Building an Effective Compliance Program and Compliant Diagnostic Systems That Work: An Overview

  • Chief Legal and Compliance Officer, XIFIN, Inc.

This blog was updated on July 8, 2022.

The healthcare industry is in a state of constant change in laws, regulations, reimbursement and payor requirements, and commercial and patient expectations. It is hard for any individual healthcare provider to keep up with all of these changes. The diagnostic business, in particular, is under pressure to stay in compliance. Over the course of the next several weeks, the XIFIN Beyond Billing Blog will feature a series of posts on the many dimensions of diagnostic provider compliance.

Topics in this series will include:

  • The need for a comprehensive compliance program
  • Protecting consumer/patient data with physical security
  • EKRA and its impact on diagnostic companies
  • Protecting consumer/patient data from breach
  • Must-have compliance capabilities for diagnostic companies
  • How outsourced billing services can help diagnostic companies maintain compliance

Compliance requirements are always changing, and any misstep can result in lost revenues, fines, and even extreme penalties like debarment, corporate integrity agreements, and criminal consequences for the company and its responsible parties. Robust revenue cycle management can address many compliance concerns that can cost an organization money, business freedom, and even exit opportunities.

Technology Infrastructure

One of the first steps when it comes to compliance is for diagnostic companies to have a robust technical infrastructure and supporting systems that are architected to manage all of an organization’s compliance-related activities. This includes, but is not limited to:

  • Compliance logic built into workflow
  • Regular compliance and workflow updates
  • Non-compliant activity indicators
  • Full audit trail
  • Rules-based workflow automation to reduce clerical decision making
  • Logic that supports state and federal regulatory requirements

Executive Strategy and Alignment

At the executive level, there needs to be a consolidated and strategic view of the legal requirements applicable to the business. This may include everything from international data security requirements, such as GDPR, to federal fraud, waste, and abuse regulations, state licensing rules, and contract law. Commercial payor contracts can also have restrictions on activities that can result in strict penalties if violated. Federal and state laws can even restrict activities under insurance and other commercial relationships.  Penalties for violations can range from recoupment of payments and fines to debarment and even jail time for individuals responsible for violations. 

Compliance as Risk Management

An effective compliance program is not only important to comply with applicable law; it is a necessary risk management approach. The hot issues of the day change and appropriate attention will enhance the likelihood of keeping the revenue you earn and preserving the value your organization creates. 

There are 7 factors that together comprise an effective diagnostic compliance program:

  1. Standards and procedures
  2. Oversight
  3. Due diligence
  4. Communication, training, and education
  5. Internal monitoring and auditing
  6. Enforcing standards
  7. Responding to issues

These factors will be covered in more detail in the next post. In short, the best way to ensure your technology infrastructure supports compliance is to make sure it includes compliance capabilities built into the logic and workflow of its systems, enables an audit trail, and has a highly secure system, communications, and business continuity at its core.

In the near term, to learn more about XIFIN’s approach and commitment to compliance, we invite you to review the Compliance page on our website. You can also expect additional compliance-related content throughout this blog series.

Published by XiFin
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