Building an effective compliance program depends heavily on dedicated leadership, open lines of communication and accountability, according to the U.S. Department of Health and Human Services Office of the Inspector General (OIG).

In addition to conducting audits and investigations, OIG offers guidance to health care organizations as to how they can develop a compliance program that will help keep them out of regulatory hot water. These include a General Compliance Program Guidance, with separate setting-specific guides currently in development.

“This is voluntary, non-binding guidance. These are recommendations from the OIG. It’s not required,” Jillian Sparks, attorney at the OIG’s Industry Guidance Branch, said during a presentation at the National Hospice and Palliative Care Organization’s Annual Leadership Conference.

OIG’s general compliance document offers seven elements of a successful compliance program:

• Written policies and procedures
• Compliance leadership and oversight
• Training and education
• Effective lines of communication with the compliance officer and disclosure program
• Enforcing standards: consequences and incentives
• Risk assessment, auditing and monitoring
• Responding to detected offenses and developing corrective action initiatives

Having organization leaders dedicated to compliance is a cornerstone of a successful program, according to OIG, though in smaller organizations this person may need to wear multiple hats in terms of their responsibilities. This begins with a compliance officer.

The compliance officer should advise the CEO, board and other organization stakeholders on potential regulatory risks that their hospice is facing and participate in operational decisions. This person should be separate from other roles such as legal, operations or financial leadership and have equal stature as other executives, OIG indicated.

In turn, the compliance officer oversees and is advised by a compliance committee that includes a range of senior managers and executives.

“We think it’s very important that their stature be that equal to that of other senior leaders, and that they be as much as possible separate from operations,” Laura Ellis, senior counsel to the Inspector General, said in the NHPCO presenation. “We understand that this is not always possible, based on the size of the organization, but you really want to try and keep them as independent as possible.”

An operator’s board also plays a part. The board is responsible for ensuring that the compliance leadership has sufficient power and resources to implement, maintain, and monitor the entity’s compliance program, OIG indicated.

The compliance officer should also have direct and open lines of communication with board members and all other relevant stakeholders, including a hospice’s personnel and contractors.

The compliance officer and committee should also oversee the development and implementation of risk assessments to determine potential regulatory liabilities, as well as internal audits and monitoring, according to Ellis. This includes plans for corrective actions for any issues identified in the risk assessment.

“An annualized risk assessment will allow you to figure out what our risks are from a compliance standpoint, which ones are the biggest ones, which ones do we want to prioritize, and how we are going to handle them,” Ellis said.