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Transcript
Clinical Services
Compliance Manual
Office of Regulatory Compliance
Draft: April 19, 2012
Page 1
Introduction
The healthcare industry is becoming highly regulated and is experiencing heighted scrutiny and
enforcement by the Office of General Inspector (OIG). Likewise, the federal regulations are constantly
changing. The Centers for Medicare and Medicaid (CMS) is charged with protecting the Medicare trust
fund and aligns with initiatives by the Office of General Counsel, the Department of Health and Human
Services and the Office of Civil Rights. The Clinical Services Compliance Manual discusses the
importance of the seven elements of an effective compliance program, as identified by the OIG, to help
gain an understanding of UNT Health’s compliance program. This manual also addresses UNT Health
Compliance Program structure.
Purpose
The purpose of the manual is to serve as a guide in creating a robust compliance program and addresses
UNT Health’s compliance program structure.
Duties
All UNTHSC employees are charged with:
 Understanding the role of a Compliance program;
 Understanding that Compliance is everyone’s responsibility;
 Abiding by the annual compliance training requirements and any other types of assigned
compliance training requirements;
 Understanding and following the Compliance and Privacy policies;
 An affirmative and ethical role in reporting any suspicious behavior by informing your
supervisor, calling the hotline, or contacting UNT Health Compliance Officer directly; and
 Respecting and protecting every patient’s privacy and their personal health information
Federal Regulations
An Effective Compliance Program1
The Office of General Inspector (OIG) has developed Compliance Program Guidance’s for health care
providers to develop internal controls to efficiently monitor adherence to applicable statutes,
regulations and program requirements. The OIG Compliance Program Guidance is modeled after the
Federal Sentencing Guidelines.
The OIG has identified 7 elements of an effective compliance program:
1. Conducting internal monitoring and auditing through the performance of periodic audits;
2. Implementing compliance and practice standards through the development of written policies,
procedures and standards of conduct;
3. Designating a Compliance Officer to monitor compliance efforts and to oversee practice
standards;
4. Conducting appropriate training and education;
5. Responding appropriately to detected offenses and developing Corrective Action Initiative;
6. Developing effective lines of communication; and
7. Enforcing disciplinary standards through well-publicized guidelines.
1
OIG Compliance Program for Individual and Small Group Physician Practices October 5, 2000
OIG Compliance Program Guidance for Third-Party Medical Billing Companies December 18, 1998
Draft: April 19, 2012
Page 2
Each of the seven elements is discussed below.
Element #1: Conducting internal monitoring and auditing through performance of periodic audits:
An ongoing evaluation process is important to a successful compliance program. This ongoing
evaluation includes not only whether the physician practice’s standards and procedures are in fact
current and accurate, but also whether the compliance program is working i.e., whether individuals are
properly carrying out their responsibilities and claims are submitted appropriately.
Auditing of claims may be done concurrently with claims submission or retrospectively when claims are
paid. The OIG recommends that a ‘snapshot’ be used for periodic claims review. The OIG states that
although there is no set formula to how many medical records should be reviewed, a basic guide is five
or more medical records per Federal payer or five to ten medical records per physician. The medical
records and the bills (claims submission) will be reviewed for compliance with applicable coding, billing
and documentation requirements. Further, one of the most important components of a successful
compliance audit protocol is an appropriate response when a problem is identified through an audit.
The specific action taken depends on the circumstances of the situation. It is a good business practice to
create a system to address how physician practices will respond to and report potential problems.
The audit will determine whether:
 Bills are accurately coded and accurately reflect the services provided as documented in the
medical record using appropriate diagnosis codes;
 Documentation is being completed correctly and timely – following Medicare’s documentation
guidelines and following Teaching Physician Regulations;
 Services or items provided are reasonable and necessary; and
 Any incentives for unnecessary services exist.
Written standards and procedures concerning proper coding must reflect the current reimbursement
principles set forth in applicable statutes, regulations and Federal, State or private payer health care
program requirements.
Claims are to be submitted only for services that the physician finds to be reasonable and necessary in
the particular case. Medicare will only pay for services that meet the Medicare definition of reasonable
and necessary – items or services for the diagnosis or treatment of illness or injury or to improve the
functioning of a malformed body member. Medicare (and many insurance plans) may deny payment for
a service that is not reasonable and necessary according to the Medicare reimbursement rules.
Timely, accurate and complete documentation is important to clinical practice care as well as supporting
a submitted claim for payment for the service provided to the patient. Physicians should reference the
Documentation Guidelines for Evaluation and Management Services published by CMS (Centers for
Medicare and Medicaid Services).
Element #2: Implementing compliance and practice standards through the development of written
policies, procedures and standards of conduct:
After an audit has been conducted and identifies the risk factors, a method for dealing with the
identified risk area is to develop a corrective action plan and developing written standards and
procedures.
Draft: April 19, 2012
Page 3
Standards and procedures can be accomplished by:
 Developing a written standards and procedure manual that at a minimum will include standards
and procedures for (1) coding and billing; (2) reasonable and necessary services; and (3)
documentation;
 Updating clinical forms periodically to make sure they facilitate and encourage clear and
complete documentation of patient care;
 Identify the clinical protocol(s), pathway(s) and other treatment guidelines followed by the
practice;
 All written arrangements with hospitals, hospices, nursing facilities, home health agencies,
durable medical equipment suppliers, pharmaceutical manufacturers and other health care
vendors shall be reviewed for compliance with Stark and Anti-kickback regulations by the UNT
System Office of General Council; and
 Not providing inappropriate inducements to patients such as routinely waiving coinsurance or
deductible amounts without following UNT Health policy
Element #3: Designation of a Compliance Officer to monitor compliance efforts to oversee practice
standards:
The Compliance Officer is responsible for overseeing the implementation and day-to-day operations of
the compliance program.
The Compliance Officer duties are:
 Overseeing and monitoring implementation of the compliance program;
 Establishing methods, such as periodic audits, to improve the practice’s efficiency and quality of
services, and to reduce the practice’s vulnerability to fraud and abuse;
 Periodically revising the compliance program in light of changes in the needs of the practice or
changes in the law and in the standards and procedures of Government and private payer
health plans;
 Developing, coordinating and participating in a training program that focuses on the
components of the compliance program, and seeks to ensure that training materials are
appropriate;
 Ensuring that the HHS-OIG List of Excluded Individuals and Entities, and the General Services
Administrations List of Parties Debarred from Federal Programs have been checked with respect
to all employees, medical staff and independent contractors; and
 Investigating any report or allegation concerning possible unethical or improper business
practices, and monitoring subsequent corrective action and/or compliance.
Element #4: Conducting Appropriate Training and Education
Compliance training and Coding and Billing training are part of an effective compliance program. The
Compliance Training focuses on the importance of the compliance program and the consequences of
non-compliance with this program including fines and penalties under federal laws and regulations, such
as Stark and Anti-kickback, civil monetary penalties and criminal penalties, and exclusion from the
Medicare program. The Coding and Billing Training focuses on Federal health care program
requirements such as documentation and coding requirements, proper billing standards and
procedures, the legal sanctions for submitting deliberately false or reckless billing, etc. Each UNT Health
employee should understand that performing their job in compliance with UNT Health policies
(standards), and state & federal laws & regulations is a condition of continued employment.
Draft: April 19, 2012
Page 4
Element #5: Responding to Detected Offenses and Developing Corrective Action Initiatives:
Upon receipt of reports or reasonable indications of suspected noncompliance, it is important that the
Compliance Officer look into the allegations to determine whether a significant violation of applicable
law or the requirements of the compliance program has occurred, and, if so, take decisive steps to
correct the problem.
Instances of noncompliance must be determined on a case-by-case basis. The existence or amount of
monetary loss to a health care program is not solely determinative of whether the conduct should be
investigated and reported to governmental authorities. There may be instances where there is no
readily identifiable monetary loss to a health care provider, but corrective actions are still necessary to
protect the integrity of the Compliance program as well as Medicare, Medicaid and other governmental
programs.
Element #6: Developing Open Lines of Communication:
An open line of communication is an integral part of implementing an effective compliance program. A
compliance program’s meaningful and open communication can include the following:
 The requirement that employees report conduct that a reasonable person would, in good faith,
believe to be erroneous or fraudulent;
 The creation of a user-friendly process for effectively reporting erroneous or fraudulent conduct
(i.e., the hotline);
o UNTHSC Ethics Hotline information is:
 1-877-606-9187
 www.reportlineweb.com
 Provisions in the standards and procedures that state that a failure to report erroneous or
fraudulent conduct is a violation of the compliance program;
 The utilization of a process that maintains the anonymity of the persons involved in the reported
possible erroneous or fraudulent conduct and the person reporting the concern whenever
possible; and
 Provisions in the standards and procedures that there will be no retribution for reporting
conduct that a reasonable person acting in god faith would have believed to be erroneous or
fraudulent.
o UNTHSC policy 3.302: Non-Retaliation Policy
Element #7: Enforcing Disciplinary Standards through Well-Publicized Guidelines:
Measures must be incorporated to ensure employees understands the consequences if they behave in a
non-compliant manner. An effective compliance program includes procedures for enforcing and
disciplining individuals who violate the compliance program. As part of the process of enforcing and
incentivizing compliance, the employee annual evaluation includes an area for the evaluation of the
employee’s compliance with law regulations and policies.
There are benefits to having a robust Compliance program. In light of the proliferation of fraud and
abuse legislation and enforcement activities directed at the health care industry, it is imperative that
health care organizations have a compliance program not only to prevent violations but also to reduce
the potential for liability should the violations occur.
The U.S. Department of Health and Human Services (HHS) Office of Inspector General believes that
significant reductions in fraud and abuse liability can be accomplished through the use of compliance
Draft: April 19, 2012
Page 5
plans. An effective compliance plan can minimize the consequences resulting from violation of the law
and may, in some cases, convince a prosecutor not to pursue a criminal action. 2
The U.S. Sentencing Commission Guidelines3 specifically mandate lesser criminal sanctions for
companies that have effective compliance plans in operations.
False Claims Act (FCA)
The civil FCA says that any person who knowingly presents, or causes to be presented, to the US
government a false or fraudulent claim for payment or approval; knowingly makes, uses, or causes to be
made or used a false record or statement to get a false or fraudulent claim paid or approved by the
government; or conspires to defraud the government by getting a false or fraudulent claim allowed or
paid violates the Act.
The statute defines knowing and knowingly as meaning that the person (1) has actual knowledge of the
information, (2) acts in deliberate ignorance of the truth or falsity of the information, or (3) acts in
reckless disregard of the truth or falsity of the information.
Between the passage of the Fraud Enforcement and Recovery Act of 2009 and the Patient Protection
and Affordable Care Act of 2010, changes to the FCA were made. Specifically, the changes address the
following:
1. Expansion of the FCA Liability for Retention of Overpayments
Previously, a ‘false record or statement’ (in original language of FCA) was required to violate the
FCA. Now, ‘knowing’ and ‘improper’ concealment or avoidance of an obligation is sufficient. The
definition of ‘knowing’ remains as stated above but enhances the prohibition of ‘knowing’ or
‘knowingly’ to:
a. Submitting for payment or reimbursement a claim known to be false or fraudulent
b. Making or using a false record or statement material to a false or fraudulent claim or to
an ‘obligation’ to pay money to the government
i. ‘Obligation’ is defined as an established duty, whether or not fixed, arising from
an express or implied contractual, grantor-grantee, or licensor-licensee
relationship, from a fee-based or similar relationship, from statute or regulation,
or from the retention of any overpayment.
c. Amended “reverse false claims” Provisions
By amending the ‘reverse false claims’ provisions, it expands liability to “knowingly and
improperly avoiding or decreasing an obligation to pay or transmit money or property to
the Government.”
2. Overpayment Obligation – 60 day time period
The Affordable Care Act provides a 60-day deadline for reporting and returning overpayments.
The deadline is (a) the date which is 60 days after the date on which the overpayment was
identified, (b) the date any correspondence cost report is due, if applicable. Failure to timely
report and return an overpayment exposes a provider to liability under the FCA.
3. Expanded the definition of “Claim”
A claim is any request or demand, whether under a contract or otherwise for money or property
and whether or not the United States has title to the money or property that is (1) presented
2
3
Health Care Compliance Association: excerpt from Compliance Professional’s Manual
U.S. Sentencing Commission Guidelines, Sentencing for Organizations, 56 Fed. Rev. 22,762 (1991)
Draft: April 19, 2012
Page 6
directly to the United States, or (2) to a contractor, grantee, or other recipient, if the money or
property is to be spent or used on the Government’s behalf or to advance a Government
program or interest and the government provides or reimburses any portion of the requested
funds.
4. Changes to the Public Disclosure Bar
Under the previous version of the FCA, cases filed by private individuals, or ‘relators’, could be
barred if it was determined that such cases were based on a public disclosure of information
arising from certain proceedings, such as civil, criminal or administrative hearings, or news
media reports. As a result, defendants frequently used the public disclosure bar as a defense to
a plaintiff’s claims and grounds for dismissal of the same. But the Affordable Care Act changed
the language of the FCA to allow the federal government to have the final word on whether a
court may dismiss a case based on a public disclosure. The language now says that ‘the court
shall dismiss an action unless opposed by the Government, if substantially the same allegations
or transaction alleges in the action or claim was publicly disclosed.”4
5. Original Source Requirement
A plaintiff may overcome the public disclosure bar outlined above if they qualify as an ‘original
source’ the definition of which was also revised under the Affordable Care Act. Previously, an
original source must have had “direct and independent knowledge of the information on which
the allegations are based.” Under the Affordable Care Act, an original source is now someone
who has “knowledge that is independent of and materially adds to the publicly disclosed
allegations or transactions.”5
6. Increased the Attorney General’s power to delegate authority to conduct Civil Investigative
Demands prior to intervening in an FCA action. The AG can now start his own investigation,
which can implicate Medicaid fraud, to return funds back to the state. States which did not have
FCA provisions in their constitution started drafting their own FCA which mirror the Federal
False Claims Act.
Under the FCA, the Department of Justice is authorized to pay rewards to those who report fraud
against the federal government in an amount of between 15 and 30 percent of what it recovers based
upon the whistleblower’s report.
The FCA has a detailed process for making a claim under the Act. Mere complaints to the government
agency are insufficient to bring claims under the Act. A lawsuit must be filed in a U.S. District Court and
under seal. After an investigation by the Department of Justice within 60 days, or frequently several
months after an extension has been granted, the Department of Justice decides whether it will pursue
the case.
The government has several options in handling cases:
1. Intervene in one or more counts of the pending qui tam action. This intervention expresses the
Government’s intention to participate as a plaintiff in prosecuting that count of the complaint.
Fewer than 25% of filed qui tam actions result in an intervention on any count by the
Department of Justice.
2. Decline to intervene in one or all counts of the pending qui tam action. If the United States
declines to intervene, the relator may prosecute the action on behalf of the United States, but
4
5
31 US.C. 3730(e)(4)(A)
31 U.S.C. 3730(e)(4)(B)
Draft: April 19, 2012
Page 7
the United States is not a party to the proceedings apart from its right to any recovery. This
option is frequently used by relators and their attorneys.
3. Move to dismiss the relator’s complaint, either because there is no case, or the case conflicts
with significant statutory or policy interests of the United States.
The Federal Sentencing Guidelines6
The Federal Sentencing Guidelines (FSG) has undergone a few revisions. The first revision was to set a
standard for sentencing individuals who committed a crime. The second major revision affects
organizations. Organization is broadly defined to include corporations, partnerships, associations, joint
stock companies, unions, trusts, pension funds, unincorporated organizations, governments and political
subdivisions thereof, and non-profit organizations. The focus of the second revision was to govern the
sentencing of organizations convicted of federal crimes. In chapter 8, where it discusses the sentencing
guidelines for organizations, is the FSG definition of an effective compliance program. It is this
chapter/area the OIG is reliant upon and drafted their 7 elements of an effective compliance program.
The FSG design for organizations reflects two key beliefs:
(1) The right kinds of actions by corporate managers can help control the likelihood of misconduct
within organizations; and
(2) A system of presumptively mandatory penalties that vary according to the degree to which
corporate managers have taken those kinds of crime-controlling actions will create incentives
for managers to take desired actions. The so-called “good corporate citizenship”.
The FSG also relies on three principal types of sanctions:
(1) Ordering the organization to remedy the harm from the offense;
(2) Penalizing the organization – on the basis of the seriousness of the offense and the
organization’s culpability - through fines; and
(3) Providing oversight of the organization through probation
Below is Chapter 8 of the FSG:
Effective Compliance and Ethics Program
§8B2.1 (a) To have an effective compliance and ethics program, for purposes of subsection (f) of §8C2.5
(Culpability Score) and subsection (c)(1) of §8D1.4 (Recommended Conditions of Probation), an
organization shall –
(1) Exercise due diligence to prevent and detect criminal conduct; and
(2) Otherwise promote an organizational culture that encourages ethical conduct and a
commitment to compliance with the law. Such compliance and ethics program shall
be reasonably designed, implemented, and enforced so that the program is
generally effective in preventing and detecting criminal conduct. The failure to
prevent or detect the instant offense does not necessarily mean that the program is
not generally effective in preventing and detecting criminal conduct.
(b) Due diligence and the promotion of an organizational culture that encourages ethical
conduct and a commitment to compliance with the law within the meaning of subsection (a)
minimally require the following:
(1) The organization shall establish standards and procedures to prevent and detect
criminal conduct.
6
www.ussc.gov
Draft: April 19, 2012
Page 8
(2)
(A) The organization’s governing authority shall be knowledgeable about the
content and operation of the compliance and ethics program and shall exercise
reasonable oversight with respect to the implementation and effectiveness of
the compliance and ethics program.
(B) High-level personnel of the organization shall ensure that the organization
has an effective compliance and ethics program, as described in this guideline.
Specific individual(s) within high-level personnel shall be assigned overall
responsibility for the compliance and ethics program.
(3)
(4)
(C) Specific individual(s) within the organization shall be delegated day-to-day
operational responsibility for the compliance and ethics program. Individual(s)
with operational responsibility shall report periodically to high-level personnel
and, as appropriate, to the governing authority, on the effectiveness of the
compliance and ethics program. To carry out such operational responsibility,
such individual(s) shall be given adequate resources, appropriate authority, and
direct access to the governing authority or an appropriate subgroup of the
governing authority.
The organization shall use reasonable efforts not to include within the
substantial authority personnel of the organization any individual whom the
organization knew, or should have known through the exercise of due diligence,
has engaged in illegal activities or other conduct inconsistent with an effective
compliance and ethics program.
(A) The organization shall take reasonable steps to communicate periodically
and in a practical manner its standards and procedures, and other aspects of the
compliance and ethics program, to the individuals referred to in subparagraph
(B) by conducting effective training programs and otherwise disseminating
information appropriate to such individuals’ respective roles and
responsibilities.
(B) The individuals referred to in subparagraph (A) are the members of the
governing authority, high-level personnel, substantial authority personnel, the
organization’s employees, and as appropriate, the organization’s agents.
(5)
(6)
Draft: April 19, 2012
The organization shall take reasonable steps:
(A) To ensure that the organization’s compliance and ethics program is
followed, including monitoring and auditing to detect criminal conduct;
(B) To evaluate periodically the effectiveness of the organization’s compliance
and ethics program; and
(C) To have and publicize a system, which may include mechanisms that allow
for anonymity or confidentiality, whereby the organization’s employees and
agents may report or seek guidance regarding potential or actual criminal
conduct without fear of retaliation.
The organization’s compliance and ethics program shall be promoted and
enforced consistently throughout the organization through (A) appropriate
incentives to perform in accordance with the compliance and ethics program;
Page 9
(7)
and (B) appropriate disciplinary measures for engaging in criminal conduct and
for failing to take reasonable steps to prevent or detect criminal conduct.
After criminal conduct has been detected, the organization shall take
reasonable steps to respond appropriately to the criminal conduct and to
prevent further similar criminal conduct, including making any necessary
modifications to the organization’s compliance and ethics program.
The organization should take reasonable steps as warranted under the
circumstances to remedy the harm resulting from the criminal conduct. These
steps may include, where appropriate, providing restitution to identifiable
victims, as well as other forms of remediation. Other reasonable steps to
respond appropriately to the criminal conduct may include self-reporting and
cooperation with authorities.
(c)
The organization should act appropriately to prevent further similar criminal
conduct, including assessing the compliance and ethics program and making
modifications necessary to ensure the program is effective. The steps taken
should be consistent with subsections (b)(5) and (c) and may include the use of
an outside professional advisor to ensure adequate assessment and
implementation of any modifications.
In implementing subsection (b), the organization shall periodically asses the risk of
criminal conduct and shall take appropriate steps to design, implement, or modify each
requirement set forth in subsection (b) to reduce the risk of criminal conduct identified
through this process.
Prioritize periodically, as appropriate, the actions taken pursuant to any requirement set
forth in subsection (b), in order to focus on preventing and detecting the criminal
conduct identified under subparagraph (A) of this note as most serious, and most likely,
to occur.
Modify, as appropriate, the actions taken pursuant to any requirement set forth in
subsection (b) to reduce the risk of criminal conduct identified under subparagraph (A)
of this note as most serious, and most likely, to occur.
§8C2.5 Culpability Score
This section goes over how fines are assessed. The major change and importance in this section
relating to assessing the score is reducing the culpability score based on the following:
If the offense occurred even though the organization had in place at the time of the offense an
effective compliance and ethics program:
a. The individual or individuals with operational responsibility for the compliance and
ethics program have direct reporting obligations to the governing authority or an
appropriate subgroup thereof (e.g. an audit committee of the board of trustees);
 ‘direct reporting obligations’ – the individual has express authority to
communicate personally to the governing authority or appropriate
subgroup thereof (A) promptly on any matter involving criminal conduct or
Draft: April 19, 2012
Page 10
potential criminal conduct, and (B) no less than annually on the
implementation and effectiveness of the compliance and ethics program.
b. The compliance and ethics program detected the offense before discover outside
the organization or before such discovery was reasonably likely;
c. The organization promptly reported the offense to appropriate governmental
authorities; and
d. No individual with operational responsibility for the compliance and ethics program
participated in, condoned, or was willfully ignorant of the offense.
§8D1.4 Recommended Conditions of Probation – Organizations
This section goes over the court probation process and is not necessary to address in this
manual.
Enforcement Actions
OIG Permissive Exclusion Guidance
Section 1128(b)(15) of the Social Security Act authorizes the Secretary of the Health and Human
Services, and by delegation OIG, to exclude an individual owner, offer or managing employee of a
“sanctioned entity”. This exclusion authority is permissive, giving the OIG the discretion whether to
exclude or not exclude:
 Owners: Individuals with an ownership or control interest in a sanctioned entity may be
excluded if they knew or should have known of the conduct that led to the sanction. Under
OIG’s guidance, if the evidence supports a finding that an owner knew or should have known of
the conduct, OIG will apply a presumption in favor of exclusion. The presumption may be
rebutted when OIG finds factors that weigh against the exclusion.
 Officers and Managing Employees: May be excluded based solely on their position within the
entity. If the officers and/or managing employees has knowledge, the same approach of a
presumption in favor of exclusion and the ability to rebut the presumption is used for officers
and managing employees who knew or should have known of the conduct. If the officers and/or
managing employees are without knowledge, the Guidance provides several factors for OIG to
consider in determining whether to exclude officers or managing employees without knowledge
of the conduct.
The OIG’s exclusion analysis differs depending on whether the individual in question is: (1) an owner or
(2) an officer or managing employee. The statute sets a higher standard for exclusion of owners. With
respect to officers and managing employees, the statue includes no knowledge element. Therefore, OIG
has the authority to exclude every officer and managing employee of a sanctioned entity.
A “managing employee” is defined as an individual (including a general manager, a business manager, an
administrator, or a director) who exercises operational or managerial control over the entity or who
directly or indirectly conducts the day-to-day operations of the entity.
OIG has developed factors that are considered in deciding whether to exclude an officer or a managing
employee in the absence of evidence that the person knew or should have known of the misconduct.
OIG states these factors serve a number of useful purposes:
1. They will allow for the development of effective investigations and investigative plans by OIG
and its law enforcement partners;
Draft: April 19, 2012
Page 11
2. They will establish and publicize a framework that will serve as a basis for OIG’s permissive
exclusion decisions;
3. They will allow for the appropriate allocation of OIG’s finite resources to actions that have the
most remedial and deterrent effect; and
4. They will positively influence individuals’ future behavior and compliance with Federal health
care program requirements by holding individuals accountable for misconduct within entities in
which they are in positions of responsibility.
The factors are informal and nonbinding. The presence or absence of any or all of these factors does not
constitute the sole grounds for determining whether OIG will pursue exclusion.
Factors to Be Considered in Implementing OIG’s Permissive Exclusion Authority
A. Circumstances of the Misconduct and Seriousness of the Offense
a. What were the nature and scope of the misconduct for which the entity was
sanctioned? What were the nature and scope of any other relevant misconduct? At
what level of the entity did the misconduct occur?
b. What was the criminal sanction imposed against the entity or any individuals? What was
the amount of any criminal fine, forfeiture, or penalty imposed? What was the amount
of any civil or administrative payment regarding related or similar issues? What was the
length of any period of exclusion imposed?
c. Was there evidence that the misconduct resulted in (1) actual or potential harm to
beneficiaries or other individuals or (2) financial harm to any Federal health care
program or any other entity? If financial loss to the programs or other persons occurred,
what was the extent?
d. Was the misconduct an isolated incident or part of a pattern of wrongdoing over a
significant period of time? Has the entity previously had similar problems with OIG, the
Centers for Medicare & Medicaid Services or its contractors, or any other Federal or
State regulatory agency? What was the nature of these problems?
B. Individual’s Role in Sanctioned Entity
a. What is the individual’s current position? What positions has the individual held with
the entity throughout his or her tenure, particularly at the time of the underlying
misconduct? What degree of managerial control or authority is involved in the
individual’s position?
b. What was the relation of the individual’s position to the underlying misconduct? Did the
misconduct occur within the individual’s chain of command?
C. Individual’s Action in Response to the Misconduct
a. Did the take steps to stop the underlying misconduct or mitigate the ill effects of the
misconduct? Did these actions take place before or after the individual had reason to
know of an investigation? If the individual can demonstrate either that preventing the
misconduct was impossible or that the individual exercised extraordinary care but still
could not prevent the conduct, OIG may consider this as a factor weighing against the
exclusion.
b. Did the individual disclose the misconduct to the appropriate Federal or State
authorities? Did the individual cooperate with investigators and prosecutors and
respond in a timely manner to lawful requests for documents and evidence regarding
the involvement of other individuals in a particular scheme?
D. Information about the Entity
Draft: April 19, 2012
Page 12
a. Has the sanctioned entity or a related entity previously been convicted of a crime or
found liable, civilly or administratively, or resolved a civil or administrative case with the
Federal or State Government or a government entity? If so, what was the prior conduct
that formed the basis for these actions?
b. What is the size of the entity? What is the corporate structure of the entity?
Statutory Obligations Regarding Medicare and Medicaid Services
Under terms of the Social Security Act, healthcare providers and practitioners are obligated to assure
that all services ordered for, or provided to, Medicare beneficiaries and Medicaid recipients (1) are
provided only when, and to the extent, medically necessary; (2) are of quality which meets
professionally recognized standards of health care; (3) are provided economically; and (4) are supported
by evidence in the medical record.7
Center for Medicare and Medicaid Services (CMS) has a process for coverage policy and that is known as
National Coverage Determinations (NCDs) which govern the coverage of particular items and services on
a national basis. Local Coverage Determinations (LCDs) are drafted by individual CMS contractors (i.e.
Trailblazers Health) and limited to their jurisdiction. However, CMS is moving towards bringing more
services under NCDs to reduce variation and uncertainty in medical necessity determinations made in
LCDs.
Medical necessity is attested to in CMS 1500 form (now sent electronically) which states:
“I certify that the services shown on this form were medically necessary for the health of the
patient and were personally rendered by me or were rendered incident to my professional
service by my employee under immediate personal supervision, except as otherwise expressly
permitted by Medicare or CHAMPUS regulations.”
Every time a claim is submitted electronically, you are verifying to the medical necessity of the service.
Additionally, the state of Texas has laws that we must abide by in our compliance program.
Texas State Laws
A. Texas Medicaid Fraud Prevention Law
The Texas Medicaid Fraud Prevention Law (FPL) is substantially similar to the federal False
Claims Act. The actions that trigger civil and criminal penalties under the Texas FPL generally
mirror those of the federal FCA, and include making a false statement of concealing information
that affects the right to a Medicaid benefit or payment and conspiring to defraud the state by
obtaining an unauthorized payment from the Medicaid program or its fiscal agent. In addition,
under the FPL, a person may also be liable if he presents a claim for payment under the
Medicaid program for a product or service that was rendered by an unlicensed provider or that
has not been approved by the patient’s treating healthcare practitioner. Texas FPL has a
provision that permits private individuals (“whistleblowers”) to bring an action on behalf of the
state and receive a portion of the recover if the case is successful. The private individual’s share
could be reduced or eliminated altogether, however, if the individual planned and initiated the
activity upon which the lawsuit was based or if the individual is convicted of criminal conduct
7
42 USC §1320c-5(a); 42 CFR §466.71(d), 1004.10
Draft: April 19, 2012
Page 13
arising from his role in the illegal activity. Like the federal FCA, the FPL includes provisions to
prevent employers from retaliating against employees for their involvement in FPL actions.
B. State Law Prohibiting Payment for Referrals
Under Texas state law, it is a state jail felony to intentionally or knowingly solicit, receive, offer
or pay any remuneration, including any kickback, bribe or rebate, in return for: (1) referring an
individual for, or arranging for the furnishing of any item or service for which payment may be
made under the Medicaid program; or (2) purchasing, leasing, ordering, or arranging for or
recommending the purchasing, leasing or ordering of any good, facility, service or item for which
payment may be made under the Medicaid program.
C. Texas Privacy Law – HB 300
The Texas Privacy Law, also referred to as House Bill 300 (HB 300), was enhanced and past by
Texas state legislature around August/September 2012. This bill generally follows the federal
HIPAA regulations by:
 Requiring training to employees of the covered entity as it relates to the covered
entity’s course of business;
 New employees must complete training not later than the 60th day after hire;
 Provisions for consumer to access their electronic health records. Texas expanded the
consumer’s access to electronic health record by stating that if a health care provider is
using an electronic health record system, the health care provider must provide access
to the consumer not later than 15 days after receipt of a written request from the
consumer and provide the requested record in electronic form unless the person agrees
to accept the record in another form;
 A health care provider is not required to provide access to a person’s protected health
information that is except from access, or to which access may be denied under 45CFR
Section 164.524 (the section refers to federal HIPAA);
 The Attorney General shall maintain an internet website that provides information
regarding consumer’s privacy rights regarding protected health information under
federal and state law listing state agencies that regulate covered entities in Texas;
detailed information regarding each agency’s complaint enforcement process; and their
contact information;
 The Attorney General will submit an annual report, to legislature, describing the number
and type of complaints received and the enforcement action taken in response to each
complaint;
 Prohibits sale of protected health information which mirrors federal HIPAA;
 Instructs covered entities to provide notice to individuals for whom a covered entity
creates or receives protected health information if the individual’s protected health
information is subject to electronic disclosure – mirrors the Notice of Privacy Practices
outlined in federal HIPAA; and
 Describes the amount a civil penalty is assessed for violations
UNT HEALTH: Compliance Program Standards
UNT Health’s compliance program standard is modeled after the OIG’s 7 elements of an effective
compliance program and is designed to accomplish the following objectives:
Draft: April 19, 2012
Page 14

To familiarize physicians and non-physician practitioners and employees involved with
professional fee billing about applicable laws, regulations, and UNT Health policies regarding
professional fee billing; (2) to promote programs and practices designed to provide reasonable
assurance that all such individuals and departments will follow such laws, regulations and
policies; (3) to reduce legal and financial risks; and (4) to provide a mechanism for
communication concerning compliance.
Additionally, UNT Health has adopted the following cornerstones for an effective compliance program:
 All clinical professional services will be documented in the medical record and such
documentation will comply with Medicare’s documentation guidelines and the Teaching
Physician Regulations regardless of payer
 All clinical professional services will be coded accurately and completely to reflect the services
provided to the patient as supported by documentation in the medical record
 For payment purposes only, all clinical professional services will be billed as per the applicable
payer regulations or contracts.
Medicare’s documentation guidelines, including documentation guidelines for Teaching Physician
Regulations will be the standard documentation requirement across all payers as part of UNT Health
Compliance Program. There are several factors that support this decision:
 It is highly unlikely or practical that the provider will know the patient’s insurance at the time of
the office visit, or at the time of an inpatient hospital visit;
 Patients may have private insurance with Medicare insurance as secondary;
 The concept of dual standards (different standard with Medicare beneficiaries verses different
standards for private payers) are not looked upon favorably; and
 The practice of picking and choosing when to follow the Teaching Physician Regulations based
on where the service was provided or if the insurance is a private payer potentially creates
uncertainty and confusion.
Routine auditing and monitoring
Each of UNT Health’s clinics is audited on a semi-annual basis. The review year follows the fiscal year
and the clinics are assigned by quarters – for example: clinic A will be reviewed in Quarter 1 and Quarter
3 of the fiscal year.
The review is a retrospective payment review – meaning the review is conducted after a payment has
been received and the sample size will be (10) records per provider will be reviewed. The retrospective
payment window is the prior three months of the current quarter. For example: clinic A will be
reviewed in Quarter 1 during the months of September – November. The paid claims data selection for
review will be for claims paid from June-August.
The criteria for selecting services:
 High utilization of certain CPT codes
 Services identified as being a risk:
o High level office visits (99214, 99204, 99205, 99215)
o Services involving residents
o Procedures
o Time based CPT codes (e.g. psychotherapy notes)
 Inpatient as well as outpatient services
Draft: April 19, 2012
Page 15

Issues identified in the Office of Inspector General’s Work Plan
There may be times when audits occur outside the routine audit schedule. These may come about
through various means, for example, a concern is brought to the Compliance department’s attention. In
this situation, the review criterion for selecting services is variable and depends on the circumstances
surrounding the stated concern.
Provider Scoring Methodology:
A scorecard is used to determine the score which lists the type of error and their associated points. The
error categories are divided into Evaluation and Management Services, Procedures and Modifiers.
Evaluation and Management Services Error Categories:
 Over/Undercoded by one level = 0 points
This finding is weighted at 0 points because there is a one level change (either up or down) and
the payment difference is minimal. For example: a 99214 was billed, but documentation
supports a 99213. The OIG does not assess penalties/fines for one level changes.
 Incorrect Provider = 2 points
This finding means documentation supports a different provider performed the service. This will
be cited only for MD, DO, NP, PA – not residents as any errors regarding residents will be cited
as Not Meeting Teaching Physician Regulations.
 Undercoded by Two or More Levels = 2 points
This finding means documentation supported a higher level of service and indicates a missed
revenue opportunity. The compliance analysts strictly go by CMS documentation guidelines and
do not challenge medical necessity. However, if the provider responds back to the analyst and
state they feel the service they billed is medically necessary; the analyst will change the findings
to agree with the level of service billed.
 Incorrect E/M Category = 3 points
This finding means documentation supported a different type of E/M service. For example: a
new patient office visit may have been billed; however, documentation supports the patient is
an established patient and therefore, the established patient office visit should have been billed.
 No Reference to Time for Time based Codes = 3 points
This finding is cited when time is not documented when it is required. For example, EM services
based on when counseling predominates the visit, requires documentation of time. Another
example is psychotherapy notes which are time based.
 Unbundling = 3 points
This finding means an E/M service was billed but should not have been because it is a
component of another service. For example, the reason for the patient visit is for the
performance of the procedure. An EM was billed because the provider performed an
examination prior to the procedure. The EM is not billable because the examination is included
in the payment of the procedure.
 Missed E/M = 3 points
This finding is cited when an Evaluation and Management service could have been billed. This
represents a missed revenue opportunity.
 ‘Incident-to’ Not Met = 3 points
This finding is cited when the criteria to bill ‘incident-to’ are not met. Some examples are:
o A physician is not present in the clinic suite to provide supervision
o A NP/PA bills for a new patient
Draft: April 19, 2012
Page 16
o






When an established patient has a new problem that the NP/PA addresses – this is not
meeting ‘incident-to’ because the physician has not seen the patient with the new
problem and has not developed a treatment plan in which services of the NP/PA would
be ‘incident-to’
Overcoded by Two or More Levels = 4 points
This finding means documentation supported an EM services that is two levels lower than the
level of service billed.
Non-billable, global period = 6 points
This finding means an EM service should not have been billed because the EM visit falls in the
global period of the surgery. Surgical procedures, for this finding to be cited, either have a 10
day or 90 day global period which includes any f/u EM service related to the surgical procedure.
Incomplete or No Documentation = 6 points
This finding means:
o Incomplete EM documentation – is used when there is limited documentation of the
key components in which an overall level for each of the key components cannot be
determined.
o No Documentation – is self explanatory
EM Services – No Signature = 6 points
This finding is cited when there is no provider signature
EM – Teaching Physician Regulations Not Met = 6 points
This finding is cited when the physician has not documented his presence and participation in
the service when a resident is involved.
Primary Care Exception Not Met = 6 points
This finding is cited when the documentation does not support physician supervision and
oversight in a ‘resident’ clinic.
Procedures
 Wrong Date of Service = 1 point
The finding is self-explanatory
 Incorrect Provider = 2 points
This finding is cited when documentation supports a different provider performed the
procedure
 Missed Procedure = 3 points
This finding is cited when documentation supports the performance of a procedure, but it was
not billed. This represents a missed revenue opportunity.
 Unbundling = 3 points
This finding is cited when two procedure codes are ‘split apart’ and billed; meaning the most
comprehensive procedure code and the related subcomponent procedure code are billed.
 Incorrect Procedure Code = 4 points
This finding is cited when documentation supports a different procedure code.
 Teaching Physician Regulations Not Met = 6 points
This finding is cited when the physician is not present for the critical portions of a major
procedure; or, when the physician is not present for the entire procedure for procedures
considered a minor procedure. The designation of a major and minor procedure is determined
by the global period days noted on Medicare Physician Fee Schedule.
 No Documentation = 6 points
This finding is self-explanatory.
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Modifiers
 Incorrect Modifier Use
This finding is cited when:
o The wrong modifier is used (used modifier 25 when it should be modifier 57)
o The service did not warrant a modifier
The provider score is determined by:
1. Adding up all the points
2. Using the sum of all the points cited in the review with the 100 point scale to determine the
error percentage rate
Example: Dr. Jones had the following findings (highlighted in yellow):
 Overcoded EM by Two or More Levels = 4
 EM – Teaching Physician Regulations Not Met = 6 points
 Teaching Physician Regulations Not Met for Procedures = 6 points
Total points = 16 points
The 16 points is then correlated to the 100 point scale to determine the percentage error rate
(highlighted in red) – in this example, it is 92%
For Modifiers
0 points = 100%
33-34 points = 83%
6
0 points- Over/Under coded by 1 level
For E/M Services
3 points - Incorrect modifier use
1-2 points = 99%
35-36 points = 82%
6
1 points- Wrong DOS
For Procedures
3-4 points = 98%
37-38 points = 81%
7
2 points- Incorrect provider
1 points- Wrong DOS
5-6 points = 97%
39-40 points = 80%
7
2 points- Undercoded by 2 or more levels
2 points- Incorrect provider
7-8 points = 96%
41-42 points = 79%
7
3 points- Incorrect E/M category
3 points- No reference to time/time-based
code
3 points- Unbundling
3 points- Missed procedure
9-10 points = 95%
43-44 points = 78%
7
3 points- Unbundling
11-12 points = 94%
45-46 points = 77%
7
4 points- Incorrect procedure code
13-14 points = 93%
47-48 points = 76%
8
3 points- missed E/M
6 point - TP Regs Not Met
15-16 points = 92%
49-50 points = 75%
8
3 points-incident to not met
6 points- No documentation for procedure
17-18 points = 91%
51-52 points = 74%
8
19-20 points = 90%
53-54 points = 73%
8
4 points- Overcoded by 2 or more levels
6 points- Non-billable - global
For Diagnoses
21-22 points = 89%
55-56 points = 72%
6 points- incomplete or no documentation
Incorrect Diagnosis
23-24 points = 88%
57-58 points = 71%
6 points- No signature
Specificity Issue
25-26 points = 87%
59-60 points = 70%
6 points - TP Regulations Not Met
Missed Diagnosis
27-28 points = 86%
61-62 points = 69%
6 points -Primary care exception not met
No Documentation
29-30 points = 85%
63-64 points = 68%
31-32 points = 84%
65-66 points = 67%
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Page 18
Total
No signature
Primary care Exception not met
Incomplete or no documentation
Non-billable - global period
Teaching Physician Regulations Not Met
Over-coded 2 or more levels
Unbundling
No reference to time (time-based codes)
Incident to not met
Missed E/m
Incorrect E/M category
Under-coded 2 or more levels
Incorrect Provider
Wrong DOS
Under-coded one level
The total provider points are also noted in this area of the provider scorecard:
0
0
0
0
0
0
0
0
0
0
0
Corrective Action Plan
For any deficiencies identified from an audit, a corrective action plan is warranted, regardless of the
department score, to document the next steps to correct the noted deficiencies.
Refunds:
In the case where UNT Health received an overpayment for a service that is not supported by
documentation, a refund will be processed by Patient Financial Services. Refunds are to be processed
within 60 days of identification of an overpayment.
Draft: April 19, 2012
Page 19
Compliance Metrics
Metrics are designed from routine audit findings and will be presented to UNT Health’s Policy and
Compliance Committee, the Clinical Services Compliance Committee, UNT Health Board meetings and to
the Institutional Compliance Officer.
Training
Each UNT Health provider and clinical staff will undergo mandatory annual training.
The physicians are assigned:
 Compliance 1: Stark, Anti-kickback, elements of a compliance program etc
 Compliance 2: Medicare’s documentation guidelines and Teaching Physician Regulations
 HIPAA
Non-physician Practitioners are assigned:
 Compliance 1: Stark, Anti-kickback, elements of a compliance program etc
 Compliance 2: Medicare’s documentation guidelines only
 HIPAA
Clinical Staff are assigned:
 Compliance 1: Stark, Anti-kickback, elements of a compliance program etc
 HIPAA
Failure to take the mandatory annual training will result in disciplinary action and may lead up to include
termination.
Additionally, topic specific modules will be assigned to providers based on their review findings from
routine audits conducted by the Office of Regulatory Compliance. The topic specific modules are:
 Evaluation and Management Services – assigned for providers who have been cited for overcoding EM services by two or more levels. Example: billed a 99215; but the documentation
supports a 99213
 Teaching Physician Regulations – assigned when residents are involved in the service and the
attending did not document his presence and participation in the care of the patient.
For providers who have not completed their assigned topic specific modules based on their review
findings, a memo will be sent to the President of UNT Health and the Chief Medical Officer for further
action.
Training is also accomplished by receiving the Clinical Services Compliance Newsletter, memos, topic
specific modules on Black Board, and attending department meetings to address compliance concerns.
Policies
UNT Health Policies
General compliance and Privacy policies have been drafted and are placed on UNT Health policy site on
the intranet. It is the responsibility of all UNT Health employees to become familiar with UNT Health’s
Compliance and Privacy policies.
Draft: April 19, 2012
Page 20
CMS Policies
Providers and clinical support staff are encouraged to access the CMS policies whenever applicable. The
CMS policies are in the National Coverage Determination (NCD) database found on the CMS website.
http://www.cms.hhs.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMsItems/CMS014961.html
Trailblazers Policies
Trailblazers’ policies are called Local Coverage Decision (LCD). Providers and clinical support staff are
encouraged to access the LCD whenever appropriate on Trailblazers website. In the absence of
Trailblazers’ Health LCD, the CMS NCD will be used.
http://www.trailblazerhealth.com/Tools/LCDs.aspx?DomainID=1
During routine audits performed by analysts in the Office of Regulatory Compliance, both the CMS
national policies and Trailblazers local coverage determination will be used.
Resources
Trailblazers’ policies, manuals and local coverage decisions will be used for review of Medicare services.
Additionally, CMS manuals will also be referenced.
For Medicaid services, the Texas Medicaid & Healthcare Partnership (TMHP) is referenced. TMHP is a
state Medicaid contractor.
Other sources are the Office of Inspector General and the Federal Register.
Medicare’s Documentation Guidelines and Teaching Physician Regulations – UNT Health Standards and
Procedures8
These standards and procedures are intended to clarify the requirements for Teaching Physician
documentation and billing and to state UNT Health’s policies to promote compliance with these
requirements.
Unless otherwise specifically provided, these standards and procedures apply with respect to all
physician services for which a claim is to be submitted by or on behalf of UNT Health.
The standards and procedures documented herein address the requirements for billing for services of
Teaching Physicians, but are not intended to provide an exhaustive statement and explanation of all
regulatory requirements applicable to physician services, and shall not be construed to excuse failure to
comply with any other regulatory requirements.
Teaching Physician Guidelines
Definitions
Teaching Physician: A physician (other than another resident) who involves residents in the care of his
or her patients.
8
Medicare Claims Processing Manual 100-04 Section 100
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Page 21
Resident: An individual who participates in an approved graduate medical education (GME) program.
The term includes interns and fellows in GME programs recognized as approved for purposed of direct
GME payments may by the Medicare Administrative Contractor (MAC). Receiving a staff or faculty
appointment or participating in a fellowship does not by itself alter the status of “resident”. Additionally,
this status remains unaffected regardless of whether a hospital includes the physician in its full time
equivalency count of residents.
Student: An individual who participates in an accredited educational program (e.g., a medical school)
that is not an approved GME program. A student is never considered to be an intern or a resident.
Medicare does not pay for any service furnished by a student.
Physically Present: The teaching physician is located in the same room (or partitioned or curtained
area, if the room is subdivided to accommodate multiple patients) as the patient and performs a faceto-face service.
Critical or Key Portion: That part (or parts) of a service that the teaching physician determines is (are) a
critical or key portion(s).
The services furnished in teaching settings are paid under the physician fee schedule if the services are:
 Personally furnished by a physician who is not a resident;
 Furnished by a resident where a teaching physician was physically present during the critical or
key portions of the service; or
 Certain E/M services furnished by a resident under the conditions of the Primary Care Exception
Evaluation and Management Services
The documentation by the Teaching Physicians requires that they personally document:
 That they performed the service or were physically present during the key or critical portions of
the service when performed by the resident; and
 The participation of the teaching physician in the management of the patient
Documentation by the resident of the presence and participation of the teaching physician is not
sufficient to establish the presence and participation of the teaching physician.
On medical reviews, the combined entries into the medical record by the teaching physician and the
resident constitute the documentation for the service and together must support the medical necessity
of the service.
UNT Health compliance standard requires teaching physicians, when working with residents rotating
through clinics (with the exception of clinics designated as Primary Care Exception) to state that they
have seen and examined the patient, reference the resident’s note and make a reference to the
management plan by either agreeing with the resident, or making changes as applicable.
Since UNT Health uses an electronic medical record system, CMS has specific instructions. CMS defines
a ‘macro’ as a command in a computer or dictation application that automatically generates
predetermined text that is not edited by the user. While it is acceptable to use a ‘macro’, CMS instructs
physicians to provide customized, patient specific information to support a medical necessity
determination. The note in the electronic medical record must sufficiently describe the specific services
furnished to the specific patient on the specific date.
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Page 22
Outpatient E/M Services
In order to comply with CMS guidance on macros, EMR has a ‘Teaching Physician Statement’ macro. It is
a drop down box where the following statement will appear: “I saw and examined the patient and
reviewed the resident’s note”. Underneath this statement will be a free text box where patient specific
information to support medical necessity is to be documented by the teaching physician.
Inpatient E/M Services
Inpatient services are provided at various hospitals within the community. Many of the area hospitals
may utilize electronic medical records that may or may not have an appropriate teaching physician
statement.
Since services performed at community hospitals by our providers are billed through UNT Health, all
providers must comply with The Office of Regulatory Compliance Medicare’s documentation standards.
With respect to documentation when residents are involved in the care of their patients, providers must
document:
 “I have seen and examined the patient”
 “ I have reviewed [resident’s name] documentation and agree with the residents findings and
plan” – if changes/additions are warranted, please state.
For hospitals still using paper records, the above statement must be written, signed and dated by the
teaching physician.
For hospitals using some form of EMR, they may have a macro with a Teaching Physician statement. The
macro must allow the teaching physician to document patient specific information. If their EMR system
does not allow this, the difference must be made up by the teaching physician documenting the
following: “I have seen and examined the patient. I have reviewed the [resident’s name]
documentation and agree with the residents findings and plan”. This must be added to your
documentation in order to comply with the Teaching Physician Regulations. Otherwise, the service
cannot be billed.
Unacceptable documentation by the teaching physician:
“Agree with above”, followed by countersignature;
“Rounded, Reviewed and Agree” followed by countersignature;
“Discussed with resident. Agree” followed by countersignature;
“Seen and agree” followed by countersignature;
“Patient seen and evaluated” followed by countersignature; and
A countersignature
Such documentation is not acceptable because the documentation does not make it possible to
determine whether the teaching physician was present, evaluated the patient, and/or had any
involvement with the plan of care.
Exceptions for E/M Services Furnished in Certain Primary Care Centers
UNT Health clinics designated as a Primary Care Exception are the following:
 PCC – Internal Medicine and Family Medicine
 Seminary Clinic
 HCW at Arlington – OB/GYN
Draft: April 19, 2012
Page 23


Northwest clinic – OB/GYN
Viola Pitts – Psychiatry
Primary care exception clinics may bill Medicare for lower and mid-level E/M services provided by
residents. Teaching physicians may submit claims for services furnished by residents in the absence of a
teaching physician:
New Patient
Established Patient
99201
99211
99202
99212
99203
99213
Additionally, the following services may be billed under the primary care exception:
 G0402: Initial preventive physical examination; face-to-face visit services limited to new
beneficiary during the first 12 months of Medicare enrollment
 G0438: Annual wellness visit, including personal preventive plan service, first visit
 G0439: Annual wellness visit, including personal preventive plan service, subsequent visit
Teaching physicians submitting claims under this exception may not supervise more than four residents
at any given time and must direct the care from such proximity as to constitute immediate availability.
The Office of Regulatory Compliance defines immediate availability as ‘within shouting distance’.
Availability by cell phone, ipad or any other electronic device is not acceptable.
Teaching physicians submitting claims under this exception must:
 Not have other responsibilities (including the supervision of other personnel) at the time the
service was provided by the resident;
 Have the primary medical responsibility for patients cared for by the residents;
 Ensure that the care provided was reasonable and necessary;
 Review the care provided by the resident during or immediately after each visit. This must
include a review of the patient’s medical history, the resident’s findings on physical
examination, the patient’s diagnosis, and treatment plan; and
 Document the extent of his/her own participation in the review and direction of the services
furnished to each patient.
In UNT Health’s EMR system, there is a template for Exception Clinics. There will be a general ‘macro’
statement: “I was available to the resident. I have reviewed and agree with the diagnosis and treatment
plan.” Further, there will be a free text box where the teaching physician will need to document:
 A brief history re-cap
 A brief re-cap to the management plan
If a service other than those listed above needs to be furnished, then the teaching physician’s
documentation for general E/M services noted above are to be followed. The macro ‘Teaching Physician
Statement’ must then be selected for the teaching physician documentation.
E/M Service Documentation Provided By Students
Any contribution and participation of a student to the performance of a billable service must be
performed in the physical presence of a teaching physician or physical presence of a resident.
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Page 24
Students may document services in the medical record. However, the documentation of an E/M service
by a student that may be referred to by the teaching physician is limited to the documentation related
to the review of systems and/or the past medical, family and social history. The teaching physician may
not refer to a student’s documentation of physical exam findings or medical decision making in his or
her personal note.
In the circumstance where a medical student performs the service in the presence of the resident, the
resident must still see and examine the patient and re-document the history (except for ROS, and PFSH),
exam and medical decision making. The teaching physician may then refer to the resident’s note and
document appropriately in the EMR macro ‘Teaching Physician Statement’ for outpatient services.
Surgical Services (including Endoscopic Operations)
The teaching surgeon is responsible for the preoperative, intra-operative and postoperative care of the
beneficiary. The teaching physician’s presence is not required during the opening and closing of the
surgical field unless these activities are considered to be critical or key portions of the procedure.
During non-critical or non-key portions of the surgery, if the teaching surgeon is not physically present,
he/she must be immediately available to return to the procedure, i.e., he/she cannot be performing
another procedure. If circumstances prevent a teaching surgeon from being immediately available, then
he/she must arrange for another qualified surgeon to be immediately available to assist with the
procedure, if needed.
Single Surgery
When the teaching surgeon is present for the entire surgery, his or her presence may be demonstrated
by notes in the medical records made by the physician, resident or operating room nurse. For purposes
of this teaching physician section, there is no required information that the teaching surgeon must enter
into the medical records.
Two Overlapping Surgeries
In order to bill Medicare for two overlapping surgeries, the teaching surgeon must be present during the
critical or key portions of both operations. Therefore, the critical or key portions may not take place at
the same time. When all of the key portions of the initial procedure have been completed, the teaching
surgeon may begin to become involved in the second procedure.
The teaching surgeon must personally document in the medical record that he/she was physically
present during the critical or key portions of both procedures.
When a teaching surgeon is not present during non-critical or non-key portions of the procedure and is
participating in another surgical procedure, he/she must arrange for another qualified surgeon to
immediately assist the resident in the other case should the need arise.
In the case of three concurrent surgical procedures, the role of the teaching surgeon in each of the cases
is classified as a supervisory service to the hospital rather than a physician service to an individual
patient and is not payable under Medicare physician fee schedule.
Resident dictation of Operative Report
Residents may dictate the operative report for a teaching physician. However, the resident needs to
state the surgeon’s presence during the entire procedure or the key portions of the procedure the
Draft: April 19, 2012
Page 25
surgeon was present for and performed and that the surgeon was immediately available in the event of
complications.
If the surgeon was present for the entire procedure, the resident may dictate in the operative note
“Dr.[attending] was present for the entire procedure.”
If the surgeon was present for key portions, the resident needs to dictate the surgeon’s presence and
performance of the key portions of the surgery and add the statement that the surgeon was
immediately available.
Minor Procedures
For procedures that take only a few minutes and involve relatively little decision making once the need
for the operation is determined, the teaching surgeon must be present for the entire procedure in order
to bill for the service. The teaching surgeon’s presence may be documented by the resident.
The teaching physician may document “I was present for the entire procedure.”
OR
The resident may document “Dr. [attending] was present for the entire procedure.”
Endoscopic Procedures
To bill Medicare for endoscopic procedures (excluding endoscopic surgery), the teaching physician must
be present during the entire viewing. The entire viewing starts at the time of insertion of the endoscope
and ends at the time of removal of the endoscope. Viewing of the entire procedure through a monitor
in another room does not meet the teaching physician presence requirement. A statement “I was
present for the entire viewing” is acceptable. The resident may also state the teaching physician’s
presence during the procedure.
The teaching physician may document “I was present for the entire viewing.”
OR
The resident may state: “Dr. [attending] was present for the entire viewing.”
Interpretation of Diagnostic Radiology and Other Diagnostic Tests
Medicare pays for the interpretation of diagnostic radiology and other diagnostic tests if the
interpretation is performed by or reviewed with a teaching physician. If the teaching physician’s
signature is the only signature on the interpretation, Medicare assumes that he/she is indicating that
he/she personally performed the interpretation.
If a resident prepares and signs the interpretation, the teaching physician must indicate that he/she has
personally reviewed the image and the resident’s interpretation and either agrees with it or edits the
findings. Medicare does not pay for an interpretation if the teaching physician only countersigns the
resident’s interpretation.
Appropriate attestation: “I have reviewed the [image/tracing] and the resident’s interpretation. I agree
with the findings [or if you disagree, edit the findings].”
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Psychiatry
The documentation standards addressed in the E/M section applies to psychiatric services. For certain
other psychiatric services, the requirement for the presence of the teaching physician during the service
may be met by concurrent observation of the service by use of a one-way mirror or video equipment.
Audio-only equipment does not satisfy to the physical presence requirement. For time-based codes,
codes that are determined by time, the teaching physician must be present for the period of time for
which the claim is made. For example, if a code requires 20-30 minutes, the teaching physician must be
present for 20-30 minutes. Do not add time spent by the resident in the absence of the teaching
physician to time spent by the resident and teaching physician with the beneficiary or time spent by the
teaching physician alone with the beneficiary. For psychiatry, the codes affected range from CPT code
90804-90829.
Time Based Codes
For procedure codes determined on the basis of time, the teaching physician must be present for the
period of time for which the claim is made. For example, if a code requires 20-30 minutes, the teaching
physician must be present for 20-30 minutes. Do not add time spent by the resident in the absence of
the teaching physician to time spent by the resident and teaching physician with the beneficiary or time
spent by the teaching physician alone with the beneficiary.
Examples of time based codes:
 Critical Care Services (CPT codes 99291-99292)
 Hospital Discharge Day Management (CPT code 99239)
 E/M codes in which counseling and/or coordination of care dominates (more than 50%) of the
encounter, and time is considered the key or controlling factor to qualify for a particular level of
E/M service;
 Prolonged services (CPT codes 99354-99359); and
 Care plan oversight (CPT codes 99339-99340, and 99374-99380)
OB Services
In the case of maternity services furnished to women who are eligible for Medicare, apply the physician
presence requirement for both types of deliveries. In order to bill for the procedure, the teaching
physician must be present for the delivery. In situations in which the teaching physician’s only
involvement was at the time of delivery, the teaching physician should bill the delivery code only. In
order to bill for the global procedures, the teaching physician must be present for the minimum
indicated number of visits when such a number is specified in the description of the code.
Medicare’s General Documentation Guidelines for Documenting E/M Services9
There are three key components in determining the overall level of an E/M service:
 History
 Exam; and
 Medical decision making
An exception to the 3 key components is when the office visit is predominately spent in counseling. In
this situation, time is the controlling factor to determine the overall E/M level.
9
Medicare Learning Network: Evaluation and Management Services Guide
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Every E/M level has an associated time. In order to bill based on time, documentation must show:
 that greater than 50% of the visit was spent in counseling; and
 brief description of topics covered
For the times associated with the E/M codes, please refer to the current year CPT Manual.
Otherwise, the documentation of the three key components must be met to bill a particular E/M level.
Documentation of History- a key component of an E/M service
There are four levels of history:
 Problem focused
 Expanded problem focused
 Detailed
 Comprehensive
Each level of history includes some or all of the following elements:
 Chief Complaint: is always documented for every patient encounter
 History of present illness (HPI);
 Review of Systems (ROS); and
 Past medical, family and social history (PFSH)
The extent of HPI, ROS, and PFSH that is obtained and documented is dependent upon clinical judgment
and the nature of the presenting problem(s).
The chart below shows the progression of the elements required for each type of history. To qualify for
a level of history, all three elements in the table must be met.
Brief
Brief
HPI
ROS
NA
Problem Pertinent
NA
NA
PFSH
Extended
Extended
Extended
Complete
Pertinent
Complete
Type of History
Problem Focused
Expanded Problem
Focused
Detailed
Comprehensive
History of Present Illness:
The HPI is a chronological description of the development of the patient’s present illness from the first
sign and/or symptom or from the previous encounter to the present. It includes the following
descriptors:
 Location;
 Quality;
 Severity;
 Duration;
 Timing;
 Context
 Modifying factors; and
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
Associated signs and symptoms
For a brief HPI, at least one to three elements of the HPI are documented.
For an extended HPI, at least four or more elements of the HPI are documented.
Review of Systems:
CMS has identified and recognized the following systems:
 Constitutional symptoms
 Eyes
 ENT
 CV
 Respiratory
 GI
 GU
 Musculoskeletal
 Integumentary
 Neurological
 Psychiatric
 Endocrine
 Hematologic/lymphatic
 Allergic/immunologic
A problem pertinent ROS inquires about the system directly related to the problem(s) identified in the
HPI. The patient’s positive and pertinent negative response to the system directly related to the
problem is documented. Typically, only one system is addressed.
An extended ROS inquires about the system directly related to the problem(s) identified in the HPI and a
limited number of additional systems. The patient’s positive responses and pertinent negative response
for two to nine systems is documented.
A complete ROS inquires about the system(s) directly related to the problem(s) identified in the HPI plus
all additional body systems. At least 10 organ systems must be reviewed and documented.
Past Medical, Family and Social History:
A pertinent PFSH review is documentation of at least one specific item from any of the three history
areas (past medical, family or social).
A complete PFSH is either a review of two history areas, or all three history areas depending on the
category of E/M service.
 For established patient office visits, ER, subsequent nursing facility care, subsequent inpatient
care:
o At least one specific item from two of the three history areas must be documented for a
complete PFSH.
 For new patient office visits, initial hospital care visits:
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o
At least one specific item from each of the three history areas must be documented for
a complete PFSH.
Other documentation tips for the ROS and PFSH:
 A ROS and/or PFSH obtained during an earlier encounter does not need to be re-recorded if
there is evidence that the physician reviewed and updated the information. The review and
update may be documented by :
o Describing any new ROS and/or PFSH information or noting there has been no change in
the information; and
o Noting the date and location of the earlier ROS and/or PFSH
 The ROS and/or PFSH may be recorded by ancillary staff or on a form completed by the patient.
To document that the physician reviewed the information, there must be a notation
supplementing or confirming the information recorded by others.
 If the physician is unable to obtain a history from the patient or other source, the record should
describe the patient’s condition or other circumstance which precludes obtaining a history.
Documentation of Exam – a key component of an E/M service
There are four exam levels:
 Problem Focused
 Expanded Problem Focused
 Detailed
 Comprehensive
A problem-focused exam is a limited examination of the affected organ system.
An expanded problem focused exam is a limited examination of the affected organ system and other
symptomatic or related organ system.
A detailed exam is an extended examination of the affected organ system and other symptomatic or
related organ system.
A comprehensive exam is a general multi-system examination which includes findings about 8 or more of
the 12 organ systems.
Additional documentation tips for examination:
 Specific abnormal and relevant negative findings of the examination of affected or symptomatic
organ system(s) should be documented. A notation of “abnormal” without elaboration is
insufficient.
 Abnormal or unexpected findings of the examination of the unaffected or asymptomatic organ
system(s) should be described.
 A brief statement or notation indicating “negative” or “normal” is sufficient to document normal
findings related to unaffected or asymptomatic organ system(s).
Medical Decision Making – a key component of an E/M service
Medical decision making involves the process of identifying diagnosis/management options, the amount
and/or complexity of data reviewed and the risk or complications of morbidity and/or mortality. Each of
these processes is discussed below.
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1. Number of Diagnoses or Management Options
The number of possible diagnoses and/or the number of management options that must be
considered is based on the number and types of problems addressed during the encounter, the
complexity of establishing a diagnosis and the management decisions that are made by the
physician.
a. For each encounter, an assessment, clinical impression and diagnosis should be
documented.
 For a presenting problem with an established diagnosis the record should reflect
whether the problem is: a) improved, well controlled, resolving or resolved; or b)
inadequately controlled, worsening or failing to change as expected
o May be explicitly stated or implied in documented decisions regarding
management plans and/or further evaluations
 For a presenting problem without an established diagnosis, the assessment or
clinical impression may be stated in the form of a differential diagnoses or as
“possible” or “rule out” diagnoses.
b. The initiation of, or changes in, treatment should be documented.
c. If referrals are made or advice sought, the record should indicate to whom the
referral/advice is sought from.
2. Amount and/or Complexity of Data
a. Document any test or procedure that is ordered, planned, scheduled or performed at the
time of the E/M encounter.
b. The review of lab, radiology and/or other diagnostic tests should be documented. An entry
in a progress note such as “WBC elevated” or “chest x-ray unremarkable” is acceptable
documentation.
c. A decision to obtain old records or decision to obtain additional history from the family,
caretaker, or other source to supplement that obtained from the patient should be
documented.
d. Relevant findings from the review of old records, and/or the receipt of additional history
from the family, caretaker or other source should be documented. If there is no relevant
information beyond that already obtained, that fact should be documented. A notation of
“old records reviewed” or “additional history obtained from family” without elaboration is
insufficient.
3. Risk of Significant Complications, Morbidity and/or Mortality
a. Comorbidities/underlying diseases or other factors that increase the complexity of medical
decision making by increasing the risk of complications, morbidity, and/or mortality should
be documented.
b. If a surgical or invasive diagnostic procedure is ordered, planned, or scheduled at the time of
the E/M encounter, the type of procedure should be documented.
c. If a surgical or invasive diagnostic procedure is performed at the time of the E/M encounter,
the specific procedure should be documented.
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d. The referral for or decision to perform a surgical or invasive diagnostic procedure on an
urgent basis should be documented or implied.
Documentation Requirements When billing an E/M Based on Time
In the case where counseling and/or coordination of care dominates (more than 50%) of the encounter
visit, then time is considered the key or controlling factor to qualify for a particular E/M level.
Requirements:
 More than 50% of the encounter time is time spent in counseling; does not include obtaining a
history, performing the exam or the medical decision making process.
 Only Provider face-to-face time with patient and/or family members
Documentation:
 Total time of visit is documented
 Time spent counseling is documented – an estimation
 Brief description of counseling
Ex #1: “During this 45 minute visit, greater than 50% of the time was spent counseling the patient on
smoking cessation programs.”
Ex#2”: During this 45 minute visit, 23 minutes was spent counseling the patient on smoking cessation
programs.”
Non-Physician Practitioners: Nurse Practitioner, Physician Assistants, Certified Nurse Midwives
UNT Health will follow Medicare requirements for ‘incident-to’ billing of Evaluation and Management
services in an office setting between a physician and a Non-Physician Practitioner (NPP) for all payers
that recognize incident-to billing. Please refer to UNT Health’s policy 14.521.
To be eligible to bill services as ‘incident-to’, the following coverage requirements must be met:
1. The services or supplies provided must be furnished during a course of treatment where the
physician performs and initial service and subsequent services of a frequency which reflects
his/her active participation in and management of the course of treatment.
 ‘Incident-to’ billing does not apply for services in the hospital or SNF setting
2. The physician must personally treat the patient on the patient’s first visit to the practice or treat
any established patient who comes to the office with a new medical condition.
3. There must be direct supervision by the physician. Direct supervision in an office setting means
the physician must be present in the office suite and immediately available to provide assistance
and direction throughout the time the service is performed. Direct supervision does not mean
the physician must be present in the same room as the NPP providing the service. Rather, the
physician must be “in the suite” (i.e. not separated by an elevator or stairwell from the area
where the service is provided). “In the suite” is commonly referred to as within shouting
distance.
4. The physician has an active part in the ongoing care of the patient.
 The physician periodically sees the patient at a frequency that reflects ongoing
management of the patient’s care.
 Direct supervision requirements must be met with respect to every non-physician
service.
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Advance Beneficiary Notice of Non-coverage (ABN)
An ABN will be provided to Medicare patients before items or services are rendered when the provider
believes Medicare is expected to deny payment, either entirely or in part, for the item or service
because it is not reasonable and necessary under Medicare program standards. The ABN allows the
beneficiary to be responsible for the payment of the item/service if Medicare denies the payment. It
also allows the beneficiary to refuse the item or service.
The Directors of Operations and the clinical supervisors shall ensure the most recent ABN form is used.
Please refer to UNT Health’s policy on Advance Beneficiary Notice of Non-coverage located in the
intranet for further details.
Notice of Privacy Practices (NPP)
UNT Health will provide patients a Notice of Privacy Practices (the ‘Notice’) as required by HIPAA. The
Notice will provide patients with notice of uses and disclosures of their protected health information
made by UNT health and of the patient’s rights and UNT Health’s legal duties with respect to protected
health information.
The Notice must be posted in a clear and prominent location where it is reasonable to expect individuals
seeking services to be able to see it and read it.
Please refer to policy 14.201 Notice of Privacy Practices for further details.
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