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  Practitioners or Other Persons 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 
practitioners 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 QIOs 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 QIOs 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 QIOs 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 practitioners or 
other persons 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 casesexcept 
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  Officers 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 Users 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 QIOs 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 practitioners 
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 reviewers review of a 
practitioners or other persons statutory obligations.  This review may occur in a number 
of ways, including: 
 
  The QIOs 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 QIOs 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  Practitioners or Others Persons 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 Offices (RO) Division of Health Plans and Providers.  The 
QIO must continue to notify the COR and the ROs 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 Offices (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 necessarye.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. 
 
  If the corrective action is not taken within the specified timeframe, if a 
o
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. 
 
  If the finding is resolved to the QIOs satisfaction, the QIO may either (a) 
o
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 QIOs 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 practitioners or other persons 
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 QIOs 
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 practitioners 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 QIOs 
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 
Panels 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 
practitioners 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 practitioners 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: 
 
  The results/findings of the QIOs review activity and the action that could 
o
be taken based on these results/findings; 
 
  A statement that action cannot be taken because the practitioner has 
o
relocated or is practicing outside our review area; 
 
  A notice that the case is being referred to the QIO in the State where he/she 
o
is now practicing for further action as deemed appropriate; and 
 
  A statement that if the practitioner again practices in the original QIOs 
o
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 QIOs 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 QIOs plan of action; 
 
4.  Issue an initial finding notice (including the right to a meeting) based on the 
receiving QIOs 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 QIOs 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 QIOs 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 QIOs 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 practitioners or other persons 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:  
 
  QIOs recommendation; 
 
  Type of offense; 
 
  Severity of the offense;   
  Practitioners or other persons 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 CFR1004.110(f). 
 
9050.2  Monetary Penalty 
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) 
 
If the QIOs 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 OIGs 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 OIGs 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 patientsor, 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) servicesoral 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 ALJs 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 
ALJs 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 OIGs 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 beneficiarys 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 OIGs 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) 
 
OIGs 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 practitioners or 
other persons 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 ALJs 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 DABs 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 91009135 
(Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) 
 
Sections 91009135 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 hospitals 
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 individuals 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 hospitals emergency department, including ancillary 
services. 
 
42 CFR 489.24(b)  Provides definitions used in 489.24. 
 
42 CFR 489.24(d)  Explains the hospitals 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 physicians or hospitals 
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 
hospitals 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 hospitals 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 hospitals 
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 individuals 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 
individuals 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 
individuals 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 hospitals 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 
DSCs 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 individuals 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 Offices 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 reviewers 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 individuals 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 individuals 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     
CMSs 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 
reviewers 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 attorneys 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 QIOs 
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 104F, accompanied 
by shaking chills, and was given aspirin.  The temperature remained elevated in 
the range of 102.6 103F 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 103104 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 QIOs 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 hospitals) 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 hospitals) 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    Violation   
substantial  recommendation to OIG 
violation 
Final sanction    Thirty days to submit   
notice  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 
QIOs 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  Final sanction  Not a  Final sanction notice to 
violation  recommendation and  substantial  OIG 
flagrant notice  violation 
  Thirty days to submit    Thirty days to submit 
additional information  additional information to 
and/or request a meeting  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 patients 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 QIOs 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 
QIOs 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  Final sanction  Not a  Second sanction notice to 
violation  recommendation and flagrant substantial  OIG 
notice  violation 
  Thirty days to submit    Thirty days to submit 
additional information and/or  additional information to 
request a meeting  OIG and consideration of 
corrective action (if 
appropriate) 
 
OIG    QIO   
DECISION  DECISION 
Do not  Sanction  Not substantial  Final sanction notice 
sanction  violation  recommendation to QIG 
  Right to an administrative    Thirty days to submit 
law judge (including a pre-  additional information to 
exclusion hearing, if  OIG 
applicable) 
 
*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. 
 
Reviewed by BFCC-QI 
Included in Package? 
Physician Reviewer 
Document Name  Yes/No/Not Applicable  
Yes/No/Not Applicable 
(N/A) 
(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)       
Reviewed by BFCC-QI 
Included in Package? 
Physician Reviewer 
Document Name  Yes/No/Not Applicable  
Yes/No/Not Applicable 
(N/A) 
(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 individuals 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 individuals 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 individuals 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 hospitals capabilities - 
including ancillary services routinely available and consultations by oncall specialist 
physicians? 
 
YES  NO 
 
Please explain your clinical rationale:     
 
 
     
 
 
1c.  Is there any evidence that there was an inappropriately long delay, based on the individuals 
clinical presentation, between the individuals 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 individuals condition is not a 
proper  basis  for  determining  whether  a  person  transferred  was  stabilized.    However,  the 
individuals outcome may be a red flag indicating that a more thorough evaluation of the 
individuals 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 individuals 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 individuals 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 individuals 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 
individuals  clinical  presentation,  between  the  individuals  arrival  and  the  provision  of 
appropriate stabilizing treatment for the individuals 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 individuals 
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 individuals 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 individuals 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 individuals 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 
individuals clinical situation, and must be placed in the individuals 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 individuals 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 individuals legal representative, 
rather than based on a physicians 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 Reviewers 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 
(QIOs contact person) at (QIOs 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  03/14/2016  N/A 
Medical Treatment and Labor Act (EMTALA), 
and Fraud and Abuse 
R12QIO  10/03/2003  Change in Terminology to CMS and QIO  N/A  N/A 
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