APMA - American Podiatric Medical Association
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
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.
• Introduction
1 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.”
2 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.
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.
1 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;
• consult with the Compliance Committee, legal counsel, and other qualified experts to resolve specific compliance issues or concerns, including clarification of any parts of the Compliance Program that are unclear, vague, void, outdated, or unworkable;
• periodically revise the Compliance Program as appropriate. This would occur typically when (a) applicable laws change; (b) it becomes clear that employees and/or other personnel do not understand the Compliance Program; (c) recurring operational problems occur that need to be addressed as part of the Compliance Program; and/or (d) other times as needed;
• discuss with legal counsel circumstances that may call for modification to the Compliance Program;
• promptly carry out all duties expressly assigned to the Compliance Officer by the Compliance Program;
• report regularly to the [Governing Body/Executive] on the operation and effectiveness of the Compliance Program and any significant developments arising under the Compliance Program;
• develop and maintain criteria for comprehensive compliance training and education programs;
• develop and maintain a monitoring and auditing process for determining whether compliance standards are being met; and
• generate and retain records and other documentations related to meetings, correspondences, and other activities regarding the Compliance Program.
The Compliance Officer may delegate any of the above-listed duties and responsibilities to qualified, reliable employees.
2 Compliance Committee
The Compliance Committee will include, at least the following members of the senior management team, [e.g., the Chief Financial Officer, the Director of Human Resources, the Director of Information Technology, the Director of Business Operations]. The Compliance Officer will serve as Chair of the Committee. The function of the Compliance Committee is to advise and assist the Compliance Officer in:
• the development, review, and approval of Practice’s compliance standards and policies;
• the development and implementation of comprehensive training and education programs;
• the implementation and oversight of the Compliance Program;
• the oversight of the process for investigating reported violations;
• the development of monitoring and auditing procedures to ensure that the Compliance Program is functioning effectively; and
• the development and oversight of Practice’s process for communicating compliance questions and concerns and reporting compliance violations.
The Compliance Committee shall meet as necessary to address significant compliance issues.
Discretion in Assigning Positions of Responsibility
Practice must avoid putting individuals who have demonstrated a propensity for violating the law in positions of substantial discretionary authority to be consistent with the standards for “effective” compliance activities under the Federal Sentencing Guidelines.
Persons with “substantial discretionary authority” are those individuals who, within the scope of their authority, exercise a substantial measure of discretion in acting on behalf of an organization. The term includes high-level personnel, individuals who exercise substantial supervisory authority and any other individual who, although not a part of an organization’s management, nevertheless exercises substantial discretion when acting within the scope of his or her authority (e.g., an individual with authority in an organization to negotiate or set price levels or an individual authorized to negotiate or approve significant contracts).
The requirements of this section apply to Practice Associates who have the authority to make substantive decisions on behalf of Practice, as well as, those whose duties include any activity that would impact Practice’s participation in/with a governmental health care program.
1 Restriction of Employees/Other Personnel Involved in Questionable Activities
1 Individuals and/or Entities Under Investigation by Governmental Healthcare Programs
Any Practice Associate who is under investigation for possible illegal activity or who is subject to a billing privilege revocation action, debarment, or exclusion proceedings under Medicare, Medicaid, or other governmental health care program, regardless of whether such activity occurred pre- or post-hiring, will be temporarily removed from direct responsibility or use of services may be temporarily suspended, at the discretion of the Compliance Officer in consultation with legal counsel. If resolution of the matter results in the individual’s and/or entity’s conviction, debarment, exclusion, or billing privilege revocation, Practice will follow the following procedure:
An investigation will be conducted to determine the severity of the problem and the need for modifications of any claims submitted to or any payments received from Medicare, Medicaid or any other governmental health care program. Under the direction of the Compliance Officer, management will determine if the employee is to be terminated, determine if accommodations could and should be made to place the employee in a position unrelated to federal health care program patients, notify the billing staff to review claims and correct any unbilled or unpaid claims accordingly. If it is determined that retroactive adjustments are to be made to claims already paid, and/or there are other potential liability or risk management issues, the Compliance Officer and legal counsel will be responsible for overseeing the required corrective actions. The need for further reporting to state licensing boards will be determined by the Compliance Officer and legal counsel. Service contracts will contain a provision allowing Practice to terminate contracts immediately for such occurrences.
3 Compliance Program Authority
No responsibility or authority related to compliance activities will be delegated to an employee, contractor, or other representative who:
• is under indictment or similar charges for criminal activity;
• is subject to debarment, exclusion, or billing privilege revocation proceeding under a governmental health care program;
• has been convicted of a criminal offense;
• is listed as debarred, excluded, or otherwise ineligible for participation in any governmental health care program;
• has had a professional license, board certification, or DEA, and state equivalent if applicable, registration suspended or revoked; or
• is subject to disciplinary action or investigation by a federal or state licensure or certification board.
2 Identifying Employees Subject to Restrictions
1 Reporting Certain Offenses
Offenses described below will be investigated and resolved by the Compliance Officer in consultation with the Compliance Committee. The Compliance Officer and Compliance Committee will determine the appropriate steps to take for reported offenses. The list of offenses includes at least the following:
• any convictions, except minor traffic offenses;
• Medicare, Medicaid, or other federal health care program debarment, exclusion, or billing privilege revocation proceedings;
• adverse governmental or judicial proceeding related to the delivery of or payment for health care services;
• any material offenses occurring on Practice’s business premises; and
• offenses that would curtail an employee’s ability to perform his or her assigned duties (e.g., the compromising of a health care professional license or license to operate a motor vehicle, or controlled substance or substance abuse violations that call into question the employee’s ability to perform his or her tasks).
2 Procedures for Reporting Employee/Other Personnel Convictions
Each employee and/or other personnel must report the offenses to his or her supervisor or the Compliance Officer immediately. Supervisors must report a notice of conviction to the Compliance Officer within one business day of receiving it.
Any reported offenses will be reviewed by the supervisor, Compliance Officer, and/or legal counsel to determine whether and to what extent the unlawful conduct requires further action by Practice.
Background Screening
As a health care provider that contracts with the federal government, it is critical that both current and prospective employees and contractors are not excluded, debarred, had a billing privilege revocation, or are otherwise ineligible to participate in Medicare, Medicaid or any government health care program.
The requirements of this section are designed to ensure that Practice employs individuals and contracts with vendors and others, who are trustworthy, law abiding, and committed to upholding Practice’s compliance standards.
1 Employees
1 Initial Employment
1 Employment Application
Practice will ask all prospective employees to disclose in their employment application or other new hire documents any history of licensure sanctions, criminal convictions, and any history of debarment, exclusion, or billing privilege revocation proceeding under Medicare, Medicaid, or other governmental health care program.
2 Background Screening
Practice will verify that prospective employees hold a current, unrestricted license and DEA registration and applicable state equivalent as required to fill the position, are not excluded, debarred, under a billing privilege revocation, or otherwise prohibited from participating in any governmental health care program. These background screening checks will be conducted before the prospective employee starts employment.
3 Effects of Background Screening
Passing the background screening is a condition of employment. Should Practice learn that an applicant failed to follow ethical or compliance standards of a prior employer, it may refuse to hire the applicant. Nothing in this section prohibits Practice from refusing to hire an applicant due to other reasons in accordance with its policies.
2 Ongoing Employment
At least annually, Practice will verify that all employees required to be licensed, certified, or registered hold a current and unrestricted license, certification or registration, and that no current employee is excluded, debarred, has had a billing privilege revocation, or is otherwise prohibited from participation in any governmental health care program. Passing the scheduled follow up screening is a condition of continued employment.
2 Contractors
Service contracts include provisions to require evidence that background screenings are conducted to confirm that each individual providing health care services has not been the subject of a licensure suspension or revocation, or any debarment, exclusion, or billing privilege revocation proceeding under Medicare, Medicaid, or other governmental health care program.
1 Initial Engagement
1 Background Screening
Practice will verify that prospective contractors hold a current, unrestricted license and DEA registration and, if applicable, state equivalent registration as required to fill the position, are not excluded, debarred, under a billing privilege revocation, or otherwise prohibited from participation in any governmental health care program. The background screening will be conducted before the prospective contractor is engaged by Practice. For service contracts that anticipate the placement of multiple individuals, background screening will be conducted before the placement or an individual under the contract.
2 Effects of Background Screening
Passing the pre-placement background screening is a condition to providing services for Practice under any contract. Should Practice learn during its background screening that a prospective contractor failed to follow ethical or compliance standards in a prior contract, it may refuse to engage the prospective contractor. Nothing in this section prohibits Practice from refusing to engage a prospective contractor due to other reasons in accordance with Practice policies.
2 Ongoing Engagement
At least annually, Practice will verify that contractors required to be licensed, certified or registered (e.g., DEA registration and applicable state equivalent) hold a current and unrestricted license, certification, or registration and that no current contractor is excluded, debarred, has had a billing privilege revocation, or is otherwise prohibited from participation in any governmental health care program. Passing the scheduled follow-up screening is a condition of continued contracting.
Compliance Training and Education
The success of Practice’s Compliance Program depends on the effectiveness of Practice’s training program. Practice must ensure that its employees and other Practice Associates are educated about the Program in general and their specific responsibilities under the Program. Practice’s compliance training and education program, as described in this section, is designed to communicate the Compliance Program’s standards and procedures to Practice Associates in a meaningful and effective manner and to ensure consistent application of Program policies and procedures.
1 Training Program Requirements
Practice maintains an ongoing compliance education program which includes the following minimum requirements:
1 Trainees
Training on compliance issues is provided to:
• all Practice Associates; and
• all Practice services contractors.
2 Training Materials
All Practice Associates are given:
• the Code of Conduct; and
• access to the Compliance Program documents.
3 Training Methods
Training sessions will utilize interactive electronic, lectures, printed materials, or other means of communication, as appropriate to accommodate the skills, experience, and knowledge of the trainees.
4 General Compliance Training
All employees will participate in general training on compliance matters at the time of hiring or initial contracting and on at least an annual basis. The general training will cover:
• the purpose, scope, and importance of adherence to the Compliance Program;
• the disciplinary consequences of failing to adhere to Compliance Program requirements;
• relevant fraud and abuse laws;
• procedures, duties, and rights with respect to investigations conducted by government agencies, insurance companies, and other regulatory bodies; and
• each individual’s duty to report misconduct and to adhere to the Compliance Program.
5 Coding & Billing Training
Anyone whose activities may affect the accuracy of claims submitted for reimbursement (e.g., individuals involved in coding and billing or who furnish professional services to Practice patients) will receive targeted training regarding:
• government and private payor reimbursement principles regarding podiatry services;
• claim development and submission processes;
• proper diagnostic, procedural, and site of service coding;
• requirements to demonstrate medical necessity;
• general prohibitions against false claims, self-referrals, and the payment or receipt of remuneration to induce referrals;
• timely completion of documentation and appending medical records after the fact;
• record retention;
• duty to report misconduct;
• additional topics relating to the practice that could put Practice at risk of noncompliance with governmental health care program requirements.
6 Employee Acknowledgment
Each employee will acknowledge in writing that he or she
• completed training (verified by appropriate training personnel);
• has received, read, and understands those Compliance Program policies that are relevant to his or her duties;
• pledges to adhere to the Compliance Program; and
• understands that promotion of and adherence to the Compliance Program is a condition of employment and a factor in Practice’s evaluation of the employee’s performance, and that failure to comply with the Compliance Program may lead to disciplinary actions, up to and including immediate discharge.
Each employee’s signed acknowledgment will be kept in his or her personnel file. An employee’s refusal to make such an acknowledgment will be noted on the employee’s acknowledgment form and may be grounds for termination of his or her employment.
7 Compliance and Billing Updates
As necessary, employees are provided with ongoing information and updates to enhance employee skills and to keep employees aware of changing compliance, billing and coding policies. The Compliance Officer will subscribe, circulate and centrally maintain the following:
• Applicable Medicare Administrative Contractor (MAC) policies;
• Trade Publications including:
o APMA News;
o APMA Weekly Focus
APMA NewsBrief
• Current year’s Current Procedure Terminology (CPT) Manual;
• Current year’s ICD Manual, when applicable;
• Current year’s HCPCS Level II Codes Manual;
• Current CCI reference manual;
• Approved clarifications or policy statements from the Medicare Administrative Contractor; and
• Other materials the Compliance Officer deems appropriate.
Lines of Communication
Practice is committed to maintaining an open communication system through which Practice Associates can obtain answers to their questions on compliance standards, policies and procedures, and report concerns about possible violations without fear of retribution.
1 Compliance Inquiry System
Anyone associated with Practice who has questions about any portion of the Compliance Program, questions the appropriateness of a particular business activity, or is unsure of the correct procedures to follow under Practice’s policies and procedures should consult with the Compliance Officer or a Compliance Committee member for clarification.
In some cases, the Compliance Officer may determine that it is appropriate to share the results of a particular inquiry among all Practice Associates to educate them on such issues and to attempt to assure consistency within Practice. If the advice or inquiry is published in any form, the questioner’s confidentiality will be protected to the extent possible.
1 General Information
The Compliance Inquiry System is designed to provide prompt answers to questions while preserving the attorney-client privilege and work product doctrine if legal counsel is consulted. Oral inquiries and answers are discouraged except in emergency situations. Any oral advice which is provided must be promptly documented in writing. Requests for advice, opinions, and clarification from legal counsel should be made exclusively through the Compliance Officer.
The Compliance Officer will assure that Practice Associates are aware that additional reference information is available via the American Podiatric Medical Association’s website at .
2 Governmental Health Care Program Requirements
Consistency and accuracy are critical standards of the Compliance Program. When an employee obtains advice or clarification about the meaning of a law, regulation, Medicare manual provision, or other rule from anyone outside Practice, the advice must be documented by the person receiving the advice and approved by the Compliance Officer [or other executive such as the Director of Business Operations] before being implemented, to ensure that it is reliable and consistent with the Compliance Program. This standard applies to any advice, opinions, or clarification from any government agency its staff or contractors, legal counsel, insurance companies, or consultants concerning interpretations of statutes, regulations, Medicare manual provisions, or any other directive affecting:
• documentation, billing procedures, coding, or other activities related to billing and claims for Medicare, Medicaid, or other third-party payor; or
• coverage determinations, guidance, or other directives about items and services that may be reimbursable under Medicare, Medicaid, or other third-party payor.
This requirement does not apply to communications between Practice’s billing staff and the MAC or other insurance companies as needed for the routine processing of claims, provided the procedures comply with the Compliance Program. Such advice or clarification will be documented and presented to the Compliance Officer in order that it may be disseminated as appropriate.
2 Compliance Reporting System
All persons covered by the Compliance Program, including employees (whether permanent or temporary), agents, and subcontractors, and all other Practice Associates, must report suspicious conduct, suspected violations of law, suspected violations of Practice’s compliance policies or procedures, and suspected violations of the Compliance Program to the Compliance Officer. Failure to report information about a violation is grounds for disciplinary action.
Reporting procedures are designed to protect the attorney-client privilege to the maximum possible extent and to maintain a record of all reports and the results of any related investigations or inquiries. Compliance reporting procedures will be posted in appropriate, conspicuous places in Practice’s offices.
Individuals making reports should be prepared to provide as much detail as possible, including names, dates and times, places, and the specific conduct the individual feels may violate the law or Practice policy. If by calling, the individual should be prepared to provide in writing any relevant documents. If in writing, the individual should try to include copies of any relevant documents and provide his or her name and a telephone number and address where he or she may be contacted.
The Compliance Officer or designee will, in good faith, make a preliminary inquiry for every reported known or suspected violation to ensure that all of the necessary information has been obtained to determine whether an investigation is warranted.
3 Protection of Employees
1 Confidentiality & Anonymity
Practice strives to maintain the confidentiality of anyone reporting a suspected violation. However, under certain circumstances, the individual’s identity may become apparent as Practice’s investigation of the allegation progresses or may have to be revealed in the event governmental authorities become involved. In addition, Practice may be legally required to report certain types of crimes or potential crimes and infractions to external government agencies.
Employees are free to ask questions and report concerns to the Compliance Officer without giving their names or other identifying information. Anonymous reports will be treated as seriously and investigated as thoroughly as those filed or communicated by employees who identify themselves.
2 Non-Retaliation
No individual will be disciplined or suffer other repercussions solely on the basis that he or she reported what he or she reasonably believed to be misconduct or a violation of the Compliance Program or Practice’s Code of Conduct. In addition, harassment or retaliation against an individual who has reported a suspected violation will not be tolerated by Practice.
However, if Practice learns that an individual knowingly fabricated, distorted, exaggerated, or minimized a report of misconduct, either to injure someone else or to protect him- or herself, the individual will be subject to disciplinary action.
Sometimes an individual who makes a report may also admit to noncompliance on his or her part. Making a report, in itself, does not guarantee protection from disciplinary action related to the underlying noncompliance. However, volunteering information about one’s own errors, misconduct, or noncompliance will be taken into account, as long as the admission is complete and truthful and was not already known to Practice (or about to be discovered). The weight to be given the report will depend on all the facts known to Practice at the time disciplinary decisions are made, according to the criteria discussed in Section VIII, “Enforcement and Discipline.”
Monitoring and Auditing
This section describes the specific procedures that Practice follows to monitor and audit the Compliance Program’s effectiveness in ensuring appropriate compliance conduct.
1 Auditing and Monitoring Compliance Program Effectiveness
1 Periodic Audits
The Compliance Officer will arrange for periodic audits of the effectiveness of the Compliance Program’s policies and procedures. Audits, at a minimum, will be designed to verify adherence to, and appropriate documentation of, Compliance Program policies and procedures, including procedures for training, discipline, and monitoring/auditing. Where appropriate, and as determined by the Compliance Officer, the audit will be conducted under the supervision of legal counsel to preserve the attorney-client privilege.
Audits will be conducted annually. The scope of each audit will be determined jointly by the Compliance Officer and the Compliance Committee. The results of each audit will be reported to the Compliance Officer, in a form determined by the Compliance Officer, who will in turn report to the [Governing Body]. If an audit reveals noncompliance with the Compliance Program, the Compliance Officer will follow the evaluation, corrective action, and/or reporting procedures set forth in the Compliance Program.
2 Criteria for Reviewers
The reviewers conducting audits of Practice’s Compliance Program must:
• have the qualifications and experience necessary to identify potential compliance issues concerning the subject matter under review;
• be objective and independent of Practice management to the extent reasonably possible;
• be given access to existing audit and health care resources, relevant personnel, and all relevant areas of operation;
• present a written evaluation concerning compliance activities to the Compliance Officer; and
• specifically identify areas where corrective actions are needed.
2 Monitoring and Auditing Practice’s Claims Process
1 Pre-submission Review
At least annually, appropriate personnel will review the documentation relating to a sample of claims before the claims are submitted for reimbursement, for purposes of matching the services provided to the reimbursement being sought. The review will focus on whether: (a) patient records, including claim forms, contain, where relevant, adequate documentation to support payment for all claimed services; (b) selected site of service and procedure codes are accurate and reflect the services provided; (c) conditions for payment and coverage criteria for podiatric services are met; (d) diagnosis codes are accurate and fully supported in the documentation; (e) the individual/s actually performing the services is/are properly identified; and (f) all other applicable requirements for payment have been met.
The pre-submission review is designed to additionally confirm that: (a) patient records, including claim forms have not been altered other then following Practice’s policy for appending a record; (b) there are no duplicative billings, such as billing both the Medicare program and the patient, Medicaid, or another payor; (c) there are no inaccurate descriptions of the nature of the services furnished, such as descriptions of non-covered services as covered services; and (d) there was no excessive billing of Medicare patients or billing for services that were provided to other patients.
The pre-submission review includes two components: (a) an external independent pre-submission baseline chart audit performed by an outside auditor every other year (“External Chart Audit”); and (b) an interim pre-submission chart audit performed internally at least annually (“Interim Chart Audit”). The Compliance Committee is responsible for determining the sample for each pre-submission audit, which will include a designated number of Medicare and Medicaid patient claims based on the payor mix.
The podiatrist performing the pre-submission review should be appropriately qualified to do such reviews and should be allotted sufficient time to examine the selected files to ensure the accuracy of their review.
2 Post-Submission Review
At least annually, a sample of denied claims will be reviewed to verify that the claims submitted accurately represent medically necessary services actually provided, are supported by sufficient documentation, and conform to applicable coverage criteria for reimbursement. The Compliance Committee is responsible for determining the sample selected for review, which will include Medicare claims and a cross section of claims for other payors. These reviews of denied claims may be performed by internal or external auditors, as determined by the Compliance Committee.
Notwithstanding the foregoing, at least quarterly, all Medicare and/or Medicaid claim denials from the previous quarter will be reviewed to determine whether those denials suggest a pattern of errors which require remedial action and whether the reason for the denials has been corrected.
3 Follow-up on Claims Review
The Compliance Officer will ensure that if any compliance issues are identified in pre-submission, post-submission, or other claims reviews, steps will be taken to remedy the situation immediately. In addition, identified problems will be the focus of additional education within Practice. Thereafter, focused review will be conducted as necessary until the Compliance Committee is comfortable that identified problems have been fully addressed.
Enforcement and Discipline
Practice’s Compliance Program can be effective only if violations of the compliance standards, policies and procedures result in disciplinary action. Disciplinary action is warranted not only when an individual has committed an offense or violation, but also when an individual should have detected a violation but fails to do so. This section explains Practice’s disciplinary procedures for Compliance Program violations.
1 Employment Discipline
Adherence to the Compliance Program is a condition of employment. Employees who fail to comply with Program requirements will be subject to disciplinary action, based on Practice’s progressive discipline policy set forth in Practice’s personnel manual. Disciplinary action may be taken for any of the following:
• participating in or authorizing an action that violates the Compliance Program;
• failing to report a violation of the Compliance Program;
• refusing to cooperate in the investigation of a suspected violation of the Compliance Program;
• failing to detect and report a violation of the Compliance Program, if such failure indicates inadequate supervision or lack of oversight by a violator’s supervisor; or
• retaliating against an individual for making a good faith report of a suspected violation of the Compliance Program.
Employees violating the Compliance Program will be disciplined in an appropriate and consistent manner, in accordance with the Practice’s personnel manual.
The [Practice Manager/similar position], in consultation with the Compliance Officer or legal counsel as needed, will be responsible for the administration and/or enforcement of any disciplinary action imposed due to violations of the Compliance Program. Based on mitigating or aggravating factors, an employee who has committed a violation of the Compliance Program may be subject to a lesser or greater level of disciplinary action than that called for otherwise under Practice’s policies. Among the factors to be considered in determining the appropriate disciplinary action in a particular situation are: the employee’s prior record, the employee’s length of service, the gravity of the conduct, whether the employee promptly reported the violation, the nature of the violation, whether the report constitutes Practice’s first awareness of the violation and the employee’s involvement, and whether the employee cooperates fully in investigating and correcting the violation. If an infraction warrants immediate termination, mitigating or aggravating factors need not be considered.
The Compliance Officer and/or [Practice Manager] will maintain records of all disciplinary actions taken for violations and, at least annually, the Compliance Officer will report to the [Governing Board] on disciplinary actions taken and the effectiveness of the disciplinary system.
Response and Prevention
To maintain the integrity of the Compliance Program, Practice must take steps to respond appropriately and prevent similar occurrences once a violation has been detected. An appropriate response may require modifying the Program. Practice will follow the procedures set forth in this section when responding to allegations of compliance violations and when taking steps to prevent the recurrence of violations.
1 Response
1 Reports of Potential Violations
All reports of potential violations will be taken seriously and responded to promptly as the circumstances may dictate. The Compliance Officer will assure that the following steps are taken in response to each such report whenever possible:
• A written record of the report will be made. The report must be as complete as possible.
• No promises will be made to the party making the disclosure regarding his or her liability or the steps Practice will take in response to the allegation.
• The Compliance Officer, after completing the written record of the reported violation, will determine what steps will be taken in response to the report, consulting with legal counsel, as he or she deems appropriate.
• The Compliance Officer will compile a summary of all allegations of violations, including the results of investigations and any subsequent punishments or remedial actions taken.
• All records related to reports of suspected violations will be preserved in accordance with Practice’s document management program.
2 Investigating Allegations
The Compliance Officer and legal counsel, if consulted, will determine the appropriate action based upon the seriousness of the allegation. If the Compliance Officer determines that an internal investigation is necessary, he or she will take steps necessary to assure that the investigation is completed as soon as is reasonable. All Practice Associates will cooperate fully with any inquires generated by the Compliance Officer or at the Compliance Officer’s direction.
An internal investigation may include:
• interviews of relevant personnel;
• a review of relevant documents; and
• engagement of legal counsel, auditors, or health care experts.
If the Compliance Officer determines that the presence of an individual under investigation could jeopardize the integrity of the investigation, he or she will seek to have the Regional Manager relieve that individual of his or her responsibilities until the investigation is completed. Further, the Compliance Officer also will take any necessary steps to secure, or prevent the destruction of, relevant documents.
In the course of investigating potential violations, those involved in the investigation will analyze and evaluate whether the allegation is well founded; and whether the activity, if validated, violates state or federal law, Practice’s Compliance Program, or otherwise puts Practice at risk of economic injury or injury to its reputation.
If a violation is found, the Compliance Officer must decide, in consultation with the Compliance Committee, legal counsel, [and/or other executive, e.g., Practice Manager] as determined by the Compliance Officer, what remedial action should be taken and whether the violation warrants reporting to enforcement authorities. Further, the Compliance Officer, in coordination with others, will determine whether violations are indeed actual wrongdoing, or errors that require corrective action.
3 Corrective Action
If a compliance violation occurs due to honest error, whether detected by report or through standard audit procedures, the Compliance Officer will develop a corrective action plan that addresses, as appropriate:
• immediate correction of any harm resulting from the violation;
• revisions to and/or development of systemic changes and/or safeguards within the Compliance Program to prevent similar noncompliance in the future;
• necessary training or retraining regarding related standards;
• monitoring systems and auditing tools to assure compliance going forward; and
• documentation of the corrective actions taken.
4 Violations
If it is determined that a violation occurred due to an actual wrongdoing the Compliance Officer will take disciplinary action pursuant to the Section VIII, “Enforcement and Discipline,” which may include all or some of the following actions:
• notifying the individual’s supervisor [and/or another executive, e.g., Practice Manager] or contracting contact that such violation has occurred and, as deemed appropriate by the Compliance Officer, notify the [Governing Body];
• recommending appropriate action to the Compliance Committee [and/or another executive, e.g., Practice Manager] including disciplinary action, training and/or notification to outside agencies/entities; and
• recommending to the Compliance Committee [and/or another executive, e.g., Practice Manager] implementation of systemic changes and/or safeguards to prevent similar noncompliance in the future.
5 Reporting Billing Errors and Overpayments to Authorities
If an investigation or audit reveals that an overpayment has occurred, the overpayment must be reported and repaid to the appropriate governmental health care program within 60 days of identifying the overpayment. The report of the overpayment must be made in accordance with the instructions of the contractor or other governmental health care program. Once a billing error has been reported and any overpayments returned, including any applicable deductibles and co-payments, no further reporting to enforcement authorities is required unless there is evidence of a pattern of, or an attempt to conceal, intentional wrongdoing.
The Compliance Officer will consult with legal counsel, as appropriate, to comply with this policy. The Compliance Officer, whenever practicable, will consult in advance with the [Governing Body] before reporting suspected violations of the law to third parties.
2 Prevention
Practice reserves the right to modify the Compliance Program from time to time for the purpose of clarifying areas, emphasizing processes related to repeated areas of non-compliance and/or incorporate new information such as:
• developments in applicable laws;
• guidance from governmental agencies;
• new publications and/or changes in the OIG Compliance Guidance or the Federal Sentencing Guidelines;
• changes in Medicare, Medicaid, or other payor policies; and
• results of compliance and claims audits.
The Compliance Officer will make such modifications in consultation with legal counsel as appropriate and promptly after appropriate notice to and approval from the [Governing Body]. All Compliance Program changes must be fully communicated to every affected employee, agent or other Practice Associate. Such changes may include additional and/or more frequent compliance training on specific compliance issues or on the Compliance Program in its entirety.
General Contracting Principles
Practice is a party to numerous contracts that bind it to specific rights and obligations according to the terms of the contracts. Therefore, Practice has adopted general contracting principles to ensure that contracts receive appropriate review and that Practice is not committed to contracts against its own best interests.
1 Execution of Contracts
Contracts will be executed only by authorized representatives of Practice and of the other contracting party.
2 Maintenance of Contracts
Original, executed contracts will be maintained by the [e.g., CEO, CFO, Compliance Officer] for central filing.
3 Provisions of Contracts
Contracts will contain a complete and accurate description of the products and/or services to be provided under the contract. Fees should be fair market value and commercially reasonable, without regard to the volume or value of referrals between the parties. Any questions or concerns about an agreement should be discussed with the Compliance Officer, in consultation with legal counsel, as necessary.
Relationships with Vendors, Non-Patient Customers, Potential/Actual Referral Sources and Referral Recipients
In the course of their duties, Practice Associates may interact with vendors, potential/actual referral sources, and outside entities to which Practice may refer health care business. A number of federal and state laws address these relationships, including those designed to protect against fraud and abuse within the health care industry, referred to herein as health care fraud and abuse laws.
Adherence to these and all laws governing business and financial relationships in the health care industry is of the utmost importance to Practice’s continued success. Many business relationships and practices that are customary and accepted in other industries may be restricted by laws applicable to the health care industry. Violation of these laws can result in serious criminal and civil penalties for Practice and the responsible Practice Associate.
This section describes the appropriate business conduct that should be followed in the context of specific business and financial relationships in the health care industry, including Practice’s general outreach and/or marketing efforts,.
1 General Business Relationships
All contacts with vendors, non-patient customers, potential referral sources and potential referral recipients must be maintained in a manner consistent with arm’s-length business relationships, must comply with applicable statutes and regulations, including without limitation the health care fraud and abuse laws, and should avoid even the appearance of impropriety.
Practice Associates are prohibited from making or receiving any direct or indirect payment to or from vendor personnel, non-patient customers or potential referral sources or potential referral recipients. Indirect payments include the use of any Practice property, services, or personnel (or Practice’s use of non-Practice property, services, or personnel) for free or at below-fair market value, as well as gifts or entertainment inconsistent with the guidelines of the OIG, and the American Podiatric Medical Association Code of Ethics.
Practice Associates are prohibited from entertaining potential referral sources or being entertained by vendors or other entities that could benefit from Practice’s referrals or business in any way that might be viewed as an attempt to influence referrals or purchases. Practice Associates should obtain approval from his or her supervisor or the Compliance Officer before entertaining or giving gifts to any potential referral source (including providing transportation or meals at business meetings) or accepting any such entertainment from potential referral recipients, for example, in the course of marketing or outreach efforts to referral sources.
2 Kickbacks and Other Improper Payments and Inducements
No Practice Associate may enter into any agreement or arrangement calling for a commission, rebate, bribe, kickback, or other payment, which such employee knows or should suspect is intended to or likely to result in an improper reward, either directly or indirectly.
Practice Associates are prohibited from offering, making, requesting, or receiving any direct or indirect payment (including any commission, rebate, bribe, or kickback) if the payment would suggest that Practice is seeking preferential treatment or is paying a reward for referrals or other business. Indirect payments are not limited to money and may include anything of value, such as the use of Practice property, services, or personnel as well as gifts or entertainment. No action that would otherwise be suspect is permissible merely because it appears to be customary in a particular location or a particular area of business activity.
1 Kickback Arrangements.
A number of arrangements with potential referral sources or referral recipients may be viewed as kickback arrangements. Referral sources can include other physicians, patients, their family members, hospitals, and long term care facilities. Some examples of kickback arrangements follow, although the list is not exhaustive:
• disguising payment for referrals as compensation for other services or a gift/entertainment provided to referral sources or by paying more than fair market value for services they have provided;
• disguising payment for referrals as a compensation for other services paid by a referral recipient that is less than fair market value for services they have provided;
• offering free or discounted services that are the financial responsibility of one health care provider in exchange for referrals of business from that health care provider that is directly payable by a federal health care program (a.k.a. “swapping);
• offering free or discounted services to beneficiaries if they agree to switch providers; and
• providing or accepting meals, entertainment, gifts, or other benefits in exchange for referrals.
These activities and any other kickback arrangements are prohibited and must be reported immediately to the Compliance Officer.
Under no circumstance may any gift, entertainment, benefit or anything of value be provided or accepted as an inducement to refer business, or generate referrals or be based on actual or anticipated referrals or business. Any questions regarding the application of this policy must be directed to the Compliance Officer before the gift, entertainment or benefit is provided to the recipient.
2 Gifts and Entertainment.
Practice Associates may only offer or accept gifts and entertainment to/from potential or actual referral sources or referral recipients or their immediate family members as provided in this Compliance Program and in accordance with any related Practice policy. Gifts and entertainment must not be in the form of cash or cash equivalent. Gifts and entertainment provided to potential or actual referral sources or their immediate family members must be tracked during the course of a calendar year to ensure they do not exceed the annual limit established by CMS. Prior to offering a gift or entertainment, the Practice Associate offering the gift should check the current balance on gifts and entertainment given to the particular recipient. Similarly, prior to accepting a gift or entertainment, the Practice Associate receiving the gift should consult with the Compliance Officer.
The Practice Associate must provide Practice with detailed information related to the gift and entertainment as Practice may request, including: the recipient’s name; the date the gift or entertainment is to be provided; the value of the gift or entertainment; a description of the gift or entertainment; and the Practice Associate providing or accepting the gift or entertainment.
The gift or entertainment must not be determined in a manner that takes into account the volume or value of referrals or other business generated by the potential or actual referral source.
Certain benefits received from referral recipients in the context of another engagement, e.g., services arrangement, do not necessarily constitute a gift as described herein, though they must meet the Practice’s standards in Section XII, “Arrangements with Hospitals, Nursing Facilities and Other Health Care Entities.”
3 Free or Below-Fair Market Value Goods or Services
Except for routine discounts to payors and certain marketing activity (such as participation in health fairs), Practice will not provide goods, services, or other items of value free of charge or at a price below fair market value to influence the flow of business to Practice.
3 Compliance with the Physician Self-referral Prohibitions
To ensure that all financial arrangements between Practice and its podiatrists or outside physicians and/or between the Practice and entities to which the Practice, or a Practice podiatrist, refers or from where the Practice receives referrals, comply with federal and state laws governing prohibitions on physician self-referrals, all arrangements involving Practice podiatrists and a health care entity/provider to which the Practice podiatrist refers or involving Practice and an outside physician who refers to Practice must be submitted, prior to execution, for approval by the Compliance Officer, in consultation with legal counsel.
One example is the situation in which a Practice, or its podiatrists, has a Medicare DMEPOS supplier enrollment and orders, i.e., makes a “referral” for DMEPOS items billed for under this enrollment. Practice shall ensure that any such referrals meet the requirements of the federal self referral law and any similar state law requirements. Specifically, the referrals shall meet the federal self-referral law’s in-office ancillary services exception which allows ordering certain DMEPOS items within a physician practice provided certain requirements are met. These requirements include, without limitation, those related to, supervision and the location where the services are rendered. In addition, the Practice will ensure that any compensation paid to the referring podiatrists meet the requirements of the federal self-referral law and/or any state equivalent by, among other things, not taking into account the volume or value of the podiatrists’ orders/referrals for DMEPOS in this situation.
Arrangements with Hospitals, Nursing Facilities and Other Health Care Entities
Federal laws, such as the anti-kickback statute, and physician self referral law, collectively “health care fraud and abuse laws,” govern financial relationships between Practice podiatrists and health care entities, to which Practice podiatrists may refer federal health care program business or from whom podiatric referrals are received. Under these laws it is illegal to provide or accept anything of value in exchange for actual or anticipated referrals or other business payable by Medicare, Medicaid or other governmental health care program. States often have similar laws.
Practice is committed to maintaining its relationships with hospitals, nursing facilities and other health care entities to which its podiatrists may refer or receive referrals in a manner consistent with arm’s length business relationships, to avoid any appearance that Practice or the providers are deriving any inappropriate benefits.
All financial arrangements between Practice and/or its podiatrists and hospitals, nursing facilities or other health care entities to which Practice podiatrists may refer or receive referrals, which include without limitation, service arrangements, and leases, must be tailored to meet the specific requirements of the health care fraud and abuse laws and any applicable state laws. While not an exhaustive list of all requirements for such agreements, at a minimum, such arrangements should be:
• set forth in writing, signed by both parties;
• provide for payment or compensation that is fair market value and not based on actual or anticipated volume or value of actual or anticipated referral;
• compensation must be set in advance prior to the commencement of the arrangement; and
• the terms of the arrangement must be commercially reasonable absent any referrals or business generated between the parties.
Practice or its podiatrists may not provide services to hospitals, nursing facilities and other health care entities to which Practice may refer or receive referrals, in exchange for compensation without a written agreement in place between the parties that complies with the health care fraud and abuse laws and all other applicable laws.
Notwithstanding, all arrangements described herein shall be submitted, prior to execution for approval by the Compliance Officer in consultation with legal counsel.
With specific regard to real estate or equipment leases, see Section XIII Rental of Office Space and Equipment.
Rental of Office Space and Equipment
Arrangements involving the rental of office space and equipment between the Practice and other health care providers or suppliers in which there is a referral relationship of any nature raise potential concerns under the antikickback law. The Practice will not enter into any office space rental arrangement that could be construed to be disguised kickbacks to induce referrals. Therefore, the rental of Practice office space must be structured according to the criteria in this policy, to conform with laws and regulations protecting certain space rental agreements and to avoid conditions that the Office of Inspector General has identified as suspect in its fraud alert concerning space rental leases.
1 LEASE AGREEMENTS
The Practice may lease office space/equipment to or from a health care provider or supplier to whom the Practice may refer patients or receive referrals only under terms of a written contract. All such leases will be reviewed on an annual basis by the Compliance Officer, in consultation with legal counsel, to ensure the arrangements meet the criteria in this policy. In particular, arrangements involving rental of consignment closets must be carefully reviewed by the Compliance Officer, in consultation with counsel.
All lease agreements between the Practice and any tenant to whom the Practice may make or receive referrals of patients must meet the following criteria:
1 The lease agreement must incorporate the following terms:
• The lease must be in writing and signed by the parties.
• The term of the lease must be for at least one year. Any “for cause” termination clause must identify the specific conditions under which the lease may be terminated. The lease may not be terminated and renegotiated during the initial one-year term.
• The lease must specify what space/equipment is covered under the lease, and it must cover all of the space/equipment rented by the parties.
• If the tenant will not be using the space/equipment on a full-time basis, the lease must specify when and for how long the space/equipment will be used, and what the exact rental charge for each use will be.
• The lease must specify the aggregate rental charge, which must be set in advance, be consistent with fair market value, and be independent of referrals between the Practice and the tenant. Rent payments may not be tied to federal health care program business.
• The space/equipment rented may not exceed that which is necessary for the tenant’s accomplishment of the commercially reasonable business purpose for the space/equipment.
2 Rental charges for common space such as a waiting room, receptionist, or other amenities should be calculated on a pro rata basis.
3 If the space is leased on a time-share or similar periodic basis, it must be occupied exclusively by the subtenant.
Professional Courtesy
Extending professional courtesy to employees and their families and other health care professionals is a long-standing practice within the health care community. Nevertheless, depending on the circumstances under which it is extended, some professional courtesy arrangements may implicate health care fraud and abuse laws. Practice values its professional relationships but, at the same time, is committed to upholding the highest legal and business standards. This section describes professional courtesy practices and explains the circumstances under which they may be extended.
1 Professional Courtesy Practices
Each of the following billing practices (and similar discounting practices) constitutes “professional courtesy” when extended to Practice employees and/or their families or other health care professionals in relation to services provided by Practice:
• waiving all or part of Practice’s fee for the services;
• “insurance only” billing, i.e., waiving coinsurance or other out-of-pocket expenses that the patient is obligated to pay.
2 Extending Professional Courtesy
“Insurance only” billing – that is, waivers of deductibles, coinsurance or copayments – is to be governed by Section XXX, “Coinsurance and Deductibles/Patient Inducement.” Practice Associates may, however, extend professional courtesy to Practice employees and their families, outside physicians, and other health care professionals or their families by waiving all or part of Practice’s fee for a service if the following conditions are met:
• The recipient is not a beneficiary of Medicare, Medicaid or any other federal health care program, or if the recipient is such a beneficiary, he/she has demonstrable financial need, as determined by Practice’s financial hardship policy.
• The recipient is not a physician or immediate family member of a physician who refers Medicare or Medicaid patients to Practice.
• The professional courtesy is provided in a regular and consistent manner that does not take into account the recipient’s ability to generate referrals or other business for Practice or the volume or value of referrals or other business the recipient generates for Practice. Under no circumstances may the amount of the discount vary by the amount of business the recipient generates for Practice.
Confidentiality
The purpose of this section is to emphasize Practice’s commitment to ensuring the confidentiality and privacy of patient information is maintained in compliance with all applicable laws and regulations.
Practice is committed to maintaining the confidentiality of individuals’ health information. The Provider maintains compliance with the Health Insurance Portability and Accountability Act (“HIPAA”) of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) of 2009, and the Privacy and Security Rules that have been promulgated pursuant to these laws.
Practice has policies and procedures in place to assure the privacy, confidentiality and security of individuals’ Protected Health Information (“PHI”). Practice has policies and procedures governing the permitted uses and disclosures of PHI as well as requirements applicable to third parties who need access to Practice’s PHI, such as a process for executing business associate agreements.
Practice has instituted security safeguards applicable to the protection of electronic information and physical access to certain equipment and software in which electronic PHI (e-PHI) is maintained. Security safeguards address, among other things, processes for accessing and using electronic medical record and billing systems, and use of portable or mobile electronic devices, such as laptops.
Practice’s policies and procedures are created for the purposes of protecting an individual’s right to have their PHI and e-PHI maintained confidentially. Practice demonstrates its compliance with such individuals’ rights in its practices such as maintaining proper privacy notices, requiring written authorizations for the disclosure of PHI when require, maintaining an accounting of disclosure, and having in place a process for investigating and notifying patients regarding breaches of unsecured PHI.
Part-time, Temporary, Locum Tenens Podiatrists
From time to time, Practice may utilize the services of part-time or temporary podiatrists. Practice must be assured of the commitment of part-time or temporary podiatrists to the standards of the Compliance Program and to all applicable laws and regulations. Practice has established this section to ensure that the relevant compliance issues are addressed appropriately.
All part-time, temporary locum tenens podiatrists will be covered by this Compliance Program and will be required to sign either an employment or independent contractor agreement, with a definite term, or attestation that includes:
• written representation that he or she:
− holds a current, unrestricted license, certification, DEA and applicable state equivalent registration required to perform the services for which Practice has engaged him or her;
− has never had a license to practice podiatry, certification or DEA and applicable state equivalent registration suspended or revoked;
− has read the provisions of the Compliance Program provided by Practice that are applicable to part-time, temporary or locum tenens podiatrists, understands them, and agrees to be bound by them;
− is not currently excluded, debarred, subject to a billing privilege revocation, or otherwise prohibited from participation in or as provider of services to any governmental health care program or any private payor insurance carrier;
− has never been convicted of any offense which would disqualify him or her from participation in the Medicare, Medicaid, or other governmental health care programs;
− has never been required to pay damages or civil penalties as part of any Medicare, Medicaid, or other governmental health care program overpayment;
− is unaware of any current or pending investigation involving him or her either directly or indirectly in allegations of billing fraud, overpayments, or related allegations; and,
− will notify Practice upon learning of any investigation that either directly or indirectly involves allegations of billing fraud, overpayments, or related allegations.
• acknowledgment that only Practice has the right to bill and receive payment for his or her services provided for Practice.
A reasonable explanation must be provided for each required representation that is not made if the part-time or temporary applicant wishes to be considered further to be employed or contracted by Practice. The Compliance Officer will review the circumstances, with assistance of legal counsel if necessary, to ensure that an offer of employment or engagement of the individual’s services does not jeopardize the continued compliance of Practice with applicable laws and regulations.
Employment arrangements with part-time podiatry personnel must meet the Internal Revenue Service’s test of an employer-employee relationship, including but not limited to payment of compensation that is reported to the IRS on Form W-2.
Part-time or temporary podiatry personnel will not be permitted to keep or duplicate the Compliance Program.
Employment
The relationship between the Practice and its employees is vital to the success of its Compliance Plan. The Practice must be assured of the commitment of all employees to the standards of the Compliance Plan and to all applicable laws.
The Practice has established procedures, as described below, to promote future compliance and to prevent the retention of individuals who have previously violated applicable compliance standards or laws -- either while employed with the Practice or elsewhere.
1 Periodic Employment Policy Review
The Practice will maintain a personnel manual that serves as a reference source for the Practice’s employment policies and procedures. The Compliance Officer will periodically review the Practice’s employment policies and practices to ensure consistency with the Compliance Plan and other legal requirements. The Compliance Officer also will review the application of such policies and procedures to the Practice’s employees.
2 Employee Eligibility Requirements
The Practice will hire and retain only persons who meet the applicable requirements set forth in Section III Discretion in Assigning Positions of Responsibility and Section IV Background Screening.
3 Employment Agreement
To the extent Practice enters into an employment agreement with an employee, all written employment contracts will include, at a minimum:
• acknowledgment that the employee has read those sections of the Compliance Program that are relevant to his or her duties and is bound by their contents, including Program requirements for employee training, duties, and discipline;
• a representation by the prospective employee as to whether he or she has ever been convicted of an offense which, if the individual were employed by the Practice, would constitute a material violation of the Compliance Program;
• a representation by the prospective employee as to whether he or she has ever been discharged from previous employment or punished by a previous employer for conduct which, if the individual were employed by the Practice, would constitute a material violation of the Compliance Program;
• an acknowledgment and acceptance by the prospective employee of the requirements for pre-employment background checks and pre-employment and/or periodic drug screening, if applicable to the prospective position.
4 Employee Compensation and Productivity Standards
To encourage and ensure support of the Compliance Plan, the Practice may structure employee compensation to include incentives for implementing Compliance Plan procedures and participating in compliance activities.
The Compliance Officer will supervise a review of the compensation system for all employees responsible for coding, billing, and related auditing functions to determine whether the system has any affect on billing and coding decisions.
The Compliance Officer also will review productivity standards for billing, coding, and related audit functions to determine if the time allotted for these duties is adequate, given the nature of work and industry standards, and to ensure that employees are not compensated in a way that provides an incentive to submit improper claims. The Compliance Officer will recommend such changes to the compensation system and productivity standards as he or she deems appropriate and necessary to ensure that this policy is observed and enforced and to avoid any unintended influence on coding and billing. As an additional step in avoiding improper claims, the Compliance Officer will consider whether it is feasible to develop meaningful disincentives for coding errors.
5 Departing Employees – Exit Interview
To detect potential violations of the Compliance Plan and as part of the monitoring and audit process, all departing employees must participate in an Exit Interview.
The Exit Interview is the Practice’s final opportunity to determine whether the departing employee has knowledge of any violations, unethical behavior, or criminal conduct within the Practice, or has information about unsafe or unsound business practices within the Practice.
The interview should be conducted while the employee is still on the payroll. It should be conducted by the Compliance Officer or legal counsel. The interview questions should be designed to determine whether the departing employee has violated any laws or requirements of the Compliance Plan and whether he or she is aware of violations committed by anyone else associated with the Practice.
The interviewer should prepare a written report of the Exit Interview, to be made a part of the employee’s personnel file. If any responses indicate possible violations or information about violations, or if the interviewer is otherwise concerned about the employee’s honesty, legal counsel should be notified immediately. An employee’s refusal to participate in an Exit Interview (and the reasons for such refusal, if known) should be noted in the employee’s personnel file.
Records Management Policies and Procedure
An effective compliance program requires a coherent and comprehensive document management system that relates to all records generated and used in their operations, including medical records, business records, personnel records, and administrative records. Practice will maintain a comprehensive records management system in accordance with this section.
1 Document Management Program
The Compliance Officer will maintain an appropriate document management program designed to address the creation, distribution, retention, storage, retrieval and destruction of all of Practice’s business records, including, but not limited to,
• all records and documentation (e.g., medical records; billing and claims documentation) required by federal or state law for participation in governmental health care programs or any other applicable federal and state laws and regulations (e.g., document retention requirements to maintain state licensure);
• all records, documentation, and verifiable and auditable data that support Practice’s claims submissions; and
• all records necessary to protect the integrity of the compliance process and confirm the effectiveness of Practice’s Compliance Program, including
− documentation that employees were adequately trained;
− reports of violations, including the nature and results of any investigations conducted;
− documentation of corrective action, including disciplinary action taken;
− policy improvements introduced in response to any internal investigation or audit;
− modifications to the Compliance Program;
− self-disclosures; and
− the results of auditing and monitoring efforts.
The Compliance Officer will audit and, as appropriate, update Practice’s document management program to ensure that the policies meet at least the following minimum requirements:
• All records will be retained for at least the minimum period as stated in applicable state or federal law or regulation, or according to any specific record retention requirements dictated by Practice’s liability insurance carriers.
• All records that may substantially affect the obligations of Practice will be retained for a period of time that will reasonably assure the availability of those records when needed.
• Adequate records will be developed and maintained to document Practice’s compliance with all relevant laws. Such records include, without limitation, proper records of the Practice’s funds and other assets and all transactions which conform to property accounting principles.
• All payments of money, transfers of property, furnish of services, and other transactions must be reflected in the appropriate accounting and other business records. With the exception of petty cash funds, the practice will not make cash payments.
• All records related to reports of violations will be preserved in accordance with law and in a manner which will assure maximum protection under the attorney-client privilege and attorney work product doctrine.
• Destruction of records will take place pursuant to a standard policy which has been developed for business reasons.
• Any destruction procedure will include a mechanism which will assure that it can be stopped to prevent the destruction of any appropriate records immediately upon receipt of service of legal process for which those records might be relevant.
• Vital records will be identified and appropriately safeguarded.
• The privacy and security of records will be appropriately assured in accordance with applicable state and federal law.
• Employee must disclose any relevant information and otherwise fully cooperate with internal or external auditors, or the Practice’s legal counsel, in the course of compliance audits or investigations.
• Records maintained on magnetic tape or other electronic data processing storage media will be preserved and stored appropriately.
2 Business Documents
1 Creation
Practice Associates will create only those documents which are: (a) required to be created by law, (b) necessary for the performance of their jobs or otherwise compelled by reason of business necessity, or (c) needed to obtain or follow legal advice. Documents not meeting those requirements will not be created.
The creation of memos or letters for the sole purpose of recording the employee’s version of events are discouraged. All memos or letters created by employees must accurately reflect the events.
False or inappropriate alternation of Practice documentation is prohibited and considered a violation of this Compliance Program.
2 Distribution
Documents created by Practice or submitted to Practice may be distributed to those persons within and outside of Practice on a need-to-know basis. Informational copies and the like will be discouraged. Documents may be distributed only to the addressee(s) and those expressly identified as requiring a copy. Any other copying, distribution, or possession of documents is prohibited.
Practice Associates are not authorized to receive or possess documents that are not necessary to their regular job performance. Ordinarily, a Practice Associate should not have a copy of a document unless he or she created the document, is the intended recipient (or designated recipient of a copy), or the document was transmitted as an attachment to a document sent to the employee. Unauthorized possession of Practice documents is a violation of Practice policy.
3 Retention
Documents created by Practice or submitted to Practice shall be retained for the time required by law and in the manner required by law.
Documents that are no longer needed on a daily basis are to be preserved and stored in accordance with Practice’s document management program.
Documents may be held beyond the legal minimum only if required for reasons set forth in the Practice document management program. Anyone who fails to surrender documents for destruction in accordance with the Compliance Program will be subject to disciplinary action. No employee may retain documents contrary to the document management program or which otherwise belong in archives.
4 Destruction
All records except those specifically authorized to be preserved must be destroyed in accordance with Practice’s document management program. Further, documents may be destroyed only pursuant to the Practice document management program. Premature destruction is a violation of Practice policy.
All records which have been the subject of an incident that could lead to litigation and all records which have been requested by an attorney or an administrative agency should be accepted from the general destruction of records policy. These records should not be destroyed until the matter is fully resolved.
5 Removal or Theft
Documents created by Practice, or provided to it by others, are the property of Practice. Employees are strictly prohibited from removing a document, whether an original or a copy, from Practice’s offices. This prohibition applies to documents “created” by the employee himself or herself. However, an employee may take a document home to work on it or access it by computer if necessary to complete an ongoing project. Documents temporarily removed from Practice’s offices may not be disclosed to individuals outside Practice, may not be copied, and must be returned promptly.
3 Medical Records
1 Condition of Records
Practice’s document management program shall ensure that medical records are legible throughout; medical records identify the patient on each page; and entries are signed by the responsible licensed provider. All appended entries to medical records are required to be signed and dated as of the date the appended entry was made.
2 Retention of Records
Practice’s document management program must incorporate the statutes and regulations concerning retention of medical records that apply to Practice.
Records known to be subject to an actual or potential claim, investigation, or legal action are to be retained indefinitely or until the matter is known to be finally resolved. Requests to review or copy patient medical records must be responded to in strict compliance with applicable statutes and regulations.
Practice’s document management program provides for (a) securing medical records against loss, unauthorized access, unauthorized reproduction, corruption, or damage and (b) the disposition of medical records in the event Practice sells or closes its practice.
3 Destruction of Records
As part of its document management program, Practice shall destroy medical records on a regular basis once the applicable retention period has expired. Adherence to a regular document destruction schedule is important to avoid any allegation that documents were deliberately destroyed in anticipation of a specific problem.
Practice shall utilize a document destruction method for medical records that is designed to preserve patient confidentiality and avoid any inadvertent disclosure of individually identifiable health care information in accordance with federal and state privacy laws.
Conflicts of Interest
Practice relies on its Practice Associates to exercise their responsibilities in the best interests of the group and the patients they serve. Employees and all Practice Associates should avoid all situations that are, or appear to be, conflicts of interest. A conflict of interest arises when a Practice Associate’s personal interest or activity may influence his or her judgment in the performance of his or her duty to Practice. While it is impractical to try to define every situation that could create a potential conflict of interest, this section discusses several situations that could raise potential conflicts. In many situations, potential conflicts can be avoided through appropriate disclosure.
1 Situations Creating a Possible Conflict of Interest
1 Financial Interests
A conflict may exist when a Practice Associate or Practice Associate’s immediate family member is in a position to influence the business decisions of Practice and directly or indirectly:
• owns or otherwise engages in the same or similar kind of business as Practice; or
• owns a significant interest in a competitor or concern with a current or prospective business relationship with Practice.
2 Outside Activities
A conflict may exist when a Practice Associate or a Practice Associate’s immediate family member, serves as director, officer, employee, or representative of a competing organization or an organization that has a current or prospective business relationship with Practice. A conflict also may exist when a Practice Associate engages in a personal business venture, charitable activity, or service in public office that prevents him or her from devoting the time and effort that his or her position at Practice requires.
3 Confidential Information
Use of confidential information obtained through the Practice Associate’s relationship with Practice for personal gain or for the benefit of others generally creates a conflict of interest.
4 Gifts
A conflict may arise through the acceptance of gifts from competitors or others having or desiring to have a business relationship with Practice if the acceptance or prospect of receiving gifts tends to limit the recipient from acting solely in the best interests of Practice. “Gifts” include any gratuitous service, loan, discount, money, or item of value. No Practice employee may accept gifts from Practice’s vendors, customers, or anyone desiring to do business with Practice, except as permitted under Section XI, “Relationships with Vendors, Non-patient Customers, Potential Referral Sources and Referral Recipients.” A Practice Associate who has any doubt about the propriety of a gift should consult with the Compliance Officer before accepting it.
5 Transactions Involving Practice
A conflict may exist when a Practice Associate or Practice Associate’s immediate family member derives personal gain from any transaction to which Practice is a party. The Practice’s [Governing Body] must approve any such transaction.
6 Business Opportunities
A Practice Associate may not take advantage of an opportunity that comes from knowledge gained in the course of employment for his or her own benefit or that of any other person or organization. At the time of hire, employees must sign a written agreement prohibiting the unauthorized disclosure of confidential information and misappropriation of Practice’s intellectual property.
2 Disclosure Procedure for Possible Conflicts
In many instances, a potential conflict of interest can be avoided through appropriate disclosure of the existence of the underlying relationship that creates the appearance of a conflict. Because each potential conflict of interest situation must be evaluated on its facts, Practice Associates should promptly disclose and discuss any potential conflict of interest with their supervisor or the Compliance Officer.
Medicare Enrollment and Participation
This section addresses Practice’s approach for maintaining Medicare enrollment and addresses aspects of participation in the Medicare program. This policy also explains Practice’s standards for accepting Medicare assignment for covered services provided to Medicare beneficiaries. By accepting assignment, Practice agrees to bill the Medicare program directly for services provided and to accept Medicare payment as payment in full (except for applicable copayments and deductibles).
1 Maintaining Medicare Enrollment
Federal law delineates specific enrollment data that must be disclosed at the time of the initial enrollment into the Medicare program. The Medicare regulations require enrollees to report changes in enrollment data and specify timeframes for reporting the data changes. Reportable changes for the group enrollment include, but are not limited to, changes in: (1) legal business or trade name; (2) addition of a practice location; (3) changes in persons or entities with ownership or controlling interests; and (4) changes in financial institution relationships, such as changes in secured lenders and bank accounts used for receiving payment. Reportable changes for individuals reassigning billing rights to Practice include, but are not limited to, changes in: (1) legal name and (2) personal contact information such as home address and personal e-mail. Additionally, all enrollees (individual and group) are required to report Final Adverse Actions. Final Adverse Actions are defined in the Medicare regulations and include certain felony convictions, license suspensions, billing privilege revocations, debarments and exclusions. For Practice, as a physician group practice, actions imposed upon it as the enrollee and actions imposed upon an individual or entity with an ownership or controlling interest in Practice, are equally reportable by Practice. Practice’s podiatrists are responsible for promptly notifying the Compliance Officer of any changes in their enrollment data and any adverse actions that may require reporting by Practice or the individual physician to the Medicare program.
Federal law also requires each Medicare enrollee to revalidate its enrollment every five (5) years. The revalidation process is initiated by the Centers for Medicare and Medicaid Services (“CMS”) by sending written correspondence to the enrollee requesting that a revalidation application be submitted. Failure to respond to a request to revalidate an enrollment provides CMS with grounds to deactivate or revoke Medicare billing privileges. The revalidation process does not relieve Practice or its podiatrists of the duty to provide timely updates to enrollment data.
Practice will: (1) periodically review enrollment data for data accuracy; (2) report changes in enrollment data within the required time frame for reporting; and (3) promptly respond to requests to provide updated information or revalidate an enrollment.
All application forms, certifications, attestations, and agreements submitted to Medicare or other government agency, including, without limitation, those related to, health care program enrollments, agreements, incentive programs (for example, the PQRS Incentive) shall be signed by an authorized representative of Practice, which includes individuals identified as Authorized or Delegated Officials on Medicare enrollment forms. Practice’s policy is to accurately prepare such submissions as any false or misleading information on such certifications, attestations or agreements could be viewed as a violation of the health care fraud and abuse laws.
Practice will maintain copies of all forms which are submitted to enroll, update an enrollment, or terminate an enrollment from the Medicare program, and any documents confirming the approval of the forms submitted. This includes copies of any cover letters, fax covers, supporting documents. When applications are submitted via Internet PECOS, Practice will maintain copies of screen shots and a print out of the application being submitted electronically.
Any individual, who is required to sign a Medicare application form, is required to review and confirm the accuracy of the information on the form prior to signing. Individual podiatrists will be provided a copy of their individual enrollment application forms and the corresponding approval of their individual enrollment.
2 Participation in the Medicare Program
Practice is enrolled in Medicare as a physician group practice. As a physician group practice, Practice has entered into a “Participating Physician” agreement, which is automatically renewed unless and until the Practice elected to terminate the agreement during the annual time period to do so. By accepting assignment, Practice agrees to bill Medicare directly for services provided, to accept Medicare payment as payment in full (except for applicable copayments and deductibles) and to not bill Medicare patients for any excess. This includes all Part B covered services rendered to individuals who are enrollees under Medicare during the time period the Participating Physician Agreement is in effect.
Practice is also enrolled in Medicare as a DMEPOS supplier. As a DMEPOS supplier, Practice was required to enter into a participation agreement, which remains in effect until the DMEPOS enrollment is terminated. The requirement to accept assignment required Practice to bill Medicare directly for services provided to beneficiaries, to accept Medicare payment as payment in full (except for applicable copayments and deductibles), and to not bill Medicare patients for any excess.
Other Nonphysician Health Care Professionals
The Practice is committed to utilizing the services of nonphysician health care professionals as appropriate within the scope granted under their state license or as otherwise permitted by law. The Practice’s billings for services of nonphysician health care professionals must comply with all requirements under the Medicare program. This policy explains specific requirements that apply to the use of nonphysician health care professionals and billing for their services.
1 “Incident to” Services
The Medicare program permits physicians to bill and be paid for health care services provided by nonphysician health care professionals in circumstances where the services are considered “incident to the physician’s professional services.” To qualify as “incident to” the services must be:
• an integral, although incidental, part of the physician's professional service;
• commonly rendered without charge or included within the physician’s bill;
• of a type that are commonly furnished in physician's offices or clinics;
• furnished under the physician's “direct personal” supervision; and performed by a full-time, part-time, or leased employee or contractor of the physician or group.
See Medicare Benefit Policy Manual, Ch. 15, § 60. Examples of “incident to” services performed by unlicensed nonphysician health care professionals include drawing blood, taking blood pressure, and giving injections. Services performed by certain licensed nonphysician health care professionals (i.e., nurse practitioners, physician assistants, etc.) operating within the scope of their state licenses may be much broader and may include services such as minor surgery, casting, etc.
1 Billing for “Incident to” Services
Under the Medicare program’s “incident to” rules, a bill is submitted as if the physician furnished the services that were actually performed by the nonphysician health care professional. The Medicare program does not require the use of a modifier for services billed under the “incident to” rules. For “incident to” services, the Medicare program pays 100 percent of the physician fee schedule, as if the physician personally performed the services.
2 Integral Part of Physician’s Professional Services
To bill for services provided by the nonphysician health care professional under the “incident to” rules, the patient must have been seen previously by the physician who ordered the services.
The physician is not required to see the patient every time the nonphysician health care professional provides “incident to” services. Instead, the “incident to” services must be part of a course of treatment initiated by a physician. The physician only needs to provide subsequent services of a frequency which reflects his or her active participation in and management of the course of treatment.
3 “Direct” Supervision”
The Medicare program’s “incident to” rules require that the services of the nonphysician health care professional must be provided under “direct” supervision by a physician in the group. The meaning of “direct” supervision depends, in part, on the setting in which the services are performed.
1 “Incident to” Services Provided in Physician’s Office or Clinic
In the physician office setting (i.e., not located on the premises of an institution), the supervising physician must be in the office suite and immediately available to provide assistance and direction throughout the time the nonphysician health care professional is providing the service. The supervising physician need not be in the room where the service is being provided. However, a telephone link is insufficient supervision.
2 “Incident to” Services Provided in Non-institutional Settings
When a nonphysician health care professional provides services in an ambulatory surgical center or other outpatient facility, the supervising physician must be in attendance in the room where the service is being provided. Availability by telephone or the presence of the physician somewhere in the facility is insufficient supervision. In the facility setting, Practice must ensure that the nonphysician health care professional is a Practice employee, not a facility employee.
3 “Incident to” Services Provided in Institutional Settings
The “incident to” rules do not apply in the institutional setting. Services provided by nonphysician health care professional that are incident to a physician’s services provided to hospital or nursing facility inpatients or outpatients are payable under the hospital or extended care benefit only, because the payment for such services is considered part of the hospital or nursing facility payment. Therefore, no separate payment may be made to a physician for services provided by nonphysician health care professionals as incident to in these setting.
2 Direct Billing for Services of Licensed Nonphysician Health Care Professionals
Services for certain licensed nonphysician health care professionals such as nurse practitioners (“NPs”), clinical nurse specialists (“CNSs”), and physician assistants (“PAs”) may be billing directly, rather then under the “incident to” rules, so long as the individuals are enrolled in Medicare and allowed to do so under the scope of their state license. If the services are billed under the “incident to” rules, they are reimbursed at 100 percent of the physician fee schedule. If the services are billed directly, they are reimbursed at a percentage, usually 85 percent, of the physician fee schedule.
A physician that employs or contracts with such non-physician health care practitioner may bill on behalf of his or her behalf regardless of the clinical setting if the services are separately covered by Medicare and are separately billable. Licensed nonphysician health care professionals must obtain a NPI number and become a part of the Medicare-enrolled group practice.
1 Direct Billing for Nurse Practitioner, Clinical Psychologist, Certified Registered Nurse Anesthetist, or Clinical Nurse Specialist Services
Practice may bill for services provided by an NP, clinical psychologist, certified registered nurse anesthetist, or CNS by way of reassignment. Such nonphysician professionals are permitted to bill Medicare directly for their services and, therefore, may reassign their right to payment for services to Practice.
2 Direct Billing for Physician Assistant Services
Under the Medicare program, physician assistants (“PAs”) are not permitted to bill Medicare directly for their services. Only the PA’s employer may bill Medicare for the PA’s services. Nevertheless, a PA is able to provide services which are directly billed by the Practice if the PA is enrolled in Medicare as part of the Practice.
Medicare Correct Coding and Billing
Practice is committed to submitting only claims that meet the coverage, coding, and billing requirements established by the relevant payors. This section establishes minimum procedures for ensuring the accuracy and appropriateness of the claims that Practice submits.
1 Correct Claims Completion
All claims for reimbursement submitted by Practice will be accurate and based upon medically necessary items and services rendered, as evidenced by verifiable documentation in the patient’s medical record. Practice has established the following procedures for ensuring the appropriateness of diagnosis and procedure codes, levels of service and other required claims items:
• The diagnosis and procedures codes for items and services reported on claims must be based on patient medical records and other documentation and must comply with all applicable official coding rules and guidelines.
• Any Healthcare Common Procedure Coding System (“HCPCS”), International Classification of Disease (“ICD”) or CPT code used by Practice billing staff will be from the current version of the respective coding system and must accurately describe the items and services provided by Practice personnel.
• The site of service codes for items and services must be based upon where services were rendered.
• The rendering provider/s noted on the claim will reflect the podiatrist who either provided or directly supervised the services identified on the claim. For services billed to Medicare, direct supervision will comply with the rules based on the site of service.
• The documentation necessary for accurate billing must be made available to Practice billing staff.
• No financial incentives may be offered to Practice billing staff or consultants to encourage the submission of claims without regard to whether the claims meet applicable coverage criteria for reimbursement or accurately represent the services rendered.
• Under no circumstances may claims be submitted for services not performed or for a level of service (e.g., recording additional units) that exceeds the services actually provided.
The Compliance Officer will take necessary steps to conduct periodic reviews that confirm the accuracy of the standards and criteria used by Practice’s podiatrists and billing staff to determine diagnostic and procedure codes, and levels of service. The Compliance Officer will assure that Practice’s podiatrists and billing staff are instructed to follow established procedures for obtaining advice concerning coding questions, as provided in Section VI, “Lines of Communication.” The Compliance Officer will assure that regular reviews and updates of these policies take place and any changes are communicated to the appropriate personnel.
The Compliance Officer will assure that Practice’s patient and billing forms are updated as appropriate to ensure they continue to promote accurate and complete documentation of the services provided and claims submitted.
2 Correct Coding Initiative (CCI)
In considering whether services may be separately billed, billing staff should refer to the National Correct Coding Initiative Coding Policy Manual for Medicare Services (“Coding Policy Manual”) to ensure that CCI requirements are followed.
In considering whether services must be billed together under one charge (i.e., “bundled”) rather than broken out and billed separately (i.e., “fragmented”), Practice billing staff should refer to the Global Surgical Services Report published by the American Podiatric Medical Association. To identify specific surgical and other services that are required under Medicare policy to be bundled in a single charge, Practice billing staff should refer to The APMA Coding Resource Center at , or some other authoritative source for CCI information and updates, and the Coding Policy Manual for MACs.
The Compliance Officer will take such steps as are deemed appropriate, consistent with the size and resources of the Practice, to ensure that the individuals responsible for billing Medicare for Practice services are aware of and follow CCI requirements.
3 Using Modifiers
Modifiers are appended to CPT codes to indicate that a service or a procedure that has been performed has been altered by some specific circumstance but not changed in its definition or code. The judicious application of modifiers obviates the necessity for separate procedure listings that may describe the modifying circumstance.
Practice should use modifiers as appropriate to identify and claim reimbursement for the services rendered. Not all modifiers are consistently used and accepted by all third-party payors. Practice billing staff should refer to Appendix A of the Current Procedural Terminology Manual and the HCPCS Level II Manual for the appropriate modifiers for Practice’s services, and follow any instructions from the local MAC regarding the use of modifiers.
4 Site of Service Differential
Generally, there are two levels of practice expense relative value units (RVUs) for each procedure code, depending on the site of service (facility and non-facility). Some services, by the nature of their codes, are performed only in certain settings and will only have one level of practice expense RVU per code. Services furnished by Practice podiatrist in a hospital, skilled nursing facility, ambulatory surgical center or similar facility, or furnished by a Practice physician outside the hospital to a hospital inpatient are subject to the lower facility practice expense RVUs. The Practice will take steps to ensure site of service differentials are appropriately used in the course of coding and billing.
Documenting and Billing Surgical Services
To ensure appropriate reimbursement for the Practice’s surgical services, documentation in the patient’s record must adequately reflect the procedure performed. The Practice will submit claims for surgical procedures only as appropriate according to the documentation in the patient’s record. This policy explains the basic procedures for documenting surgical services and for ensuring that the Practice’s claims for such services are submitted according to applicable coverage rules.
Documenting Surgical Services as Part of a Global Procedure
Medicare “bundles” certain surgery-related services with the payment for the surgical procedure itself into a “global” surgical payment. In general, a surgery charge includes the preoperative visit if it takes place within 24 hours prior to the surgery,[2] the surgery itself, and postoperative office and hospital visits for up to ninety (90) days following the surgery, unless the surgery is deemed “minor,” in which case a postoperative period of 0 to 10 days will be assigned by Medicare.
A number of specific rules and requirements apply to bundling of surgical services. The Compliance Officer will monitor the Practice’s compliance with these requirements, as applicable, by: (i) reviewing Medicare policies as set forth in local MAC’s communications contained in the Compliance Library; (ii) reviewing the APMA Coding Resource Center at or some other authoritative source for CCI information and updates; and (iii) by including compliance with these requirements in the scope of audits conducted pursuant Section VII, “Monitoring and Auditing.”
The podiatrist performing a procedure will be responsible for providing and documenting the preprocedure or preoperative and the postprocedure recovery or postoperative services included in the global procedure description in the Current Procedural Terminology Manual description of the procedure, which is available in the Compliance Library. Such services are included in the charge billed for the procedure and may not be billed separately. Intraoperative services and other components of a major surgery are not separately billable.
See the discussion of Medicare’s “Correct Coding Initiative” under Section XXII, “Medicare Correct Coding and Billing.”
Separately Billable Procedures
Certain services may be billed separately from the global procedure charge, with adequate documentation and using the appropriate modifier to support a separate claim.
1. The E & M visit that results in the initial decision to perform the procedure is not included in the global procedure charge and may be billed separately, using an appropriate modifier as necessary, unless it occurs on the same day and the procedure is a minor procedure.
2. A significant E & M service performed on the day of the procedure may be billed separately, with an appropriate modifier, if it is above and beyond the usual pre- and postoperative care and is documented in the patient record as such, along with the reasons it was medically necessary.
3. Visits, if any, during the global period that are unrelated to the diagnosis for which the surgical procedure is performed and are not complications of the surgery are not part of the global package and can be routinely billed, with an appropriate modifier.
E & M Services and Documentation
The Centers for Medicare and Medicaid Services and the American Medical Association have published, and continue to develop, Documentation Guidelines for Evaluation and Management Services (the “E & M Guidelines”).[3] In addition to providing guidance for accurately documenting podiatrist services, as the title suggests, the E & M Guidelines identify the components that are key to podiatrist evaluation and management services — for ensuring both optimum patient care and appropriate reimbursement for the Practice’s services. This policy provides the basic procedures that Practice podiatrists should follow to comply with the guidelines. The E & M Guidelines provide more detailed discussion about each component addressed here.
Documentation of Services Provided
Every Practice podiatrist who provides services to a patient will be responsible for the timely and correct documentation of the services that were rendered. No podiatrist may bill for a service, or cause a service to be billed, unless such documentation has been signed by the podiatrist (signature stamps are not permitted) and placed in the patient record.
1. Except as set forth below with respect to patient histories, the required documentation must be entered in the record or dictated personally by the podiatrist.
2. Documentation entered personally by the podiatrist must be legible. Illegible entries will be considered to constitute missing documentation.
Every patient encounter for E & M services will be documented in accordance with the E & M Guidelines. Each Practice physician will be responsible for assuring that the medical record for every patient for whom the physician provides, or supervises the provision of, E&M services includes appropriate documentation of the applicable key components of the E & M services provided or supervised by the physician as well as the physician’s electronic or handwritten signature (signature stamps are not permitted).
The podiatrist’s documentation will address all of the elements of each service provided. A patient presenting with symptoms, pathology, illness, or injury should be properly examined to define the nature and extent of the symptoms and pathology. Following an interview and examination of the patient, treatment may be rendered and suitably coded using the appropriate E & M code and modifier, if necessary. The symptoms, findings, diagnosis, and planned treatment should also be documented in the patient’s records.
Each Practice podiatrist will be responsible for acquiring a working knowledge of the key components, and the elements comprising those key components, of the E & M services that he or she routinely provides or supervises. For the purpose of this obligation, those key components include the patient history, the physical examination, and the medical decision making that determine the Current Procedural Terminology code to be assigned to the podiatric service. The components such as time, counseling, and coordination of care need be included only if they contribute to or determine the Current Procedural Terminology code assigned to the service or are relevant to the subsequent treatment of the patient. Practice physicians are responsible for familiarizing themselves with the E & M Guidelines to acquire a working knowledge of the key components, and the elements comprising those key components, of the E & M services that they routinely provide or supervise.
For purposes of this Plan, the following definitions apply:
1. New patient. A “new patient” is a patient who has not received professional services from the podiatrist or, in the case of a group practice, another podiatrist in the group within the previous three years.
2. Established patient. A patient is considered “established” if the patient has been seen by the podiatrist or, in the case of a group practice, by any podiatrist in the practice group within a three-year period.
3. Consultation. For purposes of Medicare coverage, a “consultation” is a physician professional service provided to a patient by a second physician, including a podiatrist, or consultant at the documented request of the attending physician. The request and need for a consultation must be documented by the attending physician. The consulting podiatrist must provide the attending physician with a written report for the referring physician’s use in the treatment of the patient and for inclusion in the patient’s medical record.
Medicare Covered Services by Podiatrists
Podiatrists may provide a variety of Medicare covered services, subject to certain coverage requirements. Practice podiatrists must take care to comply with the coverage requirements established by the Medicare program, as well as local coverage determinations adopted by the local MAC. This policy explains Medicare coverage requirements and local coverage determinations as they apply to the services provided by Practice podiatrists.
1 When a Podiatrist is a Physician for Medicare Purposes
Medicare recognizes podiatrists, as physicians for purposes of providing certain covered physician services. This policy explains the circumstances under which a podiatrist is recognized as a physician under the Medicare program.
1 Recognition of Doctors of Podiatric Medicine
For purposes of Medicare reimbursement for podiatric medical services, a doctor of podiatric medicine is considered a physician, so long as the podiatrist practices within the scope of practice permitted under state law. This includes recognition of a podiatrist as a physician, among other things, this list includes:
• Making the required physician certification and recertification of the medical
necessity for services;
• Having a patient in a home health agency under his/her care, and establishing and
periodically reviewing a home health plan of treatment; or
• Serving as a member of a Utilization Review (UR) committee, but only if at least two of the physicians on the UR committee are doctors of medicine or osteopathy. The performance of these functions must be consistent with the scope of the professional services provided by a doctor of podiatric medicine as authorized by applicable State law.
2 Physician Activities in Skilled Nursing Facilities
Under the Medicare Conditions of Participation, specific activities must be performed by physicians in Medicare-certified skilled nursing facilities. In this respect, Medicare defines a physician as an M.D. or a D.O. Thus, for example, a podiatrist may not serve as a skilled nursing facility’s medical director. This restriction applies only to the skilled nursing facility’s certification and does not limit the podiatric services a podiatrist may furnish in a skilled nursing facility.
3 Covered Services
Covered services are based first on the podiatrist’s scope of practice under state law. This includes laboratory tests the podiatrist is permitted to order under state law, so long as the tests are related to the diagnosis or treatment of an otherwise covered service. For example, tests to diagnose or treat flat feet would not be covered, nor would x-rays for screening or routine foot care. Podiatrists may, however, perform the services as described above in Section A of this Section XXV.
When both covered and noncovered services are furnished, the Practice will submit an itemized bill documenting the services furnished, with an appropriate indication that the bill does not include a claim for noncovered services. The Practice is not required to reduce its claim for services, however, if it also furnished incidental noncovered services as a necessary and integral part of providing covered services. For example, if toenails are trimmed to apply a cast to a foot, it is not necessary to disallow the noncovered portion (trimming toenails) of the otherwise covered treatment (applying the cast).
A claim may be submitted for an initial diagnostic service that is provided in response to a specific symptom or complaint that may indicate a condition that would be treated by covered services, even if the resulting diagnosis requires only noncovered services.
4 Local Coverage Determinations
The Practice will consult as needed with the local MAC concerning its process and requirements for establishing that services rendered are reasonable and necessary in terms of scope, frequency, and duration. For example, certain foot conditions, such as infections of feet or toenails that cause pain or deformity of a sufficient degree that ambulation is markedly limited, may require a variety of medical services, including physical examination and testing to diagnose the existence and type of infectious condition, and prescription of a regimen of self-treatment coupled with periodic follow-up examinations to evaluate the status of the lesion, watch for complicating factors, and provide active treatment. The MAC will have established specific coverage policies concerning these conditions.
The Practice will also consult as needed with the local MAC concerning its coverage policies regarding treatment that is expected to be performed by the patient at home or by the staff of a nursing facility in which the patient resides. The Practice will not submit claims for such treatment unless the care is provided as an accepted integral part of a follow-up evaluation.
Ensuring Against Billing Medicare For Non-Covered Services
Certain items and services either are not covered by or may not be billed separately to the Medicare program. Practice is committed to billing only for covered services as appropriate under the requirements of the Medicare program. This section establishes guidelines to prevent the improper billing of Medicare for noncovered items and services.
1 Noncovered Items and Services
Practice will not bill Medicare for items and services unless they are covered by the Medicare program, see Section XX, “Medicare Enrollment and Participation.” Examples of noncovered items and services include the following:
• services, “not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member;”
• podiatric medicine services involving medical devices or drugs that have not been approved by the federal Food and Drug Administration;
• cosmetic surgery (or any surgical procedures directed at improving appearance) subject to limited exceptions;[4] and
• services provided to immediate relatives or members of a podiatrists household.[5]
The Compliance Officer will develop, implement, and update, as necessary, protocols for identifying noncovered items and services, including those items and services that the local MAC has identified as noncovered under Medicare.
2 “No-pay” Bills and Charges to Patients for Statutorily Noncovered Services
Patients may not be billed for statutorily non-covered items or services, unless appropriate notice is given to the Medicare beneficiary and the beneficiary’s consent obtained. Practice will attempt to provide Medicare patients appropriate notice that the items or services would not be covered, along with an estimated charge for the non-covered items or services. At the beneficiary’s request, Practice will file a “no-pay” bill with the Medicare program when the patient requires a denial for the noncovered services in order to submit the claim to another payor or to challenge the denial. The no-pay bill will be submitted with both a GY modifier (item or service statutorily excluded, does not meet the definition of any Medicare benefit or, for non-Medicare insurers, is not a contract benefit) and GX modifier (notice of liability issued, voluntary under payor policy) if a form was signed, or only with the GY modifier if no form was signed. Practice will maintain documentation reflecting the reason for filing the claim for the noncovered service. Payment for the noncovered items and services will be collected at the time of service.
If a service that normally would be covered under the Medicare program is likely to be denied due to a lack of medical necessity, Practice must obtain an advance beneficiary notice from the Medicare beneficiary before providing the service. See Section XXIXI, “Advance Beneficiary Notices.”
3 Missed Appointments
Only services actually provided may be billed to the Medicare program. Therefore, Practice will not bill the Medicare program for missed appointments or “no-shows.” If a Practice clinic wishes to bill patients, who are insured by non-governmental payors for missed appointments, the podiatrist or billing staff must obtain, and place in the patient’s record, a signed statement from the patient to the effect that he or she understands that a bill will be rendered for a missed appointment that such charges may not be covered by insurance, and that he or she agrees to be personally responsible for payment of the charge for the missed appointment.
Ordering and Referring for Medicare Patients
Practice podiatrists play an important role in determining their patients’ needs for health care services. Payors rely on the professional judgment of a patient’s treating podiatrist to determine the medical necessity of services.
Ordering and Referring Requirements
Practice podiatrists and nonphysician practitioners who order and/or refer Medicare covered home health, laboratory, imaging, DMEPOS, certain power mobility devices and specialist services for Medicare beneficiaries must have a current enrollment record in the Provider Enrollment, Chain and Ownership System (PECOS) or have validly opted out of the Medicare program.
To the extent a Practice podiatrist or nonphysician practitioner is not enrolled in Medicare as a member of the group practice, the podiatrist or nonphysician would have to at least submit an application (i.e., the CMS 855O form) to be able to order and/or make referrals for Medicare beneficiaries to receive these delineated services.
Practice podiatrists should consult with Practice’s Compliance Officer to confirm the ability to provide such orders and/or referrals.
Signing Certificates of Medical Necessity for Home Health Services and Durable Medical Equipment
The certifications that podiatrists make when ordering home health services or durable medical equipment attest to the medical necessity of the item or service. Practice podiatrists signing Certificates of Medical Necessity must follow established protocols, as discussed in this policy.
A Practice podiatrist signing a Certificate of Medical Necessity for DME or home health services must have evaluated the patient’s condition to assess the need for home health care or the medical necessity of the item. Before signing the certification, the podiatrist should review the form to verify its completeness and the accuracy of the information provided. The podiatrist must personally complete the section of the certification form attesting to medical necessity. Practice podiatrists may not sign blank certification forms or forms that have been completed in their entirety by the DME supplier or home health agency. Further, with respect to home health services, the certifying physician must document that a face-to-face patient encounter has occurred no more than 90 days prior to or 30 days after the start of home health services. Such documentation shall be in a narrative form and address both why the patient is homebound and the patient’s need for skilled services.
Billing Agency Contracts
The Practice may receive billing and claims processing services from third parties. The Practice is committed to having only those claims that are accurate (based upon medically necessary items and services rendered or costs incurred) and substantiated (by verifiable documentation) submitted for payment. This policy establishes guidelines for the billing arrangements to which the Practice is a party, to ensure that claims submitted on behalf of the Practice comply with applicable laws, regulations, and other relevant publications.
1 Contracts for Billing Services in General
Billing work will be performed only under terms of a written contract with each billing agency performing the services, which include agencies that not only prepare the claims, but those that process and transmit the claims to third party payors, i.e., a clearinghouse. Practice shall not rely on billing software companies or billing services to contract for clearinghouse services. Rather a clearinghouse service agreement shall be directly with the Practice. All billing agency contracts will be approved on an annual basis by the Compliance Officer, in consultation with counsel, as needed, to ensure that the arrangement meets the criteria in this policy.
2 Billing Services Provided on Behalf of the Practice
All contracts between the Practice and any other entity for the billing of the Practice’s health care services should address the following issues:
• the billing agency’s experience in billing for podiatric medical services;
• allocation of responsibility for coding documentation and knowledge of standards pertaining to podiatric medicine services, and the manner of updating such information;
• the billing agency’s commitment to compliance with applicable statutes, regulations, and government guidance pertaining to billing for health care services, and privacy and security with regard to patient records;
• obligations regarding periodic monitoring of documentation and reports submitted during the term of the agreement;
• responsibility for conveying to the Practice any information received by the billing agency pertaining to Medicare and Medicaid billing, including general policy documents as well as specific correspondence, profile information, audit requests, overpayment notification, interviews, subpoenas, and summonses directed to the billing agency;
• responsibilities regarding payment of any audit related costs, even to survive the termination of the agreement, as well as availability of and access to data from prior periods;
• responsibilities regarding write-offs, appeals, and the respective parties’ obligations to assist with appeals;
• ability to terminate at will, in accordance with Medicare requirements;
• the Practice’s ownership of and access to the data on which the claims are based, documents created by the billing agency, claims submitted, collections, denials, and payor inquiries;
• confidentiality of documents provided to the billing agency by the Practice and documents created by the billing agency;
• transparency as to the billing agency’s use of a third party or clearinghouse and its agreement to facilitate the Practice’s execution of a separate agreement with such third party or clearinghouse;
• retention by the billing agency of relevant records in a manner consistent with law and the Practice’s document management system;
• the billing agency’s obligation to indemnify the Practice for its negligence and willful acts;
• time limits for bringing disputes arising out of the contract; and
• controlling law and conflicts of law.
All such contracts will be reviewed to assure that payment of the billing agency is not based on improper incentives that may encourage the submission of claims regardless of whether the claims meet applicable coverage criteria for reimbursement or accurately represent the services rendered.
Any agreements that do not contain the necessary and appropriate contract provisions will be corrected as soon as contractually permissible or as business needs dictate.
3 Reporting Billing Agents to Medicare
The Medicare enrollment rules require the reporting of billing agencies, which includes information on the CMS 855 and the Electronic Data Interchange Enrollment (EDI) enrollment forms. Practice shall prepare and review all such application forms to confirm the billing agency information is complete and accurately reflects the billing agency’s current information, e.g., legal name and tax identification numbers. The requirement to report billing agencies includes both billing services that assist in preparation of claims and clearinghouses that transmit claims.
Advance Beneficiary Notices
Medicare will not pay for a service or procedure that is not reasonable and medically necessary for a particular patient, even if the service or procedure normally would be covered under the Medicare program. An advance beneficiary notice (“ABN”) is provided to a Medicare beneficiary to give advance notice that Medicare is likely to deny payment for a particular service or procedure because it is not reasonable and necessary. The ABN also informs the patient that he or she may be financially responsible if the service or procedure is performed. This section explains the criteria Practice must apply to ensure the appropriate use of ABNs.
Practice will follow Medicare policy regarding the appropriate use of ABNs. Generally, ABNs are required at the time Practice determines the Medicare program is unlikely to pay for a particular service or procedure for a specific reason related to medical necessity.
If a federal law or regulation provides that a certain service is categorically not covered, an ABN is not necessary.
Prior to furnishing the service, Practice must notify the beneficiary that Medicare is unlikely to pay for the service and why. Practice staff should also inform the beneficiary of the possible charges for the service covered by the ABN. The Medicare beneficiary has the option to agree in writing to pay for the service and assume personal responsibility to pay for the service. To be effective, an ABN must:
• be in writing;
• identify the specific services that may be denied (procedure name and CPT/HCPCS code are recommended);
• state the specific reason why Practice believes that the service may be denied; and
• be signed by the beneficiary acknowledging that the required information was provided and that he or she assumes responsibility to pay for the service.
The beneficiary should sign the ABN at the time the service is provided. An ABN is not effective if the beneficiary signs the waiver after the service has been rendered. If a patient has not signed an ABN in a situation where one is required, neither Medicare nor the patient may be billed for the procedure or service.
ABNs should be used only as appropriate and when Practice has identified the possibility or probability that Medicare will not cover the impending service(s). ABNs that are provided to beneficiaries proactively, without reason to believe a certain service will be denied or as a routine part of patient processing without regard to a particularized need are not valid. In addition, ABNs that are blank when signed by the beneficiary are not valid.
If a beneficiary refuses to sign an ABN, Practice may decide not to provide the service. If this is not an acceptable option, a second Practice staff member should include a signed and dated note on the ABN to the effect that the beneficiary was provided with the ABN and refused to sign. The unsigned ABN noting the beneficiary’s refusal to sign should be retained in the beneficiary’s file.
All claims submitted to Medicare with a valid ABN on file will be submitted with a GA modifier (Waiver of liability statement issued as required by payor policy, individual case).
Coinsurance and Deductibles/Patient Inducement
Practice is committed to following all laws, regulations, and other governmental guidance prohibiting improper payments designed to induce patients to use Practice’s services. The OIG has raised a concern that providing services or items to patients free of charge for which patients would be otherwise obligated to pay may be an inducement to patients unless certain criteria are met. Practice has established this section to ensure that any waiver of coinsurance or deductible amounts is made under appropriate circumstances and never as an improper inducement.
1 Waiver of Coinsurance and Deductibles
Practice, its podiatrists, and its billing staff may not waive coinsurance and deductible amounts required to be paid by the patient under a health insurance program, except according to the following criteria. If a waiver is not permitted under this policy, good faith efforts must be made to collect any coinsurance and deductible amounts owed by the patient. In determining financial need and applying reasonable collection efforts, the same standards and policies should be applied to all patients, regardless of payor classification. Practice has developed a “Confidential Financial Worksheet” (subject to specifications per practice) that is utilized to document and evaluate a patient’s financial need.
1 Patients Covered By Governmental Health Care Programs
Except as noted below, Practice may only waive coinsurance or deductible obligations owed by patients covered by a governmental health care program that pays on a direct basis (including Medicare, Medicaid, Federal Employee Health Benefits Program, TRICARE/CHAMPUS, or Railroad Retirement Benefits) where it has made an individual determination to waive a patient’s coinsurance or deductible payments based on financial need or after reasonable but unsuccessful efforts have been made to collect the amount due.
Practice may not routinely offer to waive patients’ coinsurance or deductible obligations or advertise that Practice will waive coinsurance. The basis for the waiver must be documented in the patient’s billing records.
2 Patients with Private Health Care Coverage
Unless prohibited by State law or unless the insurance or managed care plan affirmatively requires collection or an attempt at collection, Practice may waive or discount coinsurance or deductible obligations owed by patients whose care is paid for entirely by private health care coverage (no secondary coverage under a federal health care program) and who are not referring physicians or members of their immediate family. If a waiver of coinsurance or deductible obligation is granted to patients with private health care coverage, their financial record must reflect: (a) that the patient’s insurance or health care coverage program does not impose an obligation to attempt collection; and (b) a Practice invoice to the third party payor that indicates clearly the amount of the waiver or discount granted to the patient. Of course, Practice also may waive or discount coinsurance or deductible amounts based on the patient’s financial need or after reasonable but unsuccessful collection efforts. The patient’s financial record should reflect the reason why the waiver or discount was granted.
3 Patients Who Are Physician Referral Sources or Immediate Family Members of a Physician Referral Source
If a patient is covered by a governmental health care program and the patient is a physician who refers patients to the Practice (or is an immediate family members of such referring physician), no waiver of coinsurance or deductible may be offered or given, absent financial need as discussed above.
If a patient is covered by a private health care insurance and the patient is a physician who refers patients to the Practice (or is an immediate family member of such a referring physician ) waiver of coinsurance or deductive may only be offered if the physician does not refer to the Practice for any of the Stark “designated health services.”[6]
2 Provision of Free Services
Practice shall not provide any service or good to patients free of charge unless permitted by this Compliance Program or otherwise by the Compliance Officer.
3 Marketing
All employees, independent contractors, and other representatives engaged in marketing for Practice will be provided with a copy of Practice’s Code of Conduct. Practice expects its employees, independent contractors, and other representatives to adhere to these ethical standards at all times. All employees engaged to market Practice’s services and products will be required to have training on ethical and legal business practices. All information about Practice used in Practice marketing efforts shall accurately reflect the types of services provided and will comply with all applicable laws, including a patient’s right to choose providers. Practice prohibits abusive marketing practices, such as engaging in high pressure sales tactics to maximize its patient population by targeting beneficiaries on the street in their homes, or offering any inducements. To ensure that its independent contractors and other representatives comply with Practice’s policies concerning ethical and legal business practices, the Code of Conduct and applicable policies should be incorporated by reference into all contracts with independent contractors.
Medicare as a Secondary Payer
The Medicare and other governmental health care programs are the secondary payors when payment will be made under: (1) an automobile policy or plan, (2) workers’ compensation, or (3) certain group health policies or plans. If the primary payor is responsible for and pays only a portion of the patient’s bill, Medicare may make supplemental payments equal to the difference between what the primary payor covered and the amount Medicare would have owed if it had been the primary payor.
This section is designed to ensure that Practice takes the steps necessary to ensure that the rules and regulations applicable to secondary payor situations are addressed.
Practice is required to obtain adequate information from all beneficiaries of Medicare and other governmental health care programs to determine whether any other payment sources exist that may be primary to Medicare and other governmental health care programs. Practice will disclose the existence of any such primary payment sources to Medicare and other governmental health care programs as part of the claims submission process to ensure that all potential benefits are coordinated appropriately.
If Practice receives an overpayment because of its application of Medicare Secondary Payor rules, the overpayment must be repaid within sixty (60) days from the date it was received.
Credit Balances
Credit balances generally are understood to be accounting entries that represent receipts of payments for medical services that either exceed the charges on the account or cannot be tied directly to specific charges. Credit balances may represent overpayments or may simply represent accounting errors, such as misapplied charges or payments. Payments creating credit balances may be from governmental health care programs, private payors, or individual patients. This section is designed to ensure that Practice timely and accurately reports and resolves credit balances.
Practice will review internal credit balance reports on a routine basis to determine whether such credit balances represent actual overpayments. Identified overpayments will be refunded promptly to the appropriate patient, governmental health care program, or private payor. For federal health care programs, overpayments should be repaid within sixty (60) days of identification.
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[1] The Federal Sentencing Guidelines are detailed policies and practices for the federal criminal justice system that prescribe the appropriate sanctions for organizations convicted of federal crimes.
[2] The global period begins 24 hours prior to surgery. A preoperative visit that takes place more than 24 hours in advance of the surgery is not included in the global period and is therefore separately billable.
[3] E&M Guidelines were published in 1995 and 1997.
[4] The exception to the Medicare exclusion includes “surgery for the prompt repair of an accidental injury or for the improvement of a malformed body member which coincidentally services some cosmetic purpose…”.
[5] “Immediate relatives” include, e.g., husband or wife; natural or adoptive children parents or siblings; stepparent, stepchild, stepbrother, or stepsister, in-laws; grandparents or grandchildren; and spouse of a grandparent or grandchild. “Members of a household” include those persons sharing a common home as part of a single family unit, including those related by blood, marriage, or adoption, domestic employees, and others who live together as part of a single family unit, with the exception of a mere boarder or roomer.
[6] “Designated health services” include clinical laboratory services; radiology services, including magnetic resonance imaging, computerized axial tomography scans, and ultrasound services; durable medical equipment and supplies, prosthetics, orthotics, and prosthetic devices and supplies; home health services; outpatient prescription drugs; inpatient and outpatient hospital services; physical therapy services, including speech-language pathology; occupational therapy services; radiation therapy services and supplies; and parental and enteral nutrients, equipment and supplies.
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