Designing and Implementing
Compliance Programs 

HYGIA specializes in creating and executing healthcare compliance programs tailored to the specific requirements of each organization, while adhering to the guidelines and criteria outlined by HHS OIG, CMS, and the U.S. Sentencing Commission. Our extensive expertise allows us to successfully implement effective compliance programs across various healthcare entities, including physician practices, SNFs (Skilled Nursing Facilities), home health and hospice services, managed care organizations, academic medical centers, hospitals, and health systems.

Customized Compliance Program Design

At HYGIA, we craft Standard Operating Procedures by customizing program elements to suit the distinct structure, operations, and culture of each organization. Our compliance program designs concentrate on the following key aspects:
  • Preventing instances of non-compliance
  • Detecting compliance risks and potential breaches
  • Addressing and correcting non-compliant actions​

Implementation of Compliance Programs

HYGIA's healthcare compliance consultants are actively involved in every phase of executing a compliance program tailored to suit your organization. We prioritize the implementation of the seven essential elements of an effective regulatory compliance program, as guided by the U.S. Sentencing Commission and HHS:
  • Putting in place written policies and standards of conduct.
  • Appointing compliance oversight.
  • Conducting training and educational initiatives.
  • Establishing effective lines of communication.
  • Conducting monitoring and audits.
  • Enforcing standards.
  • Responding to detected offenses and implementing corrective measures

Assessment of Compliance Program Effectiveness

HYGIA conducts a thorough Compliance Program Effectiveness Review to assess the current state and requirements of your compliance program. Our proprietary comprehensive evaluation protocol encompasses elements from the HHS, OIG compliance program guidance documents, and the DOJ Evaluation of Corporate Compliance Programs. Through a collaborative approach, we identify and verify the presence and efficacy of key elements within your compliance program.
Effective compliance programs entail proactive monitoring and auditing functions specifically designed to test and confirm adherence to regulatory mandates and the organization's written compliance standards. The primary focus is to determine the program's overall effectiveness.

Comprehensive Assessment of Compliance Program Effectiveness

HYGIA conducts a thorough evaluation of your compliance program, involving a review of existing documents, assessment of program operations, and conducting on-site and remote interviews to ensure a comprehensive review.
Additionally, we meticulously examine your program to gather evidence supporting the seven elements of an effective compliance program as outlined by the DOJ, and OIG. This examination encompasses regulatory requirements, industry best practices, and current enforcement trends. With our extensive experience in the healthcare sector, we offer our clients well-founded recommendations for best practices in compliance operations.

Evaluation of Compliance Program and Interviews

HYGIA's advisors conduct interviews with essential stakeholders, including key Board members, executives, managers, and focus groups. They also utilize metrics to assess the program's effectiveness and analyze high-risk areas. Furthermore, ancillary site visits and surveys are conducted to obtain a thorough understanding of the program. Throughout the process, close collaboration with the Compliance Officer ensures accuracy and precision in the evaluation.

Summary of Discoveries and Proposed Actions

After conducting the Compliance Program Effectiveness Reviews, HYGIA provides a comprehensive report containing findings and recommendations that cover each of the OIG's elements necessary for an effective compliance program. This report includes practical and actionable suggestions for enhancing areas that require improvement. As part of their oversight responsibility for the compliance program, HYGIA frequently works in tandem with the Compliance Officer to present the findings and recommendations to the Board of Directors.