17 Apr Performing tests that are not medically necessary is a major problem in clinical laboratories. What steps does the OIG recommend that labs take t
1. Performing tests that are not medically necessary is a major problem in clinical laboratories. What steps does the OIG recommend that labs take to prevent this? (list/number the steps – explain the steps)
2. The OIG recommends that labs conduct periodic compliance audits that look most closely at which topics? (list/number the topics).
Chapter 19
Clinical Laboratories
Learning Objectives
Familiarity with compliance risk areas in clinical laboratories
Seven components of compliance program
Multiple duties of a Compliance Officer
Open communication lines with employees
Techniques of auditing and monitoring
Various responses to suspected misconduct and legal violations
Benefits of an effective compliance program
Introduction
Description of clinical laboratory operations
Scope and nature of the clinical laboratory industry
OIG program guidance for clinical laboratories, its origins and purpose
Compliance Risk Areas (I)
Medical necessity
Services paid only if covered, reasonable, and necessary for the patient
Test requisition forms, annual physician notices, customized profiles, excessive utilization
Billing
Accurate coding of claims for services
Documentation to support test requests
Eliminate ambiguity before submitting claims
Compliance Risk Areas (II)
Reliance on standing orders
Only for extended course of treatment
Should be monitored and checked periodically
Compliance with applicable HHS fraud alerts
Keep staff informed of these alerts
Marketing
Honest, clear, correct, non-deceptive, and fully informative
Compliance Risk Areas (III)
Prices charged to physicians
No inducements to gain physicians’ business
Retention of records
Records required by laws/programs must be retained
Compliance as an factor in a performance plan
Evaluating performance of managers & employees
Managers’ duty to oversee subordinates’ compliance
Key Elements of a Clinical Laboratory’s Compliance Program
Policies, procedures, & standards of conduct
Designating a Compliance Officer and Committee
Conducting Effective Training and Education
Developing Effective Lines of Communication
Enforcing Standards Through Well-Publicized Disciplinary Guidelines
Auditing and Monitoring
Responding to Detected Offenses and Taking Corrective Action
Written Policies, Procedures, and Standards of Conduct
Explain how the laboratory wants its employees to behave in each of the risk areas
Publicized to all employees
Regularly updated
Employees certify that they have received, read, and understood them
Designating a Compliance Officer and a Compliance Committee
CO is catalyst for the lab’s compliance activities
Qualifications for a CO
Full-time, sufficient authority, funding and staff, access to CEO and governing board
List of CO functions
CC assists and advises the CO
List of CC functions
Conducting Effective Training and Education
Communicate policies, procedures, and standards of conduct to employees
Curriculum of training sessions
Basic training and Specialized training
New employee training with annual updates
Required attendance, condition of employment
Developing Effective Lines of Communication
Between lab CO and employees
Facilitate reporting of suspected misconduct
Several independent communication channels
Documentation of all communications
Confidentiality and non-retaliation policies
Enforcing Standards Through Well-Publicized Disciplinary Guidelines
For failure to follow laws & regulations, policies, procedures, and standards of conduct.
Levels of disciplinary action to be imposed.
Applied fairly and consistently.
Conduct background checks on new employees.
Avoid persons excluded or debarred.
Auditing and Monitoring
Monitoring and reporting on the lab’s compliance performance on a regular basis.
Periodic compliance audits conducted by internal or external auditors.
Recommended topics of compliance audits.
Sampling techniques create baseline picture.
List of other monitoring methodologies.
Responding to Detected Offenses and Taking Corrective Action
Internal investigation consisting of interviews and review of relevant documents,
Determines nature & severity of violations.
Range of corrective actions to be taken.
More intense response when there is evidence of criminal or civil violations.
Self-reporting of such violations.
Benefits of an Effective Compliance Program (I)
Reduces likelihood of false claims
Identifies weaknesses in internal systems
Provide high quality services
Demonstrates commitment to responsible corporate conduct
Insight into employee behavior regarding fraud
Benefits of an Effective Compliance Program (II)
Identifies & prevents illegal, unethical conduct
Central source for info on fraud and abuse
Facilitate employee reporting of potential problems
Enable thorough investigation of misconduct
Immediate and appropriate corrective action
Reduces exposure to civil & criminal penalties
16
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