[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

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    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

[[Page 41248]]

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