Simione™ Healthcare Consultants

Compliance Check: A Prescription for Agency Health in Today's Racing Regulatory Environment

In the world of healthcare compliance and risk, seatbelts are not optional given the fast track of ever-increasing scrutiny and government oversight of home health and hospice organizations. 

Karen Bommelje, RN, BSN, HCS-D, CHC, Senior Manager, Simione Healthcare Consultants, recommends a three-point safety check to ensure your organizational “engine” is fine-tuned with a comprehensive compliance plan, a process to evaluate its effectiveness, and a way to ensure all members of your team understand how an effective compliance plan will assist in reducing your agency’s risk. The healthcare compliance-certified nurse and seasoned leader became a national consultant in 2011 after 20 years of executive level positions in various home health and hospice organizations. Today, she counsels many agencies, providing relevant background and history on fraud and abuse, while supporting efforts to initiate and maintain effective compliance programs for post-acute providers.

According to Bommelje, an effective compliance culture does not scream “Here are the regulations, now follow them or else! Organizations who do this effectively do the right things for right reasons to positively affect all aspects of their operation.”

A Brief History of Fraud and Abuse

Operation Restore Trust (ORT)

The Office of Inspector General (OIG) initiated ORT in 1995 to prevent and detect fraud and abuse in three rapidly growing health sectors: home health agencies, nursing facilities, and durable medical equipment suppliers. The resulting activities recovered $42 million in five U.S. states, inclusive of 35 criminal convictions and 18 civil settlements.  Nearly 20 years later, recoveries totaled $29.4 billion ($16 billion since 1997) according to the Department of Health & Human Services/Department of Justice Annual OIG Report issued in March 2016.  In 2015 alone, $2.4 billion was recovered in conjunction with 983 criminal fraud investigations, 463 criminal charges filed and 613 convictions.

The False Claims Act (FCA)

The FCA has become an important government tool—if not the most important tool—for demanding healthcare providers’ compliance with the requirements of federal healthcare programs.  The federal FCA (as well as state FCAs) claim liability for any person who (1) knowingly presents or causes to be presented a false or fraudulent claim for payment; (2) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim; or (3) conspires to commit a violation.    

Whistleblower Protection Act (WPA)

Initiated in 1989, the WPA protects government employees who participate in investigations and prohibits retaliation. Currently about 70% of FCA actions are initiated by whistleblowers – with $35 billion recovered under the FCA from 1987 to 2012.

The Net Effect = Corporate Integrity Agreements (CIAs)

Nearly 20 years later, the government’s oversight activities are evident with a growing number of home care and hospice organizations signing CIAs.  These agreements with the HHS-OIG in connection with civil health care fraud settlements require the entity or individual to implement (or continue) certain integrity obligations for a period of years. The obligations are based on the 7 elements of an effective compliance program in exchange for waiver of OIG’s permissive exclusion authority.

A CIA mirrors the elements of an effective compliance plan, affirming that an organization has and shall continue to maintain a compliance program that includes, at minimum, the following elements:

  1. Compliance Officer and Compliance Committee
  2. Policies, Procedures & Standards of Conduct
  3. Effective Training & Education
  4. Effective Lines of Communication
  5. Internal Monitoring & Auditing (systemic and annual review of operations)
  6. Enforcement of Standards through Well-Publicized Disciplinary Guidelines
  7. Prompt Response to Detected Offenses and Initiation of Corrective Action

Creating a Culture of Compliance

When organizational leaders develop and implement a Compliance Program based on current regulations and identified risks, the organization’s mission and core values come into play.  Bommelje explains, “The expectation is that everyone will support the effort, and all managers will understand how compliance affects their area of responsibility in terms of resource allocation, communication and accountability.”

She contends that organizational leaders must express and reaffirm a commitment to compliance policies through open communication, established feedback mechanisms, training opportunities, performance review, transparency in all initiatives and communications, and recognition and rewards for compliance incorporated into policies and procedures.

When it comes to Compliance plan of attack, “One size does not fit all,” says Bommelje.  “Each home care and hospice organization has its unique risks, and compliance plans need to evolve and change with the organization.”

The Simione Compliance & Risk Team provides comprehensive assessment, planning and implementation services. Visit or call 800-949-0388 for more information.



OIG DHHS, Compliance Guidance for Home Health Agencies, Compliance Guidance for Hospices, Practical Guidance for Healthcare Governing Boards on Compliance Oversight

Compliance 101 Third Edition, Debbie Troklus & Greg Warner, 2011

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