1. health and fitness

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The National Association of Community Health Centers, Inc. ® ISSUE BRIEF # 77 How to Respond to an Audit or Investigation
by the Federal Government
Prepared by: Jacki Leifer, Esq. and Marcie H. Zakheim, Esq. Feldesman, Tucker, Leifer, Fidell, LLP Telephone: (202) 466-8960 December 2003 For more information contact:
Roger Schwartz, The National Association of Community Health Centers, Inc. 2001 L Street, NW ~ Suite 300, Washington, DC 20036 Telephone: (202) 296-0158 FAX: (202) 296-3526 This publication was supported by Grant/Cooperative Agreement Number U30CSOO209 from the Health Resources and
Services Administration, Bureau of Primary Health Care (HRSAlBPHC). Its contents are solely the responsibility of the
authors and do not necessarily represent the offictal views of HRSAlBPHC.
How to RespoDd to aD Audit or IDvestigatioD by the Federal Government
All Federal government grant programs hold recipients accountable for the
efficiency and effectiveness of the grant-supported project (including, but not limited to,
the appropriate expenditure of grant funds). As such, grantees may undergo periodic
audits or other "reviews" designed to ensure the grantee is meeting certain performance
standards, e.g., Primary Care Effectiveness Reviews or JCAHO accreditation.
Additionally, Federal agencies may conduct or arrange financial audits of grantees, if the
agency deems such audits to be necessary.1
In particular, as part ofits mission to protect the integrity of Department of Health
and Human Services ("HHS") programs, the HHS Office of the Inspector General
("OlG") may conduct assessments and investigations to monitor financial and
programmatic performance (including, but not limited to, consistency with program
requirements), and the financial and legal accountability of grantees. OlG audits and
investigations may occur randomly or as the result of a complaint or the actions of a
''whistleblower.'' They may also occur if a health center admits certain errors, which in
turn can trigger an audit or investigation. Health centers should note that the OlG has
several offices that may query health care providers (including health centers) regarding
their internal operations, i.e., the Office of Audit Services, the Office of Investigations,
and the Office of Evaluation and Inspection. While a query from one office may not
signal that an audit or investigation has commenced (or is about to commence), health
centers should take such communication seriously as it may identify reasons for a follow­
up investigation. 2
In addition to the HHS OlG, health centers are subject to scrutinY'by other
Federal and State departments and agencies responsible for enforcing health care laws.
These include the Department ofJustice, the Federal Bureau ofInvestigation, the Centers
for Medicare and Medicaid Services, State Medicaid Agencies and Fraud Control Units,
and State Attorneys General.
Regardless of the reason why an audit or investigation occurs, or the particular
agency that is conducting the audit or investigation, health centers should have a strategy
I Health centers that expend more that $500,000 per year are required to have an annual audit performed by .
an independent auditor, which must conform to the requirements ofOMB Circular A-133. See 45 C.F.R. §
74.26. In addition, the Bureau of Primary Health Care ("BPHCj Program Expectations require all health
centers to perform an annual independent financial audit consistent with Federal audit requirements. See
BPHC Program Information Notice ("PIN") 98-23 at p. 39.
Z The
FY 2004 OIG Work Plan identifies that among many other priorities, the OIG intends to (1) evaluate
the Health Resources and Services Administration's ("HRSA's") oversight and tracking ofhealth center
grantees' performance, and (2) assess whether grantee health centers are providing nonduplicative services,
meeting program performance measures, and ensuring that Federal funds are spent appropriately. NACHC
is planning to track the frequency and types of health center audits and investigations that the OIG and
other Federal agencies initiate throughout the year. As such, NACHC recommends that any health center
that is advised by a Federal agency that it is the subject of a Federal audit or investigation, notify Roger
Schwartz ofNACHC at (202) 296-0158.
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or plan in place to respond appropriately. This Issue Brief explains how a health center
may learn that it is the subject of a government audit or investigation, and addresses the
actions health centers can take to prepare for, or respond to, a government audit or
investigation (including the importance of conducting internal investigations both prior
to, and contemporaneous with, a government investigation). It should be noted that while
much of this Issue Brief focuses on OIG audits or investigations, the guidance contained
herein is relevant to most, if not all, external audits and investigations of the health
center.
Signs of a Federal Aeency Investigation
Government inquiries and investigations frequently begin without the knowledge
of the health care provider involved. As a result, it is essential that a health center be
familiar with the signs of a government investigation. A planned audit, which may be the
first step in an agency's investigation, is usually announced in advance, through a Federal
Register notice and a letter to the particular health center, giving the health center time to
prepare. However, the first sign of an investigation may also be more subtle, such as a
visit by government agents to the health center or to current or former employees at work
or at home. Other signs of an impending investigation include the issuance of an
informal request from the OIG or other Federal agency to review certain records, the
service of a subpoena or the service of a civil investigative demand. Issuance of a grand
jury subpoena would be a more obvious sign, and execution of a search warrant at the
health center would be an unmistakable indicator that the center is the subject of a
criminal investigation.
While no health center is inclined to think that it might be the subject of an
investigation, the government does occasionally audit or investigate unsuspecting health
care providers. In that regard, a health center director may not necessarily know when a
government agency is preparing to commence an investigation of his or her particular
health center. Accordingly, it is advisable for health centers to take certain steps ahead of
time in order to be prepared to respond most effectively to inquiries, audits, or
investigations should they be initiated.
Possible Signs of an OIG Investigation
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Planned audit.
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Visit by government agents to the health center or to current or former employees at
work or at home.
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lnformal request from the OIG to review certain records.
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OIG subpoena.
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Civil investigative demand.
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Grand jury subpoena. ~
Search warrant for the health center. Preparing for and Responding to an Audit or Investigation
To prepare and respond to an audit or investigation, health centers should follow a
series of steps, including certain pre-audit or investigation actions, as well as actions to be
taken during and/or after the audit or investigation. 3 Pre-audit or investigation actions
incluedde designIfatin~fia Pdo~nt Pderson, anhd dbevell0thPing and ehstablli' shing apprOdPria~el rdesponse
proc ures. notI Ie ID a vance, t e ea center s ou d request a etal e
explanation of the scope and purpose of the audit. In this regard, the health center can
be prepared to comply with reasonable requests that are within the scope ofthe
audit/investigation on a timely basis.
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In general, each step of the audit or investigation involves different preparatory and response actions on the part of the health center. •!.Ii;tIufjbtt~'ItlI~[~j~t~~~~t0jt~E:=::;~ , ' . During the course
of the audit, the health center should have a coordinated approach to responding to
requests for documents, interviews, and/or testimony. Mt"lf1tR&1iel'd[w'().iSlfi6Jl:il)tet~;
~.,;m~J~\ll1I~ti'f,j.b'14f!t~11e:1JjmI.tllf{em:~:i(j~~~jll-=lI'b1§1!!t~~ijjmg~ll'~'
. .~-;mli~l§ilAj~II'imllf~~~~lt~I£\![lIwmta~ After the on-site audit or
investigation is complete, the health center should review the government's findings and
deal with any adverse findings, either by developing and implementing a corrective
action plan, if the findings warrant such follow-up, or considering whether a dispute or
appeal is necessary. Each ofthese actions is detailed below.
Pre-Audit or Investigation Preparation
Designating a Point Person to Coordinate External Audit Activities
As a first step, the health center should designate an appropriate individual
within the organization to be the ''point person" in the event of a government
investigation or audit. For a planned audit, the health center's compliance officer maybe
best suited to coordinate and respond to government auditors or investigators because he
or she is responsible for the internal aUditing ofhigh-risk areas (such as coding or
billing), receiving and responding to employee concerns, investigating compliance
complaints, and correcting of findings ofnon-compliance.
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One of the best tools to assist a health center in preparing for future audits or investigations (as well as to
mitigate penalties should an audit or investigation uncover non-compliance) is the development and
implementation ofa corporate compliance program. Corporate compliance programs are discussed further
within the section below entitled Conducting Internal Investigations.
3
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an unplanned government investigation, designating qualified counsel as the initial
point person makes sense because of the potential for civil and criminal penalties.
Under such circumstances, designating a lawyer as the point person provides the
advantage of attorney-client privilege in responding to an investigation.
In general, the point person will be responsible for the management ofthe
audit response or investigation on behalfofthe health center. Specifically, the point
person should coordinate the preparation, collection, review, and production of
documents and records, ensuring that the health center has appropriately updated and
organized all records and other infonnation needed to respond to the audit/investigation.
When notified of a government investigation, the point person and/or counsel should
consider contacting the government agent or attorney handling the matter to begin a
dialogue and the process ofbuilding trust. Further, the point person should communicate
with the audit team/investigators, including working with the audit team leader or lead
investigator to determine the agenda for the on-site audit or investigation.
Decisions must also be made about which employees need to know about
the audit or investigation, and what they should be told. In this regard, the point person
should schedule staff and Board members to participate in entrance and exit conferences,
and coordinate individual interviews, as may be requested by the audit or investigation
team.
If apprised ofthe scope ofthe audit or investigation beforehand, the point
person should consider conducting a "dry run" ofthe audit to ensure that the health center
has compiled all of the materials that are likely to be requested and is prepared to answer
fully all questions that are likely to be asked. In the event of an audit or investigation that
allows for ample preparation time, all necessary infonnation should be compiled in
binders, notebooks, or in PowerPoint files-keeping each topic separate and easily
accessible for the auditors/investigators.
Examples of Potentia) Trouble Spots or Health Center Vulnerabilities
:> High risk areas (e.g., accounting/finance, Federal grants compliance, tax issues, cost
reporting, codinglbilling).
:> Cash flow peculiarities (e.g., if the center draws disproportionately high from its grant
award).
:> Patterns of poor documentation.
:> Matters that prompt internal compliance hotline calls or complaints to the compliance
officer.
:> High staff turnover in any given department.
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Developing and Establishing Response Procedures
The health center management should prepare procedures to follow in the
event that the health center is contacted by a government agent, receives a request for
documents, or must respond to any other type of government inquiry. These procedures
can be memorialized in a short memorandum that should be distributed to appropriate
officers and employees, and should include an instruction to contact the point person as
soon as possible in the event that an employee is contacted by a government agent or
auditor in any manner (i.e., telephone call, issuance of a subpoena). If the agent asks to
interview the employee, he or she should inform the point person of the request. In turn,
the point person should coordinate the timing for the interview and, as necessary
(depending on the type of investigation being conducted), seek to have a representative
of, or counsel for, the health center present at the interview.
The procedures should make clear that, .Y&YLfift~l1fatilit1l"1fGVE'~jl:ti{~
"jelfflo'Ttmdff(ir}r!q~~~t!J9lIq~~~I~'P~E;Copiesi'Pm~lt~:~l!l!~t• •';!\~}1\~E~
~.}i!!Ii!!mi~~_.'iit'~~ Further, the procedures should include an instruction
that all persons involved with the audit or investigation ~~[i~~~~~1!Jg~f_!'Qlaf'~
~Q,i--gtsd!~¥i~~~~~~~~~Jl~'i~:~1l~~~9M~91t~l¥!~~ which log should be
maintained by the point person. Ail response procedures should take into
consideration that a poorly handled response to any audit, investigation, or inquiry
may create additional difficulties for the health center later.
Actions Taken During the Investigation or Audit
Conducting an Entrance Conference
At the beginning of the investigation or audit, the health center should
request that an entrance conference be conducted between the government auditors or
investigators and the center's point person, other senior management, team members, and
possibly one or more Board members and/or counsel. The purpose of an entrance
conference is to ensure that both the health center and the investigating agency
understand, among other things, the scope of the investigation and the necessary
records, documentation, and other information to be provided to the auditors or
investigators. In this regard, the health center should attempt to secure the agency's
agreement to provide reasonable notice in terms of accessing employees and documents
throughout the process.
During the entrance conference, the health center should request that, to
the extent possible, copies of the auditor's or investigator's work papers will be provided
to the center. The health center should also seek a commitment from the auditors or
investigators to conduct an exit interview prior to preparing the fmal report, and there
should be a preliminary discussion of how potential adverse fmdings that remain
unresolved upon completion of the audit or investigation will be handled.
I Tips to Ensure the Health Center's Rights During a Government Review
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The health center should: )- Request entrance and exit interviews with the government auditors/investigators. )- Request that reasonable notice be given for scheduling interviews with health center staff and securing necessary documents from the health center.
)- Request draft copies of reports and auditor work papers so that the health center can
formally comment on findings.
Complying with Requests
The health center should provide access to requested material within the
scope ofauthorized audit or investigation. As previously discussed, an audit or
investigation may include interviews with specific health center staff. It is important to
remind health center staff that they should not assume that auditors/investigators are
"experts" on the nuances ofthe Section 330 program. Rather, they are a skills-based
team who specialize in auditing or investigating. Therefore, it is important for the point
person and management to ask questions throughout the audit/review process. It is
critical to ask about the proposed preliminary findings and the rationale behind them.
An 010 investigation, by its very nature, reflects a decision that a
heightened level of scrutiny from the Federal government is required, i.e., the A-I33
audit is not adequate to address particular concerns about the health center. Because of
the potentially severe consequences, there are special considerations for health centers to
keep in mind when responding to requests from the 010.
)- OIG Requests for Documents
As part of an 010 investigation, the government may request documents
either informally or by subpoena. There are two principles to keep in mind in responding
to these requests. First, the health center should cooperate with the investigating agents
or attorneys. Law abiding providers may end up creating problems that did not
previously exist by appearing to the investigators to be obstructing or improperly
resisting an investigation. Further, HHS administrative requirements set forth in 45
C.F.R. §74.53(e) require all grantees to provide HHS agencies, the OIG, andlor the
Comptroller General timely and unrestricted access to documents and records pertinent to
grant awards. Second, the health center should maintain control over the information
provided to the investigators. As discussed above, the point person should gather,
review, and tum over documents in an organized and controlled process.
)- OIG Requests for Interviews or Testimony
The government may also request that employees be interviewed or give
testimony in connection with an OIG investigation. The point person or counsel, at the
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outset of the investigation, should detennine which employees the government likely will
seek to question. This detennination can be made based upon conversations with the
investigating agents or attom~ys, by reviewing any request for documents (as well as the
contents of the documents sought by the government), and by speaking with employees
about who may have relevant knowledge.
Employees who are identified as likely candidates for interviews or
testimony should be notified that the investigation has begun and that they may be
questioned by government investigators.4 In speaking with investigators, or if personnel
are subpoenaed, the health center may be obligated under State law or the health center's
Bylaws or persormel policies to reimburse or indemnify employees for their legal fees.
Employers often pay the legal costs of counsel to represent employees. In any event, a
representative of the health center, preferably the health center's counsel, should be
present during any interviews or depositions.
»
Securing Outside Assistance for OIG Investigations
Often, health care providers will retain an outside law firm to assist in
complying with requests for documents, interviews, subpoenas, and other government
inquiries made in connection with an 010 investigation. Counsel experienced in
handling government investigations can help to ensure that the health center cooperates
with investigators while, at the same time, preserves its rights and privileges, as well as
those of its employees. The initial stages of an investigation (e.g., the entrance
interview) may also provide the health center with an early opportunity to minimize
the scope and consequences of an OIG inquiry. If, however, an investigation proceeds
and concludes with a notice or recommendation for some kind of adverse finding, such as
an administrative penalty or other enforcement action, it may be more difficult for
counsel to minimize the consequences of the contemplated action at that late stage in the
process.
ConduCting an Exit Interview
Once the "on-site" portion of the audit or investigation is complete, it is
advisable to conduct an exit interview with the auditors/investigators to make sure that
they received all documents, records, and other information needed to complete the
auditlinvestigation. The exit interview may also be the first opportunity for the health
center to be advised of adverse findings and have a chance to respond effectively, as well
as the last opportunity for the health center representative to ask questions
regarding the audit or investigation and to provide a more complete and accurate
response.
If an employee is subpoenaed by the DIG or otherwise requested to answer during an investigation, slbe
should notify health center management, who may choose to consult with an attorney or provide one to the
employee, ifappropriate.
4
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Actions Taken After the Audit or Investigation
After the field work is completed, the auditors or investigators typically will
prepare a draft report. The health center should ask for an opportunity to comment on the
report, both in terms of areas ofagreement and any adverse findings that the health center
might dispute, and the health center should request that its comments be incorporated into
the final audit report. Once a final report is issued, if the health center agrees with any
adverse findings, it should detennine how to resolve the problems and begin
implementation ofa corrective action plan immediately. If, on the other hand, the health
center does not agree with adverse findings. there may be an opportunity to appeal to the
Public Health Service andlor the Departmental Appeals Board. Because appeal rights
differ depending on the type of audit or investigation findings (i.e., in the case of an OIG
investigation, a notice or recommendation for some kind of administrative penalty or
other enforcement action may result, which, in turn, may convey specific appeals rights),
consulting qualified counsel for this phase is suggested.
Ofnote, many investigations arise from disgruntled employees who complain to
multiple agencies or departments. As such, investigations by one agency are often
coupled with inquiries or investigations from another agency or department. In other
words, just because one audit or investigation has concluded, it should not be asswned
that the health center is completely in the clear - another may begin soon after.
Obviously, it would behoove the health center to advise an agency that appears to want to
audit the same issue previously investigated by another agency ofthe prior investigation,
in the hopes of narrowing the scope to issues not already studied. However, if the health
center has diligently followed the steps discussed in this Issue Brief to respond
appropriately and provide requested documentation, follow-up audits or investigations
are likely to progress more smoothly.
Conducting Internal Investigations
A health center that believes that there may have been some improper conduct
within the organization should consider conducting an internal investigation prior to, or
contemporaneous with, any government investigation. Such an investigation would
include interviewing employees and reviewing documents to determine whether any
misconduct has occurred. By looking within itself, a health center may be able to correct
any irregularities or improprieties before the government begins an investigation. If,
however, the govennnent has already started an investigation, the health center should
consider conducting an internal investigation to obtain a fuller picture of its
vulnerabilities.
One ofthe best tools to assist in conducting an internal investigation is the
development and implementation of a corporate compliance program. An effective
corporate compliance program is designed to ensure, among other things, the health
center's compliance with applicable laws, regulations and policies. In particular, as part
of a corporate compliance program, health centers would (1) conduct regular internal
aUditing and monitoring oftheir compliance with the laws, regulations and policies
governing the center's administrationt management and operation, (2) investigate
potential areas of non~compliance, and (3) based on the results of such investigation,
implement corrective actions necessary to correct identified problems and ensure future
compliance. Furthert under corporate compliance programs, health center personnel (and
as applicable, Board members) are encouraged to report any actual or perceived
compliance issues to an internal compliance officer who, in turn, should initiate prompt
investigation (and, as necessary, corrective action) ofreported issues. s
Accordingly, if the issue to be investigated falls squarely within the realm of
corporate compliance, the compliance officer should direct the internal investigation. If,
however, it is clear that there is soon to be an OIG or other Federal agency investigation
and the subject of investigation is "high-risk" (i.e., accounting/finance, Federal grants
compliance, tax issues, cost reporting, coding/billing), it may be advantageous to have
qualified counsel direct (or, at a minimum, assist) the internal investigation. In so doing,
if appropriate arrangeme~ts are made, the information gathered will likely be
confidential; It will likely be protected by attorney-client privilege, and/or by the work
product doctrine. Responses by employees to counsel's questions, and studies or
projects undertaken by the health center's staff at counsel's request, generally will not be
discoverable by the government.
Legal Concepts Related to Investigations
Confidential information is infonnation the dissemination of which is restricted.
Attorney-Client Privilege is the client's right to refuse to disclose and to prevent any
other person from disclosing confidential communications between the client and the
attorney.
The Work Product Doctrine establishes that materials prepared by or for a lawyer in
anticipation oflitigation are generally exempt from discovery by another party or
compelled disclosure.
Conclusion
The manner in which a health center prepares for, and responds to, an external
investigation or audit often influences the resulting outcome. Coordinated and well­
planned preparatory steps can minimize potential confusion and disruption to operations
that could occur when a government auditor or investigator presents at the health center.
Further, management ofthe health center's response, through a designated point person,
during the field wprk phase will facilitate the work ofgovernment investigators and
auditors in an appropriate and effective manner, thereby managing risks and potentially
reducing the likelihood of adverse consequences that the investigation may have on the
health center.
S For additional infonnation regarding the development and implementation of corporate compliance
programs, please contact Malvise Scott ofNACHC at (301) 347-0400, or Jacqueline Leifer or Marcie
Zakheim of Feldesman Tucker Leifer Fidell LLP at (202) 466-8960.
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64282
Federal Register/Vol. 71, No. 211/Wednesday, November 1, 200B/Notices
Board of Governors of the Federal Reserve
System, October 27, 2006.
Jennifer J. Johnson,
Secretary ofthe Board.
[FR Doc. E6-18346 Filed 10-31-06; 8:45 am]
developing and using resources
involving health information technology
(IT) and genetic and molecular
medicine, with specific reference to
incorporating these capacities in
evidence-based clinical practice, health
BILLING CODE 6210-01-8
outcomes evaluations, and research.
DATES: Responses should be submitted
FEDERAL RESERVE SYSTEM
to the Department of Health and Human
Services on or before 5 p.m., EDT,
Formations of, Acquisitions by, and
January 2, 2007.
Mergers of Bank Holding Companies
ADDRESSES: Electronic responses are
preferred and may be addressed to
The companies listed in this notice
[email protected]. Written responses
have applied to the Board for approval,
should be addressed to Department of
pursuant to the Bank Holding Company
Board of Governors of the Federal Reserve
Health and Human Services, 200
Act of 1956 (12 U.S.C. 1841 et seq.)
System, October 27, 2006.
Independence Avenue, SW., Room
(BHC Act), Regulation Y (12 CFR Part
Jennifer J. Johnson,
434E, Washington, DC 20201, Attention:
225), and all other applicable statutes
Secretary ofthe Board.
Personalized Health Care RFI.
and regulations to become a bank
[FR Doc. E6-18347 Filed 10-31-06: 8:45 am]
A copy of this RFI is also available on
holding company andlor to acquire the
the HHS Web site at http://
assets or the ownership of, control of, or BILLING CODE 6210-01-8
www.aspe.hhs.gov/PHC/rfi. Please
the power to vote shares of a bank or
follow the instructions for submitting
bank holding company and all of the
responses.
DEPARTMENT OF HEALTH AND
banks and nonbanking companies
The submission of written materials
HUMAN SERVICES
owned by the bank holding company,
in response to the RFI should not
including the companies listed below.
exceed 75 pages, not including
The applications listed below, as well Request for Information (RFI):
Improving Health and Accelerating
appendices and supplemental
as other related filings required by the
Personalized Health Care Through
documents. Responders may submit
Board, are available for immediate
Health Information Technology and
other forms of electronic materials to
inspection at the Federal Reserve Bank
Genomic Information in Population­
demonstrate or exhibit key concepts of
indicated. The application also will be
their written responses.
available for inspection at the offices of and Community-Based Health Care
Delivery Systems
Public Access: Responses to this RFI
the Board of Governors. Interested
will be available to the public in the
persons may express their views in
AGENCY: Office ofthe Secretary,
HHS Public Reading Room, 200
writing on the standards enumerated in Department of Health and Human
Independence Avenue, SW.,
the BHC Act (12 U.S.c. 1842(c)). If the
Services.
Washington, DC 20201. Please call (202)
proposal also involves the acquisition of ACTION: Notice.
690-7453 between 9 a.m. and 5 p.m. to
a nonbanking company, the review also
arrange access. The RFI and all
SUMMARY: Advances in medicine,
includes whether the acquisition of the
responses will also be made available on
nonbanking company complies with the biomedical science, and technology
the HHS Web site at http://
present opportunities for enabling
standards in section 4 of the BHC Act
www.aspe.hhs.govIPHC/rfi. Any
health care practices to be increasingly
(12 U.S.C. 1843). Unless otherwise
information you submit will be made
patient-specific by taking into account
noted, nonbanking activities will be
public.
conducted throughout the United States. individual differences in health states,
Do not send proprietary, commercial,
disease
processes,
and
outcomes
from
Additional information on all bank
financial, business confidential, trade
interventions. Often referred to as
holding companies may be obtained
secret, or personal information that
personalized health care, the desired
from the National Information Center
impact of these types of health practices should not be made public.
Web site at http://www.ffiec.gov/nic/.
FOR FURTHER INFORMATION CONTACT: Dr.
is improved effectiveness and safety of
Unless otherwise noted, comments
medical practices. These health benefits Gregory Downing, Personalized Health
regarding each of these applications
Care Initiative, (202) 260-1911.
may be manifested through new
must be received at the Reserve Bank
approaches for predicting disease risk at SUPPLEMENTARY INFORMATION: Advances
indicated or the offices of the Board of
in medicine, biomedical science, and
an early time point, enabling
Governors not later than November 27,
preemption of disease processes prior to technology present opportunities for
2006.
enabling health care practices to be
full manifestation of symptoms,
A. Federal Reserve Bank of Chicago
increasingly patient-specific by taking
(Patrick M. Wilder, Assistant Vice
analyzing the effectiveness of different
into account individual differences in
President) 230 South LaSalle Street,
interventions in specific populations
health states, disease processes, and
Chicago, Illinois 60690-1414:
based on their genetic makeup, and
outcomes from interventions. Often
1. Capitol Bancorp Ltd., Lansing,
preventing the progression of disease
referred to as personalized health care,
Michigan; to indirectly acquire 51
and the related complications.
percent of the voting shares of Bank of
For the purpose of achieving a
the desired impact of these types of
Tacoma (in organization), Tacoma,
broader understanding of rapid changes health practices is improved
Washington.
occurring in the health care setting that
effectiveness and safety of medical
may have an impact on the future of
In connection with this Application,
practices. These health benefits may be
Capitol Development Bancorp Limited
personalized health care, the
manifested through new approaches for
VI, Lansing, Michigan, has applied to
Department of Health and Human
predicting disease risk at an early time
become a bank holding company by
Services (HHS) requests input from the
point, enabling preemption of disease
acquiring 51 percent of the voting shares public and private sectors on plans for
processes prior to full manifestation of
of Bank of Tacoma (in organization),
Tacoma, Washington.
2. Bank ofMontreal, Montreal,
Canada, Harris Financial Corp., Chicago,
Illinois, and Harris Bankcorp, Inc.,
Chicago, Illinois; to acquire 100 percent
of the voting shares of First National
Bank & Trust, Kokomo, Indiana.
3. QCR Holdings, Inc., Moline,
Illinois; to acquire 100 percent of the
voting shares of Ridgeland Bancorp,
Inc., Tony, Wisconsin, and thereby
indirectly acquire voting shares of
Farmers State Bank, Ridgeland,
Wisconsin.
Federal Register/Vol. 71, No. 211 /Wednesday, November 1, 2006/Notices
symptoms, analyzing the effectiveness
of different interventions in specific
populations, and preventing the
progression of disease and the related
complications.
The application of interoperable
electronic information technologies (IT)
in the health care setting provides new
opportunities to collect and analyze
information about diagnostic and
therapeutic interventions, as well as
health care outcomes. With many
potential applications, integrated data
analysis of multiple parameters of
health care practices has the potential to
support new approaches to evaluating
health outcomes, developing the
evidence base for best practices,
identifying individual differences in
response to therapies, supporting
research on new interventions,
automating the process of detecting and
reporting notifiable disease conditions
and health care-associated infections to
public health surveillance systems, and
enhancing safety.
In the past year, the American Health
Information Community (AHIC), a
chartered Federal advisory committee,
has made recommendations to the
Secretary to advance the development of
electronic health records (EHR). AHlC's
activities and recommendations support
a nationwide approach to developing
digital and interoperable health IT
systems that ensure the privacy and
security of patient information. Already
underway are efforts to support
consumer empowerment, health safety
and improvement, and public health
protection through broadly deployed,
harmonized information systems. As a
result of the deployment of these
capabilities throughout the health care
system, new avenues are emerging to
apply information about individual
health experiences toward improved
transparency about the quality and cost
of health care and transformation of
health care delivery, as well as decision
sugport for health practitioners.
ccurring in parallel with the
advances in health IT are advances in
molecular and genetic medicine. This
science-based approach to medicine is
now in the early stages of entry in
health care through the introduction of
diagnostics and treatments that target
specific genetic and molecular features
of disease processes. Applications of
this science and technology provide
useful information to aid in patient care
through more accurate diagnosis and
treatment at an individual leveL The
availability of genetic information
(especially the availability of this
information as part of the EHR), and the
ability to aggregate these data and
correlate them with outcomes or other
relevant findings from multiple sources,
could greatly expand our capacity for
personalized health care, providing
more specific individual information for
prevention, diagnosis, and treatment;
pointing toward clinically useful
markers; enabling safer and more
effective use of existing therapies; and
identifying potential fruitful areas for
development of new or refined
therapies.
New pathways are emerging for
affordable and more effective health
care practices through personalized
health care. The ability to integrate new
scientific knowledge, especially our
growing understanding of the human
genome, into the health care setting in
an efficient and timely fashion will rely
on robust, reliable and secure
information sources in electronically
interoperable systems. Many public and
private organizations are engaged in the
planning for future collections and
integration of health data for this
purpose. This request seeks information
that will facilitate a broader
understanding of directions being taken
and the productive role that Federal
health agencies might play in
facilitating progress, avoiding
unnecessary barriers, and achieving
optimal benefit from the opportunities
now before us.
64283
• Anticipated applications of
genomic-based clinical testing in
medical decision-making, safety
assessment, and risk management.
• Establishment ofbiospecimen
resources obtained from clinical
medical services for application in
research, clinical trials, health services
planning, clinical effectiveness, and
health outcomes evaluations.
• Organizational or institutional
practices to address ethical, legal, and
social implications regarding the use of
patient information, including genetic
data, to support personalized health
care.
• Examples of utilizing large clinical
data repositories for practical clinical
research to discover effective
technologies, therapeutics, diagnostics,
and prevention strategies for different
populations.
• Issues and challenges associated
with incorporating genomic information
as a part of a broad longitudinal data
collection.
• Needs for community-wide
standards or best practices that will
facilitate large-scale data integration and
exchange to benefit personalized health
care.
• Feasibility and potential benefits for
establishing linkages of institutional or
organizational data resources with
private and publicly available health
databases.
Information Requested
• Development of ontologies across
For the purpose of achieving a
different clinical data repositories that
broader understanding of rapid and
will facilitate the utility of the data for
emerging changes occurring in the
answering clinical research questions.
health care setting that may have an
• Models for linking clinical data
impact on the future of personalized
repositories across disparate care
health care, HHS requests input from
providers.
interested parties on plans for
• Examples of the use of disease
developing and using resources
registries to track specific diseases and
involving health IT and genetic and
response to drug therapies across
molecular medicine, with specific
different subpopulations.
reference to incorporating these
• Models for prioritizing analyses to
capacities in evidence-based clinical
fill gaps in evidence of effectiveness of
practice, health outcomes evaluations,
therapeutic interventions for different
research, and transformation of health
populations.
care delivery.
• Strategies for accumulating patient
Input is sought on the interest and
data necessary for research that may not
current planning activities of health care be available through EHRs.
systems and related organizations on the
• Concepts or models on the potential
needs and applications of these
use of clinical data and related
transformative aspects of personalized
resources for research applications.
health care. Specific areas for comment
• Models of cost-benefit analysis for include:
integrated data systems, EHR, and • Concepts on anticipated approaches clinical resources to inform medical for the use of EHR and population- and
decision-making. community-based health care system
• Opportunities and challenges for the development of electronic tools to databases for longitudinal data
aid in the integration and analysis of collection in addressing:
large datasets of clinical parameters to -Disease susceptibility.
assist in outcomes evaluations. -Clinical course and outcomes.
-Treatment response.
Potential Responders
-Evidenced-based clinical decision
HHS anticipates responses from a
support.
-Optimal healthcare delivery systems. broad range of individual organizations
64284
Federal Register/Vol. 71, No. 211/Wednesday, November 1, 2006/Notices
that have interests in health systems
change and personalized health care.
Some examples of these organizations
include:
• Community health delivery
systems.
• Health maintenance organizations.
• University-based health systems.
• State and local public health
departments.
• Other Federal agencies.
• Advocacy groups and public
interest organizations.
• Consumer and patient interests
groups.
• Health care professional societies.
• Trade industry organizations.
• Purchasers of health care.
• Health information technology
industry vendors.
Dated; October 26. 2006.
John O. Agwunobi,
Assistant Secretary for Health, Office of
Public Health and Science.
[FR Doc. E6-18371 Filed 10-31-06; 8;45 am]
Fishers Lane, rm. 1066, Rockville, MD.
The agenda for the meeting will be
posted at http://www.fda.gov/cderldrug/
unapproved_drugs.
Submit topics by mail to the Division
of Dockets Management (HFA-305),
Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD
20852. Submit topics electronically to
http://www·fda.gov/dockets/ecomments.
Submit two paper copies of any mailed
topics, except that individuals may
submit one paper copy. All requests for
discussion topics should be identified
with the docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Karen Kirchberg, Center for Drug
Evaluation and Research (HFD-330),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301-827-8916, e-mail:
karen.kirchberg<iYfda.hhs.gov.
II. Scope of the Public Workshop
As part ofFDNs goal to ensure that
all marketed drugs comply with
appropriate FDA requirements to ensure
their safety and efficacy, FDA is holding
a public workshop to educate
businesses on the drug application and
OTC monograph processes and to
discuss issues of interest to participants.
Topics for discussion include the
following: (1) The various routes for
legal marketing-NDAs, ANDAs, and
OTC monographs; (2) application
processes; (3) user fee applicability and
waivers; and (4) market exclusivity for
newly-approved drugs. The information
provided during registration will help
us determine additional topics for
discussion and how to further focus the
workshop.
m. Participation in the Public
Workshop
A. Registration
Register via e-mail to
BILLING CODE 415C1-26-P
CDER_330CA [email protected] by
I. Background
providing complete contact information
In the Federal Register of June 9, 2006 for each attendee (including name, title,
DEPARTMENT OF HEALTH AND
(71 FR 33466), FDA announced the
affiliation, e-mail address, and phone
HUMAN SERVICES
availability of a guidance entitled
number(sJ) by November 15, 2006.
"Marketed Unapproved Drugs­
Please indicate "Workshop­
Food and Drug Administration
Compliance Policy Guide" (the
Unapproved Products" in the "subject"
Marketed Unapproved Drugs CPG). The line ofthe e-mail. FDA intends to
[Docket No. 20030-0478]
guidance describes how FDA intends to respond to registration requests by e­
exercise its enforcement discretion with mail after November 15, 2006. There is
Marketed Unapproved Drugs; Public
regard to drugs marketed in the United
Workshop
no registration fee to attend. Space is
States that do not have required FDA
limited; therefore, interested parties are
AGENCY: Food and Drug Administration, approval for marketing. The guidance
encouraged to register early and FDA
HHS. explains that FDA intends to continue
may need to limit the number of
ACTION: Notice of public workshop. to give priority to enforcement actions
attendees from each firm or
involving unapproved drugs that have
organization. If you need special
SUMMARY: The Food and Drug
potential safety risks, lack evidence of
accommodations due to a disability,
Administration (FDA) is announcing a
effectiveness, and constitute health
please e-mail your request at least 7
public workshop on issues related to the fraud, among other categories. The
days before the meeting.
application process for seeking approval Marketed Unapproved Drugs CPG also
for marketed unapproved drugs. This
B.
Suggested Topics
explains how the agency intends to
will be a I-day workshop involving FDA address those situations in which a
If
you would like to request
staff and representatives from
company obtains approval to sell a drug discussion of a specific topic for the
businesses currently marketing
that other companies have sold without workshop, submit it to the Division of
unapproved drugs. The purpose of the
FDA approval for some time. In the
workshop is to provide clarification and Marketed Unapproved Drugs CPG, FDA Dockets Management (see ADDRESSES)
using the docket number, found in
direction to businesses on how to seek
encourages companies to comply with
brackets in the heading of this
approval to legally market drugs
the drug approval requirements of the
document, by November 15, 2006. We
through the new drug application (NDA) Federal Food, Drug, and Cosmetic Act.
may not be able to include all submitted
and abbreviated new drug application
Following the publication of the
topics in the workshop agenda.
(ANDA) processes and how to legally
Marketed Unapproved Drugs CPG, a
market drugs through compliance with
C. Parking, Transportation, and Security
number of drug companies have
the over-the-counter (OTC) monographs. contacted FDA seeking clarification
Limited visitor parking is available for
DATES: The public workshop will be
about how to obtain approval to legally
a fee, and the Twinbrook Metro station
held on January 9, 2007, from 9 a.m. to
market their unapproved drug products is within walking distance. Early arrival
4 p.m. Registration is open until
and whether applications for marketing is encouraged, as there will be security
November 15, 2006. Submit requests for are subject to user fees, among other
screening. Workshop participants will
specific discussion topics by November issues. The agency is committed to
be asked for government-issued picture
15,2006.
working with companies to facilitate the identification by the security officers.
ADDRESSES: The public workshop will
process of ensuring that products are
IV. Transcripts
safe and effective and meet appropriate
be held in the Center for Drug
Following the workshop, transcripts Evaluation and Research Advisory
standards for manufacturing and
will be available for review at the Committee conference room, 5630
labeling.
SUPPLEMENTARY INFORMATION: