[Federal Register Volume 74, Number 198 (Thursday, October 15, 2009)]
[Notices]
[Pages 52964-52965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24715]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Office of Inspector General; Notice for Potential Monitors for 
Quality-of-Care Corporate Integrity Agreements

AGENCY: Office of Inspector General (OIG), Department of Health and 
Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Office of Inspector General (OIG) is seeking to identify 
potential organizations to monitor health care entities under quality-
of-care Corporate Integrity Agreements (CIA) with OIG. OIG is 
interested in receiving information from organizations that believe 
they have the capability to be monitors for quality-of-care CIAs. This 
is not a request for proposals and does not commit OIG to select or 
consider a particular organization to be a monitor. Any information 
provided to OIG in response to this notice is strictly voluntary. The 
Government will not pay for information submitted in response to this 
notice.

DATES: Responses may be submitted on an ongoing basis.

ADDRESSES: Please mail or deliver any response to the following 
address: Office of Counsel to the Inspector General, Department of 
Health and Human Services, Room 5527, Cohen Building, 330 Independence 
Avenue, SW., Washington, DC 20201. Prominently identify the title of 
notice on the first page of any submitted response. Electronic 
responses may be sent to <a href="/cdn-cgi/l/email-protection#127b7f7c7d667b7177527d7b753c7a7a613c757d64"><span class="__cf_email__" data-cfemail="e48d898a8b908d8781a48b8d83ca8c8c97ca838b92">[email protected]</span></a>.

FOR FURTHER INFORMATION CONTACT: Katie A. Arnholt, Senior Counsel, 
Office of Counsel to the Inspector General, (202) 205-3203, or 
<a href="/cdn-cgi/l/email-protection#c0aba1b4a9a5eea1b2aea8afacb480afa9a7eea8a8b3eea7afb6"><span class="__cf_email__" data-cfemail="1b707a6f727e357a69757374776f5b74727c35737368357c746d">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Background

    OIG often negotiates compliance obligations with health care 
providers

[[Page 52965]]

and other entities as part of the settlement of Federal health care 
program fraud investigations arising under civil and administrative 
false claims statutes. These obligations are set forth in a CIA. A 
provider or an entity consents to a CIA in conjunction with a civil or 
administrative settlement and in exchange for OIG's agreement not to 
seek to exclude that health care provider or entity from participation 
in Medicare, Medicaid, and other Federal health care programs under 42 
U.S.C. 1320a-7. False claims submitted in violation of the False Claims 
Act or Civil Monetary Penalties Law give rise to OIG's permissive 
exclusion authority under 42 U.S.C. 1320a-7(b)(7).
    The typical term of a CIA is 5 years. CIAs seek to ensure the 
integrity of Federal health care program claims submitted by the 
provider. CIAs generally include requirements to, among other things: 
(1) Hire a compliance officer; (2) appoint a compliance committee; (3) 
develop written standards and policies; (4) implement a comprehensive 
employee training program; (5) establish a confidential disclosure 
program; (6) restrict employment of ineligible persons; (7) report 
overpayments, reportable events, and ongoing investigations/legal 
proceedings; and (8) provide an implementation report and annual 
reports to OIG on the status of the entity's compliance activities.
    When resolving cases that involve quality-of-care allegations, OIG 
often requires health care providers to enter into quality-of-care 
CIAs. OIG may enter into quality-of-care CIAs with many different types 
of health care providers, including, but not limited to, skilled 
nursing facilities, assisted-living facilities, psychiatric facilities, 
intermediate care facilities for the mentally retarded, hospitals, 
physician practices, dental practices, and management companies. Under 
these quality-of-care CIAs, health care providers agree to compliance 
obligations that include quality assurance and improvement. One such 
obligation is to retain an appropriately qualified monitor, which is 
appointed by OIG after consultation with the health care provider. The 
monitor selected contracts directly with the provider. The monitor does 
not enter into any contractual relationship with OIG or act as an agent 
for OIG.
    The monitor typically is responsible for assessing the 
effectiveness, reliability, and thoroughness of the provider's: (1) 
Internal quality control systems; (2) response to quality-of-care 
issues; (3) development and implementation of corrective action plans 
and the timeliness of such actions; (4) proactive steps to ensure that 
each patient receives care in accordance with basic care, treatment, 
and protection-from-harm standards; the governing regulations; and the 
policies and procedures required to be adopted under the CIA; and (5) 
in residential settings, compliance with staffing requirements. In 
making these assessments, the monitor conducts site visits, analyzes 
available data, observes facility and corporate-level committee 
meetings, and reviews relevant documents. The monitor submits regular 
written reports to the provider and OIG.

Responses to This Notice

    OIG is interested in hearing from organizations that believe they 
have the capability to be a monitor for quality-of-care CIAs. Please 
include in any response to this notice the following:
    1. The name of the organization;
    2. The size and location(s) of the organization;
    3. The qualifications of the organization to serve as a monitor for 
quality-of-care CIAs;
    4. The organization's capacity to monitor large providers with 
locations in multiple States;
    5. The organization's clinical experience and expertise;
    6. The organization's experience with quality assessment, 
assurance, and improvement;
    7. The organization's prior monitoring experience, including, but 
not limited to, systems reviews and auditing; and
    8. An indication of whether the organization has any current or 
prior (within the last 5 years) Federal Government contracts or is on 
any General Services Administration or HHS list of approved 
contractors.
    OIG will review each response submitted to this notice to assess 
whether the organization may be appropriate to serve as a monitor for 
quality-of-care CIAs. The assessment will not be for the purpose of 
making any definitive determination regarding whether a particular 
organization is qualified to be a monitor or creating a list of pre-
approved monitors. Factors that OIG considers when assessing whether an 
organization may be an appropriate monitor for a particular CIA 
include, among other things, the organization's clinical expertise, 
capacity to handle a particular monitoring relationship, quality 
monitoring experience, geographic location, and independence and 
objectivity. Each provider and quality-of-care CIA is unique. 
Accordingly, the selection of an appropriate monitor for any given 
quality-of-care CIA requires consideration of unique and individualized 
factors. In order to select an appropriate monitor for any individual 
quality-of-care CIA, OIG may contact an organization that submitted 
information in response to this notice to request additional 
information. In selecting a monitor, OIG will not be limited to 
organizations that submitted information in response to this notice.
    Any organization submitting information in response to this notice 
should identify any information that it believes is trade secret, or 
commercial or financial information, and privileged or confidential 
under exemption four of the Freedom of Information Act (FOIA). 
Consistent with the HHS FOIA regulations, set forth in 45 CFR Part 5, 
when OIG receives a request for such records and OIG determines that 
OIG may be required to disclose them, OIG will make reasonable efforts 
to notify the organization about these facts.

Daniel R. Levinson,
Inspector General.
[FR Doc. E9-24715 Filed 10-14-09; 8:45 am]
BILLING CODE 4152-01-P


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