[Federal Register Volume 65, Number 151 (Friday, August 4, 2000)]
[Notices]
[Pages 47995-48000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18548]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
Privacy Act of 1974; Report of New System
AGENCY: Health Care Financing, Department of Health and Human Services
(HHS), Administration (HCFA).
ACTION: Notice of new system of records.
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SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to establish a new system of records, ``National
Emphysema Treatment Trial (NETT) System, HHS/HCFA/CHPP, 09-70-0531.''
HCFA and the National Heart, Lung and Blood Institute, which is part of
the National Institutes of Health, are collaborating on an effort to
study the effectiveness of lung volume reduction surgery. The study is
called ``National Emphysema Treatment Trial.'' The purpose of this
multi-center randomized study is to evaluate the long-term outcomes of
lung volume reduction surgery on function, morbidity and mortality, and
to define appropriate patient selection criteria in order to determine
which patients will likely benefit from lung volume reduction surgery.
The primary purpose of the system of records is to maintain data
that will allow HCFA to collect and provide secure data on participants
in the randomized phase of the study, pay claims, and to monitor and
evaluate the clinical trial. Information retrieved from this system of
records will also be disclosed to: support regulatory, reimbursement
and policy functions performed within the agency or by a contractor or
consultant, another federal or state agency to enable such agency to
administer a federal health benefits program, or to enable such agency
to fulfill a requirement of a Federal statute or regulation that
implements a health
[[Page 47996]]
benefits program funded in whole or in part with federal funds, support
research, evaluation, or epidemiological projects related to the
prevention of disease or disability, or the restoration or maintenance
of health, and for payment related projects, support constituent
requests made to a congressional representative, support litigation
involving the agency, and, combat fraud and abuse in certain health
benefits programs. We have provided background information about the
proposed system in the ``Supplementary Information'' section below.
Although the Privacy Act requires only that HCFA provide an opportunity
for interested persons to comment on the proposed routine uses, HCFA
invites comments on all portions of this notice. See ``Effective
Dates'' section for comment period.
EFFECTIVE DATES: HCFA 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 July 18, 2000. To ensure that all parties have adequate time
in which to comment, the new system of records, including routine uses,
will become effective 40 days from the publication of the notice, or
from the date it was submitted to OMB and the Congress, whichever is
later, unless HCFA receives comments that require alterations to this
notice.
ADDRESSES: The public should address comments to: Director, Division of
Data Liaison and Distribution (DDLD), HCFA, Room N2-04-27, 7500
Security Boulevard, Baltimore, Maryland 21244-1850. Comments received
will be available for review at this location, by appointment, during
regular business hours, Monday through Friday from 9 a.m.-3 p.m.,
eastern time zone.
FOR FURTHER INFORMATION CONTACT: Steven Sheingold, Ph.D., HCFA, Center
for Health Plans and Providers, 7500 Security Boulevard, C4-10-07,
Baltimore, Maryland 21244-1850. His telephone number is (410) 786-5896.
SUPPLEMENTARY INFORMATION:
I. Description of the Modified System of Records
A. Background
HCFA and the National Heart, Lung and Blood Institute, which is
part of the National Institutes of Health, are collaborating on an
effort to study the effectiveness of lung volume reduction surgery. The
purpose of this multi-center randomized study is to evaluate the long-
term outcomes of lung volume reduction surgery on function, morbidity
and mortality, and to define appropriate patient selection criteria.
Data related to health care services furnished to Medicare
beneficiaries participating in the NETT will be collected and used to
monitor and evaluate the trial and its interventions. The trial is
designed to:
Establish a multi-center randomized clinical trial in
association with a prospective registry to evaluate the long-term
efficacy, morbidity and mortality associated with intensive medical
therapy with lung volume reduction surgery as compared with intensive
medical therapy alone.
Define patient selection criteria in order to determine
which patients will likely benefit from lung volume reduction surgery.
The NETT contains information on beneficiaries participating in the
study. HCFA and its evaluation contractor will use this information to
monitor and evaluate the trial and its interventions. Individual
patient data will be collected on the HCFA claim forms for fee-for-
services and Medicare managed-care beneficiaries. The trial was
scheduled to began in 1997 and will continue for 7 years from its
actual start date or until the recruitment goal of 2600 patients is
attained, whichever comes first.
B. Statutory and Regulatory Basis for System of Records
Authority for maintenance of the system is given under Section
1862(a)(1)(A) of the Social Security Act, and 42 U.S.C. 1395, which
states that Medicare must provide coverage for items and services that
are ``reasonable and necessary for the diagnosis or treatment of
illness or injury or to improve the functioning of a malformed body
member.''
II. Collection and Maintenance of Data in the System.
A. Scope of the Data Collected
The system of records will contain information about Medicare
beneficiaries with emphysema, as well as referring and servicing
physicians. Utilization and frequency of specific health care services,
the provider, and the sites of services are provided as part of the
trial. The system will also contain the beneficiary's name, address,
date of birth, sex, health insurance claim number (HIC), telephone
number, marital status, clinical outcomes, and morbidity and mortality
rates.
B. Agency Policies, Procedures, and Restrictions on the Routine Use
The Privacy Act permits us to disclose information without an
individual's consent if the information is to be used for a purpose
which 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 NETT information that can be
associated with an individual as provided for under ``Section III.
Entities Who May Receive Disclosures Under Routine Use.'' Both
identifiable and non-identifiable data may be disclosed under a routine
use.
We will only disclose the minimum personal data necessary to
achieve the purpose of NETT. HCFA has the following policies and
procedures concerning disclosures of information which will be
maintained in the system. In general, disclosure of information from
the system of records will be approved only to the extent necessary to
accomplish the purpose of the disclosure and only after HCFA:
(a) Determines that the use or disclosure is consistent with the
reason that the data is being collected, e.g., developing and
monitoring the quality of care provided to patients in the study, to
monitor and evaluate the trial and its interventions.
(b) Determines:
(1) That the purpose for which the disclosure is to be made can
only be accomplished if the record is provided in individually
identifiable form;
(2) That 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
(3) That there is a strong probability that the proposed use of the
data would in fact accomplish the stated purpose(s).
(c) Requires the information recipient to:
(1) Establish administrative, technical, and physical safeguards to
prevent unauthorized use of disclosure of the record; and
(2) Remove or destroy at the earliest time all patient-identifiable
information.
(d) Determines that the data are valid and reliable.
III. Proposed Routine Use Disclosures of Data in the System
Entities Who May Receive Disclosures Under Routine Use
These routine uses specify circumstances, in addition to those
provided by statute in the Privacy Act of 1974, under which HCFA may
release
[[Page 47997]]
information from the NETT without the consent of the individual to whom
such information pertains. Each proposed disclosure of information
under these routine uses will be evaluated to ensure that the
disclosure is legally permissible, including but not limited to
ensuring that the purpose of the disclosure is compatible with the
purpose for which the information was collected. In addition, our
policy will be to prohibit release even of non-identifiable data,
except pursuant to one of the routine uses, if there is a possibility
that an individual can be identified through implicit deduction based
on small cell sizes (instances where the 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). 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 HCFA may enter into a contractual or similar
agreement with a third party to assist in accomplishing HCFA function
relating to purposes for this system of records.
HCFA occasionally contracts out certain of its functions when this
would contribute to effective and efficient operations. HCFA 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 to return
or destroy all information at the completion of the contract.
2. To another federal or state agency:
(1) To contribute to the accuracy of HCFA's proper payment of
Medicare benefits, and/or
(2) To 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.
Other federal or state agencies in their administration of a
federal health program may require NETT information in order to support
evaluations and monitoring of Medicare claims information of
beneficiaries who are participating in the study, including proper
reimbursement for services provided.
3. To an individual or organization for research, evaluation, or
epidemiological projects related to the prevention of disease or
disability, or the restoration or maintenance of health, and for
payment related projects.
The NETT data will provide the research, evaluations and
epidemiological projects a broader, longitudinal, national perspective
of the status of patients participating in the study. HCFA anticipates
that many researchers will have legitimate requests to use these data
in projects that could ultimately improve the care provided to Medicare
patients and the policy that governs the care. HCFA understands the
concerns about the privacy and confidentiality of the release of data
for a research use.
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 some issue relating to a matter before HCFA. The member of
congress then writes HCFA, and HCFA 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, HCFA determines that the records are both relevant and
necessary to the litigation.
Whenever HCFA is involved in litigation, or occasionally when
another party is involved in litigation and HCFA's policies or
operations could be affected by the outcome of the litigation, HCFA
would be able to disclose information to the DOJ, court or adjudicatory
body involved.
6. To HCFA contractors, including but not necessarily limited to
fiscal intermediaries and carriers under Title XVIII of the Social
Security Act; to administer some aspect of a HCFA-administered health
benefits program, or to a grantee of a HCFA-administered grant program,
which program is or could be affected by fraud and abuse, for the
purpose of preventing, deterring, discovering, detecting,
investigating, examining, prosecuting, suing with respect to, defending
against, correcting, remedying, or otherwise combating such fraud and
abuse in such programs.
We contemplate disclosing information under this routine use only
in situations in which HCFA may enter into a contractual or similar
agreement with a third party to assist in accomplishing HCFA functions
relating to purposes for this system of records.
HCFA occasionally contracts out certain of its functions when this
would contribute to effective and efficient operations. HCFA must be
able to give a contractor whatever information is necessary for the
contractor to fulfill its duties. In these situations, safeguards (like
ensuring that 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 those stated in II.B above), are provided in the contract
prohibiting the contractor from using or disclosing the information for
any purpose other than that described in the contract and 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 government agency, for the purpose
of preventing, deterring, discovering, detecting, investigating,
examining, prosecuting, suing with respect to, defending against,
correcting, remedying, or otherwise combating such fraud and abuse in
health benefits program funded in whole or in part by federal funds.
Other state agencies in their administration of a Federal health
program may require NETT information for the purpose of preventing,
deterring, discovering, detecting, investigating, examining,
prosecuting, suing with respect to, defending against, correcting,
remedying, or otherwise combating such fraud and abuse in such
programs.
IV. Safeguards
A. Authorized Users
Personnel having access to the system have been trained in Privacy
Act requirements. Employees who maintain records in the system are
instructed not to release any data until the intended recipient agrees
to implement appropriate administrative, technical, procedural, and
physical safeguards
[[Page 47998]]
sufficient to protect the confidentiality of the data and to prevent
authorized access to the data. Records are used in a designated work
area and system location is attended at all times during working hours.
To assure security of the data, the proper level of class user is
assigned for each individual user level. This prevents unauthorized
users from accessing and modifying critical data. The system database
configuration includes five classes of database users:
Database Administrator class owns the database objects
(e.g., tables, triggers, indexes, stored procedures, packages) and has
database administration privileges to these objects.
Quality Control Administrator class has read and write
access to key fields in the database;
Quality Indicator (QI) Report Generator class has read-
only access to all fields and tables;
Policy Research class has query access to tables, but are
not allowed to access confidential patient identification information;
and
Submitter class has read and write access to database
objects, but no database administration privileges. This class is used
by the NETT data submission applications to receive and validate file
uploads.
B. Physical Safeguards
All server sites have implemented the following minimum
requirements to assist in reducing the exposure of computer equipment
and thus achieve an optimum level of protection and security for the
NETT system.
Access to all servers is controlled, with access limited to only
those support personnel with a demonstrated need for access. Servers
are to be kept in a locked room accessible only by specified management
and system support personnel. Each server requires a specific log on
process. All entrance doors are identified and marked. A log is kept of
all personnel who were issued a security card, key and/or combination
which grants access to the room housing the server, and all visitors
are escorted while in this room. All servers are housed in an area
where appropriate environmental security controls are implemented,
which include measures implemented to mitigate damage to AIS resources
caused by fire, electricity, water and inadequate climate controls.
Protection applied to the workstations, servers and databases
include:
User Log-ons--Authentication is performed by the Primary
Domain Controller/Backup Domain Controller of the log-on domain.
Workstation Names--Workstation naming conventions may be
defined and implemented at the agency level.
Hours of Operation--May be restricted by Windows NT. When
activated all applicable processes will automatically shut down at a
specific time and not be permitted to resume until the predetermined
time. The appropriate hours of operation are determined and implemented
at the agency level.
Inactivity Log-out--Access to the NT workstation is
automatically logged out after a specified period of inactivity.
Warnings--Legal notices and security warnings display on
all servers and workstations.
Remote Access Services (RAS)--Windows NT RAS security
handles resource access control. Access to NT resources is controlled
for remote users in the same manner as local users, by utilizing
Windows NT file and sharing permissions. Dial-in access can be granted
or restricted on a user-by-user basis through the Windows NT RAS
administration tool.
There are several levels of security found in the NETT system.
Windows NT provides much of the overall system security. The Windows NT
security model is designed to meet the C2-level criteria as defined by
the U.S. Department of Defense's Trusted Computer System Evaluation
Criteria document (DoD 5200.28-STD, December 1985). Netscape Enterprise
Server is the security mechanism for all NETT transmission connections
to the system. As a result, Netscape controls all NETT information
access requests. Anti-virus software is applied at both the workstation
and NT server levels.
Access to different areas on the Windows NT server are maintained
through the use of file, directory and share level permissions. These
different levels of access control provide security that is managed at
the user and group level within the NT domain. The file and directory
level access controls rely on the presence of an NT File System (NTFS)
hard drive partition. This provides the most robust security and is
tied directly to the file system. Windows NT security is applied at
both the workstation and NT server levels.
C. Procedural Safeguards
All automated systems must comply with federal laws, guidance, and
policies for information systems security. These include, but are not
limited to: the Privacy Act of 1974, the Computer Security Act of 1987,
OMB Circular A-130, revised, IRM Circular #10, HHS Automated
Information Systems Security Program, the HCFA Information Systems
Security Policy and Program Handbook, and other HCFA systems security
policies. Each automated information system should ensure a level of
security commensurate with the level of sensitivity of the data, risk,
and magnitude of the harm that may result from the loss, misuse,
disclosure, or modification of the information contained in the system.
V. Effects of the Proposed System of Records on Individual Rights
HCFA 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.
HCFA 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. HCFA will
collect only that information necessary to perform the system's
functions. In addition, HCFA 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.
HCFA, therefore, does not anticipate an unfavorable effect on
individual privacy as a result of the disclosure of information
relating to individuals.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
09-70-0531
SYSTEM NAME:
``National Emphysema Treatment Trial (NETT) System, HHS/HCFA/
CHPP''.
SECURITY CLASSIFICATION:
Level Three Privacy Act Sensitive Data.
SYSTEM LOCATION:
HCFA Data Center, 7500 Security Boulevard, North Building, First
Floor, Baltimore, Maryland 21244-1850.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The system of records will contain information about Medicare
beneficiaries with emphysema enrolled
[[Page 47999]]
in the randomized phase of the trial, as well as referring and
servicing physicians.
CATEGORIES OF RECORDS IN THE SYSTEM:
This system of records will contain information about Medicare
utilization and frequency of specific health care services, the
provider and provider's speciality, provider's location or sites of
services, cost of surgery, medical or pulmonary rehabilitation, extra-
site therapy, medical services necessary for treatment, and self-
administered drug therapy. The system will also contain the
beneficiary's name, address, date of birth, sex, health insurance claim
number (HIC), telephone number, marital status, clinical outcomes, and
morbidity and mortality rates.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authority for maintenance of the system is given under section 1862
(a)(1)(A) of the Social Security Act (the Act), and 42 U.S.C. 1395.
PURPOSE(S):
The primary purpose of the system of records is to maintain data
that will allow HCFA to collect and provide secure data on participants
in the randomized phase of the study, pay claims, and to monitor and
evaluate the clinical trial. Information retrieved from this system of
records will also be disclosed to: support regulatory, reimbursement
and policy functions performed within the agency or by a contractor or
consultant, another federal or state agency to enable such agency to
administer a Federal health benefits program, or 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, support research, evaluation, or epidemiological
projects related to the prevention of disease or disability, or the
restoration or maintenance of health, and for payment related projects,
support constituent requests made to a congressional representative,
support litigation involving the agency, and, 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:
The Privacy Act allows us to disclose information without an
individual's consent if the information is to be used for a purpose
which 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 use in this system meets the compatibility
requirement of the Privacy Act. We are proposing to establish the
following routine use disclosures of information which will be
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.
2. To another federal or state agency:
(1) To contribute to the accuracy of HCFA's proper payment of
Medicare benefits, and/or
(2) To 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.
3. To an individual or organization for research, evaluation, or
epidemiological projects related to the prevention of disease or
disability, or the restoration or maintenance of health, and for
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, HCFA determines that the records are both relevant
and necessary to the litigation.
6. To HCFA contractors, including but not necessarily limited to
fiscal intermediaries and carriers under title XVIII of the Social
Security Act; to administer some aspect of a HCFA-administered health
benefits program, or to a grantee of a HCFA-administered grant program,
which program is or could be affected by fraud and abuse, for the
purpose of preventing, deterring, discovering, detecting,
investigating, examining, prosecuting, suing with respect to, defending
against, correcting, remedying, or otherwise combating such fraud and
abuse in such programs.
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 government agency, for the purpose
of preventing, deterring, discovering, detecting, investigating,
examining, prosecuting, suing with respect to, defending against,
correcting, remedying, or otherwise combating such fraud and abuse in
health benefits program funded in whole or in part by Federal funds.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
The records are stored in file folders, magnetic tapes and computer
disks.
RETRIEVABILITY:
The Medicare and Medicaid records are retrieved by health insurance
claim number.
SAFEGUARDS:
HCFA has safeguards 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 systems security
requirements. Employees who maintain records in the system are
instructed not to release any data until the intended recipient agrees
to implement appropriate administrative, technical, procedural, and
physical safeguards sufficient to protect the confidentiality of the
data and to prevent unauthorized access to the data.
In addition, HCFA has physical safeguards in place to reduce the
exposure of computer equipment and thus achieve an optimum level of
protection and security for the NETT system. For computerized records,
safeguards have been established in accordance with HHS standards and
National Institute of Standards and Technology guidelines, e.g.,
security codes will be used, limiting access to authorized personnel.
System securities are established in accordance with HHS, Information
Resource Management (IRM) Circular #10, Automated Information Systems
Security Program, HCFA Automated Information Systems (AIS) Guide,
Systems Securities Policies, and OMB Circular No. A-130 (revised),
Appendix III.
RETENTION AND DISPOSAL:
HCFA will retain identifiable data for a total period of fifteen
(15) years from the date the information was last updated.
SYSTEM MANAGER AND ADDRESS:
HCFA, Director, Center for Health Plans and Providers, Program
Analysis
[[Page 48000]]
and Performance Measurement Group, 7500 Security Blvd., 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, health insurance claim
number, address, date of birth, sex, and for verification purposes, the
subject individual's name (woman's maiden name, if applicable), and
social security number (SSN). Furnishing the SSN is voluntary, but it
may make searching for a record easier and prevent delay.
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:
The NETT will use Medicare enrollment records, Medicare
beneficiaries or proxies, and medical providers (such as physicians,
medical facilities, home health care providers) for a sample of
enrollees.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. 00-18548 Filed 8-3-00; 8:45 am]
BILLING CODE 4120-03-P