[Federal Register: October 6, 2005 (Volume 70, Number 193)]
[Notices]
[Page 58432-58436]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc05-102]
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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 system titled ``Medicare
Physician Group Practice Demonstration (PGPD),'' System No. 09-70-0559.
The PGPD tests a payment methodology for physician practices that
combines Medicare fee-for-service payments with performance-based
payments for improvements in patient 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 412 of the Benefits Improvement & Protection Act of
2000, the PGPD seeks to provide incentives for physicians to adopt care
management strategies and to improve quality as defined by key
measurable processes and outcomes.
The primary purpose of the system is to establish a pay-for-
performance three year pilot with physicians to encourage the
coordination of care, promote investment in administrative structure
and process, and reward physicians for improving health care processes
and outcomes. 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: John Pilotte, 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) 786-6558 or e-mail john.pilotte@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The PGPD rewards physicians for improving
the quality and efficiency of health care services delivered to
Medicare fee-for-service beneficiaries. Mandated by Section 412 of the
Benefits Improvement and Protection Act of 2000, the PGPD seeks to: (1)
Encourage coordination of Part A and Part B services, (2) promote
efficiency through investment in administrative structure
[[Page 58433]]
and process, and (3) reward physicians for improving health outcomes.
During the three-year project, CMS will reward physician groups
that improve patient outcomes by coordinating care for chronically ill
and high cost beneficiaries in an efficient manner. The Demonstration
enables CMS the ability to test physician groups' responses to
financial incentives for improving care coordination, delivery
processes and patient outcomes, and the effect on access, cost, and
quality of care to Medicare beneficiaries.
Physician groups participating in the demonstration will continue
to be paid on a fee-for-service basis. Physician groups will implement
care management strategies designed to anticipate patient needs,
prevent chronic disease complications and avoidable hospitalizations,
and improve quality of care.
Performance payments will be derived from savings expected through
improvements in care coordination for an assigned beneficiary
population. Performance payments will be allocated between efficiency
and quality, with an increasing emphasis placed on quality during the
demonstration. The demonstration will use a total of 32 measures that
focus on common chronic illnesses and preventive services for measuring
and rewarding quality.
CMS selected ten physician groups on a competitive basis to
participate in the demonstration. The groups were selected based on a
variety of factors including technical review panel findings,
organizational structure, operational feasibility, geographic location,
and demonstration implementation strategy.
I. Description of the New System of Records
A. Statutory and Regulatory Basis for System
The statutory authority for this system is given under the
provisions of Section 412 of the Benefits Improvement & Protection Act
of 2000.
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. In addition, data will be collected
from the physician practices on their performance based on a series of
quality measures. The collected information will include: provider
name, unique provider identification number, clinic name, medical
record number, health insurance claim number, first name, last name,
gender type, birth date, as well as, background information relating to
Medicare or Medicaid issues.
II. Agency Policies, Procedures, and Restrictions on the Routine Use
The Privacy Act permits us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such disclosure of data is known as a ``routine use.''
The government will only release PGPD 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 the PGPD. 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 the Medicare expenditures of the beneficiaries assigned to
participating physician practices 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
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 patient-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 of records 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 or records.
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 PGPD information in order to support
evaluations and monitoring of Medicare claims
[[Page 58434]]
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 PGPD 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 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
incompatible 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 PGPD 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 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).
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 of records.
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.
[[Page 58435]]
CMS will collect only that information necessary to perform the
system's functions. In addition, CMS will make disclosure from the
proposed system only with consent of the subject individual, or his/her
legal representative, or in accordance with an applicable exception
provision of the Privacy Act.
CMS, therefore, does not anticipate an unfavorable effect on
individual privacy as a result of maintaining this system of records.
Dated: September 27, 2005.
Charlene Brown,
Acting Chief Operating Officer, Centers for Medicare & Medicaid
Services.
System No.: 09-70-0559.
SYSTEM NAME:
``Medicare Physician Group Practice Demonstration (PGPD)'' HHS/CMS/
ORDI.
SECURITY CLASSIFICATION:
Level 3 Privacy Act Sensitive.
SYSTEM LOCATION:
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:
This system will maintain individually identifiable data collected
on the Medicare expenditures and quality of care of beneficiaries
assigned to the participating physician practices.
CATEGORIES OF RECORDS IN THE SYSTEM:
This system will maintain individually identifiable data collected
on the Medicare expenditures of beneficiaries assigned to the
participating physician practices. In addition, data will be collected
from the physician practices on their performance based on a series of
quality measures. The collected information will include: provider
name, unique provider identification number, clinic name, medical
record number, health insurance claim number (HICN), first name, last
name, gender type, birth date, as well as, background information
relating to Medicare or Medicaid issues.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The statutory authority for this system is given under the
provisions of Section 412 of the Benefits Improvement & Protection Act
of 2000.
PURPOSE(S) OF THE SYSTEM:
The primary purpose of the system is to establish a pay-for-
performance three year pilot with physicians to encourage the
coordination of care, promote investment in administrative structure
and process, and reward physicians for improving health care processes
and outcomes. 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
OF 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 incompatible 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 HHS regulation ``Standards for Privacy of Individually Identifiable
Health Information'' (45 Code of Federal Regulations (CFR)) Parts 160
and 164, 65 Fed. Reg. 82462 (12-28-00), Subparts A and E. Disclosures
of PHI authorized
[[Page 58436]]
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 if not
directly identifiable, 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).
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. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include, but are not limited to, all pertinent National
Institute of Standards and Technology publications, the HHS Information
Systems Program Handbook, and the CMS Information Security Handbook.
RETENTION AND DISPOSAL:
CMS will retain identifiable information maintained in the PGPD
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 Programs Group, 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 Medicare 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 voluntarily participating through claims data requesting
payment for services. The PGPD information will also be collected from
the reporting of ambulatory care data by participating physician
groups.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. 05-19904 Filed 10-5-05; 8:45 am]
BILLING CODE 4120-03-P