[Federal Register Volume 71, Number 99 (Tuesday, May 23, 2006)]
[Notices]
[Pages 29643-29649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7806]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


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

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

[[Page 29644]]


ACTION: Notice of a modified or altered System of Records (SOR).

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SUMMARY: In accordance with the Privacy Act of 1974, we are proposing 
to modify or alter an existing SOR, ``Automated Survey Processing 
Environment (ASPEN) Complaints/Incidents Tracking System (ACTS),'' 
System No. 09-70-1519, last published at 68 FR 50795 (August 22, 2003). 
CMS is reorganizing its databases because of the impact of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) 
(Public Law (Pub. L.) 108-173) provisions and the large volume of 
information the Agency collects to administer the Medicare program. We 
propose to assign a new CMS identification number to this system to 
simplify the obsolete and confusing numbering system originally 
designed to identify the Bureau, Office, or Center that maintained the 
system of records. The new assigned identifying number for this system 
should read: System No. 09-70-0565.
    We propose to delete published routine uses number 5 authorizing 
disclosures to the agency of a state government, number 8 authorizing 
disclosure to researchers, and number 12 authorizing disclosure to 
another agency or instrumentality of any governmental jurisdiction. 
Disclosures permitted under routine uses number 5 and 12 will be made a 
part of proposed routine use number 2. The scope of routine use number 
2 will be broadened to allow for release of information to ``another 
Federal and/or state agency, an agency established by state law, or its 
fiscal agent.'' Routine use number 8 is being deleted because 
disclosure of ACTS data for research and evaluation purposes will be 
restricted to the release of aggregate data rather than individual-
specific data.
    CMS proposes to exempt this system from the notification, access, 
correction and amendment provisions of the Privacy Act of 1974 (5 
U.S.C. 552a (k) (2)) due to investigatory and law enforcement 
activities.
    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 MMA provisions and to update language 
in the administrative sections to correspond with language used in 
other CMS SORs. The primary purpose of this modified system is to track 
and process complaints and incidents reported against Medicare and/or 
Medicaid certified providers and suppliers, and CLIA-certified 
laboratories, these include: skilled nursing facilities, nursing 
facilities, hospitals, home health agencies, end-stage renal disease 
facilities, hospices, rural health clinics, comprehensive outpatient 
rehabilitation facilities, outpatient physical therapy services, 
community mental health centers, ambulatory surgical centers, suppliers 
of portable X-Ray services, and intermediate care facilities for 
persons with mental retardation. The 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, an agency established by state law, or its fiscal agent; (3) 
assist Quality Improvement Organizations; (4) support constituent 
requests made to a Congressional representative; (5) support litigation 
involving the agency; (6) assist a national accreditation organization 
that has been granted deeming authority by CMS; (7) assist a state-
mandated Protection and Advocacy System that provides legal 
representation and other advocacy services to beneficiaries; and (8) 
combat fraud and abuse in certain Federally-funded 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 modified or altered routine uses, 
CMS invites comments on all portions of this notice. See ``Effective 
Dates'' section for comment period.

DATES: Effective Date: 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 Homeland Security & Governmental 
Affairs, and the Administrator, Office of Information and Regulatory 
Affairs, Office of Management and Budget (OMB) on May 16, 2006. To 
ensure that all parties have adequate time in which to comment, the new 
system will become effective 30 days from the publication of the 
notice, or 40 days from the date it was submitted to OMB and the 
Congress, whichever is later. We may defer implementation of this 
system or one or more of the routine use statements listed below if we 
receive comments that persuade us to defer implementation.

ADDRESSES: The public should address comments to the CMS Privacy 
Officer, Mail Stop 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: Cheryl Hatcher, Division of National 
Systems, Finance, Systems and Budget Group, Center for Medicaid and 
State Operations, CMS, Mail Stop S3-13-15, 7500 Security Boulevard, 
Baltimore, Maryland 21244-1850. She can also be reached by telephone at 
410-786-3106, or via e-mail at [email protected].

SUPPLEMENTARY INFORMATION: ACTS is a Windows-based program designed to 
track and process complaints and incidents reported against health care 
facilities regulated by CMS and the state agencies. It is designed to 
manage all operations associated with complaint/incident tracking and 
processing, from initial intake and investigation through the final 
disposition. ACTS allows CMS to track complaints/incidents, 
allegations, investigations, disposition and certain information for 
Clinical Laboratory Improvement Amendments of 1988 (CLIA) laboratories.
    ACTS is a national tracking system used by the state agencies and 
CMS. It permits the collection procedures for complaints to be timely, 
consistent and complete. ACTS is used for all Medicare and/or Medicaid 
-certified providers and suppliers, and CLIA-certified laboratories. 
These include: skilled nursing facilities, nursing facilities, 
hospitals, home health agencies, end-stage renal disease facilities, 
hospices, rural health clinics, comprehensive outpatient rehabilitation 
facilities, outpatient physical therapy services, community mental 
health centers, ambulatory surgical centers, suppliers of portable X-
Ray services, intermediate care facilities for persons with mental 
retardation, and CLIA-certified laboratories.
    ACTS maintains Federal complaint information, as well as state 
licensure complaint information. State licensure information is both 
relevant and necessary to meet CMS' purposes. Under section 1864(a) of 
the Social Security Act, the Secretary uses the help of State health 
agencies, or other appropriate agencies, when determining whether 
health care entities meet Federal Medicare standards. Also, section 
1902(a)(9)(A) of the Social

[[Page 29645]]

Security Act requires that a State use this same agency to set and 
maintain additional standards for the State Medicaid program. Section 
1902(a)(33)(B) requires that the state use the agency utilized for 
Medicare or, if such agency is not the state agency responsible for 
licensing health institutions, the state use the agency responsible for 
such licensing to determine whether institutions meet all applicable 
Federal health standards for Medicaid participation, subject to 
validation by the Secretary. The state survey agencies perform both 
Federal certification and state licensure functions, including the 
investigation of complaints and entity-reported incidents. For example 
sections 1819(d) and 1919(d) of the Social Security Act require 
licensure under applicable state and local laws for skilled nursing and 
nursing facilities. In order to encourage efficiency in state 
operations, ACTS permits collection of Federal and state information, 
so that the states may maintain only one database, instead of multiple 
systems. CMS does seek to eliminate duplicative processes and 
unnecessary burden, to the extent possible, so that the states can 
achieve more effective management of their certification and licensure 
responsibilities.
    ACTS allows users to distinguish between Federal information and 
information that is collected for State licensure purposes. ACTS 
supports the entry of both Federal and State licensure information, 
thus reflecting the actual business practices of state agencies as they 
track complaints and incidents. In many areas, ACTS allows entry of 
both types of information while still maintaining discrete records to 
support separate and different views, reports and statistics.

 I. Description of the Modified or Altered System of Records

 A. Statutory and Regulatory Basis for SOR

    Authority for maintenance of the system is given under Sec. Sec.  
1819, 1864, 1865, 1867, 1891, 1902(a)(9)(A), 1902(a)(33)(B), and 1919 
of the Social Security Act, section 353 of the Public Health Service 
Act (42 United States Code 263a) and 42 Code of Federal Regulations 
(CFR) Subchapter G.

B. Collection and Maintenance of Data in the System

    ACTS contains information related to allegations of complaints and 
incidents filed against Medicare and/or Medicaid -certified providers 
and suppliers and CLIA-certified laboratories. ACTS contains 
identifiable information on individuals who are complainants, 
residents/patients/clients, contacts/witnesses, alleged perpetrators, 
survey team members, laboratory directors and laboratory owners, 
including the investigation of complaints and entity-reported 
incidents. The system contains demographic and identifying data, as 
well as survey and deficiency data. Identifying data includes, but is 
not limited to: name, title, address, city, state, ZIP code, e-mail 
address, telephone numbers, fax number, licensure number, social 
security number, Federal tax identification number, alias names, date 
of birth, gender, date admitted and/or date discharged.

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

A. 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 ACTS 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 ACTS. CMS has the following policies and procedures 
concerning disclosures of information that will be maintained in the 
system. Disclosure of information from this 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 track and process 
complaints and incidents reported against Medicare and/or Medicaid 
certified providers and suppliers, and CLIA-certified laboratories, 
these include: skilled nursing facilities, nursing facilities, 
hospitals, home health agencies, end-stage renal disease facilities, 
hospices, rural health clinics, comprehensive outpatient rehabilitation 
facilities, outpatient physical therapy services, community mental 
health centers, ambulatory surgical centers, suppliers of portable X-
Ray services, and intermediate care facilities for persons with mental 
retardation.
    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 
following routine use disclosures of information maintained in the 
system:
    1. To agency contractors, consultants, or to a grantee who have 
been engaged by the agency to assist in the accomplishment of a CMS 
function relating to the purposes for this system 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 enters into a contractual or similar 
agreement with a third party to assist in accomplishing a 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

[[Page 29646]]

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 and/or state agency, an agency established by 
state law, or its fiscal agent to:
    a. Contribute to the accuracy of CMS' 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. assist Federal/state Medicaid programs within the state.
    Other Federal or state agencies in their administration of a 
Federal health program may require ACTS information in order to support 
evaluations and monitoring of Medicare claims information of 
beneficiaries, including proper reimbursement for services provided. 
ACTS information can also be used to determine overall cost, 
effectiveness, and the quality of health care and services provided by 
a Federally-funded health benefits program.
    Information from ACTS may also be given to state's Adult Protective 
Services for the investigation of suspected abuse, neglect, and/or 
exploitation of adults.
    Information from ACTS may also be shared with the state's Long-Term 
Care Ombudsman program. Under the Older Americans Act, the Long-Term 
Care Ombudsman addresses complaints and advocated for improvements in 
the long-term care system.
    3. To Quality Improvement Organizations (QIO) in order to assist 
the QIO to perform Title XI and Title XVIII functions relating to 
assessing and improving quality of care.
    The QIO will work to implement quality improvement programs, 
provide consultation to CMS, its contractors, and to state agencies. 
The QIO will assist 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 a member of Congress or to a Congressional staff member in 
response to an inquiry of the Congressional office made at the written 
request of the constituent about whom the record is maintained.
    Beneficiaries sometimes request the help of a member of Congress in 
resolving an issue relating to a matter before CMS. The member of 
Congress then writes to CMS, and CMS must be able to give sufficient 
information to be responsive to the inquiry.
    5. To the Department of Justice (DOJ), court or adjudicatory body 
when:
    a. The agency or any component thereof, or
    b. any employee of the agency in his or her official capacity, or
    c. any employee of the agency in his or her individual capacity 
where the DOJ has agreed to represent the employee, or
    d. the United States Government is a party to litigation or has an 
interest in such litigation, and by careful review, 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.
    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.
    6. To a national accreditation organization that has been granted 
deeming authority or certified by the Secretary for the purpose of 
improving the quality of care provided through the provision of health 
care accreditation and related services that support performance 
improvement and monitors the quality of deemed providers/suppliers 
through the investigation of complaints. CMS will provide facility 
information to approved accreditation organizations on their accredited 
entities that are deemed for participation in the Medicare program.
    CMS anticipates that accreditation organizations will have 
legitimate requests to use these data to investigate complaints and to 
improve the care provided to patients/clients and the policies that 
govern the care provided.
    7. To a state-designated Protection and Advocacy System that 
provides legal representation and other advocacy services for the 
purposes of monitoring, investigating and attempting to remedy adverse 
conditions, and for responding to allegations of abuse, neglect and 
violations of the rights of persons with disabilities.
    Data will be released to the state-designated Protection and 
Advocacy System only on those individuals who are identified as 
patients within the state, or are legal residents of the State, 
regardless of the location of the facility in which the patient is 
receiving services.
    8. To a CMS contractor (including, but not necessarily limited to 
Medicare administrative contractors, 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 program.
    We contemplate disclosing information under this routine use only 
in situations in which CMS may enter into a contractual relationship 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 and makes 
grants 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.
    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 
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 ACTS information for the purpose of 
combating fraud 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 FR 82462

[[Page 29647]]

(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 who are familiar with the enrollees 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 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 or Altered System of Records on Individual 
Rights

    CMS proposes to modify 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 the 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: May 15, 2006.
Charlene Frizzera,
Acting Chief Operating Officer, Centers for Medicare & Medicaid 
Services.
SYSTEM NO. 09-70-0565.

SYSTEM NAME:
    ``Automated Survey Processing Environment (ASPEN) Complaints/
Incidents Tracking System (ACTS),'' HHS/CMS/CMSO.

SECURITY CLASSIFICATION:
    Level Three Privacy Act Sensitive Data.

SYSTEM LOCATION:
    The Centers for Medicare & Medicaid Services (CMS) Data Center, 
7500 Security Boulevard, North Building, First Floor, Baltimore, 
Maryland 21244-1850 and at various contractor sites and at CMS Regional 
Offices.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    ACTS contains information related to allegations of complaints and 
incidents filed against Medicare/Medicaid-certified providers and 
suppliers and CLIA-certified laboratories. ACTS contains identifiable 
information on individuals who are complainants, residents/patients/
clients, contacts/witnesses, alleged perpetrators, survey team members, 
laboratory directors and laboratory owners, including the investigation 
of complaints and entity-reported incidents.

CATEGORIES OF RECORDS IN THE SYSTEM:
    The system contains demographic and identifying data, as well as 
survey and deficiency data. Identifying data includes, but is not 
limited to: name, title, address, city, state, ZIP code, e-mail 
address, telephone numbers, fax number, licensure number, social 
security number, Federal tax identification number, alias names, date 
of birth, gender, date admitted and/or date discharged.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Authority for maintenance of the system is given under Sec. Sec.  
1819, 1864, 1865, 1867, 1891, 1902(a)(9)(A), 1902(a)(33)(B), and 1919 
of the Social Security Act, section 353 of the Public Health Service 
Act (42 United States Code 263a) and 42 Code of Federal Regulations 
(CFR) Subchapter G.

PURPOSE(S) OF THE SYSTEM:
    The primary purpose of this modified system is to track and process 
complaints and incidents reported against Medicare and/or Medicaid 
certified providers and suppliers, and CLIA-certified laboratories, 
these include: skilled nursing facilities, nursing facilities, 
hospitals, home health agencies, end-stage renal disease facilities, 
hospices, rural health clinics, comprehensive outpatient rehabilitation 
facilities, outpatient physical therapy services, community mental 
health centers, ambulatory surgical centers, suppliers of portable X-
ray services, and intermediate care facilities for persons with mental 
retardation. The 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, an agency 
established by state law, or its fiscal agent; (3) assist Quality 
Improvement Organizations; (4) support constituent requests made to a 
Congressional representative; (5) support litigation involving the 
agency; (6) assist a national accreditation organization that has been 
granted deeming authority by CMS; (7) assist a state-mandated 
Protection and Advocacy System that provides legal representation and 
other advocacy services to beneficiaries; and (8) combat fraud and 
abuse in certain Federally-funded 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

[[Page 29648]]

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 to a grantee who have 
been engaged by the agency to assist in the accomplishment of a CMS 
function relating to the purposes for this system and who need to have 
access to the records in order to assist CMS.
    2. To another Federal and/or state agency, an agency established by 
state law, or its fiscal agent to:
    a. Contribute to the accuracy of CMS' 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. assist Federal/state Medicaid programs within the state.
    3. To Quality Improvement Organizations (QIO) in order to assist 
the QIO to perform Title XI and Title XVIII functions relating to 
assessing and improving quality of care.
    4. To a member of Congress or to a Congressional staff member in 
response to an inquiry of the Congressional office made at the written 
request of the constituent about whom the record is maintained.
    5. To the Department of Justice (DOJ), court or adjudicatory body 
when:
    a. the agency or any component thereof, or
    b. any employee of the agency in his or her official capacity, or
    c. any employee of the agency in his or her individual capacity 
where the DOJ has agreed to represent the employee, or
    d. the United States Government is a party to litigation or has an 
interest in such litigation, and by careful review, 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.
    6. To a national accreditation organization that has been granted 
deeming authority or certified by the Secretary for the purpose of 
improving the quality of care provided through the provision of health 
care accreditation and related services that support performance 
improvement and monitors the quality of deemed providers/suppliers 
through the investigation of complaints. CMS will provide facility 
information to approved accreditation organizations on their accredited 
entities that are deemed for participation in the Medicare program.
    7. To a state-designated Protection and Advocacy System that 
provides legal representation and other advocacy services for the 
purposes of monitoring, investigating and attempting to remedy adverse 
conditions, and for responding to allegations of abuse, neglect and 
violations of the rights of persons with disabilities.
    8. To a CMS contractor (including, but not necessarily limited to 
Medicare administrative contractors, 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 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 
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.
    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 who are familiar with the enrollees 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 the magnetic disk sub-system of the 
Windows 2000 server. Furthermore, these records are saved to magnetic 
tape backup on a nightly basis.

RETRIEVABILITY:
    The Medicare, Medicaid, and CLIA records are retrieved by name of 
provider/supplier, Medicare provider number, ACTS Intake ID, state 
assigned Medicaid number, or other CMS assigned numbers, complainant's 
name, resident/patient/client's name, contact/witness name, alleged 
perpetrator's name, survey team member's name, surveyor identification 
number, laboratory director's name, laboratory owner's name or Federal 
tax 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

[[Page 29649]]

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:
    CMS will retain identifiable ACTS data for a total period not to 
exceed 15 years. All claims-related records are encompassed by the 
document preservation order and will be retained until notification is 
received from DOJ.

SYSTEM MANAGER(S) AND ADDRESS:
    Director, Division of National Systems, Finance, Systems and Budget 
Group, Center for Medicaid and State Operations, CMS, Mail Stop S3-13-
15, 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, HICN, provider/
supplier's name, date the complaint/incident occurred, address, date of 
birth, and gender, and for verification purposes, the subject 
individual's name (woman's maiden name, if applicable), and 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 specify the 
record contents being sought. (These procedures are in accordance with 
department regulation 45 CFR 5b.5(a)(2)).

CONTESTING RECORDS PROCEDURES:
    The subject individual should contact the system manager named 
above, and reasonably identify the records 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 following forms and the ACTS software are used to collect ACTS 
data: Medicare/Medicaid/CLIA Complaint Form (CMS-562); Statement of 
Deficiencies and Plan of Correction (CMS-2567); Post-Certification 
Revisit Report (CMS-2567B); Survey Team Composition and Workload Report 
(CMS-670); Request for Validation of Accreditation Survey for Hospital 
(CMS-2802); Request for Validation of Accreditation Survey for 
Laboratory (CMS-2802A); Request for Validation of Accreditation Survey 
for Hospice (CMS-2802B); Request for Validation of Accreditation Survey 
for Home Health Agency (CMS-2802C); and Request for Validation of 
Accreditation Survey for Ambulatory Surgical Center (CMS-2802D). 
Request for Survey of 489.20 and 489.24 Essentials of Provider 
Agreements: Responsibilities of Medicare Participating Hospitals in 
Emergency Cases (CMS-1541A) and CMS-116-CLIA Laboratory Application.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    HHS claims exemption of certain records in the system from 
notification and access procedures under 5 U.S.C. 522a(k)(2) inasmuch 
as these records are investigatory materials compiled for program (law) 
enforcement in anticipation of criminal or administrative proceedings. 
(See Department Regulation (45 CFR 5b.11)).
[FR Doc. E6-7806 Filed 5-22-06; 8:45 am]
BILLING CODE 4120-03-P