Proposed Revision of Performance Standards for State Medicaid Fraud Control Units, 62074-62077 [2011-25894]
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62074
Federal Register / Vol. 76, No. 194 / Thursday, October 6, 2011 / Notices
guidance to industry on the
implementation of the fee provisions of
section 107 of the FDA Food Safety
Modernization Act of 2011 (FSMA)
(Pub. L. 111–353). Section 107 of FSMA
amended section 743 of the Federal
Food, Drug, and Cosmetic Act to
provide FDA with the authority to
collect fees related to food. In the
Federal Register of August 1, 2011 (76
FR 45820), FDA published a notice
establishing fee rates for FY 2012 for
domestic and foreign facility
reinspections, recall orders, and
importer reinspections. On October 1,
2011, FDA will begin implementation of
the fee provisions of section 107 of
FSMA. The guidance document is
intended to provide answers to common
questions that might arise about the new
fee provisions and FDA’s plans for their
implementation in FY 2012.
This guidance is being issued
consistent with FDA’s good guidance
practices (GGP) regulation (§ 10.115 (21
CFR 10.115)). This guidance is being
implemented without prior public
comment because the Agency has
determined that prior public
participation is not feasible or
appropriate (§ 10.115(g)(2)). The Agency
made this determination because the fee
provisions of FSMA are currently being
implemented, and guidance is needed to
help effectuate the implementation. The
guidance provides information
necessary for affected persons to
understand the implementation of these
FSMA fee provisions. Although this
guidance document is immediately in
effect, it remains subject to comment in
accordance with the Agency’s GGP
regulation.
The guidance represents the Agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
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mstockstill on DSK4VPTVN1PROD with NOTICES
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding the guidance
document. It is only necessary to send
one set of comments. It is no longer
necessary to send two copies of mailed
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
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III. Electronic Access
Persons with access to the Internet
may obtain the guidance document at
either https://www.fda.gov/
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Always access an
FDA guidance document by using
FDA’s Web site listed previously to find
the most current version of the
guidance.
Dated: September 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–25831 Filed 10–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
[Docket Number: OIG–1204–N]
Proposed Revision of Performance
Standards for State Medicaid Fraud
Control Units
Office of Inspector General
(OIG), HHS.
ACTION: Notice and opportunity for
comment.
AGENCY:
This notice seeks comment on
an OIG proposal to revise standards for
assessing the performance of the State
Medicaid Fraud Control Units (MFCUs
or Units). This proposal would replace
and supersede standards published on
September 26, 1994 (59 FR 49080).
DATES: To ensure consideration, public
comments must be delivered to the
address provided below by no later than
5 p.m. on December 5, 2011.
ADDRESSES: In commenting, please refer
to the file code OIG–1204–N. Because of
staff and resource limitations, OIG
cannot accept comments by facsimile
(FAX) transmission. You may submit
comments in one of three ways (no
duplicates, please):
1. Electronically. You may submit
electronic comments on specific
recommendations and proposals
through the Federal eRulemaking Portal
at https://www.regulations.gov.
2. By regular, express, or overnight
mail. You may send written comments
to the following address: Office of
Inspector General, Office of
Congressional and Regulatory Affairs,
Department of Health & Human
Services, Attention: OIG–118–N, Room
5541, Cohen Building, 330
Independence Avenue, SW.,
Washington, DC 20201. Please allow
sufficient time for mailed comments to
SUMMARY:
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be received before the close of the
comment period.
3. By hand or courier. If you prefer,
you may deliver, by hand or courier,
your written comments before the close
of the comment period to Office of
Inspector General, Department of Health
& Human Services, Cohen Building,
Room 5541, 330 Independence Avenue,
SW., Washington, DC 20201. Because
access to the interior of the Cohen
Building is not readily available to
persons without Federal Government
identification, commenters are
encouraged to schedule their delivery
with one of our staff members at (202)
619–1343.
We do not accept comments by FAX
transmission. All submissions received
must include the agency name and
docket number for this Federal Register
document. All comments, including
attachments and other supporting
materials received, are subject to public
disclosure.
FOR FURTHER INFORMATION CONTACT:
Richard B. Stern, OIG Office of
Evaluation and Inspections, (202)
619–0480.
Patrice S. Drew, Office of External
Affairs, (202) 619–1368.
SUPPLEMENTARY INFORMATION:
I. Background
The mission of the MFCUs, as
established in Federal statute, is to
investigate and prosecute Medicaid
provider fraud and patient abuse and
neglect. The States are responsible for
operation of the MFCUs and receive
reimbursement for a percentage of their
costs from the Federal Government.
Under section 1903(a)(6) of the Social
Security Act (Act), States are
reimbursed for 90 percent of their costs
for the first 3 years of an MFCU’s
operation and 75 percent for subsequent
years. All MFCUs are currently
reimbursed at 75 percent of the costs of
operating a certified MFCU.
OIG is delegated authority under
1903(q) and 1903(a)(6) of the Act to
certify and annually recertify Units as
eligible for Federal Financial
Participation (FFP), and to reimburse
States for costs incurred in operating an
MFCU. Through the certification and
recertification process, OIG ensures that
the Units meet the requirements for FFP
set forth in section 1903(q) of the Act
and in OIG regulations found at 42 CFR
part 1007. The performance standards
set forth in this guidance document
constitute the standards that OIG will
apply in determining the effectiveness
of State Units in carrying out MFCU
required functions. As part of the
recertification process, OIG reviews
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Federal Register / Vol. 76, No. 194 / Thursday, October 6, 2011 / Notices
reports from the Units, obtains
information from other Federal and
State agencies, and conducts periodic
onsite reviews.
Under 1903(q), an MFCU must be a
‘‘single, identifiable entity of the State
government’’ and be ‘‘separate and
distinct’’ from the State Medicaid
agency. The Unit must be an office of
the State Attorney General’s office,
another State government office with
statewide prosecutorial authority, or
operate under a formal arrangement
with the State Attorney General’s office.
The MFCU must investigate and
prosecute Medicaid fraud cases, under
State law, on a statewide basis. OIG
regulations also require MFCUs to enter
into agreements with the State Medicaid
agency to ensure the referral of
suspected provider fraud cases.
Under the statute, a MFCU must also
have procedures for investigating and
prosecuting (or referring for
prosecution) allegations of patient abuse
and neglect in Medicaid-funded
facilities. A MFCU may also investigate
and prosecute abuse and neglect in
‘‘board and care’’ facilities, such as
assisted living facilities, even if such
facilities do not receive Medicaid
payments. Finally, the statute and
regulations require that MFCUs be
composed of a team of attorneys,
auditors, and investigators.
Under section 1902(a)(61) of the Act,
as added by Public Law 103–66, section
13625 (1994), all States must operate
MFCUs unless they demonstrate to the
Secretary of HHS that they can operate
without a Unit. Currently, 49 States and
the District of Columbia have
established MFCUs and 1 State, North
Dakota, operates without a MFCU after
receiving permission from HHS in 1994.
Under section 1902(a)(61), States must
operate a MFCU that effectively carries
out the functions and requirements
described in 1903(q), as determined in
accordance with standards established
by the Secretary of HHS. The guidance
proposed in this Federal Register notice
sets forth the performance standards
OIG will consider in determining
whether State MFCUs are effectively
carrying out their statutory functions
under 1903(q).
These standards amend and update
performance standards that were
initially published in 1994. The
performance standards have been used
by OIG as part of the certification
process to assess whether a MFCU is
operating effectively. Where OIG
determines there are deficiencies in
meeting the standards, OIG will work
with the Unit to improve performance.
OIG may also make recommendations
for improvement and will monitor the
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Unit’s implementation of any such
recommendations. Ultimately, a Unit
that is continuously not operating
effectively could be designated as a
high-risk grantee and OIG may make a
separate determination regarding the
Unit’s certification status under section
1903(q). Based on our experience in
overseeing the MFCUs since 1994, we
are proposing in this notice to revise the
standards.
II. Standards for Assessing MFCU
Performance
Performance Standard 1—Compliance
With Requirements
A Unit conforms with all applicable
statutes, regulations, and policy
directives, including:
A. Section 1903(q) of the Social
Security Act, containing the basic
requirements for operation of a MFCU;
B. OIG regulations for operation of a
MFCU contained in 42 CFR part 1007;
C. Other Federal regulations and
policies applicable to the Medicaid
program, including grant administration
requirements at 45 CFR part 92 and
Federal cost principles at 2 CFR part
225;
D. OIG policy transmittals as
maintained on the OIG Web site; and
E. Other applicable conditions of the
State’s award.
Performance Standard 2—Staffing
A Unit maintains reasonable staff
levels and office locations in relation to
the State’s Medicaid program
expenditures and in accordance with
staffing allocations approved in its
budget. In meeting this standard, the
following performance indicators will
be considered:
A. The Unit employs the number of
staff that is included in the Unit’s
budget estimate as approved by OIG.
B. The Unit employs a total number
of professional staff, including
attorneys, auditors, and investigators,
that is commensurate with the State’s
total Medicaid program expenditures
and that enables the Unit to effectively
investigate and prosecute (or refer for
prosecution) the volume of case referrals
and workload for both Medicaid fraud
and patient abuse and neglect.
C. The Unit employs a mix and
number of attorneys, auditors,
investigators, and other professional
staff, that is both commensurate with
the State’s total Medicaid program
expenditures and that allows the Unit to
effectively investigate and prosecute (or
refer for prosecution) the volume of case
referrals and workload for both
Medicaid fraud and patient abuse and
neglect.
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D. The Unit employs a number of
support staff in relation to its overall
size that allows the Unit to operate
effectively.
E. Office locations are distributed
throughout the State, and are adequately
staffed, commensurate with the volume
of case referrals and workload for each
location.
Performance Standard 3—Policies and
Procedures
A Unit establishes written policies
and procedures for its operations and
ensures that staff are familiar with, and
adhere to, policies and procedures. In
meeting this standard, the following
performance indicators will be
considered:
A. The Unit has written guidelines or
manuals that contain current policies
and procedures, consistent with these
performance standards, for the
investigation and prosecution of
Medicaid fraud and patient abuse and
neglect.
B. The Unit adheres to current
policies and procedures in its
operations.
C. Procedures include a process for
referring cases, when appropriate, to
Federal and State agencies. Referrals to
State agencies, including the State
Medicaid agency, should identify
whether further investigation or other
administrative action is warranted, such
as the collection of overpayments.
D. Written guidelines and manuals are
readily available to all Unit staff, either
online or in hard copy.
E. Policies and procedures address
training standards for Unit employees.
Performance Standard 4—Maintaining
Adequate Referrals
A Unit takes steps to maintain an
adequate volume and quality of referrals
from the single State Medicaid agency
and other sources. In meeting this
standard, the following performance
indicators will be considered:
A. The Unit takes steps, such as the
development of operational protocols, to
ensure that the State Medicaid agency
and other agencies refer to the Unit all
suspected provider fraud cases.
B. Consistent with 42 CFR 1007.9(g),
the Unit provides timely written notice
to the State Medicaid agency when
referred cases are accepted or declined
for investigation.
C. The Unit provides periodic
feedback to the State Medicaid agency
and other referral sources on the
adequacy of both the volume and
quality of its referrals.
D. The Unit provides timely
information to the State Medicaid
agency when the Medicaid agency
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requests information on the status of
MFCU investigations, including when
the Medicaid agency requests quarterly
certification pursuant to 42 CFR
455.23(d)(3)(ii).
E. The Unit takes steps to ensure that
the State Long Term Care Ombudsman
and other officials and agencies refer to
the Unit suspected patient abuse and
neglect cases.
F. The Unit takes steps, through
public outreach or other means, to
encourage the public to refer cases to
the Unit.
Performance Standard 5—Maintaining a
Continuous Case Flow
A Unit takes steps to maintain a
continuous case flow and to complete
cases in an appropriate timeframe based
on the complexity of the cases. In
meeting this standard, the following
performance indicators will be
considered:
A. Supervisors approve the opening
and closing of all investigations.
B. Supervisors review the progress of
cases as part of a performance
management system and take action as
necessary to ensure that each stage of an
investigation and prosecution is
completed in an appropriate timeframe.
C. Delays to investigations and
prosecutions are supported and justified
based on resource constraints or other
exigencies.
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Performance Standard 6—Case Mix
A Unit’s case mix, as practicable,
covers all significant provider types and
includes a mix of fraud and patient
abuse and neglect cases. In meeting this
standard, the following performance
indicators will be considered:
A. The Unit seeks to have a mix of
cases from all significant provider types
in the State.
B. For those States that rely
substantially on managed care entities
for the provision of Medicaid services,
the Unit includes a commensurate
number of managed care cases in its mix
of cases.
C. The Unit seeks to allocate resources
among provider types based on levels of
Medicaid expenditures or other risk
factors. Special Unit initiatives may
focus on specific provider types.
D. As part of its case mix, the Unit at
all times maintains a substantial number
of patient abuse and neglect cases.
Performance Standard 7—Maintaining
Case Information
A Unit maintains case files in an
effective manner and develops a case
management system that allows efficient
access to case information and other
performance data. In meeting this
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standard, the following performance
indicators will be considered:
A. Supervisory reviews are conducted
periodically, consistent with MFCU
policies and procedures, and are noted
in the case file.
B. Case files include all relevant facts
and information and justify the opening
and closing of the cases.
C. Significant documents, such as
charging documents and settlement
agreements, are included in the file.
D. Interview summaries are written in
a timely manner, as defined by MFCU
policies and procedures.
E. The Unit has an information
management system that manages and
tracks case information from initiation
to resolution.
F. The Unit has an information
management system that allows for the
reporting of aggregate case information.
such as training activities for provider
groups and other public integrity or law
enforcement offices; outreach and
training for State and county social
service agencies; liaison meetings with
managed care organizations; and
publication of fraud alerts or other
information for areas within the Unit’s
jurisdiction.
C. The Unit establishes annual
performance goals for each identified
outcome.
D. The Unit annually evaluates
whether it has achieved its goals.
E. If the Unit maintains a strategic
plan, the Unit aligns performance
outcomes and goals with the plan.
Performance Standard 8—Performance
Outcome and Measurement
A Unit has a process for monitoring
and measuring the outcome of cases. In
meeting this standard, the following
performance indicators will be
considered when determining how
effectively the Unit detects, investigates
and prosecutes (or refers for
prosecution) Medicaid fraud and patient
abuse and neglect:
A. The Unit maintains a performance
management system or relies upon the
State’s performance management system
as it applies to the Unit.
B. If establishing its own performance
system, the Unit develops performance
outcomes, such as the following:
1. The number of cases opened and
closed and the reason that cases are
closed.
2. The length of time taken to
determine whether to open a case
referred by the State Medicaid agency or
other referring source.
3. The number, age, and types of cases
in the Unit’s inventory/docket.
4. The number of referrals received by
the Unit and the number of referrals to
other agencies made by the Unit.
5. The dollar amount of overpayments
identified.
6. The number of cases criminally
prosecuted by the Unit or referred to
others for prosecution, the number of
individuals or entities charged, and the
number of pending prosecutions.
7. The number of criminal convictions
and the number of civil judgments.
8. The dollar amount of fines,
penalties, and restrictions ordered in a
criminal case; the dollar amount of
recoveries and the types of relief
obtained through civil judgments or
prefiling settlements.
9. Non-case specific work of the Unit
which enhances the Unit’s mission,
A Unit cooperates with OIG and other
Federal agencies in the investigation
and prosecution of Medicaid and other
health care fraud. In meeting this
standard, the following performance
indicators will be considered:
A. The Unit communicates on a
regular basis with the OIG Office of
Investigations (OI) and other Federal
agencies investigating or prosecuting
health care fraud in the State.
B. The Unit cooperates and, as
appropriate, coordinates with OI and
other Federal agencies on cases being
pursued jointly, cases involving the
same suspects or allegations, and cases
that have been referred to the Unit by
OI or another Federal agency.
C. The Unit makes available, upon
request by Federal investigators and
prosecutors, all information in its
possession concerning provider fraud or
fraud in the administration of the
Medicaid program.
D. For cases that require the granting
of ‘‘extended jurisdiction’’ to investigate
Medicare or other Federal health care
fraud, the Unit seeks permission from
OI or other relevant agencies under
procedures as set by those agencies.
E. For cases that have significant civil
fraud potential, the Unit investigates
and prosecutes such cases under State
authority or refers such cases to OIG or
the U.S. Department of Justice.
F. The Unit transmits to OIG, for
purposes of program exclusions under
section 1128 of the Act, all pertinent
information on MFCU convictions
within 30 days of sentencing, including
charging documents, plea agreements,
and sentencing orders.
G. The Unit reports qualifying cases to
the Healthcare Integrity & Protection
Databank or successor data bases.
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Performance Standard 9—Cooperation
With Federal Authorities on Fraud
Cases
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62077
Performance Standard 10—Program
Recommendations
Performance Standard 12—Fiscal
Control
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
A Unit makes statutory or
programmatic recommendations, when
warranted, to the State government. In
meeting this standard, the following
performance indicators will be
considered:
A. The Unit, when warranted and
appropriate, makes statutory
recommendations to the State
legislature to improve the operation of
the Unit, including amendments to the
enforcement provisions of the State
code.
B. The Unit, when warranted and
appropriate, makes other regulatory or
administrative recommendations
regarding program integrity issues to the
State Medicaid agency and to other
agencies responsible for Medicaid
operations or funding.
C. The Unit monitors actions taken by
the State legislature and the State
Medicaid or other agencies in response
to recommendations.
D. The Unit reports program
recommendations to OIG.
A Unit exercises proper fiscal control
over Unit resources. In meeting this
standard, the following performance
indicators will be considered:
A. The Unit director, or the director’s
designee, approves and signs the Unit’s
budget and estimated expenditures.
B. The Unit director, or the director’s
designee, approves and signs all fiscal
and administrative reports concerning
Unit expenditures.
C. The Unit maintains an equipment
inventory that is updated on a regular
basis to reflect all property under the
Unit’s control.
D. The Unit maintains an effective
time and attendance system.
E. The Unit applies generally
accepted accounting principles in its
control of Unit funding.
F. The Unit employs a financial
system in which all funds are assigned
to individual accounts according to
their source and all expenditure items
can be traced to the original funding
stream and account.
National Institutes of Health
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Performance Standard 11—Agreement
With Medicaid Agency
A Unit periodically reviews its
Memorandum of Understanding (MOU)
with the single State Medicaid agency to
ensure that it reflects current practice,
policy, and legal requirements. In
meeting this standard, the following
performance indicators will be
considered:
A. The MOU reflects current policy
and practice by both the Unit and the
State Medicaid agency.
B. The MOU meets current Federal
legal requirements as contained in law
or regulation, including 42 CFR
§ 455.21, ‘‘Cooperation with State
Medicaid fraud control units,’’ and 42
CFR 455.23, ‘‘Suspension of payments
in cases of fraud.’’
C. The MOU is consistent with
current Federal and State policy,
including any policies issued by OIG or
the Centers for Medicare & Medicaid
Services (CMS).
D. Consistent with Performance
Standard 4, the MOU establishes a
process to ensure the receipt of an
adequate volume and quality of referrals
to the Unit from the State Medicaid
agency.
E. The MOU incorporates by reference
the CMS Performance Standard for
Referrals of Suspected Fraud from a
Single State Agency to a Medicaid
Fraud Control Unit.
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Performance Standard 13—Training
A Unit maintains an annual training
plan for all professional disciplines. In
meeting this standard, the following
performance indicators will be
considered:
A. The Unit maintains a training plan
for each professional discipline that
includes an annual minimum number of
training hours and that is at least as
stringent as required for professional
certification.
B. The Unit ensures that professional
staff complies with its training plans
and maintains records of the staff’s
compliance.
C. Professional certifications are
maintained for all staff, including
continuing education requirements.
D. The Unit participates in training
offered by OIG, CMS, and other MFCUs,
as funding permits.
E. Through cross-training or by other
means, Unit staff receive training on the
role and responsibilities of the State
Medicaid agency and other law
enforcement partners.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2011–25894 Filed 10–5–11; 8:45 am]
BILLING CODE 4152–01–P
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Submission for OBM Review;
Comment Request; New Proposed
Collection, Environmental Science
Formative Research Methodology
Studies for the National Children’s
Study
Under the provisions of
Section (3507(a)(1)(D)) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for reinstatement of
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on April 27, 2011,
pages 23603–23605, and allowed 60
days for public comment. Two written
comments and two verbal comments
were received. The verbal comments
expressed support for the broad scope of
the study. The written comments were
identical and questioned the cost and
utility of the study. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Proposed Collection: Title:
Environmental Science Formative
Research Methodology Studies for the
National Children’s Study (NCS). Type
of Information Request: New. Need and
Use of Information Collection: The
Children’s Health Act of 2000 (Pub. L.
106–310) states:
SUMMARY:
(a) PURPOSE.—It is the purpose of this
section to authorize the National Institute of
Child Health and Human Development* to
conduct a national longitudinal study of
environmental influences (including
physical, chemical, biological, and
psychosocial) on children’s health and
development.
(b) IN GENERAL.—The Director of the
National Institute of Child Health and
Human Development* shall establish a
consortium of representatives from
appropriate Federal agencies (including the
Centers for Disease Control and Prevention,
the Environmental Protection Agency) to—
(1) plan, develop, and implement a
prospective cohort study, from birth to
adulthood, to evaluate the effects of both
chronic and intermittent exposures on child
health and human development; and
(2) investigate basic mechanisms of
developmental disorders and environmental
factors, both risk and protective, that
influence health and developmental
processes.
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Agencies
[Federal Register Volume 76, Number 194 (Thursday, October 6, 2011)]
[Notices]
[Pages 62074-62077]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25894]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Inspector General
[Docket Number: OIG-1204-N]
Proposed Revision of Performance Standards for State Medicaid
Fraud Control Units
AGENCY: Office of Inspector General (OIG), HHS.
ACTION: Notice and opportunity for comment.
-----------------------------------------------------------------------
SUMMARY: This notice seeks comment on an OIG proposal to revise
standards for assessing the performance of the State Medicaid Fraud
Control Units (MFCUs or Units). This proposal would replace and
supersede standards published on September 26, 1994 (59 FR 49080).
DATES: To ensure consideration, public comments must be delivered to
the address provided below by no later than 5 p.m. on December 5, 2011.
ADDRESSES: In commenting, please refer to the file code OIG-1204-N.
Because of staff and resource limitations, OIG cannot accept comments
by facsimile (FAX) transmission. You may submit comments in one of
three ways (no duplicates, please):
1. Electronically. You may submit electronic comments on specific
recommendations and proposals through the Federal eRulemaking Portal at
https://www.regulations.gov.
2. By regular, express, or overnight mail. You may send written
comments to the following address: Office of Inspector General, Office
of Congressional and Regulatory Affairs, Department of Health & Human
Services, Attention: OIG-118-N, Room 5541, Cohen Building, 330
Independence Avenue, SW., Washington, DC 20201. Please allow sufficient
time for mailed comments to be received before the close of the comment
period.
3. By hand or courier. If you prefer, you may deliver, by hand or
courier, your written comments before the close of the comment period
to Office of Inspector General, Department of Health & Human Services,
Cohen Building, Room 5541, 330 Independence Avenue, SW., Washington, DC
20201. Because access to the interior of the Cohen Building is not
readily available to persons without Federal Government identification,
commenters are encouraged to schedule their delivery with one of our
staff members at (202) 619-1343.
We do not accept comments by FAX transmission. All submissions
received must include the agency name and docket number for this
Federal Register document. All comments, including attachments and
other supporting materials received, are subject to public disclosure.
FOR FURTHER INFORMATION CONTACT:
Richard B. Stern, OIG Office of Evaluation and Inspections, (202) 619-
0480.
Patrice S. Drew, Office of External Affairs, (202) 619-1368.
SUPPLEMENTARY INFORMATION:
I. Background
The mission of the MFCUs, as established in Federal statute, is to
investigate and prosecute Medicaid provider fraud and patient abuse and
neglect. The States are responsible for operation of the MFCUs and
receive reimbursement for a percentage of their costs from the Federal
Government. Under section 1903(a)(6) of the Social Security Act (Act),
States are reimbursed for 90 percent of their costs for the first 3
years of an MFCU's operation and 75 percent for subsequent years. All
MFCUs are currently reimbursed at 75 percent of the costs of operating
a certified MFCU.
OIG is delegated authority under 1903(q) and 1903(a)(6) of the Act
to certify and annually recertify Units as eligible for Federal
Financial Participation (FFP), and to reimburse States for costs
incurred in operating an MFCU. Through the certification and
recertification process, OIG ensures that the Units meet the
requirements for FFP set forth in section 1903(q) of the Act and in OIG
regulations found at 42 CFR part 1007. The performance standards set
forth in this guidance document constitute the standards that OIG will
apply in determining the effectiveness of State Units in carrying out
MFCU required functions. As part of the recertification process, OIG
reviews
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reports from the Units, obtains information from other Federal and
State agencies, and conducts periodic onsite reviews.
Under 1903(q), an MFCU must be a ``single, identifiable entity of
the State government'' and be ``separate and distinct'' from the State
Medicaid agency. The Unit must be an office of the State Attorney
General's office, another State government office with statewide
prosecutorial authority, or operate under a formal arrangement with the
State Attorney General's office. The MFCU must investigate and
prosecute Medicaid fraud cases, under State law, on a statewide basis.
OIG regulations also require MFCUs to enter into agreements with the
State Medicaid agency to ensure the referral of suspected provider
fraud cases.
Under the statute, a MFCU must also have procedures for
investigating and prosecuting (or referring for prosecution)
allegations of patient abuse and neglect in Medicaid-funded facilities.
A MFCU may also investigate and prosecute abuse and neglect in ``board
and care'' facilities, such as assisted living facilities, even if such
facilities do not receive Medicaid payments. Finally, the statute and
regulations require that MFCUs be composed of a team of attorneys,
auditors, and investigators.
Under section 1902(a)(61) of the Act, as added by Public Law 103-
66, section 13625 (1994), all States must operate MFCUs unless they
demonstrate to the Secretary of HHS that they can operate without a
Unit. Currently, 49 States and the District of Columbia have
established MFCUs and 1 State, North Dakota, operates without a MFCU
after receiving permission from HHS in 1994. Under section 1902(a)(61),
States must operate a MFCU that effectively carries out the functions
and requirements described in 1903(q), as determined in accordance with
standards established by the Secretary of HHS. The guidance proposed in
this Federal Register notice sets forth the performance standards OIG
will consider in determining whether State MFCUs are effectively
carrying out their statutory functions under 1903(q).
These standards amend and update performance standards that were
initially published in 1994. The performance standards have been used
by OIG as part of the certification process to assess whether a MFCU is
operating effectively. Where OIG determines there are deficiencies in
meeting the standards, OIG will work with the Unit to improve
performance. OIG may also make recommendations for improvement and will
monitor the Unit's implementation of any such recommendations.
Ultimately, a Unit that is continuously not operating effectively could
be designated as a high-risk grantee and OIG may make a separate
determination regarding the Unit's certification status under section
1903(q). Based on our experience in overseeing the MFCUs since 1994, we
are proposing in this notice to revise the standards.
II. Standards for Assessing MFCU Performance
Performance Standard 1--Compliance With Requirements
A Unit conforms with all applicable statutes, regulations, and
policy directives, including:
A. Section 1903(q) of the Social Security Act, containing the basic
requirements for operation of a MFCU;
B. OIG regulations for operation of a MFCU contained in 42 CFR part
1007;
C. Other Federal regulations and policies applicable to the
Medicaid program, including grant administration requirements at 45 CFR
part 92 and Federal cost principles at 2 CFR part 225;
D. OIG policy transmittals as maintained on the OIG Web site; and
E. Other applicable conditions of the State's award.
Performance Standard 2--Staffing
A Unit maintains reasonable staff levels and office locations in
relation to the State's Medicaid program expenditures and in accordance
with staffing allocations approved in its budget. In meeting this
standard, the following performance indicators will be considered:
A. The Unit employs the number of staff that is included in the
Unit's budget estimate as approved by OIG.
B. The Unit employs a total number of professional staff, including
attorneys, auditors, and investigators, that is commensurate with the
State's total Medicaid program expenditures and that enables the Unit
to effectively investigate and prosecute (or refer for prosecution) the
volume of case referrals and workload for both Medicaid fraud and
patient abuse and neglect.
C. The Unit employs a mix and number of attorneys, auditors,
investigators, and other professional staff, that is both commensurate
with the State's total Medicaid program expenditures and that allows
the Unit to effectively investigate and prosecute (or refer for
prosecution) the volume of case referrals and workload for both
Medicaid fraud and patient abuse and neglect.
D. The Unit employs a number of support staff in relation to its
overall size that allows the Unit to operate effectively.
E. Office locations are distributed throughout the State, and are
adequately staffed, commensurate with the volume of case referrals and
workload for each location.
Performance Standard 3--Policies and Procedures
A Unit establishes written policies and procedures for its
operations and ensures that staff are familiar with, and adhere to,
policies and procedures. In meeting this standard, the following
performance indicators will be considered:
A. The Unit has written guidelines or manuals that contain current
policies and procedures, consistent with these performance standards,
for the investigation and prosecution of Medicaid fraud and patient
abuse and neglect.
B. The Unit adheres to current policies and procedures in its
operations.
C. Procedures include a process for referring cases, when
appropriate, to Federal and State agencies. Referrals to State
agencies, including the State Medicaid agency, should identify whether
further investigation or other administrative action is warranted, such
as the collection of overpayments.
D. Written guidelines and manuals are readily available to all Unit
staff, either online or in hard copy.
E. Policies and procedures address training standards for Unit
employees.
Performance Standard 4--Maintaining Adequate Referrals
A Unit takes steps to maintain an adequate volume and quality of
referrals from the single State Medicaid agency and other sources. In
meeting this standard, the following performance indicators will be
considered:
A. The Unit takes steps, such as the development of operational
protocols, to ensure that the State Medicaid agency and other agencies
refer to the Unit all suspected provider fraud cases.
B. Consistent with 42 CFR 1007.9(g), the Unit provides timely
written notice to the State Medicaid agency when referred cases are
accepted or declined for investigation.
C. The Unit provides periodic feedback to the State Medicaid agency
and other referral sources on the adequacy of both the volume and
quality of its referrals.
D. The Unit provides timely information to the State Medicaid
agency when the Medicaid agency
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requests information on the status of MFCU investigations, including
when the Medicaid agency requests quarterly certification pursuant to
42 CFR 455.23(d)(3)(ii).
E. The Unit takes steps to ensure that the State Long Term Care
Ombudsman and other officials and agencies refer to the Unit suspected
patient abuse and neglect cases.
F. The Unit takes steps, through public outreach or other means, to
encourage the public to refer cases to the Unit.
Performance Standard 5--Maintaining a Continuous Case Flow
A Unit takes steps to maintain a continuous case flow and to
complete cases in an appropriate timeframe based on the complexity of
the cases. In meeting this standard, the following performance
indicators will be considered:
A. Supervisors approve the opening and closing of all
investigations.
B. Supervisors review the progress of cases as part of a
performance management system and take action as necessary to ensure
that each stage of an investigation and prosecution is completed in an
appropriate timeframe.
C. Delays to investigations and prosecutions are supported and
justified based on resource constraints or other exigencies.
Performance Standard 6--Case Mix
A Unit's case mix, as practicable, covers all significant provider
types and includes a mix of fraud and patient abuse and neglect cases.
In meeting this standard, the following performance indicators will be
considered:
A. The Unit seeks to have a mix of cases from all significant
provider types in the State.
B. For those States that rely substantially on managed care
entities for the provision of Medicaid services, the Unit includes a
commensurate number of managed care cases in its mix of cases.
C. The Unit seeks to allocate resources among provider types based
on levels of Medicaid expenditures or other risk factors. Special Unit
initiatives may focus on specific provider types.
D. As part of its case mix, the Unit at all times maintains a
substantial number of patient abuse and neglect cases.
Performance Standard 7--Maintaining Case Information
A Unit maintains case files in an effective manner and develops a
case management system that allows efficient access to case information
and other performance data. In meeting this standard, the following
performance indicators will be considered:
A. Supervisory reviews are conducted periodically, consistent with
MFCU policies and procedures, and are noted in the case file.
B. Case files include all relevant facts and information and
justify the opening and closing of the cases.
C. Significant documents, such as charging documents and settlement
agreements, are included in the file.
D. Interview summaries are written in a timely manner, as defined
by MFCU policies and procedures.
E. The Unit has an information management system that manages and
tracks case information from initiation to resolution.
F. The Unit has an information management system that allows for
the reporting of aggregate case information.
Performance Standard 8--Performance Outcome and Measurement
A Unit has a process for monitoring and measuring the outcome of
cases. In meeting this standard, the following performance indicators
will be considered when determining how effectively the Unit detects,
investigates and prosecutes (or refers for prosecution) Medicaid fraud
and patient abuse and neglect:
A. The Unit maintains a performance management system or relies
upon the State's performance management system as it applies to the
Unit.
B. If establishing its own performance system, the Unit develops
performance outcomes, such as the following:
1. The number of cases opened and closed and the reason that cases
are closed.
2. The length of time taken to determine whether to open a case
referred by the State Medicaid agency or other referring source.
3. The number, age, and types of cases in the Unit's inventory/
docket.
4. The number of referrals received by the Unit and the number of
referrals to other agencies made by the Unit.
5. The dollar amount of overpayments identified.
6. The number of cases criminally prosecuted by the Unit or
referred to others for prosecution, the number of individuals or
entities charged, and the number of pending prosecutions.
7. The number of criminal convictions and the number of civil
judgments.
8. The dollar amount of fines, penalties, and restrictions ordered
in a criminal case; the dollar amount of recoveries and the types of
relief obtained through civil judgments or prefiling settlements.
9. Non-case specific work of the Unit which enhances the Unit's
mission, such as training activities for provider groups and other
public integrity or law enforcement offices; outreach and training for
State and county social service agencies; liaison meetings with managed
care organizations; and publication of fraud alerts or other
information for areas within the Unit's jurisdiction.
C. The Unit establishes annual performance goals for each
identified outcome.
D. The Unit annually evaluates whether it has achieved its goals.
E. If the Unit maintains a strategic plan, the Unit aligns
performance outcomes and goals with the plan.
Performance Standard 9--Cooperation With Federal Authorities on Fraud
Cases
A Unit cooperates with OIG and other Federal agencies in the
investigation and prosecution of Medicaid and other health care fraud.
In meeting this standard, the following performance indicators will be
considered:
A. The Unit communicates on a regular basis with the OIG Office of
Investigations (OI) and other Federal agencies investigating or
prosecuting health care fraud in the State.
B. The Unit cooperates and, as appropriate, coordinates with OI and
other Federal agencies on cases being pursued jointly, cases involving
the same suspects or allegations, and cases that have been referred to
the Unit by OI or another Federal agency.
C. The Unit makes available, upon request by Federal investigators
and prosecutors, all information in its possession concerning provider
fraud or fraud in the administration of the Medicaid program.
D. For cases that require the granting of ``extended jurisdiction''
to investigate Medicare or other Federal health care fraud, the Unit
seeks permission from OI or other relevant agencies under procedures as
set by those agencies.
E. For cases that have significant civil fraud potential, the Unit
investigates and prosecutes such cases under State authority or refers
such cases to OIG or the U.S. Department of Justice.
F. The Unit transmits to OIG, for purposes of program exclusions
under section 1128 of the Act, all pertinent information on MFCU
convictions within 30 days of sentencing, including charging documents,
plea agreements, and sentencing orders.
G. The Unit reports qualifying cases to the Healthcare Integrity &
Protection Databank or successor data bases.
[[Page 62077]]
Performance Standard 10--Program Recommendations
A Unit makes statutory or programmatic recommendations, when
warranted, to the State government. In meeting this standard, the
following performance indicators will be considered:
A. The Unit, when warranted and appropriate, makes statutory
recommendations to the State legislature to improve the operation of
the Unit, including amendments to the enforcement provisions of the
State code.
B. The Unit, when warranted and appropriate, makes other regulatory
or administrative recommendations regarding program integrity issues to
the State Medicaid agency and to other agencies responsible for
Medicaid operations or funding.
C. The Unit monitors actions taken by the State legislature and the
State Medicaid or other agencies in response to recommendations.
D. The Unit reports program recommendations to OIG.
Performance Standard 11--Agreement With Medicaid Agency
A Unit periodically reviews its Memorandum of Understanding (MOU)
with the single State Medicaid agency to ensure that it reflects
current practice, policy, and legal requirements. In meeting this
standard, the following performance indicators will be considered:
A. The MOU reflects current policy and practice by both the Unit
and the State Medicaid agency.
B. The MOU meets current Federal legal requirements as contained in
law or regulation, including 42 CFR Sec. 455.21, ``Cooperation with
State Medicaid fraud control units,'' and 42 CFR 455.23, ``Suspension
of payments in cases of fraud.''
C. The MOU is consistent with current Federal and State policy,
including any policies issued by OIG or the Centers for Medicare &
Medicaid Services (CMS).
D. Consistent with Performance Standard 4, the MOU establishes a
process to ensure the receipt of an adequate volume and quality of
referrals to the Unit from the State Medicaid agency.
E. The MOU incorporates by reference the CMS Performance Standard
for Referrals of Suspected Fraud from a Single State Agency to a
Medicaid Fraud Control Unit.
Performance Standard 12--Fiscal Control
A Unit exercises proper fiscal control over Unit resources. In
meeting this standard, the following performance indicators will be
considered:
A. The Unit director, or the director's designee, approves and
signs the Unit's budget and estimated expenditures.
B. The Unit director, or the director's designee, approves and
signs all fiscal and administrative reports concerning Unit
expenditures.
C. The Unit maintains an equipment inventory that is updated on a
regular basis to reflect all property under the Unit's control.
D. The Unit maintains an effective time and attendance system.
E. The Unit applies generally accepted accounting principles in its
control of Unit funding.
F. The Unit employs a financial system in which all funds are
assigned to individual accounts according to their source and all
expenditure items can be traced to the original funding stream and
account.
Performance Standard 13--Training
A Unit maintains an annual training plan for all professional
disciplines. In meeting this standard, the following performance
indicators will be considered:
A. The Unit maintains a training plan for each professional
discipline that includes an annual minimum number of training hours and
that is at least as stringent as required for professional
certification.
B. The Unit ensures that professional staff complies with its
training plans and maintains records of the staff's compliance.
C. Professional certifications are maintained for all staff,
including continuing education requirements.
D. The Unit participates in training offered by OIG, CMS, and other
MFCUs, as funding permits.
E. Through cross-training or by other means, Unit staff receive
training on the role and responsibilities of the State Medicaid agency
and other law enforcement partners.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2011-25894 Filed 10-5-11; 8:45 am]
BILLING CODE 4152-01-P