[Federal Register Volume 72, Number 88 (Tuesday, May 8, 2007)]
[Notices]
[Pages 26126-26131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8759]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of a Modified System of Records

AGENCY: Department of Health and Human Services (HHS), Center for 
Medicare & Medicaid Services (CMS).

ACTION: Notice of a Modified 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 a system titled, ``End Stage 
Renal Disease (ESRD) Program Management and Medical Information System 
(PMMIS), System No. 09-70-0520,'' and last modified at 67 Fed. Reg. 
41244 (June 17, 2002). This system contains records on individuals with 
ESRD who are entitled to receive Medicare benefits or who are treated 
by Department of Veteran Affairs (DVA) health care facilities. We 
propose to modify existing routine use number 1 that permits disclosure 
to agency contractors and consultants to include disclosure to CMS 
grantees who perform a task for the agency. The modified routine use 
will remain as routine use number 1. For further clarity, we propose to 
separate existing routine use number 3 that permit disclosures to ESRD 
Network Organizations and to Quality Improvement Organizations into 
separate routine uses. The activities performed by the 2 different type 
organizations are not so closely related that they should be combined 
in one routine use. The modified routine use will be republished as 
routine use number 3 for ESRD Network Organizations and routine use 
number 4 for Quality Improvement Organizations. We will delete routine 
use number 5 authorizing disclosure to support constituent requests 
made to a congressional representative. If an authorization for the 
disclosure has been obtained from the data subject, then no routine use 
is needed. The Privacy Act allows for disclosures with the ``prior 
written consent'' of the data subject.
    We propose to broaden the scope of the disclosure provisions of 
this system by adding a routine use to permit the release of priority 
personal information to complete a transfer out event from a losing 
ESRD facility and/or a transfer-in event to a gaining ESRD facility to: 
(1) Contribute to the accuracy of CMS' proper payment of Medicare 
benefits; and (2) enable such facilities to ensure the proper transfer 
of health records, and/or as necessary to enable such a facility to 
fulfill a requirement of a Federal statute or regulation that 
implements a health benefits program funded in whole or in part with 
Federal funds; (3) assist ESRD programs which may require PMMIS 
information for purposes related to this system. Information will be 
released to these organizations upon specific request, and only for 
those organizations if they meet the following requirements: (1) 
Provide an attestation or other qualifying information that they are 
providing assistance to qualified ESRD beneficiaries; (2) submit a 
report of the transfer-in or transfer-out event; (3) safeguard the 
confidentiality of the data and prevent unauthorized access; and (4) 
complete a written statement attesting to the information recipient's 
understanding of and willingness to abide by these provisions. The 
PMMIS data will provide the ESRD facility with information regarding 
its enrollees' enrollment status, transplant activities, dialysis 
activities, and Medicare utilization; facilitate the facility's 
required utilization reviews and medication management program 
activities; and assist in quality of care issues as they relate to the 
beneficiary. The added routine use will be numbered as routine use 
number 6.
    We are modifying the language in the remaining routine uses to 
provide a proper explanation as to the need for the routine use and to 
provide clarity to CMS's intention to disclose individual-specific 
information contained in this system. The routine uses will then be 
prioritized and reordered according to their usage. We will also take 
the opportunity to update any sections of the system that were affected 
by the recent reorganization or because of the impact of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) 
(Pub. L. 108-173) provisions and to update language in the 
administrative sections to correspond with language used in other CMS 
SORs.

[[Page 26127]]

    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: (1) Support regulatory, reimbursement, and policy 
functions performed within the Agency or by a contractor, consultant or 
grantee; (2) assist another Federal or state agency, agency of a state 
government, an agency established by state law, or its fiscal agent; 
(3) support an ESRD Network Organizations; (4) assist Quality 
Improvement Organizations (QIO) to implement quality improvement 
programs; (5) facilitate research on the quality and effectiveness of 
care provided and payment related projects; (6) permit the release of 
priority personal information to complete a transfer out event and/or a 
transfer-in event; (7) support litigation involving the agency; and, 
(8) combat fraud, waste, and abuse in certain health benefits programs. 
We have provided background information about the new system in the 
SUPPLEMENTARY INFORMATION section below. Although the Privacy Act 
requires only that CMS provide an opportunity for interested persons to 
comment on the proposed routine uses, CMS invites comments on all 
portions of this notice. See Effective Dates section for comment 
period.

DATES: Effective Dates: CMS filed a modified or altered system report 
with the Chair of the House Committee on Government Reform and 
Oversight, the Chair of the Senate Committee on Homeland Security & 
Governmental Affairs, and the Administrator, Office of Information and 
Regulatory Affairs, Office of Management and Budget (OMB) on April 12, 
2007. To ensure that all parties have adequate time in which to 
comment, the modified system, including routine uses, will become 
effective 30 days from the publication of the notice, or 40 days from 
the date it was submitted to OMB and Congress, whichever is later, 
unless CMS receives comments that require alterations to this notice.

ADDRESSES: The public should address comments to: CMS Privacy Officer, 
Division of Privacy Compliance, Enterprise Architecture and Strategy 
Group, Office of Information Services, 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 time zone.

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 Proposed System of Records

A. Statutory and Regulatory Basis for SOR

    The statutory authority for this system is given under the 
provisions of 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).

B. Collection and Maintenance of Data in the System

    This system will collect and maintain individually identifiable and 
other data collected on 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 collected information will include, but is not limited to 
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.

II. Agency Policies, Procedures, and Restrictions on the Routine Use

    A. 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. 
Proposed Routine Use Disclosures of Data in the System.'' Both 
identifiable and non-identifiable data may be disclosed under a routine 
use. We will only collect the minimum personal data necessary to 
achieve the purpose of PMMIS.
    CMS has the following policies and procedures concerning 
disclosures of information that will be maintained in the system. 
Disclosure of information from the system will be approved only to the 
extent necessary to accomplish the purpose of the disclosure and only 
after CMS:
    1. Determines that the use or disclosure is consistent with the 
reason that the data is being collected; e.g., to maintain information 
on Medicare ESRD beneficiaries, non-Medicare ESRD patients, Medicare 
approved ESRD hospitals and dialysis facilities, and Department of 
Veterans Affairs (DVA) 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. The Privacy Act allows us to disclose information without an 
individual's consent if the information is to be used for a purpose 
that is compatible with the purpose(s) for which the information was 
collected. Any such compatible use of data is known as a ``routine 
use.'' The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. We are proposing to establish the

[[Page 26128]]

following routine use disclosures of information maintained in the 
system:
    1. To agency contractors, consultants or grantees, who have been 
engaged by the agency to assist in the performance of a service related 
to this collection and who need to have access to the records in order 
to perform the activity.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual or similar 
agreement with a third party to assist in accomplishing CMS function 
relating to purposes for this system.
    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, consultant or grantee whatever information 
is necessary for the contractor, consultant or grantee to fulfill its 
duties. In these situations, safeguards are provided in the contract 
prohibiting the contractor, consultant or grantee from using or 
disclosing the information for any purpose other than that described in 
the contract and requires the contractor, consultant or grantee 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 in connection with review of 
claims, or in connection with studies or quality improvements projects 
or other review activities, 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 will work to implement quality 
improvement programs, provide consultation to CMS, its contractors, and 
its state agencies, in connection with studies or quality improvements 
projects or in performing affirmative outreach activities to 
individuals.
    4. To 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.
    QIOs will work to implement quality improvement programs, provide 
consultation to CMS, its contractors, and its state agencies, in 
connection with studies or quality improvements projects or other 
review activities.
    The 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.
    5. To an individual or organization for a research project or in 
support of an evaluation project related to the prevention of disease 
or disability, the restoration or maintenance of health, or payment 
related projects.
    The PMMIS data will provide for research or support of evaluation 
projects and a broader, longitudinal, national perspective of the 
status of Medicare beneficiaries. CMS anticipates that many researchers 
will have legitimate requests to use these data in projects that could 
ultimately improve the care provided to Medicare beneficiaries and the 
policies that govern their care.
    6. To assist with a transfer out event from a losing ESRD facility 
and/or a transfer-in event to a gaining ESRD facility to:
    a. Contribute to the accuracy of CMS' proper payment of Medicare 
benefits; and
    b. Enable such facilities to ensure the proper transfer of health 
records, and/or as necessary to enable such a facility 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
    c. Assist ESRD programs which may require PMMIS information for 
purposes related to this system.
    Information will be released to these facilities upon specific 
request, and only for those facilities if they meet the following 
requirements:
    a. Provide an attestation or other qualifying information that they 
are providing assistance to qualified ESRD beneficiaries/patients;
    b. Submit a report of the transfer-in or transfer-out event with 
the following required priority information: Name, address, HICN or 
SSN, date of birth;
    c. Safeguard the confidentiality of the data and prevent 
unauthorized access; and
    d. complete a written statement attesting to the information 
recipient's understanding of and willingness to abide by these 
provisions.
    Both the gaining and losing facilities may require priority 
information submitted as a transfer-in or transfer-out report to 
implement quality transfer of beneficiaries from one facility to 
another; provide consultation to CMS, its contractors, and its state 
agencies, in connection with transfer of patients.
    7. To the Department of Justice (DOJ), court or adjudicatory body 
when:
    a. The agency or any component thereof, or
    b. Any employee of the agency in his or her official capacity, or
    c. Any employee of the agency in his or her individual capacity 
where the DOJ has agreed to represent the employee, or
    d. The United States Government, is a party to litigation or has an 
interest in such litigation, and, by careful review, CMS determines 
that the records are both relevant and necessary to the litigation and 
that the use of such records by the DOJ, court or

[[Page 26129]]

adjudicatory body is compatible with the purpose for which the agency 
collected the records.
    Whenever CMS is involved in litigation, and occasionally when 
another party is involved in litigation and CMS policies or operations 
could be affected by the outcome of the litigation, CMS would be able 
to disclose information to the DOJ, court or adjudicatory body 
involved.
    8. To a CMS contractor (including, but not necessarily limited to, 
fiscal intermediaries and carriers) that assists in the administration 
of a CMS-administered health benefits program, or to a grantee of a 
CMS-administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud, waste, or abuse in such program.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual, grantee, 
cooperative agreement or consultant relationship with a third party to 
assist in accomplishing CMS functions relating to the purpose of 
combating fraud, waste, or abuse. CMS occasionally contracts out 
certain of its functions or makes grants or cooperative agreements when 
doing so would contribute to effective and efficient operations. CMS 
must be able to give a contractor, grantee, consultant or other legal 
agent whatever information is necessary for the agent to fulfill its 
duties. In these situations, safeguards are provided in the contract 
prohibiting the agent from using or disclosing the information for any 
purpose other than that described in the contract and requiring the 
agent to return or destroy all information.
    9. 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, 
waste, 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, waste, or abuse in such programs.
    Other agencies may require PMMIS information for the purpose of 
combating fraud, waste, and abuse in such Federally-funded programs.

B. Additional Provisions Affecting Routine Use Disclosures

    To the extent this system contains Protected Health Information 
(PHI) as defined by HHS regulation ``Standards for Privacy of 
Individually Identifiable Health Information'' (45 CFR parts 160 and 
164, subparts A and E) 65 Fed. Reg. 82462 (12-28-00). Disclosures of 
such PHI that are otherwise 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.'' (See 45 CFR 
164-512 (a)(1)).
    In addition, our policy will be to prohibit release even of data 
not directly identifiable, except pursuant to one of the routine uses 
or if required by law, if we determine there is a possibility that an 
individual can be identified through implicit deduction based on small 
cell sizes (instances where the patient population is so small that 
individuals could, because of the small size, use this information to 
deduce the identity of the beneficiary).

IV. Safeguards

    CMS has safeguards in place for authorized users and monitors of 
such users to ensure against excessive or unauthorized use. Personnel 
having access to the system have been trained in the Privacy Act and 
information security requirements. Employees who maintain records in 
this system are instructed not to release data until the intended 
recipient agrees to implement appropriate management, operational and 
technical safeguards sufficient to protect the confidentiality, 
integrity and availability of the information and information systems 
and to prevent unauthorized access.
    This system will conform to all applicable Federal laws and 
regulations and Federal, HHS, and CMS policies and standards as they 
relate to information security and data privacy. These laws and 
regulations may apply but are not limited to: The Privacy Act of 1974; 
the Federal Information Security Management Act of 2002; the Computer 
Fraud and Abuse Act of 1986; the Health Insurance Portability and 
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the 
corresponding implementing regulations. OMB Circular A-130, Management 
of Federal Resources, Appendix III, Security of Federal Automated 
Information Resources also applies. Federal, HHS, and CMS policies and 
standards include but are not limited to: All pertinent National 
Institute of Standards and Technology publications; the HHS Information 
Systems Program Handbook and the CMS Information Security Handbook.

V. Effects of the Modified System of Records on Individual Rights

    CMS proposes to establish this system in accordance with the 
principles and requirements of the Privacy Act and will collect, use, 
and disseminate information only as prescribed therein. Data in this 
system will be subject to the authorized releases in accordance with 
the routine uses identified in this system of records.
    CMS will take precautionary measures to minimize the risks of 
unauthorized access to the records and the potential harm to individual 
privacy or other personal or property rights of patients whose data are 
maintained in this system. 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 information relating to individuals.

    Dated: April 12, 2007.
Charlene Frizzera,
Acting Chief Operating Officer, Centers for Medicare & Medicaid 
Services.
System No. 09-70-0520.

System Name:
    ``ESRD Program Management and Medical Information (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 contractor 
locations.

Categories of Individuals Covered by the System:
    This system will collect and maintain individually identifiable and 
other data collected on 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.

Categories of Records in the System:
    The collected information will include, but is not limited to

[[Page 26130]]

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.

Authority for Maintenance of the System:
    The statutory authority for this system is given under the 
provisions of 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).

Purpose(s) of the System:
    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: (1) Support regulatory, reimbursement, and policy 
functions performed within the Agency or by a contractor, consultant or 
grantee; (2) assist another Federal or state agency, agency of a state 
government, an agency established by state law, or its fiscal agent; 
(3) support an ESRD Network Organizations; (4) assist Quality 
Improvement Organizations (QIO) to implement quality improvement 
programs; (5) facilitate research on the quality and effectiveness of 
care provided and payment related projects; (6) permit the release of 
priority personal information to complete a transfer out event and/or a 
transfer-in event; (7) support litigation involving the agency; and, 
(8) combat fraud, waste, 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:
    A. The Privacy Act allows us to disclose information without an 
individual's consent if the information is to be used for a purpose 
that is compatible with the purpose(s) for which the information was 
collected. Any such compatible use of data is known as a ``routine 
use.'' The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. We are proposing to establish the 
following routine use disclosures of information maintained in the 
system:
    1. To agency contractors, consultants or grantees, who have been 
engaged by the agency to assist in the performance of a service related 
to this collection and who need to have access to the records in order 
to perform the activity.
    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 in connection with review of 
claims, or in connection with studies or quality improvements projects 
or other review activities, 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 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.
    5. To an individual or organization for a research project or in 
support of an evaluation project related to the prevention of disease 
or disability, the restoration or maintenance of health, or payment 
related projects.
    6. To assist with a transfer out event from a losing ESRD facility 
and/or a transfer-in event to a gaining ESRD facility to:
    a. Contribute to the accuracy of CMS' proper payment of Medicare 
benefits; and
    b. Enable such facilities to ensure the proper transfer of health 
records, and/or as necessary to enable such a facility 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
    c. Assist ESRD programs which may require PMMIS information for 
purposes related to this system.
    Information will be released to these facilities upon specific 
request, and only for those facilities if they meet the following 
requirements:
    d. Provide an attestation or other qualifying information that they 
are providing assistance to qualified ESRD beneficiaries/patients;
    e. Submit a report of the transfer-in or transfer-out event with 
the following required priority information: Name, address, HICN or 
SSN, date of birth;
    f. Safeguard the confidentiality of the data and prevent 
unauthorized access; and
    g. Complete a written statement attesting to the information 
recipient's understanding of and willingness to abide by these 
provisions.
    7. To the Department of Justice (DOJ), court or adjudicatory body 
when:
    a. The agency or any component thereof, or
    b. Any employee of the agency in his or her official capacity, or
    c. Any employee of the agency in his or her individual capacity 
where the DOJ has agreed to represent the employee, or
    d. The United States Government, is a party to litigation or has an 
interest in such litigation, and, by careful review, CMS determines 
that the records are both relevant and necessary to the litigation and 
that the use of such records by the DOJ, court or adjudicatory body is 
compatible with the purpose for which the agency collected the records.
    8. To a CMS contractor (including, but not necessarily limited to, 
fiscal intermediaries and carriers) that assists in the administration 
of a CMS-administered health benefits program, or to a grantee of a 
CMS-administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud, waste, or abuse in such program.
    9. 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, 
waste, 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,

[[Page 26131]]

investigate, examine, prosecute, sue with respect to, defend against, 
correct, remedy, or otherwise combat fraud, waste, or abuse in such 
programs.
    B. Additional Provisions Affecting Routine Use Disclosures: To the 
extent this system contains Protected Health Information (PHI) as 
defined by HHS regulation ``Standards for Privacy of Individually 
Identifiable Health Information'' (45 CFR parts 160 and 164, subparts A 
and E) 65 FR 82462 (12-28-00). Disclosures of such PHI that are 
otherwise 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.'' (See 45 CFR 164-512 (a) (1)).
    In addition, our policy will be to prohibit release even of data 
not directly identifiable, except pursuant to one of the routine uses 
or if required by law, if we determine there is a possibility that an 
individual can be identified through implicit deduction based on small 
cell sizes (instances where the patient population is so small that 
individuals could, because of the small size, use this information to 
deduce the identity of the beneficiary).

Policies and Practices for Storing, Retrieving, Accessing, Retaining, 
and Disposing of Records in the System:
Storage:
    All records are stored on electronic media.

Retrievability:
    The collected data are retrieved by an individual identifier; e.g., 
beneficiary name or HICN, and unique provider identification number.

Safeguards:
    CMS has safeguards in place for authorized users and monitors such 
users to ensure against excessive or unauthorized use. Personnel having 
access to the system have been trained in the Privacy Act and 
information security requirements. Employees who maintain records in 
this system are instructed not to release data until the intended 
recipient agrees to implement appropriate management, operational and 
technical safeguards sufficient to protect the confidentiality, 
integrity and availability of the information and information systems 
and to prevent unauthorized access.
    This system will conform to all applicable Federal laws and 
regulations and Federal, HHS, and CMS policies and standards as they 
relate to information security and data privacy. These laws and 
regulations may apply but are not limited to: The Privacy Act of 1974; 
the Federal Information Security Management Act of 2002; the Computer 
Fraud and Abuse Act of 1986; the Health Insurance Portability and 
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the 
corresponding implementing regulations. OMB Circular A-130, Management 
of Federal Resources, Appendix III, Security of Federal Automated 
Information Resources also applies. Federal, HHS, and CMS policies and 
standards include but are not limited to: All pertinent National 
Institute of Standards and Technology publications; the HHS Information 
Systems Program Handbook and the CMS Information Security Handbook.

Retention and Disposal:
    Records will be retained until an approved disposition authority is 
obtained from the National Archives and Records Administration. All 
claims-related records are encompassed by the document preservation 
order and will be retained until notification is received from DOJ.

System Manager 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, employee 
identification number, tax identification number, national provider 
number, and for verification purposes, the subject individual's name 
(woman's maiden name, if applicable), HICN, and/or 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).

Records 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).

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. E7-8759 Filed 5-7-07; 8:45 am]
BILLING CODE 4120-03-P