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Clinical Services Compliance Manual Office of Regulatory Compliance Draft: April 19, 2012 Page 1

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Clinical Services

Compliance Manual

Office of Regulatory Compliance

Draft: April 19, 2012 Page 1

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IntroductionThe 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.

PurposeThe purpose of the manual is to serve as a guide in creating a robust compliance program and addresses UNT Health’s compliance program structure.

DutiesAll 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 Program 1 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; and7. Enforcing disciplinary standards through well-publicized guidelines.

Each of the seven elements is discussed below.

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

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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.

Standards and procedures can be accomplished by:

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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.

Element #5: Responding to Detected Offenses and Developing Corrective Action Initiatives:

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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

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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 OverpaymentsPreviously, 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 fraudulentb. Making or using a false record or statement material to a false or fraudulent claim or to

an ‘obligation’ to pay money to the governmenti. ‘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” ProvisionsBy 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 periodThe 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 directly to the United States, or (2) to a contractor, grantee, or other recipient, if the money or

2 Health Care Compliance Association: excerpt from Compliance Professional’s Manual3 U.S. Sentencing Commission Guidelines, Sentencing for Organizations, 56 Fed. Rev. 22,762 (1991)

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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 BarUnder 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 RequirementA 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 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.

4 31 US.C. 3730(e)(4)(A)5 31 U.S.C. 3730(e)(4)(B)

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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 Guidelines 6 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.(2) (A) The organization’s governing authority shall be knowledgeable about the

content and operation of the compliance and ethics program and shall exercise

6 www.ussc.gov

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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.

(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.

(3) 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.

(4) (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) 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.

(6) 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; and (B) appropriate disciplinary measures for engaging in criminal conduct and for failing to take reasonable steps to prevent or detect criminal conduct.

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(7) 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.

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.

(c) 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 potential criminal conduct, and (B) no less than annually on the implementation and effectiveness of the compliance and ethics program.

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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 – OrganizationsThis section goes over the court probation process and is not necessary to address in this manual.

Enforcement ActionsOIG Permissive Exclusion GuidanceSection 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;

2. They will establish and publicize a framework that will serve as a basis for OIG’s permissive exclusion decisions;

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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 AuthorityA. 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 Entitya. 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 Misconducta. 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 Entitya. 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

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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 ServicesUnder 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 LawsA. 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 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 Referrals7 42 USC §1320c-5(a); 42 CFR §466.71(d), 1004.10

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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 300The 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:

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

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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 monitoringEach 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 Procedureso Time based CPT codes (e.g. psychotherapy notes)

Inpatient as well as outpatient services 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

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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 pointsThis 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 pointsThis 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 pointsThis 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 pointsThis 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 pointsThis 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 pointsThis finding is cited when an Evaluation and Management service could have been billed. This represents a missed revenue opportunity.

‘Incident-to’ Not Met = 3 pointsThis 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 supervisiono A NP/PA bills for a new patiento 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’

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Overcoded by Two or More Levels = 4 pointsThis finding means documentation supported an EM services that is two levels lower than the level of service billed.

Non-billable, global period = 6 pointsThis 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 pointsThis 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 pointsThis 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 pointsThis finding is cited when documentation supports the performance of a procedure, but it was not billed. This represents a missed revenue opportunity.

Unbundling = 3 pointsThis 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 pointsThis finding is cited when documentation supports a different procedure code.

Teaching Physician Regulations Not Met = 6 pointsThis 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 pointsThis finding is self-explanatory.

Modifiers Incorrect Modifier Use

This finding is cited when:

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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 points2. Using the sum of all the points cited in the review with the 100 point scale to determine the

error percentage rateExample: 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 pointsThe 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 E/M Services For Modifiers 0 points = 100% 33-34 points = 83% 67-68 points = 66%

0 points- Over/Under coded by 1 level 3 points - Incorrect modifier use 1-2 points = 99% 35-36 points = 82% 69-70 points = 65%

1 points- Wrong DOS For Procedures 3-4 points = 98% 37-38 points = 81% 71-72 points = 64%

2 points- Incorrect provider 1 points- Wrong DOS 5-6 points = 97% 39-40 points = 80% 73-74 points = 63%

2 points- Undercoded by 2 or more levels 2 points- Incorrect provider 7-8 points = 96% 41-42 points = 79% 75-76 points = 62%

3 points- Incorrect E/M category 3 points- Missed procedure 9-10 points = 95% 43-44 points = 78% 77-78 points = 61% 3 points- No reference to time/time-based code 3 points- Unbundling 11-12 points = 94% 45-46 points = 77% 79-80 points = 60%

3 points- Unbundling 4 points- Incorrect procedure code 13-14 points = 93% 47-48 points = 76% 81-82 points = 59%

3 points- missed E/M 6 point - TP Regs Not Met 15-16 points = 92% 49-50 points = 75% 83-84 points = 58%

3 points-incident to not met 6 points- No documentation for procedure 17-18 points = 91% 51-52 points = 74% 85-86 points = 57%

4 points- Overcoded by 2 or more levels 19-20 points = 90% 53-54 points = 73% 87-88 points = 56%

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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Corrective Action PlanFor 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.

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Compliance MetricsMetrics 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.

TrainingEach 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 over-coding 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 PoliciesGeneral 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.

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CMS PoliciesProviders 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-IOMs-Items/CMS014961.html

Trailblazers PoliciesTrailblazers’ 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.

ResourcesTrailblazers’ 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 Procedures 8

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 GuidelinesDefinitionsTeaching 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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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 face-to-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 ServicesThe 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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Outpatient E/M ServicesIn 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 ServicesInpatient 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; andA 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

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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 Patient99201 9921199202 9921299203 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 StudentsAny 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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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 SurgeryWhen 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 SurgeriesIn 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 ReportResidents 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

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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 ProceduresFor 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 ProceduresTo 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 TestsMedicare 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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PsychiatryThe 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 CodesFor 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 ServicesIn 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.

Every E/M level has an associated time. In order to bill based on time, documentation must show:9 Medicare Learning Network: Evaluation and Management Services Guide

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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 serviceThere 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.

HPI ROS PFSH Type of HistoryBrief NA NA Problem FocusedBrief Problem Pertinent NA Expanded Problem

FocusedExtended Extended Pertinent DetailedExtended Complete Complete 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 Associated signs and symptoms

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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: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:

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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 serviceThere 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 serviceMedical 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.

1. Number of Diagnoses or Management OptionsThe 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

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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 Dataa. 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 Mortalitya. 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.

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

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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 setting2. 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.

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

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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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