[Federal Register Volume 67, Number 116 (Monday, June 17, 2002)]
[Notices]
[Pages 41244-41250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15007]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of Modified or Altered System
AGENCY: Centers for Medicare & Medicaid Services (CMS), (formerly the
Health Care Financing Administration), Department of Health and Human
Services (HHS).
ACTION: Notice of proposal to modify or alter a System of Records
(SOR).
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SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to modify or alter an SOR, ``End Stage Renal
Disease (ESRD) Program Management and Medical Information System
(PMMIS),'' System No. 09-70-0520. We propose to broaden the scope of
this system to include the collection and maintenance of ESRD Core
Indicators or Clinical Performance Measures (CPM). Data contained in
CPM Data Set are being added to meet statutory requirements and to
augment the usefulness of the information for research, quality
improvement projects, and policy formulation. We are deleting routine
use number 2 authorizing disclosures to organizations deemed qualified
to carry out quality assessments; number 5, authorizing disclosures to
a contractor; number 6, authorizing disclosures to an agency of a state
government; and an unnumbered routine use which authorizes the release
of information to the Social Security Administration (SSA).
Routine use number 2 is being deleted because it is not clear what
``organizations'' are being identified and who should receive
information referred to in this routine use. We will add a new routine
use to accomplish release of information in this system to ESRD Network
Organizations and Quality Improvement Organizations (QIO) to carry out
quality assessments, medical audits, quality improvement projects, and/
or utilization reviews. Disclosures allowed by routine use number 6 and
to SSA will be covered by a new routine use to permit release of
information to ``another Federal and/or state agency, agency of a state
government, an agency established by state law, or its fiscal agent.''
Disclosures previously allowed by routine use number 5 will now be
covered by proposed routine use number 1.
The security classification previously reported as ``None'' will be
modified to reflect that the data in this system is considered to be
``Level Three Privacy Act Sensitive.'' We are modifying the language in
the remaining routine uses to provide clarity to CMS' intention to
disclose individual-specific information contained in this system. The
proposed routine uses will be prioritized and reordered according to
their proposed usage. We will also update any sections of the system
that were affected by the recent reorganization and update language in
the administrative sections to correspond with language used in other
CMS SORs.
The primary purpose of the system of records is to maintain
information on Medicare ESRD beneficiaries, non-Medicare ESRD patients,
Medicare approved ESRD hospitals and dialysis facilities, and
Department of Veterans Affairs (DVA) patients. The ESRD/PMMIS is used
by CMS and the renal community to perform their duties and
responsibilities in monitoring the Medicare status, transplant
activities, dialysis activities, and Medicare utilization (inpatient
and physician/supplier bills) of ESRD patients and their Medicare
providers, as well as in calculating the Medicare covered periods of
ESRD. 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, agency of a state government, an agency
established by state law, or its fiscal agent, ESRD Network
Organizations and QIOs to implement quality improvement programs,
facilitate research on the quality and effectiveness of care provided
and 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 modified 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 modified or altered SOR 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 June 1, 2002. In any event, we will not
disclose any information under a routine use until 40 days after
publication. We may defer implementation of this SOR or one or more of
the routine use statements listed below if we receive comments that
persuade us to defer implementation.
ADDRESS: The public should address comments to: Director, Division of
Data Liaison and Distribution (DDLD), CMS, 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
daylight time.
FOR FURTHER INFORMATION CONTACT: Dennis Stricker, Director, Information
Support Group, Office of Clinical Standards and Quality, CMS, Room S3-
02-01, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. The
telephone number is (410) 786-3116. The e-mail address is
[email protected].
SUPPLEMENTARY INFORMATION:
I. Description of the Modified System
A. Background
The ESRD Program was established in 1972 pursuant to the provisions
of 299I, Public Law 92-603. Notice of this system, ESRD/PMMIS was
published in a Federal Register at 53 FR 62792 (Dec. 29, 1988), 61 FR
6645 (Feb. 21, 1996) (added unnumbered SSA use), 63 FR 38414 (July 16,
1998) (added three fraud and abuse uses), and 65 FR 50552 (Aug. 18,
2000) (deleted one and modified two fraud and abuse uses).
[[Page 41245]]
This system contains records on individuals with ESRD who are entitled
to receive Medicare benefits or who are treated by DVA health care
facilities. Data in this system are used primarily to meet and
implement statutory requirements of Public Law (Pub. L.) 92-603, to
meet other legislative requirements, support ESRD research, quality
improvement projects, and public service programs.
The legislation (Sec. 299I, Pub. L. 92-603) extended Medicare
coverage to individuals with ESRD who require dialysis or
transportation to sustain life. This legislation and subsequent
regulations also established health and safety standards applicable to
providers of ESRD services and required the establishment of ESRD
Network Coordinating Councils. The ESRD Networks were established to
serve as liaisons between the federal government and the provider of
ESRD services. This rule contained an additional requirement of the
Omnibus Reconciliation Act of 1986 (Pub. L. 99-509) required that the
Secretary establish a national ESRD registry. This registry is called
the United States Renal Data System (USRDS). The contract to administer
the USRDS was awarded by the National Institutes of Health (NIH) to the
Urban Institute on May 1, 1988, for a 5 year period. This registry
utilizes data reported by network organizations, transplant centers,
and other sources to support the analysis of alternative treatment
modes, the evaluation of allocation of resources, the analysis of
morbidity and mortality trends and other quality of care indices, and
other studies that assist the Congress in evaluating the ESRD program.
The second 5 year contract was awarded to the University of Michigan on
July 1, 1993. A 12 month extension was then executed for the period of
performance of July 1, 1999 to June 30, 1999. A 4 month extension was
then granted July 1, 1999. The next 5 year contract was awarded to the
Minneapolis Medical Research Foundation on July 1, 1999.
Public Law 95-292 established the ESRD/PMMIS. The PMMIS was created
in response to the CMS requirement to provide information on ESRD
patients once the above legislation ensured that Medicare would pay for
the dialysis treatments and kidney transplants required to sustain a
patient's life. The ESRD/PMMIS is a mission critical system to the
renal community. The PMMIS was a batch-oriented Model 204 (M204) data
system, which later evolved into the Renal Beneficiary and Utilization
System (REBUS) M204 on-line system. The acronym PMMIS is retained by a
group of data files that have been available to the ESRD community
since the batch system was created. The files remain an important
product of REBUS operations and retain the PMMIS name for purposes of
easy identification by interested users. Thus, the REBUS serves as the
primary access mechanism for the PMMIS. We currently have over 1
million individual Master File records in REBUS. Data is supplied to
REBUS by approximately 4,637 dialysis and or transplant facilities via
the 18 ESRD Networks, and the United Network for Organ Sharing.
Data contained in the Clinical Performance Measures (CPM) Data Set
is being added to the ESRD/PMMIS system of records in order to meet
statutory requirements and to augment the usefulness of the information
for research, quality improvement projects, and policy formulation. CPM
data set was developed in response to section 4558(b) of the Balanced
Budget Act of 1997, which required the Secretary to develop and
implement a method to measure and report the quality of dialysis
services under the Medicare program by the year 2000. CPM contains
information, in the form of quality measures, on entitled ESRD
beneficiaries who receive hemodialysis or peritoneal dialysis
treatments. These quality measures are designed based on the National
Kidney Foundation-Kidney Disease Outcomes Quality Initiative (K/DOQI)
Clinical Practice Guidelines. These quality measures and their
respective dimensions presently comprising the CPM are as follows:
Hemodialysis Adequacy
Monthly Measurement of Delivered Hemodialysis Dose
Method of Measurement of Delivered Hemodialysis Dose
Minimum Delivered Hemodialysis Dose
Method of Post-Dialysis Blood Urea Nitrogen (BUN) Sampling
Baseline Total Cell Volume Measurement of Dialysis
Intended for Reuse
Peritoneal Dialysis Adequacy
Measurement of Total Solute Clearance at Regular Intervals
Calculate Weekly Kt/V urea and Creatinine Clearance in a
Standard Way
Delivered Dose of Peritoneal Dialysis
Vascular Access
Maximizing Placement of Arterial Fistulae
Minimizing Use of Catheter as Chronic Dialysis Access
Preferred/Non-Preferred location of Hemodialysis Catheters
located above the waist
Monitoring Arterial Venous Grafts for Stenosis
Anemia Management
Target Hematocrit or hemoglobin for Epoetin Therapy
Assessment of Iron Among Anemic Patients or Patients
Prescribed Epoetin
Maintenance of Iron-stores Target
Administration of Supplemental Iron
Serum Albunin
B. Statutory and Regulatory Basis for System
Authority for maintenance of the system is given under sections
226A, 1875, and 1881 of the Social Security Act (the Act) (Title 42
United States Code (U.S.C.), sections 426-1, 1395ll, and 1395rr).
II. Collection and Maintenance of Data in the System
A. Scope of the Data Collected
The system contains information related to individuals with ESRD
who receive Medicare benefits or who are treated by DVA health care
facilities. The system contains information on both the beneficiary and
the provider of services. The system contains beneficiary/patient
medical records, claims data, and payment data collected from several
non-reimbursement data collection instruments and Medicare bills. The
provider of services' name, address, Medicare identification number,
types of services provided, certification and or termination date, and
ESRD network number.
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
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 PMMIS 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 PMMIS. CMS has the following policies and
procedures concerning disclosures of information that will be
maintained in the system. In general, disclosure of information from
the SOR will be approved only to the extent necessary to accomplish the
purpose of the disclosure and only after CMS:
[[Page 41246]]
1. Determines that the use or disclosure is consistent with the
reason that the data is being collected, e.g., monitoring the Medicare
status, transplant activities, dialysis activities, and Medicare
utilization of ESRD patients.
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
These routine uses specify circumstances, in addition to those
provided by statute in the Privacy Act of 1974, under which CMS may
release information from the PMMIS 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. We are proposing to
establish or modify the following routine use disclosures of
information maintained in the system:
1. To Agency contractors, or consultants who have been contracted
by the Agency to assist in accomplishment of a CMS function relating to
the purposes for this SOR and who need to have access to the records in
order to assist CMS.
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 a CMS function
relating to purposes for this SOR.
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, agency of a state
government, an agency established by state law, or its fiscal agent 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. Determine compliance with the Federal conditions that an ESRD
facility must meet in order to participate in Medicare.
Other Federal or State agencies in their administration of a
federal health program may require PMMIS information in order to
support evaluations and monitoring of Medicare claims information of
beneficiaries, including proper reimbursement for services provided.
In addition, other state agencies in their administration of a
Federal health program may require PMMIS information for the purposes
of determining, evaluating and/or assessing cost, effectiveness, and/or
the quality of health care services provided in the state.
In addition, disclosure under this routine use shall be used by
state agencies pursuant to agreements with the HHS for determining
Medicare eligibility, for quality control studies, for determining
eligibility of recipients of assistance under titles IV, XVIII, and XIX
of the Act, and for the administration of the Medicare program. Data
will be released to the state only on those individuals who are
patients under the services of a program within the state or who are
residents of that state.
We also contemplate disclosing information under this routine use
in situations in which state auditing agencies require PMMIS
information for auditing eligibility considerations. CMS may enter into
an agreement with state auditing agencies to assist in accomplishing
functions relating to purposes for this system of records.
3. To ESRD Network Organizations and Quality Improvement
Organizations in connection with review of claims, or in connection
with studies or quality improvements projects or other review
activities, conducted pursuant to Part B of Title XI of the Social
Security Act and in performing affirmative outreach activities to
individuals for the purpose of establishing and maintaining their
entitlement to Medicare benefits or health insurance plans.
ESRD Network Organizations and QIOs will work to implement quality
improvement programs, provide consultation to CMS, its contractors, and
its state agencies. The Networks and QIOs will assist the state
agencies in related monitoring and enforcement efforts; assist CMS and
intermediaries in program integrity assessment; and prepare summary
information for release to CMS.
4. To an individual or organization for a research, evaluation, or
epidemiological project related to the prevention of disease or
disability, the restoration, improvement, or maintenance of health, or
payment-related projects.
PMMIS data will provide for the research, evaluations and
epidemiological projects, a broader, longitudinal, national perspective
of the status of Medicare beneficiaries with ESRD. CMS anticipates that
many researchers will have legitimate requests to use these data in
projects that could ultimately improve the care provided to these
Medicare beneficiaries and the policy that governs the care.
5. To Members of Congress or to congressional staff members in
response to an inquiry of the congressional office made at the written
request of the constituent about whom the record is maintained.
Individuals 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.
6. 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
[[Page 41247]]
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.
Whenever CMS is involved in litigation, or occasionally when
another party is involved in litigation and CMS's 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.
7. To a CMS contractor (including, but not 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 programs.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contract 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 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.
8. 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 PMMIS information for the purpose of
combating fraud and abuse in such Federally funded programs.
B. Additional Circumstances Affecting Routine Use Disclosures
This SOR contains Protected Health Information 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), as
amended by 66 FR 12434 (2-26-01)). Disclosures of Protected Health
Information 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 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).
IV. Safeguards
A. Administrative Safeguards
The PMMIS system will conform to applicable law and policy
governing the privacy and security of Federal automated information
systems. These include but are not limited to: the Privacy Act of 1984,
Computer Security Act of 1987, the Paperwork Reduction Act of 1995, the
Clinger-Cohen Act of 1996, and the Office of Management and Budget
(OMB) Circular A-130, Appendix III, ``Security of Federal Automated
Information Resources.'' CMS has prepared a comprehensive system
security plan as required by OMB Circular A-130, Appendix III. This
plan conforms fully to guidance issued by the National Institute for
Standards and Technology (NIST) in NIST Special Publication 800-18,
``Guide for Developing Security Plans for Information Technology
Systems. Paragraphs A-C of this section highlight some of the specific
methods that CMS is using to ensure the security of this system and the
information within it.
Authorized users: Personnel having access to the system have been
trained in Privacy Act and systems security requirements. Employees and
contractors 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, CMS is monitoring
the authorized users to ensure against excessive or unauthorized use.
Records are used in a designated work area or workstation and the
system location is attended at all times during working hours.
To insure security of the data, the proper level of class user is
assigned for each individual user as determined at the Agency 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 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.
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
PMMIS 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
that 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 Automated
Information System resources caused by fire, electricity, water and
inadequate climate controls.
Protection applied to the workstations, servers and databases
include:
User Log on--Authentication is performed by the Primary
Domain
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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.
C. Procedural Safeguards
All automated systems must comply with Federal laws, guidance, and
policies for information systems security as stated previously in this
section. 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. Effect of the Modified 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. We will only
collect the minimum personal data necessary to achieve the purpose of
PMMIS. Disclosure of information from the SOR will be approved only to
the extent necessary to accomplish the purpose of the disclosure. CMS
has assigned a higher level of security clearance for the information
in this system to provide added security and protection of data in this
system.
CMS will take precautionary measures to minimize the risks of
unauthorized access to the records and the potential harm to individual
privacy or other personal or property rights. 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 the disclosure of information
relating to individuals.
Dated: June 1, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
09-70-0520
System Name:
End Stage Renal Disease (ESRD) Program Management and Medical
Information System (PMMIS), HHS//CMS/OCSQ.
Security Classification:
Level Three Privacy Act Sensitive Data.
System Location:
CMS Data Center, 7500 Security Boulevard, North Building, First
Floor, Baltimore, Maryland 21244-1850 and at various other remote
locations (see Appendix A).
Categories of Individuals Covered By the System:
Individuals with ESRD who receive Medicare benefits or who are
treated by Department of Veteran Affairs (DVA) health care facilities.
Categories of Records in the System:
The system contains information on both the beneficiary and the
provider of services. The system contains beneficiary/patient medical
records, claims data, and payment data collected from several non-
reimbursement data collection instruments and Medicare bills. The
information contains the provider's name, address, Medicare
identification number, types of services provided certification and or
termination date, and ESRD network number.
Authority for Maintenance of the System:
Authority for maintenance of the system is given under sections
226A, 1875, and 1881 of the Social Security Act (the Act)(Title 42
United States Code (U.S.C.) 426-1, 1395ii, and 1395rr).
Purpose(s):
The primary purpose of the system of records is to maintain
information on Medicare ESRD beneficiaries, non-Medicare ESRD patients,
Medicare approved ESRD hospitals and dialysis facilities, and DVA
patients. The ESRD/PMMIS is used by CMS and the renal community to
perform their duties and responsibilities in monitoring the Medicare
status, transplant activities, dialysis activities, and Medicare
utilization (inpatient and physician/supplier bills) of ESRD patients
and their Medicare providers, as well as in calculating the Medicare
covered periods of ESRD. 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, agency of a state
government, an agency established by state law, or its fiscal agent,
ESRD Network organizations and QIOs to implement quality improvement
programs, facilitate research on the quality and effectiveness of care
provided and 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:
These routine uses specify circumstances, in addition to those
provided by statute in the Privacy Act of 1974, under which CMS may
release information from the PMMIS 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).
This SOR contains Protected Health Information 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), as
amended by 66 FR 12434 (2-26-01)). Disclosures of Protected Health
Information authorized
[[Page 41249]]
by these routine uses may only be made if, and as, permitted or
required by the ``Standards for Privacy of Individually Identifiable
Health Information.'' We are proposing to establish or modify the
following routine use disclosures of information maintained in the
system:
1. To Agency contractors, or consultants who have been contracted
by the Agency to assist in accomplishment of a CMS function relating to
the purposes for this SOR and who need to have access to the records in
order to assist CMS.
2. To another Federal or state agency, agency of a state
government, an agency established by state law, or its fiscal agent 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. Determine compliance with the Federal conditions that an ESRD
facility must meet in order to participate in Medicare.
3. To ESRD Network Organizations and Quality Improvement
Organizations in connection with review of claims, or in connection
with quality improvements projects, studies, or other review
activities, conducted pursuant to Part B of Title XI of the Act and in
performing affirmative outreach activities to individuals for the
purpose of establishing and maintaining their entitlement to Medicare
benefits or health insurance plans.
4. To an individual or organization for a research, evaluation, or
epidemiological project related to the prevention of disease or
disability, the restoration, improvement, or maintenance of health, or
payment-related projects.
5. To Members of Congress or to congressional staff members in
response to an inquiry of the congressional office made at the written
request of the constituent about whom the record is maintained.
6. 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.
7. To a CMS contractor (including, but not limited to FIs 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 programs.
8. 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.
Policies and Practices for Storing, Retrieving, Accessing, Retaining,
and Disposing of Records in the System:
Storage:
All records are stored on magnetic media or hard paper copy.
Retrievability:
All Medicare records are accessible by health insurance claim
number, individual's name, or the provider identification number.
Safeguards:
CMS 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, CMS has physical safeguards in place to reduce the
exposure of computer equipment and thus achieve an optimum level of
protection and security for the PMMIS system. For computerized records,
safeguards have been established in accordance with the Department of
Health and Human Services (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
Circular 10, Automated Information Systems Security Program;
CMS Automated Information Systems Guide, Systems Securities Policies,
and OMB Circular No. A-130 (revised), Appendix III.
Retention and Disposal:
Records are maintained indefinitely.
System Manager(s) and Address:
Director, Information Support Group, Office of Clinical Standards
and Quality, CMS, Room S3-02-01, 7500 Security Boulevard, 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, provider identification number, 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 data contained in these records are obtained from Medicare ESRD
medical evidence reports, kidney transplant reports, ESRD beneficiary
reimbursement method selection forms, ESRD death notification forms,
Medicare bills, CMS Medicare Master files, ESRD facility surveys, ESRD
facility certification notices, and the Medicare/Medicaid Automated
Certification System (MMACS).
[[Page 41250]]
Systems Exempted From Certain Provisions of the Act:
None.
Appendix A
1. ESRD Network of New England, Incorporated, Post Office Box 9484,
New Haven, Connecticut 06534.
2. ESRD Network of New York, Incorporated, 1249 Fifth Avenue, A-
419, New York, New York 10029.
3. Trans-Atlantic Renal Council, Cranbury Plaza, 2525 Route 130-
Building C, Cranbury, New Jersey 08512-9595.
4. ESRD Network Organization Number 4, 200 Lothrop Street,
Pittsburgh, Pennsylvania 15213-2582.
5. Mid-Atlantic Renal Coalition, 1527 Huguenot Road, Midlothian,
Virginia 23113.
6. Southeastern Kidney Council, Incorporated, 1000 Saint Albans
Drive, Suite 270, Raleigh, North Carolina 27609.
7. ESRD Network of Florida, Incorporated, One Davis Boulevard,
Suite 304, Tampa, Florida 33606.
8. Network 8, Incorporated, Post Office Box 55868, Jackson,
Mississippi 39296-5868.
9 & 10. The Renal Network, Incorporated, 911 East 86th Street,
Suite 202, Indianapolis, Indiana 46240.
11. Renal Network of the Upper Midwest, 970 Raymond Avenue
205, Saint Paul, Minnesota 55114.
12. ESRD Network Number 12, 7509 NW T Tiffany Spring Parkway, Suite
105, Kansas City, Missouri 64153.
13. ESRD Network Organization Number 13, 6600 North Meridan Avenue,
Suite 155, Oklahoma City, Oklahoma 73116-1411.
14. ESRD Network of Texas, Incorporated, 14114 Dallas Parkway,
Suite 660, Dallas, Texas 75240-4349.
15. Intermountain ESRD Network, Incorporated, 1301 Pennsylvania
Street, Suite 220, Denver, Colorado 80203-5012.
16. Northwest Renal Network, 4702 42nd Avenue, Seattle, Washington
98116.
17. TransPacific Renal Network, 25 Mitchell Boulevard, Suite 7, San
Rafael, California 94903.
18. Southern California Renal Disease Council, 6255 Sunset
Boulevard, Suite 2211, Los Angeles, California 90082.
[FR Doc. 02-15007 Filed 6-14-02; 8:45 am]
BILLING CODE 4120-03-P