100-10 Quality Improvement Organization Manual: Chapter 9 - Sanction and Abuse Issues

Quality Improvement Organization Manual
Chapter 9 – Sanction, Emergency Medical Treatment and
Labor Act (EMTALA), Fraud and Abuse
TABLE OF CONTENTS
(Rev. 24, Issued: 02-12-16)
Transmittals for Chapter 9
9 – Section 1 – SANCTION
9000 – Introduction and Organization of Sections
9005 – Authority
9010 – Definitions Related to Sanction Activities
9015 – Roles and Responsibilities
9015.1 – QIO Responsibilities
9015.1.1 – QIO Sanction Committee
9015.1.2 – QIO Sanction Panel
9015.1.3 – Use of CMS-designated Case Review System
9015.2 – CMS Responsibilities
9015.3 – OIG Responsibilities
9020 – Identification of Potential Violations
9020.1 – How Violations Are Initially Identified
9020.2 – Statutory Obligations – Practitioner’s or Other Person’s Services
9025 – QIO Development of a Sanction Case
9025.1 – Sanction Committee Initial Review
9025.2 – Written Notification to Practitioner or Other Person
9030 – Initial Meeting with Practitioner or Other Person – Requirements
9030.1 – Composition of the QIO Sanction Panel
9030.2 – Requirements for the Meeting
9035 – QIO Sanction Panel – Initial Sanction Recommendation
9035.1 – QIO Review of Additional Information
9035.2 – QIO Sanction Panel Determination/Action
9035.3 – QIO Corrective Action Plan (CAP) Process and Procedures
9035.3.1 – Corrective Action Plan (CAP) Request
9035.3.2 – Monitoring a Corrective Action Plan (CAP)
9040 – QIO Action on Final Finding of a Violation
9040.1 – Unresolved and Affirmed Findings

9040.2 – Extenuating Circumstances – Practitioner or Other Person Involved in
Sanction Proceeding – Relocation
9040.2.1 – Practitioner or Other Person – Relocation to Another QIO State
9040.2.2 – Practitioner or Other Person – Relocation and Referral from
Another QIO
9045 – QIO Report to Office of Inspector General (OIG)
9045.1 – Manner of Reporting
9045.1.1 – Content of Report
9045.1.2 – QIO Recommendations – Report Requirements
9045.2 – OIG Rejection of QIO Recommendations
9045.3 – OIG Process – Decision to Sanction
9050 – OIG Imposition and Notification of Sanction
9050.1 – Exclusion Sanction
9050.2 – Monetary Penalty
9050.3 – Notification to Practitioner or Other Person of OIG Sanction
9050.3.1 – Written Notice Contents – Specifications
9050.4 – Patient Notification
9050.4.1 – Practitioner Elects to Inform Patients
9050.4.2 – Sanctioned Party Is a Hospital – Notification Requirements
9050.4.3 – Provider or Other Person Certification Provisions
9050.4.4 – Notice to Other Interested Parties
9050.5 – Imposing an Exclusion Sanction – OIG Responsibilities
9055 – Effect of an Exclusion Sanction and Medicare Payments and Services
9055.1 – Payment to an Excluded Practitioner or Other Person – Regulatory
Requirements
9055.2 – Exceptions to Denial of Medicare Payment (Exclusion) – Regulatory
Requirements
9055.3 – CMS Payment to Beneficiaries – Regulatory Requirements
9060 – Reinstatement after Exclusion by OIG
9065 – Appeal Rights of the Excluded Practitioner or Other Person
9065.1 – Appeal Reversal
9065.2 – Right to a Pre-exclusion Preliminary Hearing(s)
9065.3 – Right to an Administrative Review
9065.4 – Right to a Judicial Review
9 – Section 2 - Emergency Medical Treatment and Labor Act (EMTALA)
9100 – Introduction and Organization of Sections
9105 – Authority Related to EMTALA
9110 – Definitions Related to EMTALA Review Activities

9115 – Hospital Requirements
9120 – Hospital Penalties for Noncompliance
9125 – CMS Regional Office Responsibilities
9130 – QIO 5-Day Review – Responsibilities
9130.1 – Physician Reviewer Selection/Qualification
9130.2 – QIO Physician Review Process Description
9135 – QIO Review Responsibilities – 60-Day Review
9135.1 – Physician Reviewer – Selection/Qualification
9135.2 – QIO Physician Review Process Description
9135.2.1 – 60-Calendar-Day Timeframe
9135.3 – Reporting Results of the Review to CMS
9 – Section 3 – Fraud and Abuse
9200 – Scope of QIO Fraud and Abuse Review Activities
9210 – QIO Review Responsibility
9210.1 – CMS Approval Process – Referrals to the QIO from Any Source Other
than CMS
9210.2 – QIO Fraud and Abuse Review Process
9220 – Evaluation Report Requirements
9230 – Availability of Expert Witness
9230.1 – Testimony
9230.2 – Expert Witness Qualifications
9230.3 – Maintenance of Review Files
9240 – Reopening of Cases – Regulatory Guidance
Appendices
Appendix 9-1 – Office of Council to the Inspector General Mailing Address
Appendix 9-2 – Initial Sanction Notice of Substantial Violation in a Substantial Number of
Cases
Appendix 9-3 – Second Sanction Notice of Substantial Violation in a Substantial Number
of Cases
Appendix 9-4 – Synopsis of Cases for Use with 30-Day Letter
Appendix 9-5 – Initial Sanction Notice of Gross and Flagrant Violation
Appendix 9-6 – Synopsis of Cases for Use with 30-Day Letter (Gross and Flagrant
Violations Only)
Appendix 9-7 – Final QIO Sanction Notice
Appendix 9-8 – Combined Initial Sanction Notice of Substantial Violation in a Substantial
Number of Cases and in a Gross and Flagrant Violation(s)
Appendix 9-11 – EMTALA Physician Review Document Checklist

Appendix 9-12 – EMTALA Physician Review Worksheet
Appendix 9-13 – EMTALA Resolution of Disagreement Worksheet
Appendix 9-16 – 60-Day QIO Review – Opportunity for Discussion (Sample Letter to
Physician/Hospital)
NOTE: This chapter is not a substitute for the underlying law. The QIO is responsible for
complying with applicable statutes and regulations.

9 – Section 1 – Sanction
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9000 – Introduction and Organization of Sections
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
This section provides a comprehensive description of the Sanction Review process and
procedures to be followed by a Beneficiary and Family-Centered Care – Medicare Quality
Improvement Organization (QIO). In addition, the chapter provides a clear
understanding of the process the Office of Inspector General (OIG) must follow if a
violation of an obligation is confirmed. The process involves a coordinated effort between
the QIO, Centers for Medicare & Medicaid Services (CMS), Office of Inspector General
(OIG), and the practitioner or other persons involved.
Sanction means an exclusion or monetary penalty that the Secretary of the Department of
Health & Human Services (HHS) may impose on a practitioner or other person as a result
of a recommendation from a QIO.
In accordance with §1156(a) of the Social Security Act (Act), it is the obligation of any
health care practitioner and any other person (including a hospital or other health care
facility, organization, or agency) who provides health care services for which payment
may be made (in whole or in part) under this Act to assure, to the extent of his/her
authority, that services or items ordered or provided by such practitioner or person to
beneficiaries and recipients meet certain criteria. The following three statutory obligations
of practitioners and other persons, if not met, may form the basis for the initiation of a
sanction action:
1. 	Services or items ordered or furnished to Medicare patients are to be provided
economically and only when, and to the extent, medically necessary;
2. 	Services or items ordered or furnished are supported by evidence of medical
necessity and quality in the form and fashion (and at such time) that the QIO may
reasonably require for review (including copies) in exercising QIO duties and
responsibilities; and
3. 	Services or items ordered or furnished are to be of a quality that meets
professionally recognized standards of care.
In addition:
• 	When identifying a violation (see 42 CFR §1004.40), the QIO must indicate
whether the violation is a gross and flagrant violation or is a substantial violation in
a substantial number of cases (three or more instances involving a separate
admission). (See §9010 – Definitions Related to Sanctions.)

• 	When considering the sanction process, the QIO must consider the degree that the
practitioner’s actions were inconsistent with the professional knowledge at the time
care was provided and the degree of harm that occurred to the patient.
The QIO plays a key role in identifying quality of care issues that warrant a referral for
sanction activity, preparing the case for CMS and OIG, and coordinating and
communicating with the practitioner or other persons of concern. Best practices for QIO
operations in this area are that the QIO Sanction Committee and QIO Sanction Panel
should oversee and monitor the process to ensure that timelines are met, processes are
followed, and regulatory requirements are met. Upon a finding of a violation and failure
of the health care provider to resolve the matter, the QIO initiates the sanction process by
notifying the practitioner or other persons and submitting a detailed report to OIG for
review and consideration for sanction.
The remainder of this section is organized in accordance with the review process flow
from the QIO’s identification, notification, and reporting of a violation through the
detailed process that OIG follows in the imposition of a sanction through the appeal
process.
9005 – Authority
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Unless otherwise noted, statutory cites are to the Act). This section is based on, and
interprets the following authority:
§1156(a) identifies the obligations of health care practitioners and other persons (e.g.,
hospitals or other health care facilities, organizations, or agencies) who provide or order
healthcare services for which payment may be made under the Medicare or State health
care programs.
§1156(b) (1) requires that the QIO provide the practitioner or other person with notice, an
opportunity for discussion, and if appropriate, the opportunity to enter into and complete a
Corrective Action Plan.
§1156(b) provides the sanctions for a violation of the obligations in §1156(a), including
exclusion for a period of no less than 1 year or payment of an amount of up to$10,000 for
each instance in which improper or unnecessary services were furnished, ordered, or
prescribed, if appropriate).
§1156 (b)(5) (added by §4095 of the Omnibus Budget Reconciliation Act of 1987 (as
amended by §401(c)(1) of PL No. 101-597) establishes certain pre-exclusion appeal rights
for practitioners or other persons located in rural health professional shortage areas or in
counties with a population of less than 70,000 people.
42 CFR §480.139 governs disclosure of QIO deliberations.

42 CFR §1001.1901 provides the scope and effect of exclusions from Federal health care
programs of individuals and entities under Title 42 of the Code of Federal Regulations,
including certain exceptions to exclusions.
42 CFR §1001.3001-3005 describes the reinstatement process for excluded individuals
who request reinstatement to OIG.
42 CFR §1004.10 describes the statutory obligations of practitioners and other persons
who furnish services or order services.
42 CFR §1004.20 explains sanction actions that may be taken upon a finding by a QIO of
a violation of the obligations of §1156(a) and 42 CFR §1004.10.
42 CFR §1004.30 explains the basic responsibilities of a QIO in connection with
compliance by a practitioner or other person with §1156(a) and 42 CFR §1004.10.
42 CFR §1004.40 describes the actions a QIO must take when a violation of 42 CFR
§1004.10 is identified, including identifying the type of violation, obligations involved, the
situation or circumstances involved, suggested method for correcting the situation (if
appropriate), and rights of practitioners or other persons.
42 CFR §1004.40(b)(6) identifies the right of the practitioner or other person to request a
meeting with the QIO and the parameters of such a meeting.
42 CFR §1004.50 describes the QIO’s responsibilities when meeting with a practitioner
or other person who has been notified of a violation pursuant to §1004.4.
42 CFR §1004.60 describes the actions a QIO must take and certain requirements it must
meet when it affirms, modifies, or resolves its findings about a violation.
42 CFR §1004.70 describes the action a QIO must take on final finding of a violation if
the finding is not resolved to the QIO’s satisfaction as specified in 42 CFR §1004.60(a),
including submission of a report to OIG and providing notice to the practitioner or other
person.
42 CFR §1004.80 governs the QIO report to OIG for any violations identified by the QIO
that have not been resolved.
42 CFR §1004.90 requires the QIO to provide specific recommendations based on
documentation provided to OIG for consideration.
42 CFR §1004.100 describes OIG responsibilities upon receipt of the QIO report and
provides for an exclusion, as recommended by the QIO, to take effect after 120 days if
OIG does not make a determination.
42 CFR §1004.110 specifies the requirements for the issuance of the Notice of Sanction,

including an opportunity for the practitioner or other person to elect to notify patients.
42 CFR §§1004.120 – 1004.130 address the exclusion and reinstatement.
42 CFR §1004.140 provides for the limited appeal rights.
9010 – Definitions Related to Sanctions
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Dentist is limited to licensed doctors of dental surgery or dental medicine.
Economically means the services are provided at the least expensive, medically
appropriate type of setting or level of care available.
Exclusion means that items and services furnished or ordered (or at the medical direction
or on the prescription of a physician) by a specified health care practitioner, provider, or
other person during a specified period are not reimbursed under titles V, XVIII, XIX, or
XX of the Social Security Act and all other Federal non-procurement programs.
Federal Health Care Program means any plan or program that provides health benefits,
whether directly or indirectly, through insurance, or otherwise, which is funded directly or
in whole part by the United States Government or any State health care program in
accordance with 1128B(f)and (h) of the Act
Gross and flagrant violation means a violation of an obligation has occurred in one or
more instances that presents an imminent danger to the health, safety, or well-being of a
program patient or places the program patient unnecessarily in high-risk situations.
Health care service or services means services or items for which payment may be made
(in whole or in part) under the Medicare or State health care programs.
Health professional shortage area (HPSA) refers to an area designated by the HHS
Secretary and defined in 42 CFR 5.2.
Medicare Health Plan(s)(MHP): For the purpose of this chapter, this is a collective
reference to Medicare Part C Health Plans (Medicare Health Plans), Medicare Part D
Drug Plans, Cost Plans, and Health Care Prepayment Plans (HCPPs).
Metropolitan Statistical Area refers to an area defined by the Executive Office of
Management and Budget.
Obligation means any of the obligations specified in §1156(a) of the Act and 42 CFR
§1004.10.
Other person means a hospital, another health care facility, an organization, or an agency
that provides health care services or to which payment may be made (in whole or in part)
under the Medicare or State health care programs.

Pattern of care means that the care under question has been demonstrated in more than
three instances, each of which involved different admissions.
Pharmacy professional is a term limited to individuals who are licensed or registered to
provide pharmaceutical services.
Podiatric professional is a term limited to licensed doctors of podiatric medicine.
Practice area means the location where more than 50 percent of the practitioner’s or
other person’s patients are seen.
Practitioner means a physician or other health care professional licensed under State law
to practice his/her profession.
Primary medical care professional is a term limited to:
(i) Licensed doctors of medicine and doctors of osteopathy providing direct patient
care who practice in the fields of general or family practice, general internal
medicine, pediatrics, obstetrics and gynecology, surgery, and any other specialty
that is not accommodated by the remaining specialty HPSA designator, or
(ii) Facilities where care and treatment is provided to patients with health
problems other than mental disorders.
Pro area/QIO area means the geographic area subject to review by a particular QIO.
Provider means a hospital or other health care facility, agency, or organization.
Psychiatric professional is a term limited to licensed doctors of medicine who limit their
practice to psychiatry or to those facilities where care and treatment is limited to patients
with mental disorders.
Reporting Threshold means a practitioner or other person has either (a) failed
substantially to comply with any obligation in a substantial number (three or more) of
admissions, or (b) grossly and flagrantly violated any obligation in one or more instances.
Rural means any area outside an urban area.
Rural health professional shortage area means any health professional shortage area
located outside a Metropolitan Statistical Area.
Sanction means an exclusion or monetary penalty that the HHS Secretary may impose on
a practitioner or other person as a result of a recommendation from a QIO.

Serious risk includes situations that may involve the risk of unnecessary treatment,
prolonged treatment, and lack of treatment, incorrect treatment, medical complication,
premature discharge, physiological or anatomical impairment, disability, or death.
State health care program means a State plan approved under title XIX, any program
receiving funds under title V or from an allotment to a State under such title, or any
program receiving funds under title XX or from an allotment to a State under such title.
Substantial violation in a substantial number of cases means a pattern of providing care,
as defined in this section that is inappropriate, unnecessary, or does not meet recognized
professional standards of care, or is not supported by the necessary documentation of care
as required by the QIO.
Urban refers to a Metropolitan Statistical Area as defined by the Executive Office of
Management and Budget.
Vision care professional is a term limited to licensed doctors of medicine who limit their
practice to ophthalmology and to doctors of optometry.
9015 – Roles and Responsibilities
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9015.1 – QIO Role and Responsibilities
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The QIO may identify a potential violation for peer review through individual case
reviews, including beneficiary complaints and other general quality of care reviews (see
42 CFR 476 and the QIO Manual Chapters that address quality of care reviews.). Quality
of care issues may also be referred from other QIOs and other agencies for review by a
QIO physician peer reviewer. (See Chapter 5.)
This includes Medicare Administrative Contractors (MACs), Medicare health
plans(MHPs), State survey and certification agencies (SSA), other CMS contractors, CMS,
as well as other Federal Government organizations outside of CMS (e.g. the Office of
Inspector General, Department of Justice [DOJ], or Office for Civil Rights),
The QIO is responsible for ensuring that the sanction process and plan is followed in
accordance with applicable law, including 42 CFR 480, which addresses confidentiality
and disclosure requirements. (See also QIO Manual Chapter 10.)
The QIO has the following responsibilities:
(1) 	Use its authority or influence to enlist the support of other professional or
government agencies to ensure that each practitioner or other person
complies with the obligations specified in §1156(a) and 42 CFR §1004.10.

(2) 	Based on case reviews the QIO conducted (see 42 CFR part 476) and
referrals from other entities, preliminarily identify situations where an
obligation specified in 42 CFR §1004.10 is violated and identify whether the
violation meets the standard for reporting to OIG.
(3) 	Provide notice to the practitioner or other person of the preliminary finding
and an opportunity for discussion.
(4) 	If appropriate, provide an opportunity (and a suggested method) for
correcting the situation and a time period for a corrective action. (See 42
CFR §1004.40.)
(5) 	Make a final finding:
• 	To close the case where no violation has been found to be a gross and
flagrant violation or where no substantial violation is identified in a
substantial number of cases;
• 	That the violation has been resolved based on satisfactory compliance
with the corrective action plan; or
• 	To affirm or modify the initial finding that a violation is gross and
flagrant or a substantial violation in a substantial number of cases,
which must be reported to OIG.
(6) 	After making a final finding, report to OIG, in the form and manner required
by 42 CFR §1004.80, if the QIO finds that the practitioner or other person
has:
(A) Failed substantially to comply with any obligation in a substantial
number (three or more) of admissions; or
(B) Grossly and flagrantly violated any obligation in one or more
instances.
(7) 	Issue denial of payment for services or items furnished or ordered (or at the
medical direction or on the prescription of an excluded physician) by an
excluded practitioner or other person when the QIO identifies such services or
items.
NOTE: The QIO must report the findings to CMS.
NOTE: The “reporting threshold” is when the practitioner or other person has either:
(a) 	failed substantially to comply with any obligation in a substantial number
(three or more) of admissions; or

(b) 	grossly and flagrantly violated any obligation in one or more instances.
9015.1.1 – QIO Sanction Committee
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
To properly identify a violation and determine whether a practitioner or other person has
committed a gross and flagrant violation in one or more instances, or a substantial
violation in a substantial number of cases, the QIO should convene a Sanction Committee
to receive and review all cases initially identified as a violation meeting one of those
standards by a QIO peer reviewer. Use of a Sanction Committee ensures that consistent
standards and judgment are applied when the QIO identifies a gross and flagrant
violation in one or more instances, or a substantial violation in a substantial number of
cases.
The QIO Sanction Committee should comprise at least three QIO staff and/or board
members and include the Review Manager and Medical Director.
NOTE: No person who is part of the initial identification of a violation and indicated
whether the practitioner or other person has committed a gross and flagrant violation in
one or more instances, or a substantial violation in a substantial number of cases—except
for the QIO Review Manager and QIO Medical Director - should be a member of the QIO
Sanction Panel that attends a requested meeting with the practitioner or other person.
Neither shall any individual who was part of the Sanction Committee nor the peer
reviewer that identifies a potential violation participate in the final recommendation for
the final QIO finding and report to OIG. (See 42 CFR §1004.50.)
The QIO Sanction Committee should complete the following:
1. 	Receive the case upon initial referral from the peer reviewer;
2. 	Make its recommendation based on all three Physician Reviewers’ determinations.
In most cases, this means basing a recommendation on the majority of the
determinations; and
3. 	Complete its review and finding within two (2) business days after the two
additional reviews have been completed.
• 	If the QIO Sanction Committee does not identify a violation that meets the
reporting threshold, then the original case review process (e.g., beneficiary
complaint review, general quality of care review) proceeds in its normal
course.
 	If the QIO Sanction Committee identifies a violation that meets the reporting
threshold, then the QIO must notify the CMS Regional Office Contracting

Officer’s Representative (COR) within 1 business day after the sanction
recommendation is made. (See §9025.2.)
9015.1.2 – QIO Sanction Panel
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
For each violation, the QIO must convene a QIO Sanction Panel to attend a meeting with
a practitioner or other person regarding the violation and to make the final QIO finding.
The QIO Medical Director and appropriate review department staff should designate the
members of the QIO Sanction Panel. The QIO Sanction Panel must consist of a minimum
of three physician peer reviewers in addition to the QIO Medical Director and Review
Staff (42 CFR §1004.50).
The QIO Sanction Panel:
• 	Ensures that violations are reviewed and findings made in accordance with 42
CFR Part 1004, including maintaining proper documentation.
• 	Ensures that the appropriate members participate in the sanction meeting (either
in person or via teleconference) with the practitioner or other person.
• 	Oversees the monitoring of the physicians and/or other persons who are under
Corrective Action Plans (CAPs).
• 	Reviews the case(s) and prepares the final QIO finding for the report to the Office
of Inspector General (OIG), if required.
• 	Communicates with and responds to OIG regarding QIO reports when required.
9015.1.3 – Use of CMS-Designated Case Review System
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Pursuant to the contract between the QIO and CMS, QIOs are required to use the CMS-
designated case review system to record all data/information collected at the time a
determination for sanction activity is obtained, using the designated Sanction Activity
Module. Data entry should be completed as each step in the sanction process occurs. The
QIOs will refer to the appropriate Case Review System User’s Guide for instructions as
directed by CMS.
9015.2 – CMS Responsibilities
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The designated CMS COR serves as the point of contact between the QIO and CMS during
the sanction review process. CMS may issue guidance to QIOs about the Sanction process.

9015.3 – OIG Responsibilities
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
OIG receives and reviews the QIO report of a final finding. OIG has the authority to
determine if a violation of an obligation has occurred and, if so, the appropriate sanction
to be imposed.
OIG is responsible for all ongoing communications with the practitioner or other persons
and the QIO, including:
• 	The outcome of its decision about whether a violation occurred;
• 	The decision to sanction and type of sanction to be imposed;
• 	Notification of other entities as appropriate; and
• 	Reinstatement when appropriate after exclusion.
9020 – Identification of Potential Violations
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The following are the three statutory obligations of practitioners and other persons that, if
not met, may form the basis for the initiation of a sanction action (see §1856(a) of the Act
and 42 CFR §1004.10):
1. 	Services or items ordered or furnished to Medicare patients are to be provided
economically and only when, and to the extent, medically necessary.
2. 	Services or items ordered or furnished are supported by evidence of medical
necessity and quality in the form and fashion (and at such time) that the QIO may
reasonably require for review (including copies) in exercising the QIO’s duties and
responsibilities.
3. 	Items or services ordered or furnished are to be of a quality that meets
professionally recognized standards of care.
After its final finding identifying a violation that is gross and flagrant or is a substantial
violation in three or more instances, the QIO must submit a report to OIG. (The
“reporting threshold” is when the practitioner or other person has either:
(a) failed substantially to comply with any obligation in a substantial number (three or
more) of admissions; or
(b) grossly and flagrantly violated any obligation in one or more instances.
See 42 CFR §1004.30 and §9010 of this Chapter 9 for the definition of Gross and Flagrant

and Substantial Violation in three or more instances.) When considering the sanction to
recommend as part of its report, the QIO must consider the degree that the practitioner’s
actions were inconsistent with the professional knowledge at the time care was provided
and the degree of harm that occurred to the patient.
9020.1 – How Violations Are Initially Identified
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Potential violations can only be identified through a QIO physician reviewer’s review of a
practitioner’s or other person’s statutory obligations. This review may occur in a number
of ways, including:
• 	The QIO’s examination of a practitioner's or other person's services furnished, in
the conduct of multiple case reviews by multiple physician reviewers;
• 	An individual case review completed by one physician reviewer; or
• 	A referral from another entity, such as the QIO‘s Physician Reviewer, a
subcontractor providing physician peer review services, another QIO, the MAC,
licensing and certification agencies, CMS, or OIG.
Potential violations of the obligations listed in §9020 above are initially identified and
referred to the QIO for a sanction review as described in §9025 below.
9020.2 – Statutory Obligations – Practitioner’s or Others Person’s Services
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The following are examples of potential violations that may form the basis for the
initiation of a sanction action:
1. 	Standard: Services or items ordered or furnished to Medicare patients are to be
provided economically and only when, and to the extent, medically necessary.
EXAMPLE: Ordering or furnishing inappropriate or unnecessary invasive
procedures. Practitioners who implant permanent cardiac pacemakers without
clear and appropriate indications may be in violation of their obligation to provide
only services that are medically necessary.
2. 	Standard: Services or items ordered or furnished are supported by evidence of
medical necessity and quality in the form and fashion (and at such time) that you
may reasonably require for review (including copies) in exercising your duties and
responsibilities.
EXAMPLE: When the QIO conducts reviews to make decisions about the medical
necessity of services, a certain provider consistently has insufficient documentation
to support the medical necessity of the services furnished.

3. 	Standard: Items or services ordered or furnished are to be of a quality that meets
professionally recognized standards of care.
EXAMPLE: Hospital readmissions resulting from premature discharges.
Practitioners and other persons who discharge patients prematurely may be in
violation of their obligation to provide services of a quality that meets
professionally recognized standards.
9025 – QIO s – Development of a Sanction Case
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9025.1 – Sanction Committee Initial Review
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Only violations that the original peer reviewer determines meet the gross and
flagrant/substantial violation or is a substantial violation in a substantial number of cases
are sent to the Sanction Committee for sanction review. (See §9020.1.) The QIO must
identify a violation and indicate whether the violation is a gross and flagrant violation or
a substantial violation in a substantial number of cases. The referral should include at
least the following information and documentation:
• 	All physician reviewer Quality Review Determination (QRD) forms;
• 	All medical information and documentation used in the review process;
• 	All determination letter/correspondence with practitioners/providers;
• 	Information received related to the offer of the Opportunity for Discussion Stage,
if applicable; and
• 	Any new evidence submitted in requesting the Reconsideration, if applicable.
To properly identify a violation and determine whether a violation is gross and flagrant or
a substantial violation in a substantial number of cases (the “reporting threshold”), the
QIO should convene a Sanction Committee to receive and review all cases that have been
initially identified as a violation meeting the reporting threshold. In addition to the initial
review and identification of a violation that meets the reporting threshold that triggers
referral for a sanction review, at least two additional physician reviewers with similar
training as the practitioner or other person of concern should complete an additional
review of the case(s), and complete a written summary of their review findings.
These two additional case reviews should be completed within Five (5) business days and
submitted to the QIO Sanction Committee. The Committee should make its initial finding
within two (2) business days after these two additional reviews are completed.

The Sanction Committee makes an initial finding based on all three reviews (i.e., the
determinations of the original Physician Reviewer and two additional Peer Reviewers).
This initial finding determines how 42 CFR §1004.40 is applied:
• 	If the initial finding of the QIO Sanction Committee is that either (1) a
violation did not occur or (2) the violation did not meet the reporting
threshold, the QIO returns the case for continued processing of the case review
that initiated the review of the QIO Sanction Committee. Case reviews are
described in 42 CFR Part 476, and guidance on the case review process is
provided in Chapter 5 of the QIO Manual.
• 	If the QIO Sanction Committee finds that a violation that meets the reporting
threshold occurred, the QIO proceeds with notification to the practitioner or
other person. In addition, the QIO notifies the CMS COR of the initial finding
and that the QIO is initiating action under 42 CFR §1004.40.
NOTE: Any time the QIO makes an initial finding of a violation meeting the reporting
threshold that involves a MHP as defined in Section 9010, the QIO must notify the COR
and the respective Regional Office’s (RO) Division of Health Plans and Providers. The
QIO must continue to notify the COR and the RO’s Division of Health Plans and
Providers through each progressive step in the sanction review process and through the
final QIO finding and report to OIG. Medicare Health Plans include Medicare Part C
Plans (Medicare Health Plans), Medicare Part D Drug Plans, and cost plans under §1876
of the Act.
9025.2 – Written Notification to Practitioner or Other Person
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Under 42 CFR §1004.40, the QIO must send the practitioner or other person written
notice of the initial finding and other information. The QIO Sanction Panel should issue
this notice within two (2) business days of making the initial finding and notifying the
COR. (See Appendices 9.2, 9-5, and 9.8 for Initial Notification Model Letters.)
The written notification must include at least:
• 	Obligation(s) involved;
• 	Situation, circumstances, or activity that resulted in the violation;
• 	Authority and responsibility of the QIO to report violations of any obligation under
§1156(a) of the Act;
• 	Suggested method for correcting the situation and a time period for corrective
action, if appropriate;
• 	Sanction the QIO could recommend to OIG (see 42 CFR §1004.40);

• 	Right of the practitioner or other person to submit to the QIO within 30 days of
receiving the notice additional information and/or a written request for a meeting
with the QIO to review and discuss the finding (the date of receipt is 5 days after
the date on the notice, unless there is reasonable showing to the contrary); and
• 	Copy of the material the QIO used in arriving at its findings, except for the QIO
deliberations, as set forth in 42 CFR §480.139.
NOTE: Any time the QIO activates the sanction process against a Medicare Health Plan,
the QIO must notify the COR, the respective Regional Office’s (RO) Division for Medicare
Health Plan Operations, and Providers and include with that notice a copy of the initial
notice to the Health Plan.
9030 – Initial Meeting with Practitioner or Other Person – Requirements
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
If the practitioner or other person requests a meeting with the QIO within 30 days of
receiving notice of the initial QIO finding, the meeting will be with the QIO Sanction
Panel. (See 42 CFR §§1004.40(b)(6) and 1004.50.)
9030.1 - Composition of the QIO Sanction Panel
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The panel selection must meet the following requirements:
• 	The QIO Sanction Panel must consist of a minimum of three physicians.
• 	The QIO peer reviewer who was responsible for the medical judgment and
development of the initial finding of a potential violation that triggers a referral of
a practitioner or other person to the QIO for sanction (i.e., the peer reviewer
responsible for the referral to the QIO Sanction Committee) may not vote on the
recommendation at a QIO Sanction Panel meeting. The reviewers who complete
additional reviews and provide input to the Sanction Committee (see §9025.1) may
also not vote on the recommendation at a QIO Sanction Panel meeting.
• 	No physician member of the QIO Sanction Panel may be in direct economic
competition with the practitioner or other person being considered for sanction
review.
• 	No physician member of the QIO Sanction Panel may have a substantial bias for
or against the practitioner or other person being considered for sanction.
• 	At least one member of the QIO Sanction Panel meeting with the practitioner or
other person must practice in a similar geographic area (e.g., urban or rural), and
at least one member of the panel must be in the same specialty. One individual

could meet both requirements.
A dentist, optometrist, podiatrist, etc. should be included on the Sanction Panel as
necessary to accomplish equitable peer/provider review. An osteopath should be
included on the QIO Sanction panel when the physician under review is a Doctor
of Osteopathy.
• 	When appropriate, the QIO Sanction Panel should include rural hospital
representation.
• 	When appropriate, the QIO Sanction Panel should include representation from
across the State.
• 	When the sanction involves a provider of services (as defined in §1861 of the
Social Security Act) or a facility, health care practitioners other than physicians
may be added to the QIO Sanction Panel as necessary—e.g., administrators,
directors of nursing, directors of laboratory services. These professionals should
be from a provider/facility similar in size as the involved provider/facility and from
the appropriate rural versus urban area. See 42 CFR §§1004.50, 1004.60.
9030.2 - Requirements for the Meeting
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The meeting must be held within 30 days of when the QIO received the request, but this
time period may be extended for good cause. The QIO may allow the practitioner or other
person five (5) business days after the meeting to provide additional relevant information
that may affect their finding.
The practitioner or other person has the following rights at the meeting:
• 	The practitioner or other person may have an attorney present. The attorney, if
present, must be permitted to make opening and closing remarks, ask clarifying
questions, and assist the practitioner or other person in presenting testimony of
expert witnesses who may appear on behalf of the practitioner or other person.
• 	Three physicians from the QIO Sanction Panel must attend the meeting, in person
or by conference call.
• 	A verbatim record must be made of the meeting and made available to the
practitioner or other person promptly.
The QIO may also have an attorney present at the sanction meeting, but this is not
required and often is not necessary. The meeting is not a legal hearing but instead a
chance for the involved practitioner to present additional information and seek
clarification.

9035 – QIO Sanction Panel – Initial Sanction Recommendation
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9035.1 – QIO Review of Additional Information
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The QIO Sanction Panel must review any additional information received, at the meeting
or in writing after the meeting, as part of its consideration of the initial finding and
decision on its final finding.
9035.2 – QIO Sanction Panel Determination/Action
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
A majority vote of the peer reviewers who are members of the QIO Sanction Panel makes
the determination.
The QIO peer reviewer who was responsible for the medical judgment and development of
the initial finding of a potential violation that triggers a referral of a practitioner or other
person to the QIO for sanction (i.e., the peer reviewer responsible for the referral to the
QIO Sanction Committee) may not vote on the recommendation at a meeting of the QIO
Sanction Panel.
The reviewers who complete additional reviews and provide input to the Sanction
Committee (see §9025.1) may also not vote on the recommendation at a meeting of the
QIO Sanction Panel. Such individuals may be present at the meeting.
The actions the QIO Sanction Panel may take as a result of the additional information are
as follows:
a. 	Deferment of Finding: The Sanction Panel may accept or suggest a proposed
method of corrective action and timeframe for completion. (See §9035.3 below.)
Should this occur, a final QIO finding (of violation and recommended sanction) is
not made until the appropriate amount of time has elapsed for re-evaluation of the
physician or provider.
o 	If the corrective action is not taken within the specified timeframe, if a
timeframe and/or corrective action cannot be agreed upon, or if previous
corrective action plan(s) have been unsuccessful, and a gross and flagrant
violation or a substantial violation in three or more instances is confirmed,
deferment is not an option.
o 	If the finding is resolved to the QIO’s satisfaction, the QIO may either (a)
modify the initial finding and recommendation or (b) close the case as
resolved.
b. 	Reversal of Initial Finding: If the Sanction Panel members believe the additional

information presented is sufficient and that the reporting threshold has not been
met, one of the following actions can be taken:
1. 	The initial finding is reversed/resolved; or
2. 	The Panel may determine an alternate method of corrective action and
follow-up should problems remain evident that does not meet the
definitions of “gross and flagrant” or “substantial.” The Panel will
forward these confirmed quality of care concerns to the QIO’s Quality
Improvement Committee/Department for monitoring or other action.
c. 	Affirmation of Initial Finding: The Sanction Panel may decide to uphold (in
whole or in part) the initial finding of a violation and take one of the following
actions:
1. 	Refer to OIG immediately. See §9040 below; or
2. 	Recommend a written Corrective Action Plan. See §9035.3 below.
If the QIO determines, after careful consideration, that implementation of a CAP would
not be appropriate, the QIO should carefully document the rationale for the decision and
include this documentation in the report to OIG.
Written notice of the QIO action taken must be provided to the practitioner or individual
under review. (See 43 CFR §1004.60(b).)
9035.3 – QIO Corrective Action Plan (CAP) Process and Procedures
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
If the QIO Sanction Panel defers a final finding or affirms the initial findings, the Panel
may suggest a written method of correction be initiated for the situation. (See 42 CFR
§1004.60.) The QIO Sanction Panel should monitor the practitioner’s or other person’s
compliance with the corrective action plan.
The QIO has the flexibility and may use its discretion in working with the practitioner or
other person when a CAP is appropriate. When providing the written CAP, the QIO
should allot a time period when the QIO expects the situation to be corrected. This CAP
may be in conjunction with or a continuation of a prior CAP, or may be a new proposal
based on additional information received. If the initial findings are resolved to the QIO’s
satisfaction, the QIO may modify the initial finding or recommend that the case be closed.
See §9035.2 above.
9035.3.1 – Corrective Action Plan (CAP) Request
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The QIO Sanction Panel may suggest that the provider/practitioner submit a written CAP

as appropriate. If requested from the practitioner or other person, the written CAP should
be submitted to the QIO Sanction Panel within 30 days of request. The QIO Sanction
Panel must review a written CAP that the practitioner or other person submits and the
panel must approve or request modifications to it.
Regardless of whether submitted by the practitioner or other person or developed by the
QIO Sanction Panel, the CAP should include timeframes and a method of follow-up
evaluation and provide clear instructions on what constitutes successful completion of the
CAP.
The QIO must communicate the CAP to the practitioner or other person in writing and
should document acceptance of the CAP by having the practitioner or other person sign
and return a copy of the CAP to the QIO.
9035.3.2 – Monitoring a Corrective Action Plan (CAP)
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The QIO Sanction Panel should monitor and review the outcome of a CAP and determine
if the actions a practitioner takes are acceptable. The practitioner or other person must
demonstrate improvement using quantifiable measures; CMS recommends that CAPs be
monitored over a twelve (12) month period.
The QIO Sanction Panel should, at minimum, evaluate the practitioner’s results on a
quarterly basis.
• 	If at any time the QIO Sanction Panel identifies additional gross and flagrant
violations or a substantial violation in three or more instances, the Sanction Panel
should initiate the sanction review process by making a referral for an initial
finding as described in Sections 9020.1 and 9025 above.
• 	The QIO Sanction Panel may end the CAP before its planned end to pursue a
sanction recommendation to OIG if the Sanction Panel determines patients to be in
imminent danger.
• 	After the CAP ends, if the QIO Sanction Panel determines that the CAP resulted in
measureable improvement and that the finding has been resolved to the QIO’s
satisfaction, the case should be closed as resolved.
• 	If after the CAP ends, the QIO Sanction Panel determines the results not to be
acceptable, the QIO refers the matter to OIG. (See §9040.1.) The QIO Sanction
Panel’s finding shall be based on majority vote.
9040 – QIO Action on Final Finding of a Violation
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)

9040.1 – Unresolved and Affirmed Findings
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
If the final finding affirms the initial finding(s) or the initial finding is not otherwise
resolved (See §9035 above), the QIO must:
A. 	Submit a report of its final finding and sanction recommendation to OIG.
B. 	Send the affected practitioner or other person a concurrent final notice, with a
copy of all the material that is being forwarded to OIG, advising that:
1. 	The QIO has submitted its report and recommendation to OIG.
2. 	The practitioner or other person has 30 days after receiving the final
notice to submit any additional written material or documentary
evidence to OIG at its headquarters location, including that the date of
receipt is presumed to be 5 days after the date on the notice unless
there is a reasonable showing to the contrary.
3. 	Due to the 120-day statutory requirement specified in 42 CFR
§1004.100(e), the period for submitting additional information will not
be extended, and any material that OIG receives after the 30-day
period will not be considered.
C. Provide notice to the State medical board or to other appropriate licensing
boards for other practitioner types when it submits the report and
recommendations to OIG with respect to a physician or other person whom the
board is responsible for licensing. (See 42 CFR §1004.70.)
9040.2 – Extenuating Circumstances – Practitioner or Other Person
Involved in Sanction Proceeding – Relocation
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9040.2.1 – Practitioner or Other Person – Relocation to Another QIO State
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
In a case where a practitioner or other person involved in sanction proceedings relocates
to another QIO area before a final determination of a violation has occurred or a final
sanction recommendation has been made to OIG, the QIO in the first location will follow
these procedures:
1. 	If the QIO is able to make a final finding, after complying with 42 CFR §§1004.40,
1004.50, and 1004.60, the QIO will notify the practitioner (or other person) and
either close the case or forward a report of its final finding and recommended
sanction to OIG. In addition, the QIO will notify the QIO in the State of the
practitioner’s new residence or where he/she is now practicing of the action taken.

2. 	If a final determination cannot be made, the original QIO will send a written
notification to the QIO in the State of the practitioner’s new residence or where
he/she is now practicing and to the practitioner (or other person) that a final
determination cannot be made and that the documentation is being provided to the
QIO in the new jurisdiction. The notice to the QIO in the new jurisdiction must
include all documentation regarding the case and should also include the
following:
o 	The results/findings of the QIO’s review activity and the action that could
be taken based on these results/findings;
o 	A statement that action cannot be taken because the practitioner has
relocated or is practicing outside our review area;
o 	A notice that the case is being referred to the QIO in the State where he/she
is now practicing for further action as deemed appropriate; and
o 	A statement that if the practitioner again practices in the original QIO’s
review area, the original QIO will re-evaluate the case and may reopen it
depending upon the action the receiving QIO takes.
9040.2.2 – Practitioner or Other Person – Relocation and Referral from
Another QIO
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
After receiving a referral from another QIO, the QIO that accepts the referral should:
1. 	Notify the practitioner in writing of the receipt of the referral from the
originating QIO;
2. 	Specify the action to be taken;
NOTE: The receiving QIO may or may not adhere to the recommendations of the
originating QIO. However, if the originating QIO’s recommendation is not followed,
the receiving QIO should document the rationale for why another course of action was
chosen. The QIO COR will concurrently be notified of such decisions (including
rationale).
3. 	Monitor/evaluate in accordance with the receiving QIO’s plan of action;
4. 	Issue an initial finding notice (including the right to a meeting) based on the
receiving QIO’s finding for the violation and in compliance with 42 CFR §§1004.40
and 1004.5; and;

5. 	Render a final finding, with appropriate notification(s)/ report(s) as would be
performed for any other sanction action.
9045 – QIO Report to Office of Inspector General (OIG)
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9045.1 – Manner of Reporting
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
If the violation(s) identified have not been resolved, the QIO must submit a report and its
recommendation to the OIG Office of Counsel per the contact list in Appendix 9-1. (See
42 CFR §1004.80.)
9045.1.1 – Content of Report
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The QIO report must include at least the following information:
1. 	Identification of the practitioner or other person and, when applicable, the name of
the director, administrator, or owner of the entity involved;
2. 	The type of health care services involved;
3. 	A description of each failure to comply with an obligation, including specific dates,
places, circumstances, and other relevant facts;
4. 	Pertinent documentary evidence;
5. 	Copies of written correspondence, including reports of conversations with the
practitioner or other person about the violation and, if applicable, a copy of the
verbatim transcript of the meeting with the practitioner or other person;
6. 	The QIO’s finding that an obligation under §1156(a) of the Act has been violated,
that the violation is substantial and has occurred in a substantial number of cases,
or is gross and flagrant;
7. 	A case-by-case analysis and evaluation of any additional information provided by
the practitioner or other person in response to the QIO’s initial finding;
8. 	A copy of the CAP that the QIO developed and documentation of the results of the
plan;
9. 	The number of admissions by the practitioner or other person the QIO reviewed
during the period in which the violation(s) was identified;
10. The professional qualifications of QIO reviewers; and

11. The QIO sanction recommendation.
9045.1.2 – QIO Recommendation Report Requirements
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The QIO report must specify:
1. 	Sanction recommended;
2. 	Amount of monetary penalty recommended, if applicable;
3. 	Period of exclusion recommended, if applicable;
4. 	Availability of alternative sources of services in the community, with supporting
information; and
5. 	County or counties in which the practitioner or other person furnishes services.
NOTE: The QIO’s recommendation to OIG must be based on documentation of the type of
offense involved, the severity of the offense, the deterrent value of the recommended
sanction, a consideration of the practitioner’s or other person’s previous sanction record,
the availability of alternative sources of services in the community, and any other factors
that it considers relevant such as the duration of the problem. (See 42 CFR §1004.90.)
9045.2 – OIG Rejection of QIO Recommendations
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
OIG will inform the QIO of the date it received their report and recommendation, review
the report to determine whether the QIO followed the regulatory requirements, and
determine if a violation has occurred (42CFR §1004.100). If OIG decides that a sanction
is not warranted, it notifies the QIO and the affected practitioner or other person and the
licensing board that the recommendation to sanction is rejected(See 42 CFR
§1004.100(c)).
9045.3 – OIG Process –Decision to Sanction
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
If OIG decides that a violation of an obligation has occurred, it determines the
appropriate sanction by considering the:
• 	QIO’s recommendation;
• 	Type of offense;
• 	Severity of the offense;

• 	Practitioner’s or other person’s previous sanction record;
• 	Availability of alternative sources of services in the community;
• 	Any prior problems the Medicare or State health care programs have had with the
practitioner or other person; and
• 	Any other matters relevant to the particular case.
(See 42 CFR §1004.100(d).)
9050 – OIG Imposition and Notification of Sanction
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9050.1 – Exclusion Sanction
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
If the QIO recommends exclusion and OIG does not make a decision within 120 days from
the date of receipt, the exclusion sanction the QIO recommends will become effective, and
OIG will provide notice in accordance with 42 CFR§1004.110(f).
9050.2 – Monetary Penalty
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
If the QIO’s recommendation to OIG is to assess a monetary penalty, the 120-day
provision does not apply, and OIG will provide notice in accordance with 42 CFR
§1004.110(a)-(e).
9050.3 – Notification to Practitioner or Other Person of OIG Sanction
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
OIG notifies the practitioner or other person of the adverse determination and of the
sanction to be imposed. The sanction is effective 20 days from the date of the notice. The
20 days begins when the practitioner or person received the notice, with a presumed date
of receipt that is five (5) days after the date on the notice unless there is a reasonable
showing to the contrary.
9050.3.1 – Written Notice Contents – Specifications
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The notice must specify: (See 42 CFR §1004.110(c))
1. 	Legal and factual basis for the determination;

2. 	Sanction to be imposed (e.g., exclusion or monetary penalty);
3. 	Effective date and, if appropriate, the duration of the exclusion;
4. 	Appeal rights of the practitioner or other person;
5. 	Opportunity and process necessary for the practitioner or other person to use
alternative notification of patients and others (See 42 CFR §§1004.110(d) and
(e)); and
6. 	In the case of exclusion, the earliest date OIG will accept a request for
reinstatement.
9050.4 – Patient Notification
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9050.4.1 – Practitioner Elects to Inform Patients
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
OIG will provide a sanctioned practitioner or other person an opportunity to elect to
inform each of their patients of the sanction action. To elect this option, the sanctioned
practitioner or other person must, within 30 calendar days of receiving OIG’s notice,
inform both new patients and existing patients through written notice, based on a
suggested (non-mandatory) model that OIG provide to the sanctioned individual, of the
sanction and, in the case of exclusion, its effective date.
Receipt of OIG’s notice is presumed to be five (5) days after the date of the notice, unless
there is a reasonable showing to the contrary. Within this same period, the practitioner or
other person must sign and return the certification that OIG will provide with the notice.
NOTE: For the purpose of this section, the term “all existing patients” includes patients
currently under active treatment with the practitioner or other person as well as all
patients who the practitioner or other person has treated within the last 3 years. In
addition, the practitioner or other person must notify all prospective patients orally at the
time such person requests an appointment.
9050.4.2 – Sanctioned Party Is a Hospital – Notification Requirements
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
If the sanctioned party is a hospital, it must notify all physicians who have privileges at the
hospital and must post a notice in its emergency room, business office, and “in all
affiliated entities” regarding the exclusion. The term “in all affiliated entities”
encompasses all entities and properties in which the hospital has a direct or indirect
ownership interest of 5 percent or more, and any management, partnership, or control of
the entity.

9050.4.3 – Provider or Other Person Certification Provisions
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The certification will state that the practitioner or other person:
1. 	Has informed each of his/her patients in writing that the practitioner or other
person has been sanctioned, or, if a hospital, has informed all physicians having
privileges at the hospital that it has been sanctioned;
2. 	If excluded from Medicare and the State health care programs, has informed
his/her existing patients in writing that the programs will not pay for items and
services the practitioner or other person furnished or ordered (or at the medical
direction or on the prescription of an excluded physician) until he/she is reinstated,
or, if a hospital, has provided this information to all physicians having privileges
at that hospital;
3. 	If excluded from Medicare and State health care programs, will provide
prospective patients—or, if a hospital, physicians requesting privileges at that
hospital prior to furnishing or ordering (or in the case of an excluded physician,
medically directing or prescribing) services—oral information of both the sanction
and that the programs will not pay for services provided, and written notification
of the same at the time of the provision of services;
4. 	If excluded from Medicare and State health care programs and is an entity such as
a hospital, has posted a notice in its emergency room, business office, and in all
affiliated entities that the programs will not pay for services provided; and
5. 	Certifies to the truthfulness and accuracy of the notification and the statement in
the certification.
If the sanctioned practitioner or other person
(1) Does not inform his/her patients and does not return the required certification
within the 30-day period; or
(2) Returns the certification within the 30-day period but OIG obtains reliable
evidence that such person nevertheless has not adequately informed new and
existing patients of the sanction, OIG:
• 	Will see that the public is notified directly of the identity of the sanctioned
practitioner or other person, the finding that the obligation has been violated, and
the effective date of any exclusion; and
• 	May consider this failure to adhere to the certification obligation as an adverse
factor at the time the sanctioned practitioner or other person requests
reinstatement.

If the sanctioned practitioner or other person is entitled to a preliminary hearing in
accordance with 42 CFR 1004.140(a) and requests such a preliminary hearing, and the
Administrative Law Judge (ALJ) decides that he/she poses a risk to program beneficiaries,
the sanctioned practitioner or other person would have 30 days from the date of receiving
the ALJ’s decision to provide certification to OIG in accordance with 42 CFR
1004.110(d)(1). The date of receipt is presumed to be five (5) days after the date of the
ALJ’s decision, unless there is a reasonable showing to the contrary.
9050.4.4 – Notice to Other Interested Parties
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
In addition to notifying patients and the notice required by a hospital, the OIG provides
notice of the sanction to the following entities as appropriate:
1. 	The QIO that originated the sanction report;
2. 	QIOs in adjacent areas;
3. 	State Medicaid fraud control units and State licensing and accreditation bodies;
4. 	Appropriate program contractors and State agencies;
5. 	Hospitals, including the hospital where the sanctioned individual's case originated
and where the individual currently has privileges, if known; skilled nursing
facilities, home health agencies, health maintenance organizations, and federally
funded community health centers where the practitioner or other person works;
6. 	Medical societies and other professional organizations; and
7. 	Medicare administrative contractors (MACs), MHPs, health care repayment plans,
and other affected agencies and organizations.
9050.5 – Imposing an Exclusion Sanction – OIG Responsibilities
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
If an exclusion sanction is imposed because a decision was not made within 120 days after
receipt of the QIO recommendation, notification is as follows: (See 42 CFR 1004.110(f).)
1. 	As soon as possible after the 120th day, OIG will issue a notice to the practitioner
or other person affirming the QIO recommendation based on OIG’s review of the
case and that the exclusion is effective 20 days from the date of the notice; and
2. 	Notice of sanction is provided as specified in §9050.4.4.

9055 – Effect of an Exclusion Sanction on Medicare Payments and
Services
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9055.1 – Payment to an Excluded Practitioner or Other Person –
Regulatory Requirements
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
1. 	Payment will not be made under the Medicare, Medicaid, or any other Federal
health care programs as defined in §1128B(f) of the Act, including State health
care programs as defined in §1128(h), to an excluded practitioner or other person
for items or services furnished, ordered, or prescribed during the period of
exclusion.
2. 	Payment will not be made under Medicare, Medicaid, or any other Federal health
care programs to any provider for items or services ordered by an excluded
practitioner or other person when the order was a necessary precondition for
payment under Medicare when the person furnishing the item or service knew or
had reason to know of the exclusion.
3. 	Assignment of a beneficiary’s claim for items or services furnished or ordered by
an excluded practitioner or other person on or after the effective date of exclusion
will not be valid.
9055.2 – Exceptions to Denial of Medicare Payment (Exclusion) –
Regulatory Requirements
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Unless the HHS Secretary determines that the health and safety of beneficiaries warrants
the exclusion taking effect earlier, payment may be made for services or items provided up
to thirty (30) days after the effective date of exclusion for:
• 	Inpatient hospital or skilled nursing services or items furnished to a beneficiary
who was admitted before the effective date of the exclusion;
• 	Home health services and hospice care items furnished under a plan established
before the effective date of the exclusion; or
• 	Any health care items that a practitioner, provider, or supplier orders from an
excluded manufacturer before the effective date of the exclusion and delivered
within thirty (30) days of the effective date of such exclusion.
9055.3 – CMS Payment to Beneficiaries – Regulatory Requirements
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)

If a beneficiary submits claims for items or services furnished or ordered by an excluded
practitioner or other person on or after the effective date of exclusion, CMS will make
payments as follows:
1. 	The first claim for payment of benefits covered under Medicare Part B the
beneficiary submits will be paid, and the beneficiary will be immediately notified of
the exclusion.
2. 	The beneficiary's right to payment will extend to items or services the excluded
practitioner or other person furnished or ordered up to 15 days after the date on
the exclusion notice, or after the effective date of the exclusion notice, whichever is
later.
9060 – Reinstatement after Exclusion by OIG
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Exclusion will remain in effect until:
1. 	OIG's decision to exclude is reversed on appeal; or
2. 	OIG determines, pursuant to a properly filed request for reinstatement (i.e., at the
end of the minimum period of exclusion), that the basis for the exclusion no longer
exists and there is reasonable assurance that the problems will not reoccur. (See
42 CFR §§1001.3001-3005 for OIG’s reinstatement procedures) OIG may also
consider compliance with the certification obligation in connection with notice to
patients at the time of reinstatement.
9065 – Appeal Rights of the Excluded Practitioner or Other Person
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9065.1 – Appeal Reversal
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
OIG’s determination will continue in effect unless reversed by a hearing on appeal. (See
42 CFR §1004.140(b)(3).)
9065.2 – Right to Pre-exclusion Preliminary Hearing(s)
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
A practitioner or other person excluded from participation in Medicare and any State
health care programs under §1156 of the Act may request a preliminary hearing if the
location where the services are rendered to more than 50 percent of the practitioner’s or
other person’s patients at the time of the exclusion notice is in a rural Health Professional
Shortage Area (HPSA) or in a county with a population of less than 70,000. A request for
a preliminary hearing may stay the exclusion pending the decision of the ALJ at the
preliminary hearing. The preliminary hearing decision is not appealable or subject to

further administrative or judicial review. (See 42 CFR §1004.140(a)(4).)
9065.3 – Right to an Administrative Review
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
A practitioner or other person dissatisfied with an OIG determination or an exclusion that
resulted from a determination not being made within 120 days is entitled to a hearing
before an ALJ in accordance with §205(b) of the Act. If the practitioner or other person is
dissatisfied with the ALJ’s decision, he/she may appeal that decision and obtain a final
determination from the Department Appeals Board (DAB). (See 42 CFR §1005.21.)
9065.4 – Right to Judicial Review
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Any practitioner or other person dissatisfied with the DAB’s final decision may file a civil
action in accordance with the provision of §205(g) of the Act. (See 42 CFR §1005.21(k).)
9 – Section 2 – Emergency Medical Treatment and Labor Act
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9100 – Introduction and Organization of Sections 9100–9135
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Sections 9100–9135 provide a comprehensive description of the Emergency Medical
Treatment and Labor Act (EMTALA) statutory and regulatory requirements and the
supporting QIO review process and procedures. In addition, these sections provide a
clear description of the process that QIOs must follow when they receive a request for
review from the CMS Division of Survey and Certification (DSC). The process involves a
coordinated effort between the CMS DSC and the QIO.
In 1986, Congress enacted EMTALA to ensure public access to hospital emergency
services regardless of ability to pay. Section 1867 of the Social Security Act imposes
specific obligations on Medicare-participating hospitals. Hospitals that offer emergency
services are required to provide a medical screening examination to individuals who
“come to the emergency department” to determine if they have an emergency medical
condition, regardless of an individual's ability to pay. Hospitals are then required to
provide stabilizing treatment for individuals with emergency medical conditions. If a
hospital within its capability is unable to stabilize an individual, or if the individual
requests, an appropriate transfer should occur. Hospitals with specialized capabilities,
regardless of whether they offer emergency services, must accept appropriate transfers of
individuals requiring those specialized capabilities, if they have capacity at the time of the
transfer request.
9105 – Authority Related to EMTALA
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)

The Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA), PL 99-272,
revised §1866, “Agreements with Providers of Services,” of the Social Security Act (the
Act), and added §1867, “Examination and Treatment for Emergency Medical Conditions
and Women in Active Labor.” The Omnibus Budget Reconciliation Act of 1989 (OBRA
89), PL 101-239, further refined the requirements of §1154, “Functions of Peer Review
Organizations, ”§§1866 and 1867 of the Act, and deleted the word “Active” from the title
of §1867.
Sections 1866 and 1867 prohibit hospitals with emergency departments from turning away
or transferring individuals without screening for emergency medical conditions and
stabilizing such conditions or transferring the individual if they lack the capability to
provide stabilizing treatment. Section 1867 also requires hospitals with specialized
capabilities, regardless of whether they also have emergency departments, to accept
appropriate transfers of individuals needing those capabilities, assuming there is capacity
at the time of the transfer request. Hospitals are required to maintain on-call lists of
physicians who will come to the hospital to provide stabilizing treatment. Both hospitals
and physicians who violate EMTALA requirements are subject to enforcement actions; in
the case of hospitals this may include both termination of its participation in Medicare as
well as civil monetary penalties. Physicians are subject to civil monetary penalties and
also potentially to exclusion from the Medicare program.
The Omnibus Budget Reconciliation Act of 1990 (OBRA 90), PL 101-508, added
§1867(d)(3). This section, titled “Consultation with Quality Improvement
Organizations,” requires a 60-day QIO review related to EMTALA cases, unless the delay
would jeopardize the health or safety of individuals. The 5-day review is required before
CMS makes a compliance determination as part of the process of terminating a hospital’s
participation in Medicare; the 60-day review is required before OIG imposes civil
monetary penalties. The QIO review is to consider whether an individual had an
emergency medical condition; the appropriateness of a medical screen examination,
stabilizing treatment, or an appropriate transfer; and whether the individual’s condition
had been stabilized. For the 60-day review, the QIO must also offer the involved
physician(s) and hospital(s) an opportunity to discuss the case and submit additional
information before the QIO completes its review.
The following are applicable Code of Federal Regulations (CFR) references:
42 CFR §489.20.l – requires hospitals, as part of their agreement with the Medicare
program, (provider agreement) to comply with the EMTALA regulations at 42 CFR
§489.24.
42 CFR §489.20.m – requires a hospital to report to CMS or the State Survey Agency any
time it believes it received an inappropriate transfer of an individual with an unstable
emergency medical condition.
42 CFR §489.20.q – requires a hospital to post conspicuous signs specifying individuals’
EMTALA rights in its emergency department or other places that individuals entering the

emergency department are likely to notice.
42 CFR §489.20.r – requires transferring and receiving hospitals to maintain records of
transfers for 5 years; requires hospitals to maintain an on-call list of physicians to provide
stabilizing treatment for individuals with emergency medical conditions and to maintain a
log of each individual who comes to the emergency department.
42 CFR §489.24 – Explains the responsibilities of a hospital with an emergency room to
provide appropriate medical treatment to an individual who comes to an emergency
department. These responsibilities include an appropriate medical screening examination
within the capabilities of the hospital’s emergency department, including ancillary
services.
42 CFR §489.24(b) – Provides definitions used in §489.24.
42 CFR §489.24(d) – Explains the hospital’s responsibility to provide necessary
stabilizing treatment for any individual who comes to the emergency department (whether
eligible for Medicare benefits or not) and when the hospital determines that the individual
has an emergency medical condition.
42 CFR §489.24(f) – Explains recipient hospital responsibilities, regardless of whether or
not the recipient hospital has an emergency department. Includes the requirement to
accept appropriate transfers of individuals who require specialized capabilities or
facilities if the receiving hospital has the capacity to treat the individual.
42 CFR §489.24(g) – If a hospital fails to meet the requirements of 42 CFR §489.24 (a)–
(f), CMS may terminate the provider agreement in accordance with §489.53.
42 CFR §489.24(h)–(i) – Describes the QIO consultative role and obligations to CMS for
the 60-day review to provide a medical opinion to determine a physician’s or hospital’s
liability under §1867(d)(1) of the Act. 42 CFR §480.132 – Provides the general
requirements for disclosure of patient information.
42 CFR §480.133 – Provides the general requirements for disclosure of information about
Peer Review practitioners, reviewers, and institutions.
9110 – Definitions Related to EMTALA Review Activities
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Definitions provided below that refer to EMTALA are further described in 42 CFR
§489.24 (b):
1. Emergency Medical Condition means:
A. A medical condition manifesting itself by acute symptoms of sufficient severity
(including severe pain, psychiatric disturbances, and/or symptoms of substance

abuse) such that the absence of immediate medical attention could reasonably be
expected to result in:
i. 	Placing the health of the individual (or, with respect to a pregnant woman,
the health of the woman or her unborn child) in serious jeopardy;
ii. 	Serious impairment to bodily functions;
iii. 	Serious dysfunction of any bodily organ or part; or
B. With respect to a pregnant woman who is having contractions:
i. 	That there is inadequate time to effect a safe transfer to another hospital
before delivery; or
ii. 	That transfer may pose a threat to the health or safety of the woman or the
unborn child.
2. Labor means the process of childbirth beginning with the latent or early phase of labor
and continuing through the delivery of the placenta. A woman experiencing contractions
is in true labor unless a physician, certified nurse-midwife, or other qualified medical
person acting within his/her scope of practice as defined in hospital medical staff bylaws
and State law certifies that, after a reasonable time of observation, the woman is in false
labor.
3. Participating Hospital means (1) a hospital or (2) a critical access hospital as defined
in §1861(mm)(1) of the Act that has entered into a Medicare provider agreement under
§1866 of the Act.
4. “To Stabilize” with respect to an emergency medical condition as defined in 1.A above,
means to provide such medical treatment of the condition as may be necessary to assure,
within reasonable medical probability, that no material deterioration of the condition is
likely to result from or occur during the transfer of the individual from a facility or, with
respect to an emergency medical condition as defined in 1.B, that the woman has
delivered the child and the placenta.
5. Stabilized –with respect to an emergency medical condition as defined above in 1.A,
means that no material deterioration of the condition is likely, within reasonable medical
probability, to result from or occur during the transfer of the individual from a facility, or,
with respect to an emergency medical condition as defined in 1.B above, that the woman
has delivered the child and placenta.
6. Transfer means the movement (including the discharge) of an individual outside a
hospital’s facilities at the direction of any person employed by (or affiliated or associated,
directly or indirectly, with) the hospital, but does not include such a movement of an

individual who has been declared dead or leaves the facility without the permission of any
such person.
7. Capacity means the ability of the hospital to accommodate the individual requesting
examination or treatment of the transferred individual. Capacity encompasses such things
as numbers and availability of qualified staff, beds, and equipment, and the hospital’s past
practices of accommodating additional patients in excess of its occupancy limits.
9115 – Hospital Requirements
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Congress enacted the above provisions to prevent hospitals from refusing to treat
individuals requiring emergency care or inappropriately transferring or discharging
individuals with unstabilized emergency conditions. Refer to §9110 for the full definition
of an emergency medical condition.
Section 1866 of the Act contains requirements related to §1867. The related provisions
require hospitals and rural primary care hospitals to:
• 	Ensure compliance with and meet the requirements of §1867;
• 	Maintain medical and other records related to individuals transferred to or from
the hospital for five (5) years from the date of transfer;
• 	Maintain a list of physicians who are on call for duty after the initial examination
to provide treatment necessary to stabilize an individual with an emergency
condition; and
• 	Post in the emergency department (ED) a conspicuous sign(s) informing
individuals of their rights under §1867 to examination, treatment, and appropriate
transfer, as necessary, for emergency medical conditions and women in labor,
regardless of ability to pay.
Section 1867 of the Act, as interpreted at 42 CFR 489.24(b), requires participating
hospitals with emergency departments, as defined in the regulations, to provide an
appropriate medical screening examination within the capacity of the hospital’s
emergency department, including ancillary services routinely available to the emergency
department, to anyone (whether or not eligible for Medicare benefits and regardless of
ability to pay) who comes by him/herself or with another person to the hospital (including
the parking lot, ambulance owned or operated by the hospital regardless of location, and
other units in the hospital) to determine whether or not he/she has an emergency medical
condition. Unless the individual or a person acting on the individual’s behalf refuses
treatment or transfer after being advised by the hospital of the risks and benefits involved,
the hospital must provide to an individual who is determined to have an emergency
medical condition either:

• 	Further medical examination and treatment to stabilize the condition, including
delivery of the child and placenta, if relevant; or
• 	Appropriate transfer of the unstabilized individual or woman in labor to another
medical facility after a physician has certified that such transfer is in the
individual’s best medical interest or after request by the individual or person
acting on his/her behalf.
Patients who are not stable must either be treated until stabilized or transferred in
accordance with the transfer requirements. The transfer requirements apply only to
unstabilized patients. Appropriate transfers must be effected through qualified persons
and transportation equipment (if medically necessary) to a receiving hospital that has
available space and qualified personnel to treat the individual and that has agreed to
accept the individual. The medical record must accompany the individual.
In addition, a participating hospital that has specialized capabilities or facilities,
including (but not limited to) burn units, shock-trauma units, neonatal intensive care units,
or, in rural areas, regional referral centers may not refuse to accept from a referring
hospital within the boundaries of the United States an appropriate transfer of an
individual who requires such specialized capabilities or facilities if the hospital has the
capacity to treat the individual. This is the case regardless of whether the hospital with
specialized capabilities has an emergency department or not.
This law applies regardless of whether or not a hospital will receive payment for services
rendered. Participating hospitals may not delay the provision of an appropriate medical
screening examination or further medical examination and treatment to inquire about the
individual’s method of payment or insurance status. In addition, a participating hospital
may not penalize or take adverse action against a physician because the physician refuses
to authorize the transfer of an individual with an emergency condition that has not been
stabilized.
9120 – Hospital Penalties for Noncompliance
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Hospitals that fail to meet the requirements of §1867 or the EMTALA-related
requirements of §1866 may have their Medicare provider agreements terminated. In
addition, a hospital with fewer than 100 beds is subject to an OIG-levied Civil Monetary
Penalty (CMP) of up to $25,000 for each negligent violation, while a hospital with 100 or
more beds is subject to fines of not more than $50,000 per violation. A physician who is
responsible for the examination, treatment, or transfer of an individual in a participating
hospital, including a physician on-call for the care of such an individual, and who
negligently violates a requirement, is subject to a CMP of not more than $50,000 for each
such violation, and if the violation is gross and flagrant, or repeated, to exclusion from
participation in Medicare and State health care programs.

A participating hospital may not penalize or take adverse action against a physician or a
qualified medical person because either practitioner refuses to authorize the transfer of an
individual with an emergency condition that has not been stabilized or against any
employee because the employee reports a violation of an EMTALA requirement.
Additionally, individuals suffering personal harm as a direct result of a violation may
bring civil action against the hospital for damages for personal injury under the law of the
State in which the hospital is located. Medical facilities suffering financial loss as a direct
result of a participating hospital’s violation may bring a civil action against the hospital for
financial loss under the law of the State in which the hospital is located. Filing a civil
action is limited to a period of 2 years after the date of the alleged violation. There is no
CMS, QIO, or OIG involvement in any private civil actions.
9125 – CMS Regional Office Responsibilities
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
When the CMS Regional Office Division of Survey and Certification (DSC) receives a
complaint, information, or an allegation about inappropriate or lack of emergency
medical screening, stabilizing treatment, appropriate transfer, or failure to accept an
appropriate transfer, DSC is responsible for authorizing the State Survey Agency to
conduct an investigation and develop a report of this investigation for the Regional Office
DSC’s consideration. If the Regional Office DSC finds that the case involves a possible
violation of §1867 and this determination rests wholly or in part on the clinical aspects of
the case, then the DSC must consult with the QIO before determining whether the hospital
has violated EMTALA, unless delay in obtaining a QIO review would jeopardize the
health or safety of individuals. Clinical aspects of the case may include questions such as
whether the individual had an emergency medical condition, whether there was an
appropriate medical screening examination, whether a hospital had the capability to
provide stabilizing treatment, whether an individual’s emergency medical condition was
stabilized, whether a transfer was appropriate, whether a recipient hospital had the
required capability and capacity to provide stabilizing treatment and any other questions
as necessary.
See §9130 for the process followed when CMS has questions or concerns about a QIO
review.
The Regional Office DSC must send the following information/documents to the QIO:
• 	All relevant information for clinical review (e.g., medical record, draft State
Agency Report [Form CMS 2567], and other items as listed on the EMTALA
Physician Review Checklist in Appendix 9-11);
• 	EMTALA Physician Review Document Checklist (Appendix 9-11);
• 	EMTALA Physician Review Worksheet (Appendix 9-12);and

• 	EMTALA Case Resolution of Disagreement Worksheet (Appendix 9-13)when
applicable.
NOTE: The Regional Office DSC uses this worksheet to document information and
actions when issues are identified with the QIO process/decisions. (See §9130.)
If the Regional Office DSC determines that there is a violation and the case meets the
criteria for referral that OIG established, DSC will forward all supporting documentation
to the QIO for a 60-day review, when applicable to the facts of the case, at the same time
it makes the referral to OIG. The supporting documentation provided to the QIO should
include the State Agency report, a copy of the medical record(s), copies of letters to the
hospital(s) from CMS regarding any enforcement actions, and a copy of the five (5)-day
advisory medical review. The Regional Office should not delay forwarding the case to the
QIO if all documentation is not available.
As a part of the 60-day review, the QIO is required to provide the physician/hospital an
opportunity to discuss the case and an opportunity to submit additional information.
(See 42 CFR §489.24(h)(2) and §9135.2.1.)
The QIO 60-day review required to support OIG enforcement is considered a separate
review and has no substantive bearing on the original Regional Office DSC determination
related to CMS enforcement. If there is a discrepancy between the five (5)-day and 60-day
review findings, that discrepancy may affect whether OIG pursues the case for CMPs or
physician exclusion, but it may not change the Regional Office’s original determination of
noncompliance. The Regional Office DSC will have already followed its procedures and
taken enforcement action as appropriate to protect other individuals who seek emergency
care at the hospital.
The Regional Office DSC may, but is not obligated to, release the five (5) day QIO review
results to the affected physician and/or hospital, and to the individual or his/her
representative. The sixty (60) day review remains confidential until such time as the OIG
investigation is complete. The QIO physician reviewer’s identity is confidential unless
he/she consents to release his/her identity in accordance with the disclosure regulations.
(See 42 CFR §§480.132 and 480.133.) The QIO physician peer reviewer identity is kept
confidential from all requestors, including DSC, unless the reviewer agrees to the release
of his/her identity. See 42 CFR §§480.139(a) and 489.24(i). Furthermore, the physician
peer reviewer name is redacted from all documentation provided to CMS and other
parties, unless the physician agrees to release his/her name.
NOTE: QIO review is not required in cases where a delay in effecting a sanction would
jeopardize the health and safety of individuals or in situations where medical review is
inappropriate (e.g., cases where the individual was denied a medical screening
examination).
NOTE: The hospital and/or practitioner may only contact the CMS Regional Office DSC
if they have questions about the EMTALA review, and they may NOT contact the QIO
during the five (5)-day review period.

9130 – QIO 5-Day Review Responsibilities
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
If the Regional Office DSC finds that the case involves a possible violation of §1867 and
this determination rests wholly or in part on the clinical aspects of the case, the DSC must
consult with the QIO before determining whether the hospital has violated EMTALA,
unless delaying to obtain a QIO review would jeopardize the health or safety of
individuals. Clinical aspects of the case may include questions such as whether the
individual had an emergency medical condition, whether there was an appropriate
medical screening examination, whether a hospital had the capability to provide
stabilizing treatment, whether an individual’s emergency medical condition was stabilized,
whether a transfer was appropriate, whether a recipient hospital had the required
capability and capacity to provide stabilizing treatment, and any other questions as
necessary.
In reviewing cases, the QIO physician reviewer should consider information that the
treating physician:
1. 	Had, could have had, and should have had available to him/her at the time of the
individual's visit; and
2. 	Could have discovered reasonably and which was necessary to adequately care for
the individual (e.g., the physician should have conducted an adequate history
interview) at the time of the individual’s visit.
The Regional Office DSC may also require the QIO to participate in an informal
discussion that the Regional Office sets up with the affected physician/hospital to discuss
the case.
NOTE: CMS has the authority and responsibility to determine whether the law has been
violated. The QIO physician reviewer MUST NOT state an opinion about whether a
violation has occurred.
9130.1 – Physician Reviewer Selection/Qualifications
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The QIO should select a physician to review the case who is a specialist (actively
practicing in his/her specialty and, whenever possible, board-certified) in either the
specialty of the physician who attended the patient or the specialty indicated by the
condition of the patient whose care is under review. Whenever possible, the physician
reviewer should practice in a similar setting as that of the physician who attended the
patient.
Select a physician who agrees in writing to conduct the review in accordance with the
requirements in §9130.2 and to testify as an expert witness, if necessary, to properly

adjudicate the case.
NOTE: A QIO is precluded from disclosing information that would identify a QIO
physician reviewer without his/her consent (42 CFR 480.133(a)(2)(iii)). Therefore, the
QIO must ensure that each physician reviewer is aware of the potential need to serve as
expert witnesses and, prior to review of cases, secure a statement of willingness to serve as
an expert witness to certify his/her availability for expert witness testimony. QIOs must
maintain a file containing the names of physician reviewers. Upon request from OIG,
QIOs must provide the names of individuals who reviewed specific medical records to
serve as expert witnesses.
9130.2 – QIO Physician Review Process Description
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The QIO will conduct a 5-day review when the Regional Office DSC requests. The QIO
physician peer reviewer will:
1. 	Provide his/her clinical assessment of the case based solely on the documentation
the CMS Regional Office DSC provides;
2. 	Not state whether an EMTALA violation occurred; and
3. 	Complete the necessary paperwork, including:
• 	EMTALA Physician Review Document Checklist (Appendix 9-11); and
• 	EMTALA Physician Review Worksheet (Appendix 9-12).
NOTE: It is NOT permissible for the QIO to offer a meeting to discuss the EMTALA
review case with the hospital and/or practitioner(s). If the QIO physician reviewer needs
additional information, the QIO is to communicate directly with the CMS Regional Office
DSC that assigned the case.
The QIO must forward the original EMTALA Physician Review Worksheet (Appendix 9-
12) provided by the Regional Office DSC to the QIO physician peer reviewer for
completion.
• 	The QIO can use the Physician Reviewer Worksheet provided by DSC as an
original form to be completed by the Physician Reviewer. In addition, the QIO
physician reviewer MUST include a legibly written (if not completed
electronically) response and complete rationale for EACH question on the
EMTALA Physician Review Worksheet. (See Appendix 9-12.)
NOTE: CMS highly recommends that the QIO Physician Reviewer be well
versed on key regulatory definitions, such as “emergency medical condition” and
“stabilized” as well as the criteria for appropriate EMTALA medical screening

examinations and transfers. (The QIO must provide all reviewers with the link to
CMS’s interpretive guidelines explaining the EMTALA requirements in detail and
encourage reviewers to consult this guidance when they have questions about any
aspects of the Physician Review Worksheet. This guidance is available at:
http://cms.hhs.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/som107ap_v_emerg.pdf.) The QIO
should enter the physician reviewer responses from the EMTALA Physician
Review Worksheet (Appendix 9-12) verbatim into the CMS-designated review
system if available, and keep a file copy for their records in accordance with
record keeping requirements.
• 	The QIO MUST NOT change the physician reviewer response unless the
physician reviewer gives his/her approval. 	approval should be noted on the
original EMTALA Physician Review Worksheet.
• 	A copy of the original EMTALA Physician Review Worksheet (with the physician
reviewer’s name redacted) should be forwarded to the CMS Regional Office DSC.
NOTE: See the EMTALA Physician Review Document Checklist (Appendix 9-11) for a
complete list of documents that the QIO physician peer reviewer reviewed. This checklist
MUST be sent to the Regional Office DSC upon review completion.
When completing the EMTALA Physician Review Worksheet (Appendix 9-12), the QIO
physician reviewer should NOT provide a statement or opinion on either of the following:
• 	His or her opinion as to whether an EMTALA violation occurred; and/or
• 	Other observations about the case that are not specifically asked to be addressed
(e.g., personal comments regarding the case).
The criteria for an acceptable EMTALA physician review are as follows:
1. 	The review must meet all timeliness, administrative, and clinical requirements; and
2. 	The review must be consistent with:
• 	Accepted standards of medical practice;
• 	EMTALA statutory definitions;
• 	Evidence-based clinical standards; and
• 	Sound clinical judgment.
If the CMS Regional Office DSC identifies an administrative concern with the EMTALA
Physician Review Worksheet, the DSC will make a request to correct the issues. This may

involve a direct discussion between the QIO and DSC Regional Office.
NOTE: A concern with the EMTALA Physician Review Worksheet is considered
administrative when the review is incomplete, unclear, internally inconsistent, and/or
suggests an apparent lack of understanding of the EMTALA standards that govern the
review.
If the CMS Regional Office DSC identifies a concern with the clinical components of the
review, then the DSC representative, CMS designated representative, and COR will
discuss the case. As a result of this discussion, one or more of the following may occur:
1. 	The QIO COR will ask for a re-review by the same physician reviewer, or
2. 	The QIO COR will ask for a re-review (which would be the second re-review if the
same physician who did the initial review has already conducted a re-review) by a
completely new QIO physician reviewer.
NOTE: A concern is considered clinical when the opinion rendered appears biased, does
not follow accepted standards of medical practice, or addresses issues outside the expert
competency of the QIO physician reviewer.
9135 – QIO Review Responsibilities – 60-Day Review
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The Regional Office DSC will notify the QIO of EMTALA cases that it is referring to OIG.
Before OIG can assess a CMP or exclude a physician from the Medicare program, the
QIO must review the case and provide a report of the findings to the originating Regional
Office, which is responsible for forwarding the report to OIG. The QIO review includes
offering the involved physician(s) and hospital(s) an opportunity to discuss the case and to
submit additional information before OIG may impose sanctions.
For the 60-Day EMTALA Review Process, the QIO will follow the Physician Peer Review
five (5)-day EMTALA Review Process described in §9130.2. In addition, the following
instructions also apply for the 60-day review process.
The QIO must provide a written notice of the opportunities to the affected
physician/hospital (see 42 CFR §489.24(h)(2)) and arrange the meeting either by
telephone or face-to-face. The letter should identify the name of the individual and the
date he/she presented to the emergency room. (See Appendix 9-16, 60-Day QIO Review-
Opportunity for Discussion Model Letter.)
Notify OIG at the appropriate CMS Regional Office of the time and date the hospital and,
if applicable, the physician are meeting with the QIO, or notify OIG that the hospital and,
if appropriate, the physician have declined the opportunity to do so.
The hospital and/or the physician have the right to legal counsel present during the

meeting. However, the QIO may control the attorney’s scope, extent, and manner of any
questioning or any other presentation. The QIO may also have legal counsel present. The
QIO may reasonably limit the number of witnesses and length of testimony if such
testimony is irrelevant or repetitive. The QIO is not obligated to consider any additional
information that the hospital and/or the physician submit after the meeting, unless the QIO
requests them to submit additional information to support their assertions before the end
of the meeting. In this case, the QIO provides the hospital and/or the physician additional
time, not to exceed five (5) calendar days from the meeting, to submit the relevant
information. The QIO is required to keep a recording of the hospital and/or practitioner
meeting. However, it is not necessary to hire a professional stenographer to produce a
written transcript of the meeting. An audio recording is acceptable unless a written
transcript subsequently is requested by CMS Regional Office DSC or OIG.
If the hospital and/or practitioner(s) elect to discuss the case with the QIO during a formal
meeting, the QIO and physician peer reviewer WILL NOT provide a clinical opinion
about the case during this meeting.
If the hospital and/or practitioner request a copy of the QIO physician peer review five
(5)-day review results, they should be directed to contact the CMS Regional Office DSC,
which is responsible for addressing and fulfilling all requests for documents from the
hospital and/or physician involved in the case.
Considering all the information on the case, the QIO sends its 60-day physician review
worksheet along with pertinent documentation to the Regional Office DSC, who will
forward a copy to OIG.
9135.1 – Physician Reviewer Selection/Qualification
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
NOTE: The QIO should make every effort to have the same physician peer reviewer
complete both the five (5)-day and 60-day EMTALA reviews for the same case.
The QIO should select a physician to review the case who is a specialist (actively
practicing in his/her specialty and, whenever possible, board-certified) in either the
specialty of the physician who attended the patient or the specialty indicated by the
condition of the patient whose care is under review. Whenever possible, the physician
reviewer should practice in a similar setting as that of the physician who attended the
patient.
Select a physician who agrees in writing to conduct the review in accordance with the
requirements in §9130.2 and §9135 and to testify as an expert witness, if necessary, to
properly adjudicate the case.
9135.2 – QIO Physician Review Process Description
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)

9135.2.1 – 60-Calendar-Day Timeframe
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The timeframe is as follows:
Calendar Day 1: The QIO receives the record from the CMS Regional Office DSC.
Calendar Day 15: Notify the involved hospital and, if appropriate, the involved physician
via certified letter, return receipt requested. The letter should inform the hospital and/or
physician that the QIO is reviewing the case as well as the opportunity to discuss the case
(in person or by phone). Inform the hospital/physician that they may submit additional
information within 30 calendar days of receiving the letter. (See Appendix 9-16, 60-Day
QIO Review-Opportunity for Discussion Model Letter.)
The letter must also contain:
• 	The name of each individual who is the subject of the violation;
• 	The date on which each violation occurred;
• 	A statement that the rights to discuss the case and provide additional information
will be waived if the invitation is not accepted; and
• 	A copy of 42 CFR §489.24.
When a meeting is scheduled, notify the Regional Office DSC and OIG of the time and
date.
Calendar Day 20: The above letter(s) is (are) presumed to have been received by the
hospital and/or physician.
Calendar Day 50: Discussion and hospital/physician submission of data, if desired, is
complete.
Calendar Day 60: The QIO completes the review. The Regional Office DSC must receive
the QIO final physician review and report (facsimile or through a secure electronic system
approved by CMS) no later than close of business on calendar day 60. If submitted
electronically, a signed hard copy must be sent to the DSC by mail. The QIO 60-day
report must contain:
• 	The name of the hospital or physician (or both, where applicable);
• 	The name of the individual and the dates and times the individual arrived at and
was transferred (or discharged) from the hospital; and
• 	The completed QIO physician review worksheet.

NOTE: Do not state an opinion or conclusion about whether a violation has occurred.
9135.3 – Reporting Results of the Review to CMS
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Submit to CMS a report of cases referred to the QIO for review and entered into the CMS
designated review system. The required data will be submitted in accordance with the
QIO Manual Chapter 10 confidentiality and disclosure instructions.
9 – Section 3 – Fraud and Abuse
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9200 – Scope of QIO Fraud and Abuse Review Activities
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
In accordance with the QIO contract and 42 CFR Part 476, the QIO must make available
the medical expertise necessary to conduct reviews and render quality of care and medical
necessity decisions in cases CMS refers to the QIO. The referrals may involve Medicare
services in settings other than those normally covered by the QIO reviews.
If the QIO identifies possible practice or performance patterns of fraud or abuse situations
during its regular case review activity, regardless of whether these situations/issues are
within the QIO area of responsibility, the QIO should notify the Federal or State fraud and
abuse enforcement agency that has jurisdiction, or in the case of a provider, the
appropriate intermediary component pursuant to 42 CFR §480.133. See also 42 CFR
§480.137.
9210 – QIO Review Responsibility
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9210.1 – CMS Approval Process – Referrals to the QIO from Any Source
Other than CMS
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Every request should be in writing, offer clear and cogent rationale, and be submitted
through the COR for the QIO contract. After receiving such a request, the QIO should,
consistent with the contract:
• 	Analyze the request to determine the appropriate staff hours and associated
budget the QIO will require; and
• 	Submit both the request and the QIO cost analysis to the QIO COR.
• 	In the event that the QIO receives a fraud or abuse review referral from

any source other than CMS, it should notify the CMS COR before the QIO
conducts the review.
9210.2 – QIO Fraud and Abuse Review Process
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
When the QIO receives a referral or request for a fraud and abuse review, the QIO should
notify the CMS COR. For these cases, the QIO will investigate the issues and decide on
any matters involving medical necessity or quality of care. The QIO should provide
written evaluations of all cases to CMS or the outside agency, as appropriate, within 45
calendar days of receiving the referral or within the timeframe agreed upon between the
QIO and CMS.
Physician reviewers should be board-certified (although this is not required) and actively
practicing in the same specialty or specialties as the physician who treated the patient
whose case resulted in the review. In addition, whenever possible, the physician reviewer
should practice in a setting similar to that of the physician who attended the patient.
CMS or the outside agency will ensure that all relevant case materials are available to the
QIO on the day the case is referred for investigation. Therefore, the entire 45 days is
available for the QIO to complete the review.
9220 – Evaluation Report Requirements
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The QIO written report should contain:
1. 	The physician review findings as to the medical appropriateness, necessity, and
quality of the services provided;
2. 	The basis for the determination; and
3. 	When applicable, any advice on additional development needed to properly
adjudicate any remaining issues.
The report must be signed by the QIO authorized representative (e.g., the Executive
Director or Medical Director) and include the titles and qualifications of the physician
reviewer(s).
When the QIO forwards the report, the QIO should include with it all materials that CMS
or the outside agency provided to the QIO. After reviewing the cases included in the QIO
report, the QIO can initiate a sanction investigation and recommendation if the issues
found are within the QIO area of responsibility. Otherwise, the QIO involvement with the
particular case usually ends with the evaluation report submitted to CMS.

9230 – Availability of Expert Witness
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
9230.1 – Testimony
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Physician reviewers who participate in the medical record review process must be
available for expert witness testimony about the medical findings contained in the QIO
evaluation report. When asked to serve in the role of expert witness, the physician
reviewer in each case will be provided with instructions from the referring component.
9230.2 – Expert Witness Qualifications
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Expert witnesses should be board-certified (although this is not required) and actively
practicing in the same specialty or specialties as the physician or physicians who treated
the patient whose case is under review. In addition, whenever possible, the expert witness
should practice in a setting similar to that of the physician who attended the patient. The
QIO must ensure that physician reviewers are aware of the potential need to serve as
expert witnesses. Prior to reviewing a case, the QIO should secure a statement of
willingness to serve as an expert witness from the physician reviewers to certify his/her
availability for expert witness testimony.
9230.3 – Maintenance of Review Files
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
The QIO should maintain a file that contains the names of physician reviewers who
reviews these cases. Upon request from OIG, DOJ, or another outside agency for expert
witnesses, the QIO will provide the names of individuals who reviewed specific medical
records.
9240 – Reopening of Cases – Regulatory Guidance
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Cases that the QIO previously reviewed may be reopened at any time under the following
circumstances:
• 	A QIO or its subcontractor may review and issue denial of payment any time there
is a finding that the claim for service involves fraud or a similar abusive practice
that does not support a finding of fraud. An initial denial determination or change
as a result of a DRG validation may be reopened and revised anytime there is a
finding that it was obtained through fraud or a similar abusive practice that does
not support a finding of fraud. (42 CFR §476.96(c)).

• 	Whenever there is a finding that a reconsidered determination review or a re-
review determination of a DRG change was obtained through fraud or a similar
abusive practice, and that does not support a formal finding of fraud, then the QIO
should reopen and revise the reconsidered determination or the DRG change, or
notify the appropriate ALJ or Appeals Council so that they may reopen a decision
of theirs (42 CFR §478.48(c)).

Appendices
Appendix 9-1 – Office of Council to the Inspector General Mailing
Address
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Exclusions/Civil Monetary Penalties Contact:
Office of Council to the Inspector General
Chief, Administrative and Civil Remedies Branch
330 Independence Avenue, SW
Cohen Building Room 5527
Washington, DC 20201
Fraud Questions:
Assistant Special Agent in Charge
Investigations Branch
(800)-447-8477

Appendix 9-2 – Initial Sanction Notice of Substantial Violation in a
Substantial Number of Cases
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
QIO LETTERHEAD
(Name and Address of Practitioner or Provider)
(Dear Dr. 	:) Or (Dear Mr./Mrs./Ms. 	:)
The purpose of this notice is to inform you that (name of QIO), the Quality Improvement
Organization (QIO) for the State of (name of State), has concluded that there is a
reasonable basis for determining that (you have) (your hospital has) violated (your) (its)
obligation(s) under §1156(a) of the Social Security Act (the Act) to assure that the
services provided to program beneficiaries are:
[SELECT OBLIGATION(S) VIOLATED]. Choose (1), (2), and/or (3) from below:
(1) Provided economically and only when, and to the extent, they are medically necessary;
(2) Of a quality that meets professionally recognized standards of health care; and/or
(3) Supported by the appropriate evidence of medical necessity and quality of the services
in a form and fashion and at such time as may be required.
(Name of QIO) has concluded that there is a reasonable basis for determining that (you
have) (your hospital has) failed to comply substantially with your statutory obligations in a
substantial number of cases.
• 	If the QIO determines finally that such a violation has occurred and recommends a
sanction to the Secretary of the Department of Health & Human Services (HHS),
and if a final determination is made by the Secretary through the Office of
Inspector General (OIG) to impose a sanction, (YOU) (YOUR HOSPITAL) MAY
BE EXCLUDED FROM PARTICIPATING IN PROGRAMS UNDER TITLES V,
XVIII, XIX, AND XX of the Social Security Act (including THE MEDICARE
PROGRAM AND ANY STATE HEALTH CARE PROGRAM AS DEFINED IN
§1128(h) OF THE ACT) EITHER PERMANENTLY OR FOR A SPECIFIED
PERIOD OF TIME OF AT LEAST 1 YEAR OR, ALTERNATIVELY, REQUIRED
TO PAY THE UNITED STATES GOVERNMENT A MONETARY PENALTY
AS A CONDITION FOR (YOUR) (YOUR HOSPITAL'S) CONTINUED
PARTICIPATION IN THE MEDICARE AND STATE HEALTH CARE
PROGRAMS. Therefore, you are strongly encouraged to contact the (name of
QIO) to provide additional information and/or meet with (name of QIO).
• 	An in-depth discussion of the cases involved is included below in the case
summary section.

• 	You will be given an opportunity to provide additional information and/or request
a meeting with (name of QIO). Although no sanction recommendation will be
made to OIG after this meeting, it is nevertheless an important first step in the
sanction process. The “Additional Information” section explains how to submit
the additional information and/or request a meeting.
• 	Enclosure 1 provides a brief overview of the sanction process.
OBLIGATIONS
Section 1156 of the Act (42 U.S.C. 1320c-5) imposes certain obligations upon health care
practitioners and other persons who furnish or order services under Medicare or State
health care programs. These obligations are to assure that the services are:
(l) Provided economically and only when, and to the extent, they are medically necessary;
(2) Of a quality that meets professionally recognized standards of health care; and
(3) Supported by the appropriate evidence of medical necessity and quality of the services
in a form and fashion and at such time as may be required. See also 42 CFR Part 1004.
QIO RESPONSIBILITIES
The Secretary of HHS has a contract with the (name of QIO) to review Medicare services.
Section 1156(b) of the Act provides that if (name of QIO) determines that a practitioner or
other person has failed to comply substantially with any of these obligations in a
substantial number of cases or has grossly and flagrantly violated such obligation in one or
more instances, (name of QIO) must report such determinations to the HHS OIG, along
with a recommendation for an appropriate sanction. If OIG agrees with the QIO’s
recommendation and finds that the practitioner or other person is unable or unwilling
substantially to comply with his/her statutory obligations, OIG may impose a sanction.
These sanctions may include exclusion from eligibility to provide services to patients of
the Medicare program and State health care programs, such as Medicaid, on a payable
basis either permanently or for a specified period of time. Alternatively, payment of a
monetary penalty in the amount of the actual or estimated cost of medically improper or
unnecessary services may be required as a condition for continued eligibility to receive
payment under the programs.
VIOLATION OF OBLIGATION – CASE SUMMARY
The (name of QIO) has reviewed medical records pertaining to (your medical practice)
(the health care services and items furnished in your hospital). As a result of this review,

the (name of QIO) is concerned that (your medical practice) (your hospital's health care
services and items furnished to program beneficiaries), as documented in these medical
records, does not appear to comply substantially with the obligations imposed on (you)
(your hospital) under the Act in the following respects:
(Include an in-depth discussion of each situation, circumstance, or activity that resulted in
a violation as well as the obligation involved.)
EXAMPLES:
Providing Services Not Medically Necessary and/or Not Provided in the Most Economical
Setting
1. Chart No. 	Admission Date
• 	Hospitalization was totally unnecessary for this active, 72-year-old male who
was not acutely ill and did not receive intensive medical services. All he
required was a protective environment and assistance with activities of daily
living. His dementia, which resulted in his not taking medications properly,
was caused by Alzheimer's disease.
2. Chart No. 	Admission Date
• 	Although this patient had lowered hemoglobin, it was not so low that the 65-
year-old female required transfusing. The diagnostic studies needed to
ascertain the cause of her anemia could have been performed safely and
effectively on an outpatient basis.
Providing Services That Do Not Meet Professionally Recognized Standards of Care
1. Chart No. 	Admission Date
• 	Several glaring omissions exist in the initial evaluation and management of this
non-surgical patient. For example, recent hematemesis is mentioned in the
history, but no nasal gastric tube was passed and no rectal exam was
performed.
• 	In addition, no additional Hemoglobin or Hematocrits were obtained. A
marked deficiency of management occurred on the second day of
hospitalization when the patient spiked a temperature to 104°F, accompanied
by shaking chills, and was given aspirin. The temperature remained elevated in
the range of 102.6– 103°F for the next 2 days. No evaluation or treatment of
the elevated temperature was undertaken until the fifth day of the stay.
2. Chart No. 	Admission Date

• 	This insulin-dependent diabetic was admitted for a cholecystectomy. Her
preoperative blood sugar was 103, but this was drawn 1 week prior to
admission. Her post-operative course was eventful in that she had an elevated
temperature of 103–104° on the third and fourth postoperative days, for which
the physician ordered the administration of IV antibiotics. A fasting blood
sugar drawn on the third post-operative day was 300. No other laboratory
studies were performed. On the fifth post-operative day, the day before her
discharge, she complained of lower abdominal pain and was noted on that date,
as well as the day of discharge, to be lethargic.
• 	Her fasting blood sugar on the day of discharge was 380. Because there were
no studies to determine the source of her fever, the evaluation of her febrile
state was not adequate. In addition, the evaluation of her diabetic condition
was not adequate to determine the possible presence of impending diabetic
ketoacidosis.
-ETC.-
A summary of the information (name of QIO) considered in arriving at the above findings
is enclosed.
CORRECTIVE ACTION PLAN (if applicable)
[Describe the method and timeframe for correcting the identified violation(s)].
ADDITIONAL INFORMATION
If you do not believe that the care rendered in the above cases is in violation of (your)
(your hospital's) obligations under §1156, you may, within 30 days of the date of receiving
this notice, submit additional information to and/or request a meeting with (name of QIO).
The date of receipt is presumed to be 5 days after the date on this letter. The additional
information and/or request for a meeting should be submitted to:
(Contact Person) (Name of QIO) (Address)
IF YOU REQUEST A MEETING
The purpose of the meeting is to allow (you) (your hospital) to present (your) (the
hospital's) views regarding the care rendered to program beneficiaries in the above cited
cases, to discuss those views with the (name of QIO), and to assist (name of QIO) in
making its final determination as to whether such care failed to comply with the statutory
obligations of §1156 of the Act and its recommendation about the appropriate sanction.

• 	The meeting will be held within 30 calendar days of your request. The (name of
QIO) will contact you regarding date, time, and place for the meeting. The
meeting date may be extended, but only if you can demonstrate good cause.
• 	You may have an attorney represent (you) (your hospital) at the meeting. The
attorney may make opening and closing statements, assist you in presenting expert
testimony, and ask clarifying questions.
• 	You may bring professional (expert) witnesses to testify on (your) (your hospital's)
behalf. The purpose of the witnesses is to discuss relevant medical views
pertaining to the above-cited cases.
You should bring to the meeting all relevant documentation (including office records)
regarding the cases in question to fully support your views.
Sincerely yours,
(QIO Medical Director)
Enclosures:
(1) Overview of the Sanction Process; and
(2) Summary of Information Used in Determining Findings.
Enclosure 1: Overview of Sanction Process for Substantial Violations
INITIAL SANCTION NOTICE*
Thirty days to submit additional information and/or request a meeting and consideration of
corrective action (if appropriate)
QIO DECISION
Not a substantial violation
Second sanction notice
Thirty days to submit additional information and/or request a meeting and consideration of
corrective action (if appropriate)
QIO DECISION
Not a substantial violation
Final sanction notice recommendation to OIG
Thirty days to submit additional information
OIG DECISION

Do not sanction
Sanction
Right to appeal to an administrative law judge (including a pre-exclusion hearing, if
applicable)
* The enclosed letter is an initial sanction notice.

Appendix 9-3 – Second Sanction Notice of Substantial Violation in a
Substantial Number of Cases
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
QIO LETTERHEAD
(Name and Address of Practitioner or Provider)
(Dear Dr. 	:) or (Dear Mr./Mrs./Ms. 	:)
[The purpose of this notice is to inform you that (name of QIO), the Quality Improvement
Organization (QIO) for the State of (name of State), has reviewed the additional
information you submitted in response to our letter of _________. It has been determined
that this material does not modify the original determination of (name of QIO) that there
was a reasonable basis for determining that (your medical practice does) (the health care
services and items furnished in your hospital do) not comply with the obligations imposed
on you under §1156(a) of the Social Security Act (the Act) and that, in fact, specific
violations of (your) obligations do exist.]
AND/OR
[The purpose of this letter is to advise you that, based on its most recent review, the (name
of QIO) has concluded that there is a reasonable basis for determining that (you have)
(your hospital has) failed to substantially comply with the corrective action plan you
submitted to the (name of QIO) on (date) and which was approved on (date). The (name
of QIO) has determined that previously identified problems persist.]
(Name of QIO) has concluded that there is a reasonable basis for determining that (you
have) (your hospital has) violated your obligation to assure that the services provided to
program beneficiaries are:
[SELECT OBLIGATION(S) VIOLATED]. Choose (1), (2), and/or (3) from below:
(1) Provided economically and only when, and to the extent, they are medically necessary;
(2) Of a quality that meets professionally recognized standards of health care; and/or
(3) Supported by the appropriate evidence of medical necessity and quality of the services
in a form and fashion and at such time as may be required.
If the QIO determines finally that such a violation has occurred and recommends a
sanction to the Secretary of the Department of Health & Human Services (HHS), and if a
final determination is made by the Secretary through the Office of Inspector General
(OIG) to impose a sanction, (YOU) (YOUR HOSPITAL) MAY BE EXCLUDED FROM
PARTICIPATING IN PROGRAMS UNDER TITLES V, XVIII, XIX, AND XX OF THE
SOCIAL SECURITY ACT (INCLUDING THE MEDICARE PROGRAM AND ANY

STATE HEALTH CARE PROGRAM AS DEFINED IN §1128(h) OF THE ACT)
EITHER PERMANENTLY OR FOR A SPECIFIED PERIOD OF TIME OF AT LEAST 1
YEAR OR, ALTERNATIVELY, REQUIRED TO PAY THE UNITED STATES
GOVERNMENT A MONETARY PENALTY AS A CONDITION OF (YOUR) (YOUR
HOSPITAL'S) CONTINUED PARTICIPATION IN THE MEDICARE AND STATE
HEALTH CARE PROGRAMS.
Because of the serious nature of a QIO’s final determination to recommend a sanction to
OIG, you are strongly encouraged to contact (name of QIO) to provide additional
information to assist you in responding to the initial determination of a violation and/or to
set up a meeting with the (name of QIO). THE MEETING WITH THE QIO WILL BE
YOUR ONLY OPPORTUNITY TO DISCUSS YOUR SITUATION WITH THE QIO
BEFORE IT MAKES A FINAL DECISION WHETHER TO RECOMMEND TO OIG
THAT (YOU) (YOUR HOSPITAL) BE SANCTIONED.
• 	An in-depth discussion of the cases involved is included below in the case
summary section. A detailed synopsis of cases is also enclosed.
• 	The “Additional Information” section explains how to submit the additional
information and/or request a meeting.
• 	Enclosure 1 provides a brief overview of the sanction process.
VIOLATION OF OBLIGATION – CASE SUMMARY
The (name of QIO) has reviewed medical records pertaining to (your medical practice) or
(the health care services and items furnished in your hospital) (if applicable: and the
additional information you submitted to [name of QIO]). a result of this review, the (name
of QIO) has a reasonable basis for determining that (you have) (your hospital has) failed to
comply substantially with the obligations imposed on you under the Act in the following
respects:
1. Chart No. 	Admission Date
• 	Conclusion:
2. Chart No. 	Admission Date
• 	Conclusion:
-ETC.-
A copy of the material (name of QIO) used in arriving at this initial determination is
enclosed. Also enclosed is a detailed case synopsis identifying each case (name of QIO)
reviewed, the issues (name of QIO) raised, your response to the issues raised, and (name
of QIO)’s final determination. (See Appendix 9-4 for Synopsis of Cases.)

It has also been determined that the violations of (your obligations) (your hospital's
obligations) under §1156 of the Act are serious enough to warrant recommending to the
HHS OIG that sanctions be imposed upon (you) (your hospital) pursuant to Federal statute
and regulations. The sanction to be recommended is [exclusion from participation in the
Medicare and State health care programs for a period of _____years] OR [a monetary
penalty in the amount of _____ to be paid to the Government of the United States as a
prerequisite for (your) (your hospital’s) continued participation in the Medicare and State
health care programs].
If OIG agrees with the QIO's recommendation and finds that (you are) (your hospital is)
unable or unwilling substantially to comply with your statutory obligations, OIG may
impose a sanction.
[NOTE: If a corrective action plan was offered, include information here].
ADDITIONAL INFORMATION
By this letter you are hereby formally notified that you may submit to the (name of QIO),
within 30 days of the date of receiving this letter, additional information which you feel
might modify our position and/or a written request to meet with us to review and discuss
case specifics. The date of receipt is presumed to be five (5) days after the date on this
letter.
The additional information and/or request for a meeting should be submitted to:
(Contact Person)
(Name of QIO) (Address)
IF YOU REQUEST A MEETING
The purpose of the meeting is to allow (you) (your hospital) to present (your) (your
hospital's) views regarding the care rendered to program beneficiaries in the above-cited
cases, to discuss these views with the (name of QIO), and to respond to the initial
determination of a violation before (name of QIO) makes a final decision whether to
recommend a sanction to OIG.
• 	The meeting will be held within 30 calendar days of your request. The (name of
QIO) will contact you regarding date, time, and place for the meeting. The
meeting date may be extended, but only if you can demonstrate good cause.
• 	You may have an attorney represent (you) (your hospital) at the meeting. The
attorney may make opening and closing statements, assist (you) (your hospital) in
presenting expert testimony, and ask clarifying questions.

• 	(You) (Your hospital) may bring professional (expert) witnesses to testify on
(your) (your hospital’s) behalf. The purpose of the witnesses is to discuss relevant
medical views pertaining to the above-cited cases.
• 	The (name of QIO) will make a verbatim record of the meeting and provide this
record to you as soon as is practicable, but no later than the time a sanction
recommendation (if any) is forwarded to OIG.
• 	You should bring all relevant documentation (including office records) regarding
the cases cited above to the meeting to fully support your views.
• 	You may request that the physician at the QIO who determined that there is a
reasonable basis for concluding that (you have) (your hospital has) violated one or
more obligations under the Act appear at the meeting to discuss the basis for
his/her determination, although the QIO does not have to grant that request.
• 	You may object to any member of the QIO being permitted to participate in the
decision of (your) (your hospital's) case if you believe that he/she has a personal
bias against or is in direct economic competition with (you) (your hospital).
• 	If, prior to the end of the meeting with (name of QIO), you believe that additional
documentation exists which relates to the cases or issues discussed at the meeting,
you may request an additional period of time (not to exceed 5 days) to submit the
relevant information to (name of QIO). If the (name of QIO) concurs, it may grant
an additional period of time (not to exceed 5 days) for the submission of this
information.
Sincerely yours,
(QIO Medical Director)
Enclosures:
(1) Overview of Sanction Process;
(2) Summary of Information Used in Determining Findings;
(3) Case Synopsis; and
(4) Current QIO Instruction.
Enclosure 1: Overview of Sanction Process for Substantial Violations
INITIAL SANCTION NOTICE

Thirty (30) days to submit additional information and/or request a meeting and
consideration of a corrective action (if applicable)
QIO DECISION
Not a substantial second sanction notice* violation
Thirty (30) days to submit additional information and/or request a meeting and
consideration of corrective action (if appropriate)
*The enclosed letter is a second sanction notice.
QIO DECISION
Not a
substantial
violation
Violation
recommendation to OIG
Final sanction
notice
Thirty days to submit
additional information to
OIG and consideration of
OIG DECISION
Do not
sanction
Sanction
Right to an administrative
law judge (including a pre-
exclusion hearing, if
applicable)

Appendix 9-4 – Synopsis of Cases for Use with 30-Day Letter
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
(Substantial Number of Cases Only)
Case #: ______________ 	Physician: ______________
Admitted: ____________ 	Discharged: _____________
Principal Diagnosis: 	(Diverticulosis)
Secondary Diagnosis: 	(Hemorrhoids and Arteriosclerotic heart disease)
Procedures Performed: 	(Sigmoidoscopy Barium Enema Colonoscopy)
Example: An 80-year-old patient admitted in stable condition with history of constipation,
pain in lower left abdominal quadrant, and occasional rectal bleeding. The
admitting/working diagnosis was possible sigmoid tumor. No outpatient evaluation was
performed prior to admission. The hospital course was unremarkable and pain due to
constipation was attributable to poor dietary habits.
Issues Raised and Discussed with Practitioner:
1. 	Why wasn't there some outpatient workup to determine cause of rectal bleeding and
extent of bleeding?
2. 	A colonoscopy was performed in the presence of a normal barium enema. The
validity of performing this study is in question, particularly since a sigmoidoscopy
was performed a few days before the colonoscopy and revealed the presence of
large internal hemorrhoids.
3. 	There was no evidence of instructions about importance of diet, exercise, and
adequate fluid intake on prevention of constipation.
Oral Arguments or Written Information Provided by Practitioner:
1. 	A rectal examination performed in the office prior to admission was positive for
occult blood. Complete blood count not performed because frank bleeding just
started; therefore, Hgb and Crit would not yet be deviant.
2. 	The patient complained of weakness; therefore, the preparation for a barium enema
would have made him weaker. Since he was not bleeding at the time of the
sigmoidoscopy, the decision was made to perform a more extensive examination.
I believed that the colonoscopy was more reliable than a barium enema.

3. 	This 80 year old patient has not followed my instructions in the past.
QIO Evaluation of Arguments or Written Information Presented:
1. 	A rectal examination is not an adequate workup for a patient who was not acutely ill
(i.e., complained of occasional bleeding). The CBC performed upon admission and
on the day following admission indicated an Hgb of 12 and a Crit of 36, certainly
well within normal range.
2. 	The admission history and physical examination states that the patient was "in no
acute distress." No measures were taken (either prophylactically or therapeutically)
to indicate that the patient was in any acute distress. The prep for the colonoscopy
is not any less stringent than the prep for the barium enema.
3. 	The ongoing treatment of his condition is so dependent upon such items as dietary
habits, it is most important that this information be emphasized and reinforced
multiple times with an aged individual.
CONCLUSION OF QIO:
The physician violated his statutory obligations as follows:
1. 	Substantially violated his obligation to order or furnish only care that is medically
necessary by:
a. 	Unnecessarily admitting patient to the hospital in that the diagnostic studies
performed could have been performed on an outpatient basis.
b. 	Inappropriately performing a colonoscopy in the presence of normal barium
enema results.
2. 	Substantially violated his/her obligation to provide such evidence of medical
necessity and quality of health care services provided as a QIO may reasonably
require by failing to adequately document the reasons for admission and
performance of procedures.
3. 	Substantially violated his/her obligation to furnish care which meets professionally
recognized standards of quality by failing to provide adequate instructions to
prevent readmission of this patient in the future.
Case #: ______________ 	Physician: ______________
Admitted: ____________ 	Discharged: _____________
Principal Diagnosis: 	(Peripheral vascular disease)

Secondary Diagnosis: 	(Hypokalemia, History of Cancer of Uterus)
Procedures Performed: 	(Venogram, Arteriogram)
Example: A 73-year-old patient admitted to hospital because of leg cramps.
Admitting/working diagnosis was thrombophlebitis.
Issues Raised and Discussed with Practitioner:
1. 	Admission history and physical examination failed to support the diagnosis of
thrombophlebitis; however, the patient received parenteral Heparin therapy for four
days without sufficient documentation to support its use.
2. 	Progress notes for four days were illegible, and the progress notes written on two
days do not permit assessment of need for hospital level of care.
3. 	Physical examination documents the presence of an abdominal fistula. There is no
further reference made to this significant abnormality.
4. 	Why was there no review of old records in this patient who could not give an
adequate history of past illnesses?
5. 	No documentation of pelvic examination in this patient with previous total
abdominal hysterectomy with radiation for uterine cancer.
Oral Arguments or Written Information Provided by Practitioner:
1. 	There was marked edema of the leg, and the patient responded to touch as if the leg
was painful; therefore, I believed that this patient had a thrombophlebitis. (Since
this patient was confused and uncooperative, I was unable to elicit correct responses
to questions asked about symptomatology.) I did not see the necessity of
performing a venogram before beginning intravenous Heparin therapy since this is
the treatment of choice for acute thrombophlebitis.
2. 	All physicians have illegible handwriting. All that is important is that I can read
what I wrote. If the patient got better, why should the QIO nitpick about the quality
of my handwriting?
3. 	I saw no need to investigate the abdominal fistula since it was evident to me that she
had it for a number of years, it was not draining, and she did not exhibit any signs of
an infection in this area.
4. 	She was admitted in the evening, and the medical records department was closed.

5. 	There was no need to subject this patient to a pelvic examination even if she had
cancer in the past.
QIO Evaluation of Arguments or Written Information Presented:
1. 	The edema and redness of the legs were bilateral, not just contralateral. There also
was not contralateral redness. Given the fact that the signs and symptoms do not
lend themselves to an appropriate conclusion that the patient had an acute
thrombophlebitis, treatment with intravenous Heparin was not medically indicated
without additional diagnostic findings to confirm the diagnosis.
2. 	The fact that some physicians have poor handwriting is no excuse to have
practically no progress notes for the stay. It is imperative that all people rendering
care (as well as internal and external review entities) be able to read the progress
notes so that they can understand what the physician perceives is happening to the
patient (for example, if a particular treatment modality is improving the patient's
condition).
3. 	There was an inadequate description of the abdominal fistula in the chart. Given the
information submitted, we agree that non-treatment of the fistula is not an issue.
4. 	The medical records could have been obtained the next morning. It is essential to
have the past records to adequately care for the patient.
5. 	We continue to believe that a pelvic examination should have been performed.
6. 	Also, given the history of radiation for uterine cancer, the edema of the legs could
have been related to metastatic disease, and there was no workup for this.
CONCLUSION OF QIO:
The physician violated his statutory obligations as follows:
1. 	Substantially violated his obligation to order or furnish care that meets
professionally recognized standards of quality by:
a. 	Failing to understand the appropriate diagnosing of thrombophlebitis.
b. 	Failing to document a pelvic examination in a patient with previous total
hysterectomy with radiation for uterine cancer.
2. 	Substantially violated his obligation to provide such evidence of medical necessity
and quality of health care services provided as a QIO may reasonably require by:

a. 	Failing to write a progress note on two days and failure to write legible
progress notes on four days.
b. 	Failing to obtain the previous medical records and include vital information
from those records in the medical records for the stay.
Case #: ______________ 	Physician: ______________
Admitted: ____________ 	Discharged: _____________
Principal Diagnosis: Chronic Obstructive Pulmonary Disease
Secondary Diagnosis: Myocardial Ischemia Arteriosclerotic Heart Disease Diabetes
Mellitus, Adult Onset Urinary Tract Infection
A 78-year-old patient with past history of myocardial ischemia admitted with acute
crushing chest pain radiating down his left arm. Patient also complained of shortness of
breath.
Issues Raised and Discussed with Practitioner:
1. 	Inappropriate admission to a hospital without active coronary care unit.
2. 	Inadequate evaluation of this patient's complaints of chest pain and shortness of
breath. Although a LDH and CPK were performed as part of the SMA-21, no
cardiac enzymes were drawn, and no additional cardiac evaluation was performed,
other than an EKG.
3. 	The initial ABGs were abnormal, yet no follow-up ABGs or other studies were
performed. In addition, there were no changes to the treatment plan based upon the
abnormal ABGs.
4. 	Why wasn't a medical consultation ordered?
Oral Arguments or Written Information Provided by Practitioner:
1. 	The patient's family phoned and stated that the patient had acute chest pain. Since I
happened to be at XYZ Hospital, where I only occasionally practice, I told them I
would meet them there.
2. 	Since the initial enzymes were normal, I saw no need to have them repeated. This
hospital was unable to perform many of the sophisticated tests one would perform in
other hospitals.

3. 	Given he had a history of underlying lung disease and I had seen him with ABGs
that abnormal before, I did not believe that I needed to intervene. I also believed that
the abnormal ABGs were as a result of his hyperventilating due to his apprehension.
4. 	I had cared for this gentleman for a number of years, and I felt that if I called in a
consultant, it would frighten him. I have more than adequately cared for people with
the same problems in my 52 years of medical practice.
QIO Evaluation of Arguments or Written Information Presented:
1. 	The XXX Hospital, which is less than half a block away from the XYZ Hospital,
has a Coronary care unit. Since the physician has privileges at that hospital also, he
should have instructed the patient's family to take him there, as the admission
history and physical examination indicates that the patient complained of crushing
chest pain, unlike any he had ever experienced.
2. 	The initial enzymes many times will not indicate the presence of an acute infarct.
Since the admission history states that the patient arrived at the hospital within 30
minutes of the onset of the pain, the blood work was performed early in relation to
the onset of symptoms.
3. 	The ABGs, at a minimum, should have been repeated to ascertain if there was
something that needed to be addressed, either prophylactically or therapeutically.
The fact that the ABGs had been that abnormal in the past is not relevant. The acute
exacerbation of a chronic lung disease can cause havoc with the treatment of a
patient.
4. 	A surgeon, faced with an acute medical crisis, particularly in one of his non-surgical
patients, should obtain a medical consultation. The patient's fears could have been
assuaged by reassuring him that he was being cared for by a "team" of health care
professionals.
CONCLUSION OF QIO:
The physician violated his statutory obligations as follows:
1. 	Substantially violated his obligation to furnish care that meets professionally
recognized standards of quality by:
a. 	Failing to investigate adequately the chest pain, which was the presenting
complaint.
b. 	Failing to repeat blood gases on a patient admitted with abnormal blood
gases.

c. 	Failing to adequately treat a patient with abnormal blood gases.
d. 	Failure to transfer patient to medical service in the absence of a surgical
problem.
Case #: ______________ 	Physician: ______________
Admitted: ____________ 	Discharged: _____________
Principal Diagnosis: 	(Noninfectious gastroenteritis)
Secondary Diagnosis: (Arteriosclerotic Heart Disease)
(Diabetes Mellitus, Adult Onset)
Example: A 75-year-old female with history of nausea, vomiting, and diarrhea of three
days duration. Although patient complained of weakness, admission electrolytes were
normal, and no additional diagnostic studies were obtained other than a chest X-ray, EKG,
and SMA-21. She received intravenous fluids; however, the rate of administration was
ordered as KVO.
Issues Raised and Discussed with Practitioner:
1. 	Inappropriate admission to a hospital for a clinically stable patient.
2. 	If patient was not stable, why were additional diagnostic studies not performed or
fluid replacement not more aggressive?
Oral Arguments or Written Information Provided by Practitioner:
1. 	The patient's family phoned and reported that she had nausea, vomiting, and
diarrhea of three days duration. Knowing that the aged dehydrate quickly, I feared
that this was the case and, thus, admitted her. I had no way of knowing that her
electrolytes would be normal.
2. 	Once it was determined that her electrolytes were normal, I saw no need to do
anything other than to treat her symptoms (i.e., medication for diarrhea). I saw no
need to administer intravenous fluids and set her up for a round of congestive heart
failure.
QIO Evaluation of Arguments or Written Information Presented:
1. 	An evaluation of her condition could have been performed on an outpatient basis
(e.g., a physical examination for signs of dehydration, electrolytes, etc.).
2. 	The QIO is not alleging that the physician should have put the patient in a fluid
overload. Rather, the QIO is pointing out that the physician, upon admission, must

not have believed that the patient was not stable in that intravenous fluid
replacement was limited to a KVO order.
CONCLUSION OF QIO:
The physician violated his statutory obligations as follows:
1. 	Substantially violated his obligation to order or furnish only care that is medically
necessary by unnecessarily admitting patient to the hospital.

Appendix 9-5 – Initial Sanction Notice of Gross and Flagrant Violation
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
QIO LETTERHEAD
(Name and Address of Practitioner or Provider)
(Dear Dr. 	:) or (Dear Mr./Mrs./Ms. 	:)
The purpose of this notice is to inform you that (name of QIO), the Quality Improvement
Organization (QIO) for the State of (name of State), has concluded that there is a reasonable
basis for determining that (you have) (your hospital has) violated (your) (its) obligation
under §1156 of the Social Security Act (the Act) to assure that the services provided to
program beneficiaries are:
(SELECT OBLIGATION(S) VIOLATED). Choose (1), (2), and/or (3) from below:
(1) Provided economically and only when, and to the extent, they are medically necessary;
(2) Of a quality that meets professionally recognized standards of health care; and/or
(3) Supported by the appropriate evidence of medical necessity and quality of the services
in a form and fashion and at such time as may be required.
(Name of QIO) has concluded that there is a reasonable basis for determining that (you
have) (your hospital has) grossly and flagrantly violated (your) (its) statutory obligations.
• 	If the QIO determines finally that such a violation has occurred and recommends a
sanction to the Secretary of the Department of Health & Human Services (HHS),
and if a final determination is made by the Secretary through the Office of Inspector
General (OIG) to impose a sanction, (YOU) (YOUR HOSPITAL) MAY BE
EXCLUDED FROM PARTICIPATING IN PROGRAMS UNDER TITLES V, XVIII,
XIX, AND XX OF THE SOCIAL SECURITY ACT (INCLUDING THE MEDICARE
PROGRAM AND ANY STATE HEALTH CARE PROGRAM AS DEFINED IN
§1128(h) OF THE ACT) EITHER PERMANENTLY OR FOR A SPECIFIED
PERIOD OF TIME OF AT LEAST 1 YEAR OR, ALTERNATIVELY, REQUIRED
TO PAY THE UNITED STATES GOVERNMENT A MONETARY PENALTY
AS A CONDITION FOR (YOUR) (YOUR HOSPITAL'S) CONTINUED
PARTICIPATION IN THE MEDICARE AND STATE HEALTH CARE
PROGRAMS.
Because of the serious nature of a final determination by the QIO to recommend a sanction
to OIG, you are strongly encouraged to contact (name of QIO) to provide additional
information to assist you in responding to the initial determination of a violation and/or to
set up a meeting with the (name of QIO).

THE MEETING WITH THE QIO WILL BE YOUR ONLY OPPORTUNITY TO
DISCUSS (YOUR) (YOUR HOSPITAL'S) SITUATION WITH THE QIO BEFORE IT
MAKES A FINAL DECISION WHETHER TO RECOMMEND TO OIG THAT (YOU)
(YOUR HOSPITAL) BE SANCTIONED. IF, AS A RESULT OF THE MEETING, A
CORRECTIVE ACTION PLAN (CAP) IS IMPLEMENTED, NO FINAL DECISION
WILL BE MADE UNTIL THE END OF THE CAP PERIOD.
• 	An in-depth discussion of the cases involved is included below in the case summary
section. A detailed synopsis of cases is also enclosed.
• 	The “Additional Information” section explains how to submit additional information
to and/or request a meeting with the QIO.
• 	Enclosure 1 provides a brief overview of the sanction process.
OBLIGATIONS
Section 1156 of the Act (42 U.S.C. 1320c-5) imposes certain obligations upon health care
practitioners and other persons who furnish or order services under Medicare or State health
care programs. These obligations are to assure that the services are:
(1) Provided economically and only when, and to the extent, they are medically necessary;
(2) Of a quality that meets professionally recognized standards of health care; and
(3) Supported by the appropriate evidence of medical necessity and quality of the services
in a form and fashion and at such time as may be required. See also 42 CFR Part 1004.
QIO RESPONSIBILITIES
The Secretary of HHS has a contract with the (name of QIO) to review Medicare services.
Section 1156(b) of the Act provides that if (name of QIO) determines that a practitioner or
other person either has failed to comply substantially with any of these obligations in a
substantial number of cases, or has grossly and flagrantly violated any such obligation in
one or more instances, (name of QIO) must report such determination(s) to the HHS OIG,
along with a recommendation for appropriate sanction actions. If OIG agrees with the
QIO’s recommendation and finds that the practitioner or other person is unable or unwilling
substantially to comply with his/her statutory obligations, OIG may impose a sanction.
These sanctions may include exclusion from eligibility to provide services to patients of the
Medicare and State health care programs on a payable basis either permanently or for a
specified period of time. Alternatively, payment of a monetary penalty in the amount of the
actual or estimated cost of medically improper or unnecessary services may be required as a
condition for continued eligibility to receive payment under the programs.
VIOLATION OF OBLIGATION – CASE SUMMARY

The (name of QIO) has reviewed medical records pertaining (to your medical practice), or
(to the health care services and items furnished in your hospital). As a result of this review,
the (name of QIO) has a reasonable basis for determining that (you have) (your hospital
has) grossly and flagrantly violated (your) (its) obligations under §1156 of the Act in the
following respects:
1. Chart No. 	Admission Date
• 	Conclusion:
2. Chart No. 	Admission Date
• 	Conclusion:
-ETC.-
A copy of the material (name of QIO) used in arriving at this initial determination is
enclosed. Also enclosed is a detailed case synopsis identifying each case (name of QIO)
reviewed, the issues (name of QIO) raised, your response to the issues raised, and (name of
QIO)’s final determination. (See Appendix 9-6 for Sample Synopsis of a Case.)
It has also been initially determined that the violations of (your) (your hospital's)
obligations under §1156 of the Act are serious enough to warrant recommending to HHS
that sanctions be imposed upon you pursuant to Federal statute and regulations. The
sanction to be recommended is (exclusion from participation in the Medicare and State
health care programs [for a period of _____ years]) or (that [you] [your hospital] pay to the
Government of the United States a monetary penalty in the amount of as a condition for
your continued participation in the Medicare and State health care programs).
CORRECTIVE ACTION PLAN (if applicable)
[Describe the method and timeframe for correcting the identified violation(s)].
ADDITIONAL INFORMATION
By this letter you are hereby formally notified that you may submit to the (name of QIO),
within 30 days of the date of receiving this letter, additional information that you feel might
modify our position and/or a written request to meet with us to review and discuss case
specifics. The date of receipt is presumed to be five (5) days after the date on this letter.
The additional information and/or request for a meeting should be submitted to:
(Contact Person)
(Name of QIO)

(Address)
IF YOU REQUEST A MEETING
The purpose of the meeting is to allow (you) (your hospital) to present (your) (your
hospital's) views regarding the care rendered to program beneficiaries in the above-cited
cases, to discuss these views with the (name of QIO), and to respond to the initial
determination of a violation before (name of QIO) makes a final decision whether to
recommend a sanction to OIG.
• 	The meeting will be held within 30 calendar days of your request. The (name of
QIO) will contact you regarding date, time, and place for the meeting. The meeting
date may be extended, but only if you can demonstrate good cause.
• 	You may have an attorney represent (you) (your hospital) at the meeting. The
attorney may make opening and closing statements, assist (you) (your hospital) in
presenting expert testimony, and ask clarifying questions.
• 	(You) (Your hospital) may bring professional (expert) witnesses to testify on (your
hospital's) behalf. The purpose of the witnesses is to discuss relevant medical views
pertaining to the above-cited cases.
• 	The (name of QIO) will make a verbatim record of the meeting and provide this
record to you as soon as is practicable, but no later than the time a sanction
recommendation (if any) is forwarded to OIG.
• 	You should bring all relevant documentation (including office records) regarding
the cases cited above to the meeting to fully support your views.
• 	You may request that the physician at the QIO who determined that there is a
reasonable basis for concluding that (you have) (your hospital has) violated one or
more obligations under the Act appear at the meeting to discuss the basis for the
determination, although the QIO does not have to grant that request.
• 	You may object to any member of the QIO being permitted to participate in the
decision of (your) (your hospital's) case if you believe that he/she has a personal
bias against or is in direct economic competition with (you) (your hospital).
• 	If, prior to the end of the meeting with (name of QIO), you believe that additional
documentation exists that relates to the cases or issues discussed at the meeting, you
may request an additional period of time (not to exceed 5 days) to submit the
relevant information to (name of QIO). If the (name of QIO) concurs, it may grant
an additional period of time (not to exceed 5 days) for the submission of this
information.

Sincerely yours,
(QIO Medical Director)
Enclosures:
(1) Overview of Sanction Process;
(2) Summary of Information Used in Determining Findings;
(3) Case Synopsis; and
(4) Current QIO Instructions.
Enclosure 1: Overview of Sanction Process for Gross and Flagrant Violations
INITIAL SANCTION NOTICE*
Thirty (30) days to submit additional information and/or request a meeting and
consideration of corrective action (if appropriate)
QIO DECISION
Not a gross
violation
Final sanction
recommendation and
flagrant notice
Not a
substantial
violation
Final sanction notice to
OIG
Thirty days to submit
additional information
and/or request a meeting
Thirty days to submit
additional information to
OIG and consideration of
corrective action
(if appropriate)
OIG DECISION
OIG
DECISION
Do not sanction Sanction
Right to an administrative
law judge (including a pre-
exclusion hearing, if
applicable)
*The enclosed letter is an initial sanction notice.

Appendix 9-6 - Synopsis of Cases for Use with 30-Day Letter
(Gross and Flagrant Violations Only)
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Case #: ______________ 	Physician: ______________
Admitted: ____________ 	Discharged: _____________
Example:
Principal Diagnosis: 	(Diabetes with Hyperosmolar Coma)
Diagnoses: 	(Pneumonia, Arteriosclerotic Heart Disease, Status Post Cerebral
Thrombosis)
Procedures Performed: N/A REVIEW SUMMARY
This 72-year-old patient was admitted in a comatose state from a nursing home with the
diagnosis of diabetes mellitus with hyperosmolar coma. The patient’s initial blood sugar
was 926, with no ketoacidosis. A portable chest X-ray was obtained shortly after
admission; however, the radiologist stated on the report that a second X-ray should be
obtained to rule out the presence of pneumonia. The patient's temperature was 102 degrees
upon admission, but on the following day it spiked to 104 degrees. No serum osmolality
levels were obtained (or calculated), the chest X-ray was not repeated timely, and no blood
or sputum cultures were ordered. The patient was given 5% dextrose in water and large
amount of insulin; however, the patient expired on the second day of the stay.
SPECIFIC FINDINGS
The physician violated his statutory obligation as follows:
• 	GROSSLY AND FLAGRANTLY failed to furnish proper medical care that meets
professionally recognized standards of care.
• 	Failed to order the appropriate diagnostic tests for a diabetic hyperglycemic patient
with no ketoacidosis.
• 	Failed to use isotonic salt solution to rehydrate the patient.
• 	Failed to repeat a questionable chest X-ray for a diabetic patient in hyperosmolar
coma.
• 	Failed to order diagnostic studies to ascertain the cause of the fever.

Appendix 9-7 – Final QIO Sanction Notice
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
(Name and Address of Practitioner or Provider)
(Dear Dr. 	:) or (Dear Mr./Mrs./Ms. 	:)
As you are aware, on (date), (name of QIO), the Quality Improvement Organization (QIO)
for the State of (Name of State), informed (you) (your hospital) of an initial identification of
a possible (substantial) (gross and flagrant) violation of obligations in the care of (a)
program patient(s). Subsequently, (name of QIO) informed (you) (your hospital) by letter,
dated (date), of its conclusion that there was a reasonable basis for determining that (you)
(your hospital) had, in fact, (substantially) (grossly and flagrantly) violated the obligations
under §1156 of the Social Security Act (the Act).
Section 1156 of the Act (42 U.S.C. 1320c-5) imposes certain obligations upon health care
practitioners and other persons who furnish or order services under Medicare or State health
care programs. These obligations are to assure that the services are:
(1) Provided economically and only when, and to the extent, they are medically necessary;
(2) Of a quality that meets professionally recognized standards of health care; and
(3) Supported by the appropriate evidence of medical necessity and quality of the services
in a form and fashion as may be required.
On the basis of additional information provided in response to the above letters and the
results of corrective action measures, if applicable, (name of QIO) has determined that
(you have) (your hospital has) failed to comply with the obligation(s) (CHOOSE (1), (2),
and/or (3) from paragraph above) imposed on you by §1156 of the Act. Therefore, the
(name of QIO) has submitted a recommendation to the Secretary of the Department of
Health & Human Services, Office of Inspector General (OIG), that (you) (your hospital) be:
1. 	Excluded from participating (as a provider) in the Medicare program and any State
health care program as defined in §1128(h) of the Act for a period of _____ years;
OR
2. 	Required to pay to the United States Government a monetary penalty in the amount
of _____ as a condition for [your] [your hospitals] continued participation in the
Medicare and State health care programs.)
The (name of QIO) has determined that (you have) (your hospital has) (substantially)
(grossly and flagrantly) violated the obligations under §1156 of the Act in the following
respects:

1. Chart No. 	Admission Date
• 	Conclusion:
2. Chart No. 	Admission Date
• 	Conclusion:
-ETC.-
A copy of the material (name of QIO) used in arriving at this determination is enclosed.
Also enclosed is a detailed case synopsis identifying each case (name of QIO) reviewed, the
issues (name of QIO) raised and to which you responded, and a clear statement of the
factual bases for the (name of QIO)’s determination in each case that (you) (your hospital)
violated (your) (its) obligations under the Program. This information is the same material
that is being sent to OIG.
(You) (Your hospital) may submit, within 30 days from the date of receiving this letter, any
additional material that affects the recommendation (to exclude (you) (your hospital) from
Medicare and State health care programs) (to impose a monetary penalty). The date of
receipt is presumed to be 5 days after the date on this letter. Such material should be sent
to:
Office of Inspector General
Administrative and Civil Remedies Branch – Social Security Act §1156 Coordinator
330 Independence Avenue, SW
Mail Stop: Room 5527
Cohen Building
Washington, DC 20201
If OIG agrees with our recommendation and determines that (you are) (your hospital is)
either unwilling or unable to comply with your obligations under §1156, it may impose a
sanction. OIG may accept, reject, or modify our sanction recommendation. OIG is
required by law to determine, within 120 days after receiving an exclusion recommendation
from the QIO, whether a sanction action is warranted. Therefore, where an exclusion has
been recommended, the time period for submitting additional material to OIG will not be
extended, and any material received by OIG after the 30-day period will not be considered.
Sincerely yours,
(QIO Medical Director)
Enclosures

Appendix 9-8 – Combined Initial Sanction Notice of Substantial Violation
in a Substantial Number of Cases and in a Gross and Flagrant
Violation(s)
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
QIO LETTERHEAD
(Name and Address of Practitioner or Provider)
(Dear Dr. 	:) or (Dear Mr./Mrs./Ms. 	:)
The purpose of this notice is to inform you that (name of QIO), the Quality Improvement
Organization (QIO) for the State of (name of State), has concluded that there is a reasonable
basis for determining that (you have) (your hospital has) violated (your) (its) obligation(s)
under §1156 of the Social Security Act (the Act) to assure that the services provided to
program beneficiaries are:
(SELECT OBLIGATION(S) VIOLATED). Choose (1), (2), and/or (3) from below:
(1) Provided economically and only when, and to the extent, they are medically necessary;
(2) Of a quality that meets professionally recognized standards of health care; and/or
(3) Supported by the appropriate evidence of medical necessity and quality of the services
in a form and fashion and at such time as may be required.
(Name of QIO) has concluded that there is a reasonable basis for determining that (you
have) (your hospital has) failed to comply substantially with your statutory obligations in a
substantial number of cases and grossly and flagrantly violated your statutory obligations.
• 	If the QIO determines finally that such violations have occurred and recommends a
sanction to the Secretary of the Department of Health & Human Services (HHS),
and if a final determination is made by the Secretary through the Office of Inspector
General (OIG) to impose a sanction, (YOU) (YOUR HOSPITAL) MAY BE
EXCLUDED FROMPARTICIPATING IN PROGRAMS UNDER TITLES V, XVIII,
XIX, AND XX OF THE SOCIAL SECURITY ACT (INCLUDING THE MEDICARE
PROGRAM AND ANY STATE HEALTH CARE PROGRAM AS DEFINED IN
§1128(h) OF THE ACT) EITHER PERMANENTLY OR FOR A SPECIFIED
PERIOD OF TIME OF AT LEAST 1 YEAR OR, ALTERNATIVELY, REQUIRED
TO PAY THE UNITED STATES GOVERNMENT A MONETARY PENALTY
AS A CONDITION FOR (YOUR) (YOUR HOSPITAL'S) CONTINUED
PARTICIPATION IN THE MEDICARE AND STATE HEALTH CARE
PROGRAMS. Therefore, you are strongly encouraged to contact the (name of QIO)
to provide additional information and/or meet with (name of QIO).

• 	An in-depth discussion of the cases involved is included below in the case summary
sections for both types of violations.
You will be given an opportunity to provide additional information and/or request a
meeting with (name of QIO) to discuss both types of violations. The “Additional
Information” section explains how to submit additional information and/or request a
meeting that covers/includes these violations. Although no sanction
recommendation based on the substantial viola tions in a substantial number of
cases will be made to OIG after this initial meeting, it is nevertheless an important
first step in the sanction process. With respect to substantial violations in a
substantial number of cases, you are entitled (after this initial meeting) to another
opportunity to provide additional information and/or request a meeting with (name
of QIO). With respect to gross and flagrant violations, you are not entitled to this
additional opportunity before a sanction recommendation can be made to OIG.
• 	THE INITIAL MEETING WITH THE QIO MAY BE (YOUR) (YOUR
HOSPITAL'S) ONLY OPPORTUNITY (WITH RESPECT TO GROSS AND
FLAGRANT VIOLATIONS) TO DISCUSS (YOUR) (YOUR HOSPITAL'S)
SITUATION WITH THE QIO BEFORE IT MAKES A FINAL DECISION
WHETHER TO RECOMMEND TO OIG THAT (YOU) (YOUR HOSPITAL) BE
SANCTIONED BASED ON A GROSS AND FLAGRANT VIOLATION(S).
Therefore, because of the serious nature of a QIO’s final determination to
recommend a sanction to OIG based on the gross and flagrant violation(s), you are
strongly encouraged to contact (name of QIO) to provide additional information to
assist you in responding to the initial determination of a violation and/or to set up a
meeting with the (name of QIO).
IF, AS A RESULT OF THE INITIAL MEETING WITH (name of QIO)
PROVIDED AS A RESULT OF THE NOTIFICATION YOU HAVE JUST
RECEIVED, A CORRECTIVE ACTION PLAN (CAP) IS IMPLEMENTED, NO
FINAL DECISION WILL BE MADE UNTIL THE END OF THE CAP PERIOD.
DEPENDING ON WHETHER THE VIOLATION(S) INVOLVES A GROSS AND
FLAGRANT OR SUBSTANTIAL VIOLATION, YOU MAY BE ENTITLED TO
AN ADDITIONAL OPPORTUNITY TO MEET WITH (name of QIO). YOU
ALSO ARE NOTIFIED THAT ANY VIOLATIONS THAT HAVE BEEN
INITIALLY FOUND TO BE GROSS AND FLAGRANT ARE ALSO
CONSIDERED TO BE SUBSTANTIAL VIOLATIONS. THEREFORE, THESE
CASES ARE ALSO LISTED UNDER SUBSTANTIAL VIOLATIONS IN A
SUBSTANTIAL NUMBER OF CASES.
• 	Enclosure 1 provides a brief overview of the sanction process for concurrent
identification of gross and flagrant and substantial violations in a substantial number
of cases.

OBLIGATIONS
Section 1156 of the Act (42 U.S.C. 1320c-5) impose certain obligations upon health care
practitioners and other persons who furnish or order services under Medicare or State health
care programs. These obligations are to assure that the services are:
(1) Provided economically and only when, and to the extent, they are medically necessary;
(2) Of a quality that meets professionally recognized standards of health care; and
(3) Supported by the appropriate evidence of medical necessity and quality of the services
in a form and fashion and at such time as may be required. See also 42 CFR Part 1004.
QIO RESPONSIBILITIES
The Secretary of HHS has a contract with the (name of QIO) to review Medicare services.
Section 1156(b) of the Act provides that if (name of QIO) determines that a practitioner or
other person either has failed to comply substantially with any of these obligations in a
substantial number of cases, or has grossly and flagrantly violated any such obligation in
one or more instances, (name of QIO) must report such determination(s) to the HHS OIG,
along with a recommendation for appropriate sanction actions. If OIG agrees with the
QIO’s recommendation and finds that the practitioner or other person is unable or unwilling
substantially to comply with his/her statutory obligations, OIG may impose a sanction.
These sanctions may include exclusion from eligibility to provide services to patients of the
Medicare and State health care programs on a payable basis either permanently or for a
specified period of time. Alternatively, payment of a monetary penalty in the amount of the
actual or estimated cost of medically improper or unnecessary services may be required as a
condition for continued eligibility to receive payment under the programs.
• 	The section below entitled "GROSS AND FLAGRANT VIOLATION(S)" identifies
the case(s) in which the (name of QIO) has initially determined that (you have)
(your hospital has) grossly and flagrantly violated (your) (its) statutory obligations.
The section below entitled "SUBSTANTIAL VIOLATIONS" identifies the cases in
which the (name of QIO) has initially determined that (you have) (your hospital has)
substantially violated (your) (its) statutory obligations. An in-depth discussion of
each case is included in the enclosed case synopsis.
GROSS AND FLAGRANT VIOLATION(S) OF OBLIGATION – CASE SUMMARY
The (name of QIO) has reviewed medical records pertaining (to your medical practice) (to
the health care services and items furnished in your hospital). As a result of this review, the
(name of QIO) has a reasonable basis for determining that (you have) (your hospital has)
grossly and flagrantly violated (your) (its) obligations under §1156 of the Act in the
following respects:

1. Chart No. 	Admission Date
• 	Conclusion:
2. Chart No. 	Admission Date
• 	Conclusion:
-ETC.-
A copy of the material (name of QIO) used in arriving at this initial determination is
enclosed. Also enclosed is a detailed case synopsis identifying each case (name of QIO)
reviewed, the issues (name of QIO) raised, your response to the issues raised, and (name of
QIO) final determination. (See Appendix 9-6 for Sample Synopsis of a Case.)
You are also notified that any violations that have been initially found to be gross and
flagrant are also considered to be substantial violations.
CORRECTIVE ACTION PLAN FOR GROSS AND FLAGRANT VIOLATION(S)
(if applicable)
Describe the method and timeframe for correcting the identified violation(s).
SUBSTANTIAL VIOLATION OF OBLIGATION IN A SUBSTANTIAL NUMBER OF
CASES – CASE SUMMARY
The (name of QIO) has reviewed medical records pertaining to (your medical practice) (the
health care services and items furnished in your hospital). As a result of this review, the
(name of QIO) is concerned that (your medical practice) (your hospital's health care
services and items furnished to program beneficiaries) as documented in these medical
records does not appear to comply substantially with the obligations imposed on you under
the Act in the following respects:
(Include an in-depth discussion of each situation, circumstance, or activity that resulted in a
violation as well as the obligation involved.)
EXAMPLE:
Providing Services Not Medically Necessary and/or Not Provided in the Most Economical
Setting:
1. Chart No. 	Admission Date
• 	Conclusion:

2. Chart No. 	Admission Date
• 	Conclusion:
Providing Services That Do Not Meet Professionally Recognized Standards of Care:
1. Chart No. 	Admission Date
• 	Conclusion:
2. Chart No. 	Admission Date
• 	Conclusion:
A summary of the information considered by (name of QIO) in arriving at the above
findings is enclosed.
CORRECTIVE ACTION PLAN FOR SUBSTANTIAL VIOLATIONS (If applicable)
Describe the method and timeframe for correcting the identified violation(s).
ADDITIONAL INFORMATION
By this letter you are hereby formally notified that you may submit to the (name of QIO),
within 30 days of the date of receiving this letter, additional information for both gross and
flagrant violation(s) and substantial violations that you feel might modify our position
and/or a written request to meet with us to review and discuss case specifics. You may
request, if you wish, to meet and discuss both types of violations at a combined meeting or
you may opt for separate meetings to discuss each type. The date of receipt is presumed to
be 5 days after the date on this letter.
The additional information and/or request for a meeting should be submitted to:
(Contact Person)
(Name of QIO) (Address)
IF YOU REQUEST A MEETING
The purpose of the meeting with (name of QIO) is to allow you to present (your) (your
hospital's) views regarding the care rendered to program beneficiaries in the above-cited
cases, to discuss these views with the (name of QIO), and to respond to the initial
determination of a violation before (name of QIO) makes a final decision whether to
recommend a sanction to OIG. As stated above, you are entitled to an additional
opportunity to meet with the (name of QIO) with regard to substantial violations in a
substantial number of cases before (name of QIO) makes a final decision to recommend

sanction to OIG for this type of violation.
• 	The meeting will be held within 30 calendar days of your request. The (name of
QIO) will contact you regarding date, time, and place for the meeting. The meeting
date may be extended, but only if you can demonstrate good cause.
• 	You may have an attorney represent (you) (your hospital) at the meeting. The
attorney may make opening and closing statements, assist you in presenting expert
testimony, and ask clarifying questions.
• 	You may bring professional (expert) witnesses to testify on (your) (your hospital's)
behalf. The purpose of the witnesses is to discuss relevant medical views pertaining
to this case. The (name of QIO) will make a verbatim record of the meeting and
provide this record to you, as soon as is practicable, but no later than the time a
sanction recommendation for a gross and flagrant violation (if any) is forwarded to
OIG.
• 	You should bring all relevant documentation (including office records) regarding
the cases cited above to the meeting to fully support your views.
• 	You may request that the physician at the QIO who determined that there is a
reasonable basis for concluding that you have violated one or more obligations
under §1156 of the Social Security Act appear at the meeting to discuss the basis for
the determination, although the QIO does not have to grant that request.
• 	You may object to any member of the QIO being permitted to participate in the
decision of (your) (your hospital's) case if you believe that he/she has a personal
bias against or is in direct economic competition with (you) (your hospital).
• 	If, prior to the end of the meeting with (name of QIO), you believe that additional
documentation exists (with respect to the gross and flagrant violations) that relates
to the cases or issues discussed at the meeting, you may request an additional period
of time (not to exceed 5 days) to submit the relevant information to (name of QIO).
If the (name of QIO) concurs, it may grant an additional period of time (not to
exceed 5 days) for the submission of this information).
Sincerely yours,
(QIO Medical Director)
Enclosures:
(1) Overview of Sanction Process;

(2) Summary of Information Used in Determining Findings;
(3) Case Synopsis; and
(4) Current QIO Instructions.
Enclosure 1: Overview of Sanction Process for a Combined Initial Sanction Notification for
Gross and Flagrant Violations and Substantial Violations
INITIAL SANCTION NOTICE*
Thirty days to submit additional information and/or request a meeting and consideration of
corrective action (if appropriate)
NOTE: You may opt to discuss the different types of violations at separate initial meetings.
QIO DECISION
Not a gross
violation
Final sanction
recommendation and flagrant
notice
Not a
substantial
violation
Second sanction notice to
OIG
Thirty days to submit
additional information and/or
request a meeting
Thirty days to submit
additional information to
OIG and consideration of
corrective action (if
appropriate)
OIG
DECISION
QIO
DECISION
Do not
sanction
Sanction 	Not substantial
violation
Final sanction notice
recommendation to QIG
Right to an administrative
law judge (including a pre-
exclusion hearing, if
applicable)
Thirty days to submit
additional information to
OIG
*The enclosed letter is a combined initial sanction notice.

Appendix 9-11 – EMTALA Physician Review Document Checklist
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
Instructions:
• 	The CMS Regional Office Division of Survey and Certification will indicate
whether each of the documents listed below is included in the EMTALA review
package. All of the documents listed should be included in the package, if available.
• 	The QIO Physician Reviewer will mark “Yes” for each document reviewed and
“No” for each document included in the EMTALA review package but not
reviewed. The Physician Reviewer should review all documents included in the
package.
Document Name
Included in Package?
Yes/No/Not Applicable
(N/A)
Reviewed by BFCC-QI
Physician Reviewer
Yes/No/Not Applicable
(N/A)
Hospital Medical Record(s):
Initial Facility
Hospital Medical Record(s):
Facility to which patient was
transferred
Ambulance Report
Form CMS-2567, Statement
of Deficiencies and Plan of
Correction (marked as
“Draft” for 5-Day review,
“Final” for 60-Day review)
Transcripts of notes of
relevant interviews (staff,
patient, family, other
witnesses, etc.)
Hospital census as provided
by the facility, including
capacity of relevant units
(such as ICU, inpatient
psychiatric unit, OB unit)
Staffing schedules (by unit)

Document Name
Included in Package?
Yes/No/Not Applicable
(N/A)
Reviewed by BFCC-QI
Physician Reviewer
Yes/No/Not Applicable
(N/A)
Description of hospital
services/capabilities
Physician on-call schedule at
the time of case, including
description of specialty/
privileges
Patient written transfer
request (if not in medical
record)
Relevant hospital policies/
procedures/protocols
Police report and/or court
order(s) for involuntary
commitment
Other
Other
Other

Appendix 9-12 – EMTALA Physician Review Worksheet
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
5 - Day Review 	60 - Day Review
NOTE: 	A separate Worksheet must be completed by the QIO Physician Reviewer for each
medical record reviewed. 	To facilitate accurate completion, the CMS Regional Office (RO) will
complete Section I for each medical record sent to the QIO along with the request for review.
The RO must label each medical record with the unique patient identifier as found on the draft Form
CMS 2567.
SECTION I
Complaint Control Number: 	Patient Identifier Number on Draft 2567:
Name of Patient: 	DOB:
Name of Alleged Violating Hospital and/or Physician:
City: 	State: 	CMS Certification Number:
Date and Time of Admission to Emergency Services: 	_________________________________
Date and Time of Discharge from Emergency Services:
Name of Receiving Hospital (if applicable):
Receiving Hospital Location:
City: 	State: 	CMS Certification Number:
Date and Time of Admission to Receiving Hospital (if applicable):
Manner of Transport:
Receiving Hospital Distance from Sending Hospital (if applicable and known):
SECTION II
Note to Physician Reviewer: 	Please complete the following questions to address issues related to
EMTALA. 	Please be sure to include your clinical rationale for your findings, and make any
summary comments and comments on other aspects of the case in the summary section on the
last page of this document. Please keep in mind that the purpose of your comments is to provide
your clinical perspective on the care rendered, for the CMS 5-day EMTALA review or for the OIG
60-day EMTALA review.
Therefore, 	please refrain from making ANY statements about whether or not a violation of
EMTALA has occurred, as that decision is the responsibility of CMS and the OIG only.

(Violations of EMTALA may also constitute negligence under state malpractice law. 	However,
determining negligence is not part of and should not be mentioned in your EMTALA review.)
MEDICAL SCREENING EXAMINATION
Note to Physician Reviewer: Depending upon an individual’s presenting symptoms, an appropriate
medical screening examination can range from a simple process involving only a brief history
and physical examination to a complex process that also involves performing ancillary studies and
procedures such as (but not limited to) lumbar puncture, clinical laboratory tests, CT scans and
other diagnostic tests and procedures, some of which may require the services of an on-call specialist
to order, conduct or interpret.
A hospital must provide appropriate screening services within the full capabilities of its staff and
facilities, including access to specialists who are on call.
An Emergency Medical Condition is defined as EITHER: (1) a medical condition manifesting itself
by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances and/or
symptoms of substance abuse) such that the absence of immediate medical attention could reasonably
be expected to result in: placing the individual’s health (or, with respect to a pregnant woman, the
health of the woman or her unborn child) in serious jeopardy; or serious impairment to bodily
functions; or serious dysfunction of any bodily organ or part; OR (2) with respect to a pregnant
woman who is having contractions, that there is inadequate time to effect a safe transfer to another
hospital before delivery, or that the transfer may pose a threat to the health or safety of the woman
or the unborn child. (See 42 CFR 489.24(b))
1. 	Did the hospital provide a medical screening examination that was, within reasonable
clinical confidence, sufficient to determine whether or not an EMERGENCY MEDICAL
CONDITION (as defined above) existed? More specifically:
1a. Was the medical screening examination appropriate given all of the individual’s medical
complaints and signs and symptoms at the time the individual presented?
YES 	NO
Please explain your clinical rationale:
1b. Was the medical screening examination appropriate given the hospital’s capabilities -
including ancillary services routinely available and consultations by on–call specialist
physicians?
YES 	NO
Please explain your clinical rationale:

1c. Is there any evidence that there was an inappropriately long delay, based on the individual’s
clinical presentation, between the individual’s arrival and the provision of an appropriate
medical screening examination?
YES 	NO
Please explain your clinical rationale:
EMERGENCY MEDICAL CONDITION
2. Did this individual have an EMERGENCY MEDICAL CONDITION as defined by Part (1)
of the definition noted above? (Individual conditions meeting the definition in Part 2 above are
addressed in subsequent questions.)
YES 	NO
Please explain your clinical rationale:
3. 	Was this individual a pregnant woman who was having contractions?
YES 	NO
Please explain your clinical rationale:
(If “NO” is checked, skip questions #3a & #3b and proceed to #4)

3a. 	If “YES” is checked in #3 and the pregnant woman was transferred/discharged, at the
time of transfer/discharge, could it be determined with reasonable medical certainty that there
would be adequate time to effect a safe transfer to another hospital before delivery?
YES 	NO 	N/A
Please explain your clinical rationale:
3b. 	If 	“YES” 	is 	checked 	in 	#3 	and 	the 	pregnant 	woman 	with 	contractions 	was
transferred/discharged, 	at 	the 	time 	of 	transfer/discharge 	could 	it 	be 	determined, 	with
reasonable medical certainty, that the transfer/discharge would not pose a threat to the health or
safety of the pregnant woman or the unborn child?
YES 	NO 	N/A
Please explain your clinical rationale:
STABILIZING TREATMENT
Note to Physician Reviewer: 	Terms relating to “stabilization” are specifically defined under
EMTALA. These terms DO NOT REFLECT the common usage in the medical profession, but
instead focus on the medical risks associated with a particular transfer/discharge. 	Thus, when
answering questions related to “stability” for EMTALA, please be very careful to refer to the
definition provided below. In addition, the clinical outcome of an individual’s condition is not a
proper basis for determining whether a person transferred was stabilized. 	However, the
individual’s outcome may be a “red flag” indicating that a more thorough evaluation of the
individual’s condition at the time of transfer was needed.
Under EMTALA, to stabilize means, with respect to part 1 of the definition of an “emergency
medical condition,” to provide such medical treatment of the condition necessary to assure, within
reasonable medical probability, that no material deterioration of the condition is likely to result
from or occur during the transfer/discharge of the individual from the hospital, or in the case of
part 2 of the definition, concerning a pregnant woman having contractions, that the pregnant
woman has delivered the child and placenta.

4. 	If the individual had an emergency medical condition (EMC), was the EMC “stabilized”
(as defined above) prior to the time of the individual’s transfer or discharge?
YES 	NO 	N/A
Please explain your clinical rationale:
Note to Physician Reviewer: 	A hospital must provide appropriate stabilizing treatment services
for an emergency medical condition within the full capabilities of its staff and facilities, including
access to specialists who are on call.
5a. 	Is there any evidence that the hospital was equipped with such staff, services, or
equipment necessary to “stabilize” the individual’s emergency medical condition??
YES 	NO 	N/A
Please explain your clinical rationale:
5b. 	If the hospital had the capability to stabilize the individual and the individual’s emergency
medical condition was not stabilized prior to transfer/discharge, is there any information
available to indicate WHY the emergency medical condition was NOT “stabilized” prior to
discharge/transfer?
YES 	NO 	N/A
If yes, does this rationale have a sound clinical basis?

5c. 	Is there any evidence that there was an inappropriately long delay, based on the
individual’s 	clinical 	presentation, 	between 	the individual’s 	arrival 	and 	the 	provision 	of
appropriate stabilizing treatment for the individual’s emergency medical condition?
YES 	NO 	N/A
Please explain your clinical rationale:
Note to Physician Reviewer: 	A hospital is required to inform the individual or the individual’s
legal representative of the risks and benefits of further examination and treatment. 	If the
individual/representative then refuses to consent to further examination or treatment, the medical
record must contain a description of the examination or treatment, or both, which was refused, as
well as documentation of the individual/representative having been informed of these risks/benefits.
6. 	Does the medical record indicate the individual refused to consent to necessary stabilizing
treatment?
YES 	NO
(If “NO” is checked, skip question #6a and proceed to #7)
6a. If “YES” is checked and if the medical record contains a description of the communication
to the individual/legal representative of the risks and benefits and benefits of further examination
or treatment, was this communication appropriate, based on the information available to the
hospital at the time of the refusal?
YES 	NO 	N/A
Please explain:

APPROPRIATE TRANSFERS
7a. 	If your response to question 5a was "NO” finding that the hospital was not capable of
stabilizing the individual’s emergency medical condition, what were the required specialized
capabilities that the hospital lacked?
7b. 	If the individual was transferred to another hospital, did the sending hospital provide
further examination and stabilizing treatment, within its capacity (including ancillary services
routinely available to it) to minimize the risks of transfer to the individual’s health and, where
relevant, the health of the unborn child?
YES 	NO 	N/A
Please explain your clinical rationale:
8. 	If the individual was transferred to another hospital, to minimize the risks of transfer, were
qualified personnel and transportation equipment, including medically appropriate life support
measures, used to effect (i.e., accomplish) the transfer?
YES 	NO 	N/A
Please explain your clinical rationale:
9a. 	If this individual was transferred to another hospital for stabilizing treatment of an
unstabilized emergency medical condition, do you find that, considering the individual’s clinical
condition at the time of transfer and any other pertinent information available at that point
in time, the medical benefits reasonably expected from appropriate medical treatment at the

other hospital outweighed the increased risk to the individual (or woman in labor or unborn
child) from being transferred?
YES 	NO 	N/A
Please explain your clinical rationale:
Note to physician reviewer: The physician certification required for an appropriate transfer must
be in writing, must contain a summary of the specific risks and benefits pertaining to this
individual’s clinical situation, and must be placed in the individual’s medical record.
9b. 	Do you find that the summary of risks and benefits of transfer contained in the physician
certification was appropriate, based on the information available to the hospital at the time of
transfer about the individual’s condition?
YES 	NO 	N/A*
Please explain:
*Check N/A not only if this case does not involve a transfer, but also if there was no
physician certification in the medical record
9c. 	If the transfer was at the request of the individual or the individual’s legal representative,
rather than based on a physician’s certification of the benefits outweighing the risks, and the
medical record documents this, do you find that the likely risks of the transfer were identified for
the individual/representative?
YES 	NO
Please explain your clinical rationale:
10. Does the documentation suggest that the transferring hospital sent to the receiving
hospital all available and pertinent medical documentation related to the emergency medical
condition?
YES 	NO 	N/A

Please explain:
RESPONSIBILITY OF HOSPITALS WITH SPECIALIZED DIAGNOSTIC OR
TREATMENT CAPABILITIES OR FACILITIES
Note to Physician Reviewer: While "specialized capabilities or facilities” include such facilities
as burn units, shock-trauma units, neonatal intensive care units or regional referral centers, it also
includes many more clinical characteristics. 	Most simply, if an individual with an emergency
medical condition needs services to stabilize that condition that cannot be made available in a
clinically appropriate timeframe at the hospital where the individual presented, but which are
available at another hospital, the hospital with these capabilities/services must accept a request for
transfer, if it has the capacity to provide the needed stabilizing treatment .
11. Is there any evidence that a Medicare-participating hospital that refused a transfer request
has specialized capabilities or services (not available at the sending hospital) that the individual
required?
YES 	NO 	N/A
Please explain:
(If “NO” or “N/A” is checked, skip question #11a and go to #12.)
11.a 	If “YES” is checked in #11, is there evidence that the hospital with specialized capabilities
or services lacked the capacity to treat the individual requesting stabilizing treatment, at the time
of the request?
Please explain:
QUALITY
12. 	Do you have any specific concerns about the quality of care rendered to the individual
that have not already been addressed fully above?
YES 	NO

If yes, please explain your clinical rationale:
SUMMARY OF FINDINGS:
13. 	Please summarize the key facts of the case below and any concerns or clarifications to
your answers above with regard to this case. Remember, do not state an opinion regarding
whether EMTALA was violated.

I agree to provide medical advice to the Centers for Medicare & Medicaid Services and/or
the Office of Inspector General, as necessary, to properly adjudicate any issues and to testify
as an expert witness on behalf of the Office of Inspector General, if necessary.
Physician Reviewer Name (printed): _________________________________________
Physician Reviewer Signature: 	_______________________________________________
Specialty: 	Date: _____________________
Case ID:
Time Required to Complete This Review: 	hours 	minutes

Appendix 9-13 – EMTALA Resolution of Disagreement Worksheet
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
QIO Physician Reviewer’s Review of EMTALA Case
Resolution of Disagreement (ROD) Worksheet
Request Date: < Insert current date>
To: < Insert DQI PO name>
From: <Insert CMS RO DSC and CMO name>
Contact information: <Insert CMS RO DSC phone number and email>
Facility: < Insert facility name>
Survey Date: <Insert date of facility survey>
QIO Review Date: <Insert date of QIO review>
Type of QIO Review (check one): _ __ 5-day review ___ 60-day review
SECTION I: (To be completed by RO DSC)
Summary of RO DSC concerns and/or reason for disagreement with QIO review:
<Please be as specific as possible including references to sources of material used to back-up
concerns (e.g. medical record, PR Worksheet, etc). Bulleted statements are acceptable as long as
they are complete.>
Attachments:
__ Physician Review Worksheet
__ Medical Record/s
__ Other (Explain) _____________________________

SECTION II: (To be completed by RO CMO)
Summary of RO CMO concerns and/or reason for disagreement with QIO review:
<Please be as specific as possible including references to sources of material used to back-up
concerns (e.g. medical record, PR Worksheet, etc). Bulleted statements are acceptable as long as
they are complete.>
Summary of RO DSC and CMO concerns (check all that apply):
____ Incomplete review
____Opinion inconsistent with accepted standards of practice
____Opinion outside of professional scope
____Lack of understanding of EMTALA regulations
____Evidence of biased opinion or conflict of interest
SECTION III: (To be completed by RO DQI PO)
• 	Date received: <Insert date DQI PO received the ROD Form>
Case Review with QIO DQI PO
• 	Meeting Date: < Insert date DQI PO met with DSC and CMO representatives to discuss
concerns and/or areas of disagreement and next steps>
• 	Meeting participants: <Insert name, title and RO affiliation of participants>
• 	Meeting summary: < Insert additional pertinent notes and/or areas of agreement from the
discussion>
• 	Next steps: <Insert the agreed upon next steps by CMS staff.>
Example: “All of the meeting participants agreed to discuss the review with the QIO Medical
Director and to request a re-review based on the concerns identified above. The DQI PO will
make arrangements for the meeting which will include…..”

CMS Staff Case Review with QIO Medical Director
• 	Meeting Date: < Insert date CMS Staff and QIO Medical Director met to review the case.>
• 	Meeting participants: <Insert name, title and RO affiliation of participants>
• 	Meeting summary: < Insert additional pertinent notes and/or areas of agreement from the
discussion>
• 	Next steps: <Insert the agreed upon next steps by CMS staff and QIO Medical Director by
checking one of the following.>
____ Request for re-review of initial review
____ Request for 2nd 5-day review
____ Referred to OIG for 60 day review
____ 60-day review opinion different from 5-day review
____ Other (explain): ________________________________________________
Final PO Action
• 	Forward a copy of the ROD Worksheet to the designated RO Beneficiary Protection Lead for
tracking purposes.

Appendix 9-16 – 60-Day QIO Review – Opportunity for Discussion
(Sample Letter to Physician/Hospital)
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16)
(Date)
(Name and Address of Hospital Administrator/Physician) RE: (Hospital Provider Number)
Dear (Name of Hospital Administrator/Physician):
This letter is to inform you that the (name of QIO), the Quality Improvement Organization for
the State of (name of State), has received notification from the Centers for Medicare & Medicaid
Services (CMS) that your hospital has violated the requirements of 42 CFR 489.20 and 42 CFR
489.24 (commonly referred to as "EMTALA" or "dumping" violations) and that CMS is
referring your case for possible sanctions as a result of this (these) violation(s). A list of the
deficiencies was provided in separate correspondence sent to you on (date) by the Division of
Survey & Certification, Region, in (State where Regional Office is located).
In this matter, it is the responsibility of the (name of QIO) to provide the hospital and/or
physician(s) a reasonable opportunity for discussion and submission of additional information
related to the violations prior to (name of QIO) issuing a report of the findings to CMS.
You may request a meeting, either by phone or in person, to discuss the case(s) and to submit
additional information. (Name of QIO) must receive the additional information within 30 days
of your receiving this notice. A meeting, should you request one, must occur within that 30-day
time period. The date of receiving this notice is presumed to be 5 days after the certified mail
date on the notice, unless there is a reasonable showing to the contrary.
The meeting is intended to afford the hospital and/or physician(s) a full and fair opportunity to
present their views regarding the cases with the following provisions:
• 	The hospital and/or physician has (have) the right to have legal counsel present during the
meeting. (Name of QIO) may also have legal counsel present and will control the scope,
as well as the extent and manner, of any questioning or any other presentation by the
attorney representing the hospital and/or physician.
• 	(Name of QIO) will make arrangements for a verbatim transcript of the meeting to be
recorded in the event that CMS or the Office of Inspector General (OIG) requests a
transcript. If CMS or OIG requests a transcript, the hospital and/or physician may
request that CMS provide a copy of the transcript.
• 	The hospital and/or physician(s) will be afforded the opportunity to present, with the
assistance of legal counsel, expert testimony in either oral or written form on the medical
issues presented. (Name of QIO) may limit the number of witnesses and the length of the
testimony if such testimony is unrelated to the case or provides information that has
already been presented. The physician and/or hospital may disclose patient records to

potential expert witnesses without violating any non-disclosure requirements set forth in
Title 42, Part 480 of the Code of Federal Regulations.
• 	(Name of QIO) is not obligated to consider any additional information provided by the
hospital and/or physician after the meeting unless, before the end of the meeting, it is
requested by (name of QIO). If additional information is requested, the hospital and/or
physician will have five (5) calendar days from the date of the meeting to provide the
requested information.
A report of (name of QIO) findings in this case will be submitted directly to the Regional Office
who will forward a copy to OIG. Upon request, the (referring Regional Office) will provide
copies of (name of QIO) medical assessment report to (name of hospital administrator and/or
affected physician(s)).
Copies of the regulations in 42 CFR §§489.20 and 42 CFR 489.24 are enclosed. The name(s) of
the individuals who were the subject of the violations and dates of occurrence are as follows:
PATIENT LISTING & DATE OF SERVICE (Name of Hospital)
Patient 	Date of Violation
(Patient's name) 	(Date)
If you have any questions related to this letter or wish to schedule a meeting, please contact
(QIO’s contact person) at (QIO’s phone number).
Sincerely,
QIO Medical Director (or designated person) Enclosure

Transmittals Issued for this Chapter
Rev # 	Issue Date 	Subject 	Impl Date 	CR#
R24QIO 	02/12/2016 	QIO Manual Chapter 9 – “Sanction, Emergency
Medical Treatment and Labor Act (EMTALA),
and Fraud and Abuse”
03/14/2016 	N/A
R12QIO 	10/03/2003 	Change in Terminology to CMS and QIO 	N/A 	N/A
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