[Federal Register: October 6, 2005 (Volume 70, Number 193)]
[Notices]
[Page 58442-58446]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc05-105]
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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).
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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 ``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