonstration, payments will
be made to physician practices that
meet or exceed performance standards
established by CMS. There will be two
categories of performance payments.
One payment will be made for clinical
systems based on the number of patients
who are Medicare beneficiaries with a
chronic condition; and the other will be
made for clinical quality based on the
number of beneficiaries with the
specific diseases of diabetes, congestive
heart failure, or coronary artery disease.
Payment for clinical quality will also be
made for meeting standards on various
screening measures. Payments can vary
based on performance.
The three year demonstration project
will be launched in four states, with up
to 2,800 physicians from solo and small
to medium-sized group practices
participating, including practices in
both urban and rural areas. The project
is expected to become operational in
2006, with physicians being paid in
2006, 2007, and 2008. It will operate in
the same four states as initiated the
Doctor’s Office Quality—Information
Technology project (California, Utah,
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06OCN1.SGM
06OCN1
Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Notices
Arkansas, and Massachusetts), thus
allowing the Quality Improvement
Organizations (QIOs) in those states to
provide support to participating
physicians.
I. Description of the New System of
Records
A. Statutory and Regulatory Basis for
System
The authority for maintenance of this
system is given under the provisions of
Section 649 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA)
(Public Law 108–173).
B. Collection and Maintenance of Data
in the System
This system will maintain
individually identifiable data collected
on the Medicare expenditures of
beneficiaries assigned to the
participating physician practices. The
data will consist of clinical quality
measures collected from the individual
physician practices participating in the
demonstration. The collected
information will contain: provider
name, unique provider identification
number, unique demonstration practice
identification number, beneficiary
health insurance claim number, and
whether the beneficiary received the
services described by the clinical
measure and was counted in either the
numerator and/or the denominator of
the performance measure calculation for
the physician.
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 MCMP information that can
be associated with an individual as
provided for under ‘‘Section III.
Proposed Routine Use Disclosures of
Data in the System.’’ Both identifiable
and non-identifiable data may be
disclosed under a routine use.
We will only collect the minimum
personal data necessary to achieve the
purpose of MCMP. CMS has the
following policies and procedures
concerning disclosures of information
that will be maintained in the system.
Disclosure of information from the
system will be approved only to the
extent necessary to accomplish the
purpose of the disclosure and only after
CMS:
VerDate Aug<31>2005
19:52 Oct 05, 2005
Jkt 208001
1. Determines that the use or
disclosure is consistent with the reason
that the data is being collected, e.g., to
collect and maintain data on Medicare
expenditures of the beneficiaries
assigned to participating physician
practices that is relevant to calculating
physician based performance on clinical
quality measures and making
performance payments to participating
physician practices.
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 information
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
The Privacy Act allows us to disclose
information without an individual’s
consent if the information is to be used
for a purpose that is compatible with the
purpose(s) for which the information
was collected. Any such compatible use
of data is known as a ‘‘routine use.’’ The
proposed routine uses in this system
meet the compatibility requirement of
the Privacy Act. We are proposing to
establish the following routine use
disclosures of information maintained
in the system:
1. To agency contractors or
consultants who have been engaged by
the agency to assist in the performance
of a service related to this system and
who need to have access to the records
in order to perform the activity.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
58443
into a contractual or similar agreement
with a third party to assist in
accomplishing CMS function relating to
purposes for this system. CMS
occasionally contracts out certain of its
functions when doing so would
contribute to effective and efficient
operations. CMS must be able to give a
contractor or consultant whatever
information is necessary for the
contractor or consultant to fulfill its
duties. In these situations, safeguards
are provided in the contract prohibiting
the contractor or consultant from using
or disclosing the information for any
purpose other than that described in the
contract and requires the contractor or
consultant to return or destroy all
information at the completion of the
contract.
2. To another Federal or state agency
to:
a. Contribute to the accuracy of CMS’s
proper payment of Medicare benefits,
b. Enable such agency to administer a
Federal health benefits program, or as
necessary to enable such agency to
fulfill a requirement of a Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal funds, and/or
c. Assist Federal/state Medicaid
programs within the state.
Other Federal or state agencies in
their administration of a Federal health
program may require MCMP
information in order to support
evaluations and monitoring of Medicare
claims information of beneficiaries,
including proper reimbursement for
services provided.
3. To an individual or organization for
a research project or in support of an
evaluation project related to the
prevention of disease or disability, the
restoration or maintenance of health, or
payment related projects.
The MCMP data will provide for
research or in support of evaluation
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.
4. To a member of Congress or to a
congressional staff member in response
to an inquiry of the congressional office
made at the written request of the
constituent about whom the record is
maintained.
Beneficiaries sometimes request the
help of a member of Congress in
resolving an issue relating to a matter
before CMS. The member of Congress
then writes CMS, and CMS must be able
E:\FR\FM\06OCN1.SGM
06OCN1
58444
Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Notices
to give sufficient information to be
responsive to the inquiry.
5. To the Department of Justice (DOJ),
court or adjudicatory body when:
a. The agency or any component
thereof, or
b. Any employee of the agency in his
or her official capacity, or
c. Any employee of the agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. The United States Government is a
party to litigation or has an interest in
such litigation, and by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation and that the use of such
records by the DOJ, court or
adjudicatory body is compatible with
the purpose for which the agency
collected the records.
Whenever CMS is involved in
litigation, and occasionally when
another party is involved in litigation
and CMS’ policies or operations could
be affected by the outcome of the
litigation, CMS would be able to
disclose information to the DOJ, court or
adjudicatory body involved.
6. To a CMS contractor (including, but
not necessarily limited to fiscal
intermediaries and carriers) that assists
in the administration of a CMSadministered health benefits program,
or to a grantee of a CMS-administered
grant program, when disclosure is
deemed reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud or
abuse in such program.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
into a contractual relationship or grant
with a third party to assist in
accomplishing CMS functions relating
to the purpose of combating fraud and
abuse.
CMS occasionally contracts out
certain of its functions and makes grants
when doing so would contribute to
effective and efficient operations. CMS
must be able to give a contractor or
grantee whatever information is
necessary for the contractor or grantee to
fulfill its duties. In these situations,
safeguards are provided in the contract
prohibiting the contractor or grantee
from using or disclosing the information
for any purpose other than that
described in the contract and requiring
the contractor or grantee to return or
destroy all information.
7. To another Federal agency or to an
instrumentality of any governmental
jurisdiction within or under the control
VerDate Aug<31>2005
19:52 Oct 05, 2005
Jkt 208001
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
information for the purpose of
combating fraud and abuse in such
Federally-funded programs.
B. Additional Provisions Affecting
Routine Use Disclosures
This system contains Protected Health
Information (PHI) as defined by HHS
regulation ‘‘Standards for Privacy of
Individually Identifiable Health
Information’’ (45 Code of Federal
Regulation Parts 160 and 164, 65 Fed.
Reg. 82462 (12–28–00), Subparts A and
E. Disclosures of PHI 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 not directly
identifiable information, except
pursuant to one of the routine uses or
if required by law, if we determine there
is a possibility that an individual can be
identified through implicit deduction
based on small cell sizes (instances
where the patient population is so small
that individuals who are familiar with
the enrollees could, because of the small
size, use this information to deduce the
identity of the beneficiary).
IV. Safeguards
CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations include but
are not limited to: the Privacy Act of
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
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 ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: all pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
V. Effects of the 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.
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 is 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.
Dated: September 27, 2005.
Charlene Brown,
Acting Chief Operating Officer, Centers for
Medicare & Medicaid Services.
System No.: 09–70–0562
SYSTEM NAME:
‘‘Medicare Care Management
Performance Demonstration (MCMP)’’
HHS/CMS/ORDI.
SECURITY CLASSIFICATION:
Level 3 Privacy Act Sensitive.
SYSTEM LOCATION:
This system is maintained at the
Centers for Medicare & Medicaid
E:\FR\FM\06OCN1.SGM
06OCN1
Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Notices
Services (CMS) Data Center, 7500
Security Boulevard, North Building,
First Floor, Baltimore, Maryland 21244–
1850, and CMS contractors and agents at
various locations.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
The data will be maintained on
individual physicians participating in
the demonstration. In order to collect
this data and use it to determine
incentive payments to physicians, the
system will also maintain individually
identifiable information on Medicare
beneficiaries assigned to physicians
participating in the demonstration.
CATEGORIES OF RECORDS IN THE SYSTEM:
The data will consist of clinical
quality measures collected from
physician participating in the
demonstration. The collected
information will contain provider name,
unique provider identification number,
unique demonstration practice
identification number, beneficiary
health insurance claim number (HICN),
beneficiary demographic and diagnostic
information relevant to the measure,
and whether the beneficiary received
the services described by the clinical
measure and was counted in either the
numerator and/or the denominator of
the performance measure calculation for
the physician.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The authority for maintenance of this
system is given under the provisions of
Section 649 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (Public Law
108–173).
PURPOSE(S) OF THE SYSTEM:
The primary purpose of the system is
to establish a pay-for-performance three
year pilot with physicians to promote
the adoption and use of health
information technology to improve the
quality of patient care for chronically ill
Medicare patients. Information retrieved
from this system will also be disclosed
to: (1) Support regulatory,
reimbursement, and policy functions
performed within the agency or by a
contractor or consultant; (2) assist
another Federal or state agency with
information to enable such agency to
administer a Federal health benefits
program, or to enable such agency to
fulfill a requirement of Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal funds; (3) assist an
individual or organization for a research
project or in support of an evaluation
project related to the prevention of
disease or disability, the restoration or
VerDate Aug<31>2005
19:52 Oct 05, 2005
Jkt 208001
maintenance of health, or payment
related projects; (4) support constituent
requests made to a congressional
representative; (5) support litigation
involving the agency; and (6) combat
fraud and abuse in certain 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
The Privacy Act allows us to disclose
information without an individual’s
consent if the information is to be used
for a purpose that is compatible with the
purpose(s) for which the information
was collected. Any such compatible use
of data is known as a ‘‘routine use.’’ The
proposed routine uses in this system
meet the compatibility requirement of
the Privacy Act. We are proposing to
establish the following routine use
disclosures of information maintained
in the system:
1. To agency contractors or
consultants who have been engaged by
the agency to assist in the performance
of a service related to this system and
who need to have access to the records
in order to perform the activity.
2. To another Federal or state agency
to:
a. Contribute to the accuracy of CMS’s
proper payment of Medicare benefits,
b. Enable such agency to administer a
Federal health benefits program, or as
necessary to enable such agency to
fulfill a requirement of a Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal funds, and/or
c. Assist Federal/state Medicaid
programs within the state.
3. To an individual or organization for
a research project or in support of an
evaluation project related to the
prevention of disease or disability, the
restoration or maintenance of health, or
payment related projects.
4. To a member of Congress or to a
congressional staff member in response
to an inquiry of the congressional office
made at the written request of the
constituent about whom the record is
maintained.
5. To the Department of Justice (DOJ),
court or adjudicatory body when:
a. The agency or any component
thereof, or
b. Any employee of the agency in his
or her official capacity, or
c. Any employee of the agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. The United States Government is a
party to litigation or has an interest in
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
58445
such litigation, and by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation and that the use of such
records by the DOJ, court or
adjudicatory body is compatible with
the purpose for which the agency
collected the records.
6. To a CMS contractor (including, but
not necessarily limited to fiscal
intermediaries and carriers) that assists
in the administration of a CMSadministered health benefits program,
or to a grantee of a CMS-administered
grant program, when disclosure is
deemed reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud or
abuse in such program.
7. To another Federal agency or to an
instrumentality of any governmental
jurisdiction within or under the control
of the United States (including any state
or local governmental agency), that
administers, or that has the authority to
investigate potential fraud or abuse in,
a health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud or abuse in such programs.
B. Additional Provisions Affecting
Routine Use Disclosures
This system contains Protected Health
Information (PHI) as defined by
Department of Health and Human
Services (HHS) regulation ‘‘Standards
for Privacy of Individually Identifiable
Health Information’’ (45 Code of Federal
Regulations (CFR) Parts 160 and 164, 65
FR 82462 (12–28–00), Subparts A and E.
Disclosures of PHI 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 not directly
identifiable information, except
pursuant to one of the routine uses or
if required by law, if we determine there
is a possibility that an individual can be
identified through implicit deduction
based on small cell sizes (instances
where the patient population is so small
that individuals who are familiar with
the enrollees could, because of the small
size, use this information to deduce the
identity of the beneficiary).
E:\FR\FM\06OCN1.SGM
06OCN1
58446
Federal Register / Vol. 70, No. 193 / Thursday, October 6, 2005 / Notices
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
CMS for adequate storage and security.
All claims-related records are
encompassed by the document
preservation order and will be retained
until notification is received from the
DOJ.
STORAGE:
All records are stored on magnetic
media.
RETRIEVABILITY:
Information collected will be
retrieved by the name or other
identifying information of the
participating provider, and may also be
retrievable by HICN at the individual
beneficiary record level.
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 ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. Office of Management and
Budget Circular A–130, Management of
Federal Resources, Appendix III,
Security of Federal Automated
Information Resources also applies.
Federal, HHS, and CMS policies and
standards include but are not limited to:
all pertinent National Institute of
Standards and Technology publications;
the HHS Information Systems Program
Handbook and the CMS Information
Security Handbook.
RETENTION AND DISPOSAL:
CMS will retain identifiable
information maintained in the MCMP
system of records for a period of 6 years.
Data residing with the designated claims
payment contractor shall be returned to
CMS at the end of the project, with all
data then being the responsibility of
VerDate Aug<31>2005
19:52 Oct 05, 2005
Jkt 208001
SYSTEM MANAGER AND ADDRESS:
Director, Medicare Demonstration
Program Group, Office of Research
Development and Information, CMS,
7500 Security Boulevard, Mail stop C4–
17–27, 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, and for verification purposes, the
subject individual’s name, provider
identification number, and the patient’s
medical record 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:
Information maintained in this system
will be collected from physicians
volunteering to participate in the MCMP
Demonstration. Additional data will be
collected from Medicare claims
payment records.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. 05–19907 Filed 10–5–05; 8:45 am]
BILLING CODE 4120–03–P
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
The Essentials of Food and Drug
Administration Device Regulations: A
Primer for Manufacturers and
Suppliers; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA) Philadelphia
District, in cooperation with AdvaMed’s
Medical Technology Learning Institute,
is announcing a public workshop on
FDA device regulations. This 1 1/2-day
public workshop for start up and small
device manufacturers and their
suppliers will include both industry and
FDA perspectives and a question and
answer period.
Date and Time: The public workshop
will be held on Tuesday, October 11,
2005, from 8:30 a.m. to 5:30 p.m. and
Wednesday, October 12, 2005, from 8:30
a.m. to 12 noon.
Location: The public workshop will
be held at The Wyndham Philadelphia
at Franklin Plaza, 17th and Race St.,
Philadelphia, PA 19103, 215–448–2000.
For further hotel information and
driving directions, go to https://
www.wyndham.com/hotels/PHLFP.
(FDA has verified the Web site address,
but is not responsible for subsequent
changes to the Web site after this
document publishes in the Federal
Register.)
Contact:
For FDA: Judy Summers-Gates, Food
and Drug Administration, rm. 900,
U.S. Customhouse, 200 Chestnut
St., Philadelphia, PA 19106, 215–
717–3008, FAX: 215–597–4660, email: judith.summersgates@fda.gov.
For AdvaMed: Krystine McGrath,
202–434–7237, FAX: 202–783–
8750, kmcgrath@advamed.org; or
Dia Black, 202–434–7231, FAX:
202–783–8750, e-mail:
dblack@avamed.org.
Registration: Send registration
information (including name, title, firm
name, address, telephone, and fax
number), and the registration fee of $350
per person to the AdvaMed contacts (see
Contact). The registration fee for FDA
employees is waived. To register via the
Internet go to https://www.advamed.org/
philadelphia. (FDA has verified the Web
site address, but is not responsible for
subsequent changes to the Web site after
this document publishes in the Federal
Register.)
E:\FR\FM\06OCN1.SGM
06OCN1
Agencies
[Federal Register Volume 70, Number 193 (Thursday, October 6, 2005)]
[Notices]
[Pages 58442-58446]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19907]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of a New System of Records
AGENCY: Department of Health and Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a new System of Records (SOR).
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to establish a new SOR titled ``Medicare Care
Management Performance Demonstration (MCMP),'' System No. 09-70-0562.
MCMP demonstration tests a payment methodology for physician practices
that combines Medicare fee-for-service payments with performance-based
payments for improvements in information technology systems, patient
education, care management, and quality of care. Improvements in these
areas are expected to generate savings to the Medicare program to
offset the costs of the performance payments. Mandated by Section 649
of the Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 (MMA), the MCMP Demonstration seeks to provide incentives for
physicians to adopt and integrate information technology systems into
their practices, and to improve quality as defined by key measurable
outcomes.
The primary purpose of the system is to establish a pay-for-
performance three year pilot with physicians to promote the adoption
and use of health information technology to improve the quality of
patient care for chronically ill Medicare patients. Information
retrieved from this system will also be disclosed to: (1) Support
regulatory, reimbursement, and policy functions performed within the
agency or by a contractor or consultant; (2) assist another Federal or
state agency with information to enable such agency to administer a
Federal health benefits program, or to enable such agency to fulfill a
requirement of Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal funds; (3)
assist an individual or organization for a research project or in
support of an evaluation project related to the prevention of disease
or disability, the restoration or maintenance of health, or payment
related projects; (4) support constituent requests made to a
congressional representative; (5) support litigation involving the
agency; and (6) combat fraud and abuse in certain 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 27, 2005. In any event, we will not disclose any
information under a routine use until 40 days after publication. We may
defer implementation of this system or one or more of the routine use
statements listed below if we receive comments that persuade us to
defer implementation.
ADDRESSES: The public should address comments to: CMS Privacy Officer,
Division of Privacy Compliance Data Development, CMS, Mail Stop N2-04-
27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments
received will be available for review at this location, by appointment,
during regular business hours, Monday through Friday from 9 a.m.-3
p.m., eastern time zone.
FOR FURTHER INFORMATION CONTACT: Jody Blatt, Research Analyst, Division
of Payment Policy, Medicare Demonstration Programs Group, Office of
Research Development and Information, CMS, Mail Stop C4-17-27, 7500
Security Boulevard, Baltimore, Maryland 21244-1850. The telephone
number is (410) 786-6921 or e-mail jody.blatt@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: Section 649 of (MMA) requires the Secretary
of Health and Human Services to ``establish a pay-for-performance
demonstration program with physicians to meet the needs of eligible
beneficiaries through the adoption and use of health information
technology and evidence-based outcomes measures.'' The resulting
demonstration, known as MCMP Demonstration, provides incentives to
primary care physician practices for (1) clinical systems, which
encompasses the implementation and use of information technology,
patient education, and care management, and (2) clinical quality, which
encompasses using evidence-based outcome measures. The objectives of
the demonstration are to: (1) Promote continuity of care, (2) stabilize
medical conditions, (3) reduce adverse health outcomes, and (4) prevent
or minimize acute episodes of chronic conditions that require an
emergency room visit or hospitalization.
In the demonstration, payments will be made to physician practices
that meet or exceed performance standards established by CMS. There
will be two categories of performance payments. One payment will be
made for clinical systems based on the number of patients who are
Medicare beneficiaries with a chronic condition; and the other will be
made for clinical quality based on the number of beneficiaries with the
specific diseases of diabetes, congestive heart failure, or coronary
artery disease. Payment for clinical quality will also be made for
meeting standards on various screening measures. Payments can vary
based on performance.
The three year demonstration project will be launched in four
states, with up to 2,800 physicians from solo and small to medium-sized
group practices participating, including practices in both urban and
rural areas. The project is expected to become operational in 2006,
with physicians being paid in 2006, 2007, and 2008. It will operate in
the same four states as initiated the Doctor's Office Quality--
Information Technology project (California, Utah,
[[Page 58443]]
Arkansas, and Massachusetts), thus allowing the Quality Improvement
Organizations (QIOs) in those states to provide support to
participating physicians.
I. Description of the New System of Records
A. Statutory and Regulatory Basis for System
The authority for maintenance of this system is given under the
provisions of Section 649 of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA) (Public Law 108-173).
B. Collection and Maintenance of Data in the System
This system will maintain individually identifiable data collected
on the Medicare expenditures of beneficiaries assigned to the
participating physician practices. The data will consist of clinical
quality measures collected from the individual physician practices
participating in the demonstration. The collected information will
contain: provider name, unique provider identification number, unique
demonstration practice identification number, beneficiary health
insurance claim number, and whether the beneficiary received the
services described by the clinical measure and was counted in either
the numerator and/or the denominator of the performance measure
calculation for the physician.
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 MCMP information that can be
associated with an individual as provided for under ``Section III.
Proposed Routine Use Disclosures of Data in the System.'' Both
identifiable and non-identifiable data may be disclosed under a routine
use.
We will only collect the minimum personal data necessary to achieve
the purpose of MCMP. CMS has the following policies and procedures
concerning disclosures of information that will be maintained in the
system. Disclosure of information from the system will be approved only
to the extent necessary to accomplish the purpose of the disclosure and
only after CMS:
1. Determines that the use or disclosure is consistent with the
reason that the data is being collected, e.g., to collect and maintain
data on Medicare expenditures of the beneficiaries assigned to
participating physician practices that is relevant to calculating
physician based performance on clinical quality measures and making
performance payments to participating physician practices.
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
information 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
The Privacy Act allows us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such compatible use of data is known as a ``routine
use.'' The proposed routine uses in this system meet the compatibility
requirement of the Privacy Act. We are proposing to establish the
following routine use disclosures of information maintained in the
system:
1. To agency contractors or consultants who have been engaged by
the agency to assist in the performance of a service related to this
system and who need to have access to the records in order to perform
the activity.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual or similar
agreement with a third party to assist in accomplishing CMS function
relating to purposes for this system. CMS occasionally contracts out
certain of its functions when doing so would contribute to effective
and efficient operations. CMS must be able to give a contractor or
consultant whatever information is necessary for the contractor or
consultant to fulfill its duties. In these situations, safeguards are
provided in the contract prohibiting the contractor or consultant from
using or disclosing the information for any purpose other than that
described in the contract and requires the contractor or consultant to
return or destroy all information at the completion of the contract.
2. To another Federal or state agency to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits,
b. Enable such agency to administer a Federal health benefits
program, or as necessary to enable such agency to fulfill a requirement
of a Federal statute or regulation that implements a health benefits
program funded in whole or in part with Federal funds, and/or
c. Assist Federal/state Medicaid programs within the state.
Other Federal or state agencies in their administration of a
Federal health program may require MCMP information in order to support
evaluations and monitoring of Medicare claims information of
beneficiaries, including proper reimbursement for services provided.
3. To an individual or organization for a research project or in
support of an evaluation project related to the prevention of disease
or disability, the restoration or maintenance of health, or payment
related projects.
The MCMP data will provide for research or in support of evaluation
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.
4. To a member of Congress or to a congressional staff member in
response to an inquiry of the congressional office made at the written
request of the constituent about whom the record is maintained.
Beneficiaries sometimes request the help of a member of Congress in
resolving an issue relating to a matter before CMS. The member of
Congress then writes CMS, and CMS must be able
[[Page 58444]]
to give sufficient information to be responsive to the inquiry.
5. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government is a party to litigation or has an
interest in such litigation, and by careful review, CMS determines that
the records are both relevant and necessary to the litigation and that
the use of such records by the DOJ, court or adjudicatory body is
compatible with the purpose for which the agency collected the records.
Whenever CMS is involved in litigation, and occasionally when
another party is involved in litigation and CMS' policies or operations
could be affected by the outcome of the litigation, CMS would be able
to disclose information to the DOJ, court or adjudicatory body
involved.
6. To a CMS contractor (including, but not necessarily limited to
fiscal intermediaries and carriers) that assists in the administration
of a CMS-administered health benefits program, or to a grantee of a
CMS-administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud or abuse in such program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual relationship or
grant with a third party to assist in accomplishing CMS functions
relating to the purpose of combating fraud and abuse.
CMS occasionally contracts out certain of its functions and makes
grants when doing so would contribute to effective and efficient
operations. CMS must be able to give a contractor or grantee whatever
information is necessary for the contractor or grantee to fulfill its
duties. In these situations, safeguards are provided in the contract
prohibiting the contractor or grantee from using or disclosing the
information for any purpose other than that described in the contract
and requiring the contractor or grantee to return or destroy all
information.
7. To another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any state or local governmental agency), that
administers, or that has the authority to investigate potential fraud
or abuse in, a health benefits program funded in whole or in part by
Federal funds, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud or abuse in such programs.
Other agencies may require information for the purpose of combating
fraud and abuse in such Federally-funded programs.
B. Additional Provisions Affecting Routine Use Disclosures
This system contains Protected Health Information (PHI) as defined
by HHS regulation ``Standards for Privacy of Individually Identifiable
Health Information'' (45 Code of Federal Regulation Parts 160 and 164,
65 Fed. Reg. 82462 (12-28-00), Subparts A and E. Disclosures of PHI
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 not
directly identifiable information, except pursuant to one of the
routine uses or if required by law, if we determine there is a
possibility that an individual can be identified through implicit
deduction based on small cell sizes (instances where the patient
population is so small that individuals who are familiar with the
enrollees could, because of the small size, use this information to
deduce the identity of the beneficiary).
IV. Safeguards
CMS has safeguards in place for authorized users and monitors such
users to ensure against excessive or unauthorized use. Personnel having
access to the system have been trained in the Privacy Act and
information security requirements. Employees who maintain records in
this system are instructed not to release data until the intended
recipient agrees to implement appropriate management, operational and
technical safeguards sufficient to protect the confidentiality,
integrity and availability of the information and information systems
and to prevent unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations 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. 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.
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 is 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.
Dated: September 27, 2005.
Charlene Brown,
Acting Chief Operating Officer, Centers for Medicare & Medicaid
Services.
System No.: 09-70-0562
SYSTEM NAME:
``Medicare Care Management Performance Demonstration (MCMP)'' HHS/
CMS/ORDI.
SECURITY CLASSIFICATION:
Level 3 Privacy Act Sensitive.
SYSTEM LOCATION:
This system is maintained at the Centers for Medicare & Medicaid
[[Page 58445]]
Services (CMS) Data Center, 7500 Security Boulevard, North Building,
First Floor, Baltimore, Maryland 21244-1850, and CMS contractors and
agents at various locations.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The data will be maintained on individual physicians participating
in the demonstration. In order to collect this data and use it to
determine incentive payments to physicians, the system will also
maintain individually identifiable information on Medicare
beneficiaries assigned to physicians participating in the
demonstration.
CATEGORIES OF RECORDS IN THE SYSTEM:
The data will consist of clinical quality measures collected from
physician participating in the demonstration. The collected information
will contain provider name, unique provider identification number,
unique demonstration practice identification number, beneficiary health
insurance claim number (HICN), beneficiary demographic and diagnostic
information relevant to the measure, and whether the beneficiary
received the services described by the clinical measure and was counted
in either the numerator and/or the denominator of the performance
measure calculation for the physician.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The authority for maintenance of this system is given under the
provisions of Section 649 of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (Public Law 108-173).
PURPOSE(S) OF THE SYSTEM:
The primary purpose of the system is to establish a pay-for-
performance three year pilot with physicians to promote the adoption
and use of health information technology to improve the quality of
patient care for chronically ill Medicare patients. Information
retrieved from this system will also be disclosed to: (1) Support
regulatory, reimbursement, and policy functions performed within the
agency or by a contractor or consultant; (2) assist another Federal or
state agency with information to enable such agency to administer a
Federal health benefits program, or to enable such agency to fulfill a
requirement of Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal funds; (3)
assist an individual or organization for a research project or in
support of an evaluation project related to the prevention of disease
or disability, the restoration or maintenance of health, or payment
related projects; (4) support constituent requests made to a
congressional representative; (5) support litigation involving the
agency; and (6) combat fraud and abuse in certain 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
The Privacy Act allows us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such compatible use of data is known as a ``routine
use.'' The proposed routine uses in this system meet the compatibility
requirement of the Privacy Act. We are proposing to establish the
following routine use disclosures of information maintained in the
system:
1. To agency contractors or consultants who have been engaged by
the agency to assist in the performance of a service related to this
system and who need to have access to the records in order to perform
the activity.
2. To another Federal or state agency to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits,
b. Enable such agency to administer a Federal health benefits
program, or as necessary to enable such agency to fulfill a requirement
of a Federal statute or regulation that implements a health benefits
program funded in whole or in part with Federal funds, and/or
c. Assist Federal/state Medicaid programs within the state.
3. To an individual or organization for a research project or in
support of an evaluation project related to the prevention of disease
or disability, the restoration or maintenance of health, or payment
related projects.
4. To a member of Congress or to a congressional staff member in
response to an inquiry of the congressional office made at the written
request of the constituent about whom the record is maintained.
5. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government is a party to litigation or has an
interest in such litigation, and by careful review, CMS determines that
the records are both relevant and necessary to the litigation and that
the use of such records by the DOJ, court or adjudicatory body is
compatible with the purpose for which the agency collected the records.
6. To a CMS contractor (including, but not necessarily limited to
fiscal intermediaries and carriers) that assists in the administration
of a CMS-administered health benefits program, or to a grantee of a
CMS-administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud or abuse in such program.
7. To another Federal agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any state or local governmental agency), that
administers, or that has the authority to investigate potential fraud
or abuse in, a health benefits program funded in whole or in part by
Federal funds, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud or abuse in such programs.
B. Additional Provisions Affecting Routine Use Disclosures
This system contains Protected Health Information (PHI) as defined
by Department of Health and Human Services (HHS) regulation ``Standards
for Privacy of Individually Identifiable Health Information'' (45 Code
of Federal Regulations (CFR) Parts 160 and 164, 65 FR 82462 (12-28-00),
Subparts A and E. Disclosures of PHI 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 not
directly identifiable information, except pursuant to one of the
routine uses or if required by law, if we determine there is a
possibility that an individual can be identified through implicit
deduction based on small cell sizes (instances where the patient
population is so small that individuals who are familiar with the
enrollees could, because of the small size, use this information to
deduce the identity of the beneficiary).
[[Page 58446]]
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
All records are stored on magnetic media.
RETRIEVABILITY:
Information collected will be retrieved by the name or other
identifying information of the participating provider, and may also be
retrievable by HICN at the individual beneficiary record level.
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. Office of Management and Budget
Circular A-130, Management of Federal Resources, Appendix III, Security
of Federal Automated Information Resources also applies. Federal, HHS,
and CMS policies and standards include but are not limited to: all
pertinent National Institute of Standards and Technology publications;
the HHS Information Systems Program Handbook and the CMS Information
Security Handbook.
RETENTION AND DISPOSAL:
CMS will retain identifiable information maintained in the MCMP
system of records for a period of 6 years. Data residing with the
designated claims payment contractor shall be returned to CMS at the
end of the project, with all data then being the responsibility of CMS
for adequate storage and security. All claims-related records are
encompassed by the document preservation order and will be retained
until notification is received from the DOJ.
SYSTEM MANAGER AND ADDRESS:
Director, Medicare Demonstration Program Group, Office of Research
Development and Information, CMS, 7500 Security Boulevard, Mail stop
C4-17-27, 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, and for verification
purposes, the subject individual's name, provider identification
number, and the patient's medical record 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:
Information maintained in this system will be collected from
physicians volunteering to participate in the MCMP Demonstration.
Additional data will be collected from Medicare claims payment records.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. 05-19907 Filed 10-5-05; 8:45 am]
BILLING CODE 4120-03-P