[Federal Register Volume 63, Number 139 (Tuesday, July 21, 1998)]
[Notices]
[Pages 39101-39104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19376]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
Privacy Act of 1974; Report of New System
AGENCY: Department of Health and Human Services (HHS), Health Care
Financing 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, called
``End-Stage Renal Disease (ESRD) Managed Care Demonstration System,''
HHS/HCFA/OSP No. 09-70-0067. We have provided background information
about the proposed new system in the Supplementary Information section
below. Although the Privacy Act requires only that the ``routine uses''
portion of the system be published for comment, HCFA invites comments
on all portions of this notice.
DATES: HCFA filed a new system report with the Chairman of the
Committee on Government Reform and Oversight of the House of
Representatives, the Chairman of the Committee on Governmental Affairs
of the Senate, and the Administrator, Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), on July 9,
1998. The new system of records, including routine uses, will become
effective 40 days from the date submitted to OMB and the Congress,
unless HCFA receives comments which require alteration to this notice.
ADDRESSES: The public should address comments to the HCFA Privacy Act
Officer, Division of Freedom of Information & Privacy, Office of
Information Services, Health Care Financing Administration, 7500
Security Boulevard, C2-01-11, Baltimore, Maryland 21244-1850. Comments
received will be available for review at this location by appointment,
Monday through Friday 9 a.m.-3 p.m., eastern time zone.
FOR FURTHER INFORMATION CONTACT: Paul Eggers, Office of Strategic
Planning, Health Care Financing Administration, 7500 Security
Boulevard, C3-24-07, Baltimore, Maryland 21244-1850. His telephone
number is (410) 786-6691.
SUPPLEMENTARY INFORMATION: The ESRD Managed Care Demonstration System
data file contains information on beneficiaries enrolled in the ESRD
Managed Care Demonstration. This information will be used by HCFA and
its evaluation contractor to monitor and evaluate the demonstration.
The system
[[Page 39102]]
will include information on utilization of specific health care
services, cost and quality of those services, clinical outcomes and
effectiveness of care, and patient satisfaction.
Primary data collected by the evaluator and the managed care
organizations will be linked to HCFA administrative data to provide
information necessary for monitoring and evaluating the demonstration
and its interventions. The demonstration is designed to test the
feasibility and effectiveness of the following:
Removal of the barrier to ESRD enrollment. At present,
ESRD-eligible beneficiaries cannot enroll in Medicare health
maintenance organizations (HMOs) (although they may remain enrolled if
they develop ESRD subsequent to enrollment). Under the demonstration,
the sites will have year-round open enrollment of ESRD beneficiaries.
ESRD-focused case management, and the potential benefits
to patient, provider, and payer, with particular emphasis on whether
outcomes of care are improved.
Preventive and supportive interventions and more
comprehensive benefit coverage for ESRD patients. Section 2355 of the
Deficit Reduction Act of 1989, as amended, requires that HCFA pay the
demonstration sites a capitation rate based on 100 percent of fee-for-
service costs, rather than 95 percent. In order to justify receiving
the additional 5 percent, the HMO is obliged to offer extra, non-
Medicare-covered benefits beyond those that would have been available
in the absence of the demonstration.
An ESRD capitation rate that adjusts for patient age,
cause of renal failure, treatment status, and services as an
alternative to both fee-for-service and the current capitation rate for
ESRD patients in HMOs, that is unadjusted for demographic or treatment
factors.
Individual patient-level data will be collected and linked from a
variety of sources, including, but not limited to: Surveys conducted by
the evaluation contractor, including those using the Kidney Disease
Quality of Life (KDQOL) instrument; data from the End-Stage Renal
Disease (ESRD) Program Management and Medical Information System
(PMMIS) maintained by HCFA; no-pay claims data submitted by the sites
during the course of the demonstration; claims data on fee-for-service
comparison patients; and clinical data in regard to dialysis adequacy
measures, such as those collected by HCFA's core indicators studies.
The Privacy Act permits us to disclose information without the
written consent of individuals for ``routine uses''--that is,
disclosures that are compatible with the purpose for which we collected
the information. The proposed routine uses in the new system meet the
compatibility criterion of the statute. We anticipate the disclosures
under the routine uses will not result in any unwarranted adverse
effects on personal privacy.
Dated: July 9, 1998.
Nancy-Ann Min DeParle,
Administrator.
09-70-0067
SYSTEM NAME:
End-Stage Renal Disease (ESRD) Managed Care Demonstration System,
HHS/HCFA/OSP.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Health Care Financing Administration, Office of Information
Services, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Medicare ESRD beneficiaries enrolled in the ESRD Managed Care
Demonstration and Medicare ESRD beneficiaries in comparison groups.
CATEGORIES OF RECORDS IN THE SYSTEM:
Individual-level information on demographics, utilization of
specific health care services, cost and quality of those services,
clinical outcomes and effectiveness of care, and patient satisfaction
will be collected.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authority for maintenance of the system is section 2355 of the
Deficit Reduction Act of 1984, Pub. L. 98-369, as amended by section
4207(b)(4) of the Omnibus Budget Reconciliation Act (OBRA) of 1990,
Pub. L. 101-508, and as amended by section 13567(b) of OBRA 1993, Pub.
L. 103-66.
PURPOSE(s):
To collect and maintain information on beneficiaries enrolled in
the ESRD Managed Care Demonstration, and ESRD beneficiaries in
comparison groups, in order to monitor and evaluate the demonstration.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
These routine uses specify additional circumstances under which
HCFA may release information from the ESRD Managed Care Demonstration
System without the consent of the individual to whom such information
pertains. Each proposed disclosure of information under these routine
uses will be evaluated to ensure that the disclosure is legally
permissible, including, but not limited to, ensuring that the purpose
of the disclosure is compatible with the purpose for which the
information was collected. Also, HCFA will require each prospective
recipient of such information to agree in writing to certain conditions
to ensure the continuing confidentiality and physical safeguards of the
information. More specifically, as a condition of each disclosure under
these routine uses, HCFA will, as necessary and appropriate:
(a) Determine that no other Federal statute specifically prohibits
disclosure of the information;
(b) Determine that the use or disclosure does not violate legal
limitations under which the information was provided, collected, or
obtained;
(c) Determine that the purpose for which the disclosure is to be
made:
(1) Cannot reasonably be accomplished unless the information is
provided in individually identifiable form,
(2) Is of sufficient importance to warrant the effect on, or the
risk to, the privacy of the individual(s) that additional exposure
of the record(s) might bring, and
(3) There is a reasonable probability that the purpose of the
disclosure will be accomplished.
(d) Require the recipient of the information to:
(1) Establish reasonable administrative, technical, and physical
safeguards to prevent unauthorized access, use, or disclosure of the
record or any part thereof. The physical safeguards shall provide a
level of security that is at least the equivalent of the level of
security contemplated in OMB Circular No. A-130 (revised), Appendix
III--Security of Federal Automated Information Systems which sets forth
guidelines for security plans for automated information systems in
Federal agencies;
(2) Remove or destroy the information that allows subject
individual(s) to be identified at the earliest time at which removal or
destruction can be accomplished, consistent with the purpose of the
request;
(3) Refrain from using or disclosing the information for any
purpose other than the stated purpose under which the information was
disclosed; and
(4) Make no further uses or disclosure of the information, except:
[[Page 39103]]
(i) To prevent or address an emergency directly affecting the
health or safety of an individual;
(ii) For use on another project under the same conditions, provided
HCFA has authorized the additional use(s) in writing; or
(iii) When required by law;
(e) Secure a written statement or agreement from the prospective
recipient of the information whereby the prospective recipient attests
to an understanding of, and willingness to abide by the foregoing
provisions and any additional provisions that HCFA deems appropriate in
the particular circumstances; and
(f) Determine whether the disclosure constitutes a computer
``matching program'' as defined in 5 U.S.C. 552a(a)(8). If the
disclosure is determined to be a computer ``matching program,'' the
procedures for matching agreements as contained in 5 U.S.C. 552a(o)
must be followed.
Disclosure may be made:
1. To a Congressional office, from the record of an individual, in
response to an inquiry from the Congressional office made at the
request of that individual;
2. To the Bureau of Census for use in processing research and
statistical data directly related to the programs administered in whole
or in part by HCFA;
3. To the Department of Justice, to a court or other tribunal, or
to another party before such tribunal, when:
(a) HHS, or any component thereof; or
(b) Any HHS employee in his or her official capacity; or
(c) Any HHS employee in his or her individual capacity, where the
Department of Justice (or HHS, where it is authorized to do so) has
agreed to represent the employee; or
(d) The United States, or any agency thereof, where HHS determines
that the litigation is likely to affect HHS or any of its components,
is a party to litigation or has an interest in such litigation, and HHS
determines that the use of such records by the Department of Justice,
the tribunal, or the other party is relevant and necessary to the
litigation and would help in the effective representation of the
governmental party or interest, provided, however, that in each case
HHS determines that such disclosure is compatible with the purpose for
which the records were collected.
4. To an individual or organization for a research, demonstration,
evaluation, or epidemiological project related to the prevention of
disease or disability, the restoration or maintenance of health, or for
purposes of determining, evaluating and/or assessing cost,
effectiveness, and/or the quality of health care services provided.
5. To a contractor for the purpose of collating, analyzing,
aggregating or otherwise refining or processing records in this system,
or for developing, modifying, and/or manipulating automated information
systems (ADP) software. Data would also be disclosed to contractors
incidental to consultation, programming, operation, user assistance, or
maintenance for ADP or telecommunications systems containing or
supporting records in the system.
6. To a peer review organization or ESRD network for health care
quality improvement projects conducted in accordance with its contract
with HCFA.
7. To state Medicaid agencies pursuant to agreements with the
Department of Health and Human Services for determining Medicaid and
Medicare eligibility of recipients of assistance under titles IV,
XVIII, and XIX of the Social Security Act, and for the complete
administration of the Medicaid program.
8. To an agency of a state Government, or established by state law,
for purposes of determining, evaluating and/or assessing cost,
effectiveness, and/or the quality of health care services provided in
the state.
9. To another Federal or state agency:
(a) To contribute to the accuracy of HCFA's proper payment of
Medicare health benefits, including release to the Social Security
Administration for its assistance in the implementation of HCFA's
Medicare and Medicaid programs, or
(b) As necessary to enable such agency to fulfill a requirement of
a Federal statute or regulation, or a state statute or regulation that
implements a program funded in whole or in part with Federal funds.
10. To a HCFA contractor, including but not limited to, fiscal
intermediaries and carriers under title XVIII of the Social Security
Act, to administer some aspect of a HCFA-administered grant program,
which program is or could be affected by fraud or 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 or
abuse in such programs.
11. 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 or abuse in a
health benefits program funded in whole or in part by Federal funds.
12. To any entity that makes payment for, or oversees
administration of, health services, for the purpose of preventing,
deterring, discovering, detecting, investigating, examining,
prosecuting, suing with respect to, defending against, correcting,
remedying, or otherwise combating such fraud or abuse against such
entity or the program or services administered by such entity,
provided:
(a) Such entity enters into an agreement with HCFA to share
knowledge and information regarding actual or potential fraudulent or
abusive practices or activities regarding the delivery or receipt of
health care services, or regarding securing payment or reimbursement
for health care services, or any practice or activity that, if directed
toward a HCFA-administered program, might reasonably be construed as
actually or potentially fraudulent or abusive;
(b) Such entity does, on a regular basis, or at such times as HCFA
may request, fully and freely share such knowledge and information with
HCFA, or as directed by HCFA, with HCFA's contractors; and
(c) HCFA determines that it may reasonably conclude that the
knowledge or information it has received or is likely to receive from
such entity could lead to preventing, deterring, discovering,
detecting, investigating, examining, prosecuting, suing with respect
to, defending against, correcting, remedying, or otherwise combating
fraud or abuse in the Medicare, Medicaid, or other health benefits
program administered by HCFA or 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 on magnetic tapes and computer disks.
RETRIEVABILITY:
The records are retrieved by health insurance claim number.
SAFEGUARDS:
Access is limited to authorized HCFA personnel and HCFA contractor
employees in the performance of their duties. HHS contractors and
collaborating researchers are required to comply with the provisions of
the Privacy Act, and are required to sign Assurance of Confidentiality
Forms (or
[[Page 39104]]
Data Security Statements) that are kept on file by the contractor. For
computerized records, safeguards established in accordance with
Department 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; and HCFA Automated Information
Systems (AIS) Guide, Systems Securities Policies, and OMB Circular No.
A-130 (revised), Appendix III.
RETENTION AND DISPOSAL:
Records are maintained with identifiers as long as needed for
program research.
SYSTEM MANAGER(S) AND ADDRESS:
Director, Office of Strategic Planning (OSP), Health Care Financing
Administration, 7500 Security Boulevard, Baltimore, Maryland 21244-
1850.
NOTIFICATION PROCEDURE:
The subject individual should write the system manager, who will
require the system name, health insurance claim number, and, for
verification purposes, name, address, date of birth, and sex to
ascertain whether or not the individual's record is in the system.
RECORD ACCESS PROCEDURE:
Same as notification procedures. Requestors should also reasonably
specify the record contents being sought. (These access procedures are
in accordance with the Department Regulation 45 CFR 5b.5(a)(2).)
CONTESTING RECORD PROCEDURES:
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 identifying information contained in these records is obtained
from demonstration enrollees, and from the group health plans operating
the demonstration and their participating providers. These data will be
linked with HCFA administrative data, such as claims and enrollment
data.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. 98-19376 Filed 7-20-98; 8:45 am]
BILLING CODE 4120-03-P
