Privacy Act of 1974; System of Records, 2230-2233 [2019-01157]
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Federal Register / Vol. 84, No. 25 / Wednesday, February 6, 2019 / Notices
Prevention, and the Agency for Toxic
Substances and Disease Registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
Privacy Act of 1974; System of
Records
[FR Doc. 2019–01213 Filed 2–5–19; 8:45 am]
AGENCY:
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Notice of a Modified System of
Records.
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Chief Operating Officer, CDC,
pursuant to Public Law 92–463. The
grant applications and the discussions
could disclose confidential trade secrets
or commercial property such as
patentable material, and personal
information concerning individuals
associated with the grant applications,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)DD19–001, Research Approaches to
Improve the Care and Outcomes of
People Living with Spina Bifida
Component C.
Dates: April 11, 2019
Times: 10:00 a.m.–6:30 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Jaya
Raman Ph.D., Scientific Review Officer,
CDC, 4770 Buford Highway, Mailstop
F80, Atlanta, Georgia 30341, Telephone:
(770) 488–6511, kva5@cdc.gov.
The Chief Operating Officer, Centers
for Disease Control and Prevention, has
been delegated the authority to sign
Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–01209 Filed 2–5–19; 8:45 am]
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The Department of Health and
Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS),
proposes to modify an existing system
of records subject to the Privacy Act,
System No. 09–70–0541, titled Medicaid
Statistical Information System (MSIS).
This system of records covers the
national Medicaid dataset, consisting of
standardized enrollment, eligibility, and
paid claims data about Medicaid
recipients which is used to administer
Medicaid at the federal level, produce
statistical reports, support Medicaid
related research, and assist in the
detection of fraud and abuse in the
Medicare and Medicaid programs. CMS
is changing the name of the system of
records to Transformed-Medicaid
Statistical Information System (T–MSIS)
and making other modifications which
are explained below.
DATES: In accordance with 5 United
States Code (U.S.C.) 552a(e)(4) and (11),
this notice is applicable February 6,
2019, subject to a 30-day period in
which to comment on the routine uses.
Submit any comments by March 8,
2019.
SUMMARY:
Centers for Disease Control and
Prevention
Written comments should
be submitted by mail or email to: CMS
Privacy Act Officer, Division of
Security, Privacy Policy & Governance,
Information Security & Privacy Group,
Office of Information Technology, CMS,
Location N1–14–56, 7500 Security
Blvd., Baltimore, MD 21244–1870, or
walter.stone@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
General questions about the system of
records may be submitted to Darlene
Anderson, Health Insurance Specialist,
Data and Systems Group, Center for
Medicaid and CHIP Services (CMCS),
CMS, Mail Stop S2–22–16, 7500
Security Blvd., Baltimore, MD 21244;
telephone number (410) 786–9828;
email address Darlene.Anderson@
cms.hhs.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
I. Program and IT System Changes
Prompting this SORN Modification
The Transformed Medicaid Statistical
Information System (T–MSIS) is
replacing the Medicaid Statistical
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Information System (MSIS) as the
information technology (IT) system that
houses the national Medicaid dataset. It
is a joint effort by the states and CMS
to build an improved Medicaid dataset
that addresses problems identified with
Medicaid data in MSIS. T–MSIS
provides improved program monitoring
and oversight, technical assistance with
states, policy implementation, and datadriven and high-quality Medicaid and
CHIP programs that ensure better care,
access to coverage, and improved
health.
To improve Medicaid program
oversight, CMS is requiring states to
submit new files and data elements in
T–MSIS which were not collected in
MSIS, for the purpose of improving the
quality of the data extracts the states
submit to CMS on a quarterly or other
periodic basis. Following consultation
with a wide array of stakeholders, CMS
established over 1,000 data elements for
T–MSIS. This expands on the
approximately 400 data elements
collected in MSIS. T–MSIS builds on
the original five MSIS files, consisting of
eligibility files and four types of claims
files (inpatient, long-term care,
pharmacy, and other), by adding files
for third-party liability, managed-care
plans, and Medicaid providers, and by
adding T–MSIS analytic files (TAF).
Currently, each state submits five
extracts to CMS on a quarterly basis.
These data are used by CMS to assist in
federal reporting for the Medicaid and
Children’s Health Insurance Program
(CHIP). Several reasons culminated in
the CMS mission to improve the
Medicaid dataset repository, including
incomplete data, questionable results,
multiple data collections from states,
multiple federal data platforms and
analytic difficulties in interpreting and
presenting the results. In addition,
timeliness issues have prompted CMS to
re-evaluate its processes and move
toward a streamlined delivery, along
with an enhanced data repository. The
new T–MSIS extract format is expected
to further CMS goals for improved
timeliness, reliability and robustness
through monthly updates and an
increase in the amount of data
requested.
II. Modifications to SORN 09–70–0541
The following modifications have
been made to SORN 09–70–0541 in
order to reflect changes to the system of
records resulting from the IT system
change from MSIS to T–MSIS and to
update the SORN generally:
• The SORN has been reformatted to
conform to the revised template
prescribed in OMB Circular A–108,
issued December 23, 2016.
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• The name of the system of records
has been changed from ‘‘Medicaid
Statistical Information System (MSIS)’’
to ‘‘Transformed—Medicaid Statistical
Information System (T–MSIS), HHS/
CMS/CMCS.’’
• Address information in the System
Location and System Manager(s)
sections has been updated.
• The Authority section now cites 42
U.S.C. 1396b(r) in place of a public law
citation and includes one new authority,
42 U.S.C. 18001, et seq.
• The Purpose section has been
revised to omit a summary of the
routine uses and to include additional
purposes for which T–MSIS records
may be used (‘‘reduce the number of
reports CMS requires of the states,
provide data needed to improve
beneficiary quality of care, improve
program integrity, and support the
states, the private market, and
stakeholders with key information’’).
• The Categories of Individuals
section, which was previously limited
to Medicaid recipients and Medicaid
providers, now also includes nonMedicaid individuals, third party data
submitters, and contact persons.
• The Categories of Records section
now specifies categories of records in
addition to listing data elements; groups
the data elements by category of
individual; adds name, address, phone
number, TIN/EIN, NPI, MBI and
‘‘information about health care services
the clinician provided to Medicaid
recipients and the measures and
activities the clinician used in providing
the services;’’ and omits ‘‘information
used to determine whether a sanction or
suspension is warranted.’’
• The Record Source Categories
section now describes the sources as
‘‘state Medicaid agencies or territories,
which collect the information directly
from Medicaid recipients or their
providers or other authorized
representatives’’ (instead of as state
Medicaid agencies and systems and
CMS Form 2082).
• The following changes have been
made to the Routine Uses section:
Æ In routine use 2, at c., redundant
wording (‘‘within the state’’) has been
removed after the phrase ‘‘assist federal/
state Medicaid programs.’’
Æ Routine use 5 has been revised to
omit unnecessary wording limiting the
disclosures to uses ‘‘compatible with the
purpose for which the agency collected
the records.’’ (The wording is
unnecessary because it restates the
definition of a routine use.)
Æ One new routine use has been
added, numbered as 3, which permits
disclosures to support federally-funded
benefit programs.
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Æ The fraud, waste, and abuse routine
use which was added May 29, 2013 is
now numbered as 8.
Æ The two breach response-related
routine uses which were added
February 14, 2018 are now numbered as
9 and 10.
• The Storage section now states that
records are stored ‘‘in an information
technology (IT) system’’ (instead of ‘‘on
computer diskette and magnetic
media’’).
• The Retrieval section previously
listed these personal identifiers:
beneficiary identification number, social
security number (SSN), HICN, and
provider identification number. It now
groups the identifiers by category of
individual and includes additional
identifiers (e.g., MBI and NPI).
• The Retention and Disposal section
has been revised to state that
identifiable ‘‘T–MSIS’’ data will be
retained ‘‘for a period of 10 years’’ after
the final determination of ‘‘the
applicable enrollment, eligibility, or
claim’’ is completed (instead of stating
that identifiable ‘‘MSIS’’ data will be
retained ‘‘for a total period not to exceed
10 years’’ after the final determination
of ‘‘the case’’ is completed).
• The Safeguards section has been
updated to list examples of applicable
safeguards (security guards, badges and
cameras, locks, limiting user access
based on roles and two-factor
authentication, encryption, firewalls,
intrusion detection systems).
• The procedures for making access,
correction and amendment, and
notification requests have been revised.
In the previous iteration of the SORN,
the verification procedures required the
individual’s name (woman’s maiden
name, if applicable). The individual had
the option of furnishing the SSN to
prevent delay in locating the record(s).
The new process to verify identity
requires a notarized signature or a
statement under penalty of perjury
(instead of requiring name and‘
woman’s maiden name if applicable).
Additionally, in order to locate the
record(s), the individual’s name and
SSN are now required (previously, SSN
was optional for this purpose).
Barbara Demopulos,
Privacy Advisor, Division of Security, Privacy
Policy and Governance, Information Security
and Privacy Group, Office of Information
Technology, Centers for Medicare & Medicaid
Service.
SYSTEM NAME AND NUMBER:
Transformed—Medicaid Statistical
Information System (T–MSIS), HHS/
CMS/CMCS, System No. 09–07–0541.
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SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
The address of the agency component
responsible for the system of records is:
The CMS Data Center, 7500 Security
Blvd. North Bldg., First Floor,
Baltimore, MD 21244–1850.
SYSTEM MANAGER(S):
Director, Data and Systems Group,
Center for Medicaid and CHIP Services,
CMS Mail Stop S2–22–16, 7500 Security
Boulevard, Baltimore, MD 21244–1850,
telephone number (410) 786–9361.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 1396a(a)(6), 1396b(r), and
18001 et seq.
PURPOSE(S) OF THE SYSTEM:
The primary purpose of the system is
to establish an accurate, current, and
comprehensive database containing
standardized enrollment, eligibility, and
paid claims data about Medicaid
recipients to be used for the
administration of Medicaid at the
federal level, produce statistical reports,
support Medicaid related research, and
assist in the detection of fraud and
abuse in the Medicare and Medicaid
programs. T–MSIS will also reduce the
number of reports CMS requires of the
states, provide data needed to improve
beneficiary quality of care, improve
program integrity, and support the
states, the private market, and
stakeholders with key information.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
The records in this system of records
are about the following categories of
individuals:
• Medicaid recipients (including
individuals in the dual eligible
population, individuals enrolled in the
CHIP program, and non-Medicaid
individuals);
• Medicaid providers (i.e., physicians
and providers of healthcare services to
the Medicaid and CHIP population);
• Any non-Medicaid individuals
whose information is contained in a
record about a Medicaid recipient or
Medicaid provider;
• Third party data submitters; i.e.,
third party administrators or
independent insurance company
personnel who are required to report
claims information pertaining to
Medicaid recipients; and
• Contact persons such as parents and
guardians of Medicaid recipients who
are minors, CHIP recipients, and nonMedicaid individuals.
CATEGORIES OF RECORDS IN THE SYSTEM:
The categories of records are:
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• Original MSIS files:
Æ Eligibility files
Æ claims files (for inpatient, long-term
care, pharmacy, and other claims)
• New files added to T–MSIS
database:
Æ Third-party liability
Æ managed care plans
Æ Medicaid providers
• New T–MSIS analytic files (TAF):
Æ Beneficiary files (monthly
beneficiary summary, annual
beneficiary summary)
Æ claims files (for inpatient, long-term
care, pharmacy, and other claims)
Æ providers of healthcare services to
the Medicaid and CHIP population; and
Æ managed care plans
Data elements about each category of
individual may include the following:
• Medicaid recipients: Name, address,
assigned Medicaid identification
number, social security number (SSN),
Medicare beneficiary identifier (MBI),
date of birth, gender, ethnicity and race,
medical services, equipment, and
supplies for which Medicaid
reimbursement is requested,
individually identifiable health
information (i.e., health care utilization
and claims data), and health insurance
claim number (HICN).
• Medicaid providers: Name, address,
phone number, email address, business
address, date of birth, tax identification
number/employer identification number
(TIN/EIN), national provider identifier
(NPI), SSN, prescriber identification
number, and other assigned clinician
numbers, and information about health
care services the clinician provided to
Medicaid recipients and the measures
and activities the clinician used in
providing the services.
• Any non-Medicaid individuals:
Name, address, phone number, email
address, and SSN or other identifying
number.
• Third party data submitters: Name,
address, phone number, and email
address.
• Contact persons: Name, address,
phone number, email address, TIN/EIN,
or other identifying number.
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RECORD SOURCE CATEGORIES:
Information in the system of records
is obtained from state Medicaid agencies
or territories, which collect the
information directly from Medicaid
recipients or their providers or other
authorized representatives (such as
parents and guardians of Medicaid
recipients who are minors).
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
PURPOSES OF SUCH USES:
The agency may disclose a record
about an individual record subject from
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this system of records to parties outside
HHS, without the individual’s prior
written consent, pursuant to these
routine uses:
1. To support agency contractors,
consultants, or CMS grantees who have
been engaged by the agency to assist in
the performance of a service related to
the collection and who need to have
access to the records in order to perform
the activity.
2. To assist 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’
proper management of Medicare/
Medicaid 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.
3. To assist another federal or state
agency, agency of a state government, an
agency established by state law, or its
fiscal agent to enable such agency to
administer a federal benefits program, or
as necessary to enable such agency to
fulfill a requirement of a federal statute
or regulation funded in whole or in part
with federal funds.
4. 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.
5. To the Department of Justice (DOJ),
court or adjudicatory body when:
a. The agency or any component
thereof;
b. any employee of the agency in his
or her official capacity;
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.
6. To a CMS contractor (including
fiscal intermediaries and carriers)
assisting in the administration of a
CMS-administered health benefits
program, or to a grantee of a CMSadministered 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
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combat fraud, waste, and abuse in such
program.
7. 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, and
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, and abuse in such programs.
8. To disclose to health plans, defined
for this purpose as plans or programs
that provide health benefits, whether
directly, through insurance, or
otherwise, and including—(1) a policy
of health insurance; (2) a contract of a
service benefit organization; and (3) a
membership agreement with a health
maintenance organization or other
prepaid health plan, 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.
Disclosures may include provider and
beneficiary-identifiable data.
9. To appropriate agencies, entities,
and persons when (a) HHS suspects or
has confirmed that there has been a
breach of the system of records; (b) HHS
has determined that as a result of the
suspected or confirmed breach there is
a risk of harm to individuals, HHS
(including its information systems,
programs, and operations), the federal
government, or national security; and (c)
the disclosure made to such agencies,
entities, and persons is reasonably
necessary to assist in connection with
HHS’ efforts to respond to the suspected
or confirmed breach or to prevent,
minimize, or remedy such harm.
10. To another federal agency or
federal entity, when HHS determines
that information from this system of
records is reasonably necessary to assist
the recipient agency or entity in (a)
responding to a suspected or confirmed
breach or (b) preventing, minimizing, or
remedying the risk of harm to
individuals, the recipient agency or
entity (including its information
systems, programs, and operations), the
federal government, or national security,
resulting from a suspected or confirmed
breach.
Additional Circumstances Affecting
Routine Use Disclosures: To the extent
this system contains Protected Health
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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), 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)).
The disclosures authorized by
publication of the above routine uses
pursuant to 5 U.S.C. 552a(b)(3) are in
addition to other disclosures authorized
directly in the Privacy Act at 5 U.S.C.
552a(b)(2) and (b)(4)–(11).
POLICIES AND PRACTICES FOR STORAGE OF
RECORDS:
All records are stored in an
information technology (IT) system.
RECORD ACCESS PROCEDURES:
POLICIES AND PRACTICES FOR RETRIEVAL OF
RECORDS:
All data collected on Medicaid
recipients, Medicare beneficiaries, and
any non-Medicaid individuals are
retrieved by the individual’s name,
Medicare beneficiary identifier (MBI),
health insurance claim number (HICN),
SSN, address, and date of birth. The
data collected on Medicaid providers
will be retrieved by the provider’s name,
address, National Provider Identifier
(NPI), TIN/EIN and other identifying
provider numbers. Information about
third party data submitters who are
individuals will be retrieved by name,
address, and TIN/EIN. Records about
contact persons will be retrieved by
name, email address and business
address.
POLICIES AND PRACTICES FOR RETENTION AND
DISPOSAL OF RECORDS:
CMS will retain identifiable T–MSIS
data for a period of 10 years after the
final determination of the applicable
enrollment, eligibility, or claim is
completed. Any claims-related records
encompassed by a document
preservation order may be retained
longer (i.e., until notification is received
from the Department of Justice).
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ADMINISTRATIVE, TECHNICAL, AND PHYSICAL
SAFEGUARDS:
CMS has safeguards in place to
prevent records from being accessed by
unauthorized persons and monitors
authorized users to ensure against
excessive or unauthorized use.
Examples of these safeguards include:
protecting the facilities where records
are stored or accessed with security
guards, badges and cameras, securing
hard-copy records in locked file
cabinets, file rooms or offices during offduty hours, limiting access to electronic
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databases to authorized users based on
roles and two-factor authentication (user
ID and password), using a secured
operating system protected by
encryption, firewalls, and intrusion
detection systems, requiring encryption
for records stored on removable media,
and training personnel in Privacy Act
and information security requirements.
Records that are eligible for destruction
are disposed of using destruction
methods prescribed by NIST SP 800–88.
Before disclosing records to a party
outside CMS, CMS requires the
intended recipient 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.
An individual seeking access to a
record about him/her in this system of
records must submit a written request to
the System Manager indicated above.
The request must contain the
individual’s name and particulars
necessary to distinguish between
records on subject individuals with the
same name, such as NPI or TIN, and
should also reasonably specify the
record(s) to which access is sought. To
verify the requester’s identity, the
signature must be notarized or the
request must include the requester’s
written certification that he/she is the
person he/she claims to be and that he/
she understands that the knowing and
willful request for or acquisition of
records pertaining to an individual from
an agency under false pretenses is a
criminal offense subject to a $5,000 fine.
Additionally, in order to locate the
record(s), the individual’s name and
SSN are required.
CONTESTING RECORD PROCEDURES:
Any subject individual may request
that his/her record be corrected or
amended if he/she believes that the
record is not accurate, timely, complete,
or relevant or necessary to accomplish
a Department function. A subject
individual making a request to amend or
correct his record shall address his
request to the System Manager
indicated, in writing, must verify his/
her identity in the same manner
required for an access request, and must
provide his/her name and SSN for the
purpose of locating the record. The
subject individual shall specify in each
request: (1) The system of records from
which the record is retrieved; (2) The
particular record and specific portion
which he/she is seeking to correct or
amend; (3) The corrective action sought
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(e.g., whether he/she is seeking an
addition to or a deletion or substitution
of the record); and, (4) His/her reasons
for requesting correction or amendment
of the record. The request should
include any supporting documentation
to show how the record is inaccurate,
incomplete, untimely, or irrelevant.
NOTIFICATION PROCEDURES:
Individuals wishing to know if this
system contains records about them
should write to the System Manager
indicated above and follow the same
instructions under Record Access
Procedures.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
71 FR 65527 (Nov. 8, 2006), 78 FR
32257 (May 29, 2013), 83 FR 6591 (Feb.
14, 2018).
[FR Doc. 2019–01157 Filed 2–5–19; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0060]
Joint Meeting of the
Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Psychopharmacologic
Drugs Advisory Committee and the Drug
Safety and Risk Management Advisory
Committee. The general function of the
committees is to provide advice and
recommendations to FDA on regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
Consistent with FDA’s regulation, notice
is being published with less than 15
days prior to the date of the meeting
based on a determination that an
immediate meeting of the
Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee is
needed. This Federal Register notice
could not be published 15 days prior to
SUMMARY:
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Agencies
[Federal Register Volume 84, Number 25 (Wednesday, February 6, 2019)]
[Notices]
[Pages 2230-2233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01157]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Privacy Act of 1974; System of Records
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Notice of a Modified System of Records.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS), proposes to modify an existing
system of records subject to the Privacy Act, System No. 09-70-0541,
titled Medicaid Statistical Information System (MSIS). This system of
records covers the national Medicaid dataset, consisting of
standardized enrollment, eligibility, and paid claims data about
Medicaid recipients which is used to administer Medicaid at the federal
level, produce statistical reports, support Medicaid related research,
and assist in the detection of fraud and abuse in the Medicare and
Medicaid programs. CMS is changing the name of the system of records to
Transformed-Medicaid Statistical Information System (T-MSIS) and making
other modifications which are explained below.
DATES: In accordance with 5 United States Code (U.S.C.) 552a(e)(4) and
(11), this notice is applicable February 6, 2019, subject to a 30-day
period in which to comment on the routine uses. Submit any comments by
March 8, 2019.
ADDRESSES: Written comments should be submitted by mail or email to:
CMS Privacy Act Officer, Division of Security, Privacy Policy &
Governance, Information Security & Privacy Group, Office of Information
Technology, CMS, Location N1-14-56, 7500 Security Blvd., Baltimore, MD
21244-1870, or walter.stone@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT: General questions about the system of
records may be submitted to Darlene Anderson, Health Insurance
Specialist, Data and Systems Group, Center for Medicaid and CHIP
Services (CMCS), CMS, Mail Stop S2-22-16, 7500 Security Blvd.,
Baltimore, MD 21244; telephone number (410) 786-9828; email address
Darlene.Anderson@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Program and IT System Changes Prompting this SORN Modification
The Transformed Medicaid Statistical Information System (T-MSIS) is
replacing the Medicaid Statistical Information System (MSIS) as the
information technology (IT) system that houses the national Medicaid
dataset. It is a joint effort by the states and CMS to build an
improved Medicaid dataset that addresses problems identified with
Medicaid data in MSIS. T-MSIS provides improved program monitoring and
oversight, technical assistance with states, policy implementation, and
data-driven and high-quality Medicaid and CHIP programs that ensure
better care, access to coverage, and improved health.
To improve Medicaid program oversight, CMS is requiring states to
submit new files and data elements in T-MSIS which were not collected
in MSIS, for the purpose of improving the quality of the data extracts
the states submit to CMS on a quarterly or other periodic basis.
Following consultation with a wide array of stakeholders, CMS
established over 1,000 data elements for T-MSIS. This expands on the
approximately 400 data elements collected in MSIS. T-MSIS builds on the
original five MSIS files, consisting of eligibility files and four
types of claims files (inpatient, long-term care, pharmacy, and other),
by adding files for third-party liability, managed-care plans, and
Medicaid providers, and by adding T-MSIS analytic files (TAF).
Currently, each state submits five extracts to CMS on a quarterly
basis. These data are used by CMS to assist in federal reporting for
the Medicaid and Children's Health Insurance Program (CHIP). Several
reasons culminated in the CMS mission to improve the Medicaid dataset
repository, including incomplete data, questionable results, multiple
data collections from states, multiple federal data platforms and
analytic difficulties in interpreting and presenting the results. In
addition, timeliness issues have prompted CMS to re-evaluate its
processes and move toward a streamlined delivery, along with an
enhanced data repository. The new T-MSIS extract format is expected to
further CMS goals for improved timeliness, reliability and robustness
through monthly updates and an increase in the amount of data
requested.
II. Modifications to SORN 09-70-0541
The following modifications have been made to SORN 09-70-0541 in
order to reflect changes to the system of records resulting from the IT
system change from MSIS to T-MSIS and to update the SORN generally:
The SORN has been reformatted to conform to the revised
template prescribed in OMB Circular A-108, issued December 23, 2016.
[[Page 2231]]
The name of the system of records has been changed from
``Medicaid Statistical Information System (MSIS)'' to ``Transformed--
Medicaid Statistical Information System (T-MSIS), HHS/CMS/CMCS.''
Address information in the System Location and System
Manager(s) sections has been updated.
The Authority section now cites 42 U.S.C. 1396b(r) in
place of a public law citation and includes one new authority, 42
U.S.C. 18001, et seq.
The Purpose section has been revised to omit a summary of
the routine uses and to include additional purposes for which T-MSIS
records may be used (``reduce the number of reports CMS requires of the
states, provide data needed to improve beneficiary quality of care,
improve program integrity, and support the states, the private market,
and stakeholders with key information'').
The Categories of Individuals section, which was
previously limited to Medicaid recipients and Medicaid providers, now
also includes non-Medicaid individuals, third party data submitters,
and contact persons.
The Categories of Records section now specifies categories
of records in addition to listing data elements; groups the data
elements by category of individual; adds name, address, phone number,
TIN/EIN, NPI, MBI and ``information about health care services the
clinician provided to Medicaid recipients and the measures and
activities the clinician used in providing the services;'' and omits
``information used to determine whether a sanction or suspension is
warranted.''
The Record Source Categories section now describes the
sources as ``state Medicaid agencies or territories, which collect the
information directly from Medicaid recipients or their providers or
other authorized representatives'' (instead of as state Medicaid
agencies and systems and CMS Form 2082).
The following changes have been made to the Routine Uses
section:
[cir] In routine use 2, at c., redundant wording (``within the
state'') has been removed after the phrase ``assist federal/state
Medicaid programs.''
[cir] Routine use 5 has been revised to omit unnecessary wording
limiting the disclosures to uses ``compatible with the purpose for
which the agency collected the records.'' (The wording is unnecessary
because it restates the definition of a routine use.)
[cir] One new routine use has been added, numbered as 3, which
permits disclosures to support federally-funded benefit programs.
[cir] The fraud, waste, and abuse routine use which was added May
29, 2013 is now numbered as 8.
[cir] The two breach response-related routine uses which were added
February 14, 2018 are now numbered as 9 and 10.
The Storage section now states that records are stored
``in an information technology (IT) system'' (instead of ``on computer
diskette and magnetic media'').
The Retrieval section previously listed these personal
identifiers: beneficiary identification number, social security number
(SSN), HICN, and provider identification number. It now groups the
identifiers by category of individual and includes additional
identifiers (e.g., MBI and NPI).
The Retention and Disposal section has been revised to
state that identifiable ``T-MSIS'' data will be retained ``for a period
of 10 years'' after the final determination of ``the applicable
enrollment, eligibility, or claim'' is completed (instead of stating
that identifiable ``MSIS'' data will be retained ``for a total period
not to exceed 10 years'' after the final determination of ``the case''
is completed).
The Safeguards section has been updated to list examples
of applicable safeguards (security guards, badges and cameras, locks,
limiting user access based on roles and two-factor authentication,
encryption, firewalls, intrusion detection systems).
The procedures for making access, correction and
amendment, and notification requests have been revised. In the previous
iteration of the SORN, the verification procedures required the
individual's name (woman's maiden name, if applicable). The individual
had the option of furnishing the SSN to prevent delay in locating the
record(s). The new process to verify identity requires a notarized
signature or a statement under penalty of perjury (instead of requiring
name and` woman's maiden name if applicable). Additionally, in order to
locate the record(s), the individual's name and SSN are now required
(previously, SSN was optional for this purpose).
Barbara Demopulos,
Privacy Advisor, Division of Security, Privacy Policy and Governance,
Information Security and Privacy Group, Office of Information
Technology, Centers for Medicare & Medicaid Service.
SYSTEM NAME AND NUMBER:
Transformed--Medicaid Statistical Information System (T-MSIS), HHS/
CMS/CMCS, System No. 09-07-0541.
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
The address of the agency component responsible for the system of
records is: The CMS Data Center, 7500 Security Blvd. North Bldg., First
Floor, Baltimore, MD 21244-1850.
SYSTEM MANAGER(S):
Director, Data and Systems Group, Center for Medicaid and CHIP
Services, CMS Mail Stop S2-22-16, 7500 Security Boulevard, Baltimore,
MD 21244-1850, telephone number (410) 786-9361.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
42 U.S.C. 1396a(a)(6), 1396b(r), and 18001 et seq.
PURPOSE(S) OF THE SYSTEM:
The primary purpose of the system is to establish an accurate,
current, and comprehensive database containing standardized enrollment,
eligibility, and paid claims data about Medicaid recipients to be used
for the administration of Medicaid at the federal level, produce
statistical reports, support Medicaid related research, and assist in
the detection of fraud and abuse in the Medicare and Medicaid programs.
T-MSIS will also reduce the number of reports CMS requires of the
states, provide data needed to improve beneficiary quality of care,
improve program integrity, and support the states, the private market,
and stakeholders with key information.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The records in this system of records are about the following
categories of individuals:
Medicaid recipients (including individuals in the dual
eligible population, individuals enrolled in the CHIP program, and non-
Medicaid individuals);
Medicaid providers (i.e., physicians and providers of
healthcare services to the Medicaid and CHIP population);
Any non-Medicaid individuals whose information is
contained in a record about a Medicaid recipient or Medicaid provider;
Third party data submitters; i.e., third party
administrators or independent insurance company personnel who are
required to report claims information pertaining to Medicaid
recipients; and
Contact persons such as parents and guardians of Medicaid
recipients who are minors, CHIP recipients, and non-Medicaid
individuals.
CATEGORIES OF RECORDS IN THE SYSTEM:
The categories of records are:
[[Page 2232]]
Original MSIS files:
[cir] Eligibility files
[cir] claims files (for inpatient, long-term care, pharmacy, and
other claims)
New files added to T-MSIS database:
[cir] Third-party liability
[cir] managed care plans
[cir] Medicaid providers
New T-MSIS analytic files (TAF):
[cir] Beneficiary files (monthly beneficiary summary, annual
beneficiary summary)
[cir] claims files (for inpatient, long-term care, pharmacy, and
other claims)
[cir] providers of healthcare services to the Medicaid and CHIP
population; and
[cir] managed care plans
Data elements about each category of individual may include the
following:
Medicaid recipients: Name, address, assigned Medicaid
identification number, social security number (SSN), Medicare
beneficiary identifier (MBI), date of birth, gender, ethnicity and
race, medical services, equipment, and supplies for which Medicaid
reimbursement is requested, individually identifiable health
information (i.e., health care utilization and claims data), and health
insurance claim number (HICN).
Medicaid providers: Name, address, phone number, email
address, business address, date of birth, tax identification number/
employer identification number (TIN/EIN), national provider identifier
(NPI), SSN, prescriber identification number, and other assigned
clinician numbers, and information about health care services the
clinician provided to Medicaid recipients and the measures and
activities the clinician used in providing the services.
Any non-Medicaid individuals: Name, address, phone number,
email address, and SSN or other identifying number.
Third party data submitters: Name, address, phone number,
and email address.
Contact persons: Name, address, phone number, email
address, TIN/EIN, or other identifying number.
RECORD SOURCE CATEGORIES:
Information in the system of records is obtained from state
Medicaid agencies or territories, which collect the information
directly from Medicaid recipients or their providers or other
authorized representatives (such as parents and guardians of Medicaid
recipients who are minors).
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND PURPOSES OF SUCH USES:
The agency may disclose a record about an individual record subject
from this system of records to parties outside HHS, without the
individual's prior written consent, pursuant to these routine uses:
1. To support agency contractors, consultants, or CMS grantees who
have been engaged by the agency to assist in the performance of a
service related to the collection and who need to have access to the
records in order to perform the activity.
2. To assist 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' proper management of
Medicare/Medicaid 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.
3. To assist another federal or state agency, agency of a state
government, an agency established by state law, or its fiscal agent to
enable such agency to administer a federal benefits program, or as
necessary to enable such agency to fulfill a requirement of a federal
statute or regulation funded in whole or in part with federal funds.
4. 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.
5. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component thereof;
b. any employee of the agency in his or her official capacity;
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.
6. To a CMS contractor (including fiscal intermediaries and
carriers) assisting 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, and abuse in such program.
7. 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, and 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, and abuse in such programs.
8. To disclose to health plans, defined for this purpose as plans
or programs that provide health benefits, whether directly, through
insurance, or otherwise, and including--(1) a policy of health
insurance; (2) a contract of a service benefit organization; and (3) a
membership agreement with a health maintenance organization or other
prepaid health plan, 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. Disclosures
may include provider and beneficiary-identifiable data.
9. To appropriate agencies, entities, and persons when (a) HHS
suspects or has confirmed that there has been a breach of the system of
records; (b) HHS has determined that as a result of the suspected or
confirmed breach there is a risk of harm to individuals, HHS (including
its information systems, programs, and operations), the federal
government, or national security; and (c) the disclosure made to such
agencies, entities, and persons is reasonably necessary to assist in
connection with HHS' efforts to respond to the suspected or confirmed
breach or to prevent, minimize, or remedy such harm.
10. To another federal agency or federal entity, when HHS
determines that information from this system of records is reasonably
necessary to assist the recipient agency or entity in (a) responding to
a suspected or confirmed breach or (b) preventing, minimizing, or
remedying the risk of harm to individuals, the recipient agency or
entity (including its information systems, programs, and operations),
the federal government, or national security, resulting from a
suspected or confirmed breach.
Additional Circumstances Affecting Routine Use Disclosures: To the
extent this system contains Protected Health
[[Page 2233]]
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), 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)).
The disclosures authorized by publication of the above routine uses
pursuant to 5 U.S.C. 552a(b)(3) are in addition to other disclosures
authorized directly in the Privacy Act at 5 U.S.C. 552a(b)(2) and
(b)(4)-(11).
POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
All records are stored in an information technology (IT) system.
POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:
All data collected on Medicaid recipients, Medicare beneficiaries,
and any non-Medicaid individuals are retrieved by the individual's
name, Medicare beneficiary identifier (MBI), health insurance claim
number (HICN), SSN, address, and date of birth. The data collected on
Medicaid providers will be retrieved by the provider's name, address,
National Provider Identifier (NPI), TIN/EIN and other identifying
provider numbers. Information about third party data submitters who are
individuals will be retrieved by name, address, and TIN/EIN. Records
about contact persons will be retrieved by name, email address and
business address.
POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:
CMS will retain identifiable T-MSIS data for a period of 10 years
after the final determination of the applicable enrollment,
eligibility, or claim is completed. Any claims-related records
encompassed by a document preservation order may be retained longer
(i.e., until notification is received from the Department of Justice).
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:
CMS has safeguards in place to prevent records from being accessed
by unauthorized persons and monitors authorized users to ensure against
excessive or unauthorized use. Examples of these safeguards include:
protecting the facilities where records are stored or accessed with
security guards, badges and cameras, securing hard-copy records in
locked file cabinets, file rooms or offices during off-duty hours,
limiting access to electronic databases to authorized users based on
roles and two-factor authentication (user ID and password), using a
secured operating system protected by encryption, firewalls, and
intrusion detection systems, requiring encryption for records stored on
removable media, and training personnel in Privacy Act and information
security requirements. Records that are eligible for destruction are
disposed of using destruction methods prescribed by NIST SP 800-88.
Before disclosing records to a party outside CMS, CMS requires the
intended recipient 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.
RECORD ACCESS PROCEDURES:
An individual seeking access to a record about him/her in this
system of records must submit a written request to the System Manager
indicated above. The request must contain the individual's name and
particulars necessary to distinguish between records on subject
individuals with the same name, such as NPI or TIN, and should also
reasonably specify the record(s) to which access is sought. To verify
the requester's identity, the signature must be notarized or the
request must include the requester's written certification that he/she
is the person he/she claims to be and that he/she understands that the
knowing and willful request for or acquisition of records pertaining to
an individual from an agency under false pretenses is a criminal
offense subject to a $5,000 fine. Additionally, in order to locate the
record(s), the individual's name and SSN are required.
CONTESTING RECORD PROCEDURES:
Any subject individual may request that his/her record be corrected
or amended if he/she believes that the record is not accurate, timely,
complete, or relevant or necessary to accomplish a Department function.
A subject individual making a request to amend or correct his record
shall address his request to the System Manager indicated, in writing,
must verify his/her identity in the same manner required for an access
request, and must provide his/her name and SSN for the purpose of
locating the record. The subject individual shall specify in each
request: (1) The system of records from which the record is retrieved;
(2) The particular record and specific portion which he/she is seeking
to correct or amend; (3) The corrective action sought (e.g., whether
he/she is seeking an addition to or a deletion or substitution of the
record); and, (4) His/her reasons for requesting correction or
amendment of the record. The request should include any supporting
documentation to show how the record is inaccurate, incomplete,
untimely, or irrelevant.
NOTIFICATION PROCEDURES:
Individuals wishing to know if this system contains records about
them should write to the System Manager indicated above and follow the
same instructions under Record Access Procedures.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
71 FR 65527 (Nov. 8, 2006), 78 FR 32257 (May 29, 2013), 83 FR 6591
(Feb. 14, 2018).
[FR Doc. 2019-01157 Filed 2-5-19; 8:45 am]
BILLING CODE 4120-03-P