[Federal Register: August 5, 2005 (Volume 70, Number 150)]
[Notices]
[Page 45397-45401]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au05-54]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of a New System of Records
AGENCY: Department of Health and Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a New System of Records.
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SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to establish a new system titled ``Federal
Reimbursement of Emergency Health Services Furnished to Undocumented
Aliens (Section 1011),'' System No. 09-07-0546. The system will contain
enrollment and payment request information, in support of a short-term
program which pays hospitals, certain physicians, and ambulance
providers (including Indian Health Service (IHS) facilities whether
operated by the IHS or by an Indian Tribe or tribal organization) for
their otherwise un-reimbursed costs of services provided under the
provisions of section 1867 (Emergency Medical Treatment and Labor Act)
(EMTALA) of the Social Security Act (the Act) and related hospital
inpatient and outpatient services and ambulance services furnished to
undocumented aliens, aliens paroled into the United States (U.S.) at a
U. S. port of entry for the purposes of receiving such services, and
Mexican citizens permitted temporary entry to the U.S. for not more
than 30 days under the authority of a biometric machine readable border
crossing identification card (also referred to as a ``laser visa'')
issued in accordance with the requirements of regulations prescribed
under the Immigration and Nationality Act. This system is being
established under provisions of Section 1011 of the Medicare
Prescription Drug, Improvement and Modernization Act of 2003
Modernization Act of 2003 (MMA).
The primary purpose of the system is to maintain information
collected on individuals who submit an enrollment application and make
payment requests associated with Section 1011 of the MMA, and other
information designed to support the enrollment, claims payment, and
research reporting functions of the Section 1011 program. Information
retrieved from this system will also be disclosed to: (1) Support
regulatory, payment activities, and policy functions performed within
the agency or by a designated contractor or consultant; (2) combat
fraud and abuse in certain health benefits programs; (3) assist another
Federal or state agency with information to enable such agency to
administer a Federal health benefits program, or 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; (4) funds support constituent requests made to a Congressional
representative; and, (5) support litigation involving the agency. We
have provided background information about the new system in the
SUPPLEMENTARY INFORMATION section below. Although the Privacy Act
requires only that the ``routine use'' portion of the system be
published for comment, CMS invites comments on all portions of this
notice. See DATES section for comment period.
DATES: CMS filed a new system 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 July 21, 2005. In any event, we will not disclose any
information under a routine use until 40 days after publication. 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: CMS Privacy Officer,
Division of Privacy Compliance Data Development (DPCDD), CMS, 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 time zone.
FOR FURTHER INFORMATION CONTACT: Section 1011 Project Officer, Center
for Medicare Management, CMS, Mailstop C4-10-07, 7500 Security
Boulevard, Baltimore, Maryland 21244-1850.
SUPPLEMENTARY INFORMATION: Sections 1866(a)(1)(I), 1866(a)(1)(N), and
1867 of the Act impose specific obligations on
[[Page 45398]]
Medicare-participating hospitals that offer emergency services. These
obligations concern individuals who come to a hospital emergency
department and request examination or treatment for medical conditions,
and apply to all of these individuals, regardless of whether or not
they are beneficiaries of any program under the Act. Section 1867 of
the Act sets forth requirements for medical screening examinations of
medical conditions, as well as necessary stabilizing treatment or
appropriate transfer. In addition, section 1867(h) of the Act
specifically prohibits a delay in providing required screening or
stabilization services in order to inquire about the individual's
payment method or insurance status. Section 1867(d) of the Act provides
for the imposition of civil monetary penalties on hospitals responsible
for negligently violating a requirement of that section, through
actions such as the following: (a) Negligently failing to appropriately
screen an individual seeking medical care; (b) negligently failing to
provide stabilizing treatment to an individual with an emergency
medical condition; or (c) negligently transferring an individual in an
inappropriate manner. (Section 1867(e)(4) of the Act defines
``transfer'' to include both transfers to other health care facilities
and cases in which the individual is released from the care of the
hospital without being moved to another health care facility.)
These provisions, taken together, are frequently referred to as the
Emergency Medical Treatment and Labor Act (EMTALA), also known as the
patient antidumping statute. EMTALA was passed in 1986 as part of the
Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA).
Congress enacted these antidumping provisions in the Act because of its
concern with an increasing number of reports that hospital emergency
rooms were refusing to accept or treat individuals with emergency
conditions if the individuals did not have insurance.
I. Description of the New System of Records
A. Statutory and Regulatory Basis for System
The authority to conduct the program is given under the provisions
of Section 1011 of the Medicare Prescription Drug, Improvement and
Modernization Act of 2003 (Pub. L. 108-173).
B. Collection and Maintenance of Data in the System
The Section 1011 program includes the provider name and
identification number, provider address, provider employer
identification number, provider banking information, provider federal
tax identification number, patient's control number, medical record
number, date of service, patient's gender, zip code, state and county,
the principle diagnosis code, admitting diagnosis code, and total
charges. It also includes claims information related to Section 1011
payment requests, and other research information needed to pay claims
and administer the Section 1011 program.
II. Agency Policies, Procedures, and Restrictions on the Routine
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 Section 1011 program information that
can be associated with an individual provider 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. Identifiable data includes individual records with
Section 1011 program information and identifiers. Non-identifiable data
includes individual records with Section 1011 program information and
masked identifiers or Section 1011 program information with identifiers
stripped out of the file.
We will only disclose the minimum personal data necessary to
achieve the purpose of the Section 1011 program. 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 system will be approved only for the minimum information necessary
to accomplish the purpose of the disclosure 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
needed when submitting an enrollment application and make payment
requests associated with Section 1011(a) of the MMA;.
2. Determines that:
a. The purpose for which the disclosure is to be made can only be
accomplished if
b. The record is provided in individually identifiable form;
c. 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
d. 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 Section 1011 program 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 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 the performance of a service related to this
system 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 agency business
functions relating to purposes for this system of records.
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 whatever information is necessary for the
[[Page 45399]]
contractor to fulfill its duties. In these situations, safeguards are
provided in the contract prohibiting the contractor from using or
disclosing the information for any purpose other than that described in
the contract and requires the contractor to return or destroy all
information at the completion of the contract.
2. To a CMS contractor that assists in the administration of a CMS-
administered health benefits 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.
3. 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 Section 1011 program information for the
purpose of combating fraud and abuse in such Federally-funded programs.
Releases of information would be allowed if the proposed use(s) for the
information proved compatible with the purposes of collecting the
information.
4. To another Federal or state agency to:
a. Contribute to the accuracy of CMS'' proper payment of a health
benefit, or
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.
Other Federal or state agencies in their administration of a
Federal health program may require Section 1011 program information in
order to ensure that proper payment for services were provided.
Releases of information would be allowed if the proposed use(s) for the
information proved compatible with the purpose for which CMS collects
the information.
5. 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.
Individuals sometimes request the help of a Member of Congress in
resolving some 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
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' 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. A determination would be made in each instance that, under
the circumstances involved, the purposes served by the use of the
information in the particular litigation is compatible with a purpose
for which CMS collects the information.
B. Additional Provisions Affecting Routine Use Disclosures
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, 65 FR 82462 (12-28-00),
Subparts A and E. Disclosures of PHI 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 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 include 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 NIST
publications; the HHS Information Systems Program Handbook and the CMS
Information Security Handbook.
V. Effects of the New 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
[[Page 45400]]
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 monitor the collection and reporting of Section 1011 data.
Section 1011 information on patients is submitted to CMS in a standard
payment system. Accuracy of the data is important since incorrect
information could result in the wrong payment for services. CMS will
utilize a variety of onsite and offsite edits and audits to increase
the accuracy of Section 1011 payment requests.
CMS will take precautionary measures (see item IV. above) 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 is 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 maintaining this system of records.
Charlene Brown,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0546
SYSTEM NAME:
``Federal Reimbursement of Emergency Health Services Furnished to
Undocumented Aliens (Section 1011)'' HHS/CMS/CMM.
SECURITY CLASSIFICATION:
Level 3, Privacy Act Sensitive.
SYSTEM LOCATION:
CMS Data Center, 7500 Security Boulevard, North Building, First
Floor, Baltimore, Maryland 21244-1850 and CMS contractors and agents at
various locations.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The Section 1011 program will include information on individuals
who have elected to participate in the Section 1011 program, claims
information related to Section 1011 payment requests, and information
needed to pay claims and administer the Section 1011 program.
CATEGORIES OF RECORDS IN THE SYSTEM:
The Section 1011 program includes the provider name and
identification number, provider address, provider employer
identification number, provider banking information, provider Federal
tax identification number, patient's control number, medical record
number, date of service, patient's gender, zip code, state and county,
the principle diagnosis code, admitting diagnosis code, and total
charges. It also includes claims information related to Section 1011
payment requests, and other research information needed to pay claims
and administer the Section 1011 program.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
The authority to conduct the program is given under the provisions
of Section 1011 of the Medicare Prescription Drug, Improvement and
Modernization Act of 2003 (Pub. L. 108-173).
PURPOSE (S) OF THE SYSTEM:
The primary purpose of the system is to maintain information
collected on individuals who submit an enrollment application and make
payment requests associated with Section 1011 of the MMA, and other
information designed to support the enrollment, claims payment, and
research reporting functions of the Section 1011 program. Information
retrieved from this system will also be disclosed to: (1) Support
regulatory, payment activities, and policy functions performed within
the agency or by a designated contractor or consultant; (2) combat
fraud and abuse in certain health benefits programs; (3) assist another
Federal or state agency with information to enable such agency to
administer a Federal health benefits program, or 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; (4) funds support constituent requests made to a Congressional
representative; and, (5) support litigation involving the agency.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OR USERS AND THE PURPOSES OF SUCH USES:
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 Section 1011 program 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 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 the performance of a service related to this
system and who need to have access to the records in order to perform
the activity.
2. To a CMS contractor 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.
3. 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.
4. To another Federal or State agency to:
a. Contribute to the accuracy of CMS' proper payment of a health
benefit, or
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.
5. 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.
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;
[[Page 45401]]
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.
B. Additional Provisions Affecting Routine Use Disclosures
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, 65 FR 82462 (12-28-00),
Subparts A and E. Disclosures of PHI 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 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 claim records are stored on magnetic media. Patient eligibility
information may be maintained electronically or in paper format.
RETRIEVABILITY:
Providers will retrieve medical records by the patient control
number. Provider IDs and patient control numbers are used to facilitate
inquiries into specific claims as needed.
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 include 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 NIST
publications; the HHS Automated Information Systems Security Handbook
and the CMS Information Security Handbook.
RETENTION AND DISPOSAL:
CMS will retain identifiable Section 1011 data for an indefinite
period. Data residing with the designated claims payment contractor
shall be returned to CMS at the end of the fifth program year, with all
data then being the responsibility of CMS for adequate storage and
security.
SYSTEM MANAGER AND ADDRESS:
Section 1011 Project Officer, Center for Medicare Management, CMS,
7500 Security Boulevard, Mail Stop C4-10-07, 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, and for verification
purposes, the subject individual's name and provider identification
number and the patient's medical record number.
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:
Information maintained in this system will be collected from
individuals volunteering to participate in Section 1011 program through
the enrollment application and claims data requesting payment for
services.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. 05-15165 Filed 8-4-05; 8:45 am]
BILLING CODE 4120-03-P