Podiatry Practice

COMPLIANCE PLAN

[Insert Date]

TABLE OF CONTENTS

I. Introduction 1

A. Purpose of the Compliance Plan 1

1. Compliance Standards & Procedures 1

2. Discretion in Assigning Positions of Responsibility 1

3. Oversight Responsibilities 1

4. Training and Education 2

5. Monitoring and Auditing 2

6. Enforcement and Discipline 2

7. Response and Prevention 2

B. Questions and Clarification 2

II. Compliance Oversight Responsibilities 4

A. Compliance Officer 4

B. Compliance Committee 5

III. Discretion in Assigning Positions of Responsibility 6

A. Restriction of Employees/Other Personnel Involved in Questionable Activities 6

1. Individuals and/or Entities Under Investigation by Governmental Healthcare Programs 6

2. Compliance Program Authority 7

B. Identifying Employees Subject to Restrictions 7

1. Reporting Certain Offenses 7

2. Procedures for Reporting Employee/Other Personnel Convictions 8

IV. Background Screening 9

A. Employees 9

1. Initial Employment 9

2. Ongoing Employment 9

B. Contractors 10

1. Initial Engagement 10

2. Ongoing Engagement 10

V. Compliance Training and Education 11

A. Training Program Requirements 11

1. Trainees 11

2. Training Materials 11

3. Training Methods 11

4. General Compliance Training 11

5. Coding & Billing Training 12

6. Employee Acknowledgment 12

7. Compliance and Billing Updates 13

VI. Lines of Communication 14

A. Compliance Inquiry System 14

1. General Information 14

2. Governmental Health Care Program Requirements 14

B. Compliance Reporting System 15

C. Protection of Employees 16

1. Confidentiality & Anonymity 16

2. Non-Retaliation 16

VII. Monitoring and Auditing 17

A. Auditing and Monitoring Compliance Program Effectiveness 17

1. Periodic Audits 17

2. Criteria for Reviewers 17

B. Monitoring and Auditing Practice’s Claims Process 18

1. Pre-submission Review 18

2. Post-Submission Review 18

3. Follow-up on Claims Review 19

VIII. Enforcement and Discipline 20

A. Employment Discipline 20

IX. Response and Prevention 22

A. Response 22

1. Reports of Potential Violations 22

2. Investigating Allegations 22

3. Corrective Action 23

4. Violations 24

5. Reporting Billing Errors and Overpayments to Authorities 24

B. Prevention 24

X. General Contracting Principles 26

A. Execution of Contracts 26

B. Maintenance of Contracts 26

C. Provisions of Contracts 26

XI. Relationships with Vendors, Non-Patient Customers, Potential/Actual Referral Sources and Referral Recipients 27

A. General Business Relationships 27

B. Kickbacks and Other Improper Payments and Inducements 28

1. Kickback Arrangements. 28

2. Gifts and Entertainment. 29

3. Free or Below-Fair Market Value Goods or Services 29

C. Compliance with the Physician Self-referral Prohibitions 30

XII. Arrangements with Hospitals, Nursing Facilities and Other Health Care Entities 31

XIII. Rental of Office Space and Equipment 33

A. LEASE AGREEMENTS 33

1. The lease agreement must incorporate the following terms: 33

2. Rental charges for common space such as a waiting room, receptionist, or other amenities should be calculated on a pro rata basis. 34

3. If the space is leased on a time-share or similar periodic basis, it must be occupied exclusively by the subtenant. 34

XIV. Professional Courtesy 35

A. Professional Courtesy Practices 35

B. Extending Professional Courtesy 35

XV. Confidentiality 37

XVI. Part-time, Temporary, Locum Tenens Podiatrists 38

XVII. Employment 40

A. Periodic Employment Policy Review 40

B. Employee Eligibility Requirements 40

C. Employment Agreement 40

D. Employee Compensation and Productivity Standards 41

E. Departing Employees – Exit Interview 41

XVIII. Records Management Policies and Procedure 43

A. Document Management Program 43

B. Business Documents 45

1. Creation 45

2. Distribution 45

3. Retention 45

4. Destruction 46

5. Removal or Theft 46

C. Medical Records 46

1. Condition of Records 46

2. Retention of Records 46

3. Destruction of Records 47

XIX. Conflicts of Interest 48

A. Situations Creating a Possible Conflict of Interest 48

1. Financial Interests 48

2. Outside Activities 48

3. Confidential Information 48

4. Gifts 49

5. Transactions Involving Practice 49

6. Business Opportunities 49

B. Disclosure Procedure for Possible Conflicts 49

XX. Medicare Enrollment and Participation 50

A. Maintaining Medicare Enrollment 50

B. Participation in the Medicare Program 51

XXI. Other Nonphysician Health Care Professionals 52

A. “Incident to” Services 52

1. Billing for “Incident to” Services 52

2. Integral Part of Physician’s Professional Services 53

3. “Direct” Supervision” 53

B. Direct Billing for Services of Licensed Nonphysician Health Care Professionals 54

1. Direct Billing for Nurse Practitioner, Clinical Psychologist, Certified Registered Nurse Anesthetist, or Clinical Nurse Specialist Services 54

2. Direct Billing for Physician Assistant Services 54

XXII. Medicare Correct Coding and Billing 55

A. Correct Claims Completion 55

B. Correct Coding Initiative (CCI) 56

C. Using Modifiers 56

D. Site of Service Differential 57

XXIII. Documenting and Billing Surgical Services 58

XXIV. E & M Services and Documentation 60

XXV. Medicare Covered Services by Podiatrists 62

A. When a Podiatrist is a Physician for Medicare Purposes 62

1. Recognition of Podiatric Degrees 62

2. Physician Activities in Skilled Nursing Facilities 62

B. Covered Services 63

C. Local Coverage Determinations 63

XXVI. Ensuring Against Billing Medicare For Non-Covered Services 64

A. Noncovered Items and Services 64

B. “No-pay” Bills and Charges to Patients for Statutorily Noncovered Services 65

C. Missed Appointments 65

XXVII. Ordering and Referring for Medicare Patients 66

XXVIII. Billing Agency Contracts 67

A. Contracts for Billing Services in General 67

B. Billing Services Provided on Behalf of the Practice 67

C. Reporting Billing Agents to Medicare 69

XXIX. Advance Beneficiary Notices 70

XXX. Coinsurance and Deductibles/Patient Inducement 72

A. Waiver of Coinsurance and Deductibles 72

1. Patients Covered By Governmental Health Care Programs 72

2. Patients with Private Health Care Coverage 72

3. Patients Who Are Physician Referral Sources or Immediate Family Members of a Physician Referral Source 73

B. Provision of Free Services 73

C. Marketing 73

XXXI. Medicare as a Secondary Payer 75

XXXII. Credit Balances 76

[Name of Practice] v

Code of Conduct

The development and implementation of the Compliance Plan and related compliance standards, policies, procedures, and activities (collectively, the Compliance Program) are fundamental to establishing a culture within [Practice Name] (the “Practice”) that promotes prevention, detection, and resolution of instances of conduct that do not conform with federal or state laws, Practice’s policies and procedures, or ethical business practices. Each person associated with Practice has a duty to commit to compliance in the performance of his or her services and to promote the “culture” in all aspects such performance.

This Code of Conduct affirms Practice’s commitment to conducting its business and operations in accordance with the highest legal and ethical standards. Practice intends to fully comply with federal, state, and local statutes, regulations, and policies applicable to its operations and business dealings with the public and at all governmental levels. The [Governing Body] has reviewed and approved the Compliance Plan and authorized the Compliance Officer and management of Practice to develop, and update as needed, policies and procedures to implement the Compliance Plan. Accordingly, this Code of Conduct applies to all Practice employees, agents, officers, directors and contractors (“Practice Associates”) and must be strictly observed.

Healthcare is a complex, highly regulated, interdisciplinary, service-oriented industry, which continually faces changes in technology, delivery systems, standards of care, treatment protocols, rules and regulations, funding and reimbursement, and service needs of our patients and their families. With that complexity in mind, Practice established the following Standards of Conduct, standards that address many -- although by no means all -- of the responsibilities we all have regarding personal conduct, service to patients and their families, handling of the Practice’s business affairs, and compliance with all laws.

·  Practice Associates are required to comply with applicable laws and regulations and are expected to give their best efforts and full diligence in ensuring that the standards of this Code of Conduct are met.

·  Practice is committed to providing care to patients in a compassionate, respectful, and ethical manner without regard to race, color, religion, sex, age, national origin, marital status, sexual orientation, physical appearance, political preference, disability, or other illegal grounds. Decisions about the care of patient will be made in accordance with the clinical needs of the patients and in compliance with professional standards of care and ethical considerations.

·  Practice is committed to ensuring the accuracy of all filings with the government, including patient medical and billing records and claims for payment, and filings related to its participation or contracting with federal and state health care programs.

·  Practice pledges to foster open lines of communication to ensure that its patient care services, business and operations are conducted in accordance with the highest legal and ethical standards. When Practice Associates are uncertain about the application of laws or regulations, standard of care, or ethical considerations, they should seek advice and guidance from their supervisor or the Compliance Officer.

[Name of Practice]

I.  Introduction

A.  Purpose of the Compliance Plan

Practice’s Compliance Plan has been fully adopted by its governing [Governing Body] as the foundation of Practice’s overall legal and ethical compliance efforts and to apply to Practice Associates.

This Compliance Plan has been designed in consideration of the Office of Inspector General’s (“OIG”) Compliance Guidance as well as the seven elements of an effective compliance program established by the Federal Sentencing Guidelines for Organizational Defendants.[1] The Compliance Plan incorporates the elements of an effective compliance program, which are set forth below.

1.  Compliance Standards & Procedures

Practice has adopted and incorporated into its Compliance Program, compliance standards, policies and procedures that address issues most applicable to podiatry practice. These standards, policies and procedures will be updated as needed to reflect developments and changes in the law, payor policies, and industry guidance.

2.  Discretion in Assigning Positions of Responsibility

Practice has adopted appropriate procedures to avoid putting individuals who it knew, or should have known, were inclined to engage in illegal activity in positions of substantial discretionary authority. Appropriate procedures include making a diligent inquiry about the employment and other relevant history of prospective and current Practice Associates. Practice’s standards for ensuring that it employs individuals and contracts with vendors and others, who are trustworthy, law abiding, and committed to upholding Practice’s compliance standards are set forth in Section III, “Discretion in Assigning Positions of Responsibility” and Section IV, “Background Screening”.

3.  Oversight Responsibilities

Practice designates a high-level individual to serve as the Compliance Officer and to oversee implementation of and adherence to the Compliance Program and appoints additional individuals to its Compliance Committee to advise the Compliance Officer and to assist in the implementation of the Compliance Program. These oversight responsibilities are discussed in Section II, “Compliance Oversight Responsibilities.”

4.  Training and Education

Practice takes steps to effectively communicate its compliance standards, policies and procedures by requiring all employees and contractors involved in the delivery of patient care services and related business operations to participate in training programs and by distributing written materials that explain what is required in a practical manner. Practice’s compliance training program is discussed in Section V, “Compliance Training and Education.”

5.  Monitoring and Auditing

Practice has developed an ongoing internal evaluation process that includes a review of whether Practice’s standards, policies and procedures are current and accurate, and whether the compliance program is being successfully implemented, i.e., whether Practice Associates are following program standards, policies and procedures, and properly carrying out their responsibilities. The internal monitoring and auditing process Practice has developed is discussed in Section VII, “Monitoring and Auditing.”

6.  Enforcement and Discipline

Practice strives to ensure that its employees and other Practice Associates understand that there are consequences for violating the Compliance Plan and that such enforcement is applied in a consistent and appropriate manner. Practice’s enforcement and discipline standards are discussed in Section VIII, “Enforcement and Discipline.”

7.  Response and Prevention

In the event Practice suspects or detects a compliance violation, it aims to take all reasonable steps to respond appropriately to the current issue and, as applicable, to prevent future offenses; including making any needed changes to its Compliance Plan, its standards, or its policies and procedures. Practice’s process and steps for ensuring appropriate responses to actual or potential compliance violations are discussed in Section IX, “Response and Prevention.”

B.  Questions and Clarification

Questions concerning interpretation of any portion of this Compliance Plan, standards, or policies and procedures, should be directed to a supervisor, a member of the senior management team, or the Compliance Officer. Practice strives to maintain communication that promote open discussions of compliance concerns and encourage the reporting of suspected problems without fear of retribution. Practice has established a Compliance Inquiry System, which is described in Section VI, “Lines of Communication.” for asking questions or raising concerns. Additionally, all Practice Associates are encouraged to share with the Compliance Officer their comments and suggestions for improving the Compliance Program.

II.  Compliance Oversight Responsibilities

Although every Practice Associate is responsible for helping to implement Practice’s compliance efforts, Practice has assigned primary oversight of its compliance efforts to its Compliance Officer who will be given all necessary powers and resources to carry out his or her duties. In addition, Practice has established a Compliance Committee to oversee the effectiveness of the Compliance Program and to provide assistance to the Compliance Officer in identifying potential compliance risks and implementing the Compliance Program.

A.  Compliance Officer

The Compliance Officer is appointed by the [Governing Body/Executive] to oversee that Practice’s operations comply with the standards, policies and procedures set forth in the Code of Conduct and Compliance Program and the overall implementation of the Compliance Plan. In order to fulfill these obligations, the Compliance Officer will:

·  know and understand all aspects of the Compliance Program;

·  assure that responsibilities under the Compliance Program are delegated only to persons who are morally fit, honest, and capable of making the judgments called for in the delegation;