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###### Department of Health and Human Services

# AGENCY:

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

# ACTION:

Notice.

# 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                         *imnotice@oig.hhs.gov.*

# FOR FURTHER INFORMATION CONTACT:

                        Katie A. Arnholt, Senior Counsel, Office of Counsel to the Inspector General, (202) 205-3203, or                         *katie.arnholt@oig.hhs.gov.*

# SUPPLEMENTARY INFORMATION:

## Background

                    OIG often negotiates compliance obligations with health care providers                           ( print 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