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New Regulators, New Rules, New Risks


DOJ, OIG, CMS and CDC Institute New Programs

If you thought that the Federal government’s spotlight that has shined on healthcare compliance programs over the last almost two decades would abate anytime soon, you need to take a closer look at recent activity.  Rulings, guidance and advisories from the Department of Justice (DOJ), Centers for Medicare & Medicaid Services (CMS), the Office of the Inspector General (OIG) and the Center for Disease Control (CDC) show that the pace of new regulations and the scrutiny on compliance programs continues to increase.  All of this new activity requires diligence from compliance, regulatory and accreditation officers to reduce risk, protect the organization and keep senior leadership in compliance and out of trouble.  

In October, the Office of the Inspector General (OIG) is expected to release its annual work plan for next year which will provide further guidance on where the government will place its emphasis when reviewing healthcare compliance programs.  The demands on compliance, regulatory and accreditation officers in healthcare facilities continue to grow.  As compliance and regulatory requirements continue to increase, the need for improved policies and procedures and expanded training increases with it.

Here is a brief overview of recent information from the Federal agencies with links where you can explore each in more detail.

Department of Justice 
The DOJ had several compliance developments over the last few weeks.

The U.S. Department of Justice is hiring a compliance expert to help evaluate whether to charge corporations that fail to detect and prevent wrongdoing by employees.  This person has not yet been named but it is reported that he or she is a former prosecutor who ran compliance programs in the health care, financial and technology industries.

The Department of Justice (DOJ) also issued new guidance regarding individual accountability for corporate wrongdoing.  The intent is to change the Department’s approach to corporate investigations, to facilitate individual prosecutions for corporate misconduct.  The expected impact is that people responsible for corporate misconduct will not be permitted to walk away while the company and its employees and shareholders pay the price.

Long Term Care Condition of Participation
For the first time in 25 years, the Centers for Medicare & Medicaid Services (CMS) is proposing modifying the conditions of participation (CoP) for long-term care (LTC) facilities

CMS will require an individualized care plan for patients transferring into a Long Term Care facility and assessment plans for residents transferring into and out of Long Term Care facilities.  CMS is clearly signaling the fundamental need for increased scrutiny and planning for care transitions for patients.

CDC Advisory
The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices.  The advisory is in response to system-wide infection control lapses that have exposed a gap in patient safety procedures.

Healthcare facilities are being advised to review policies and procedures, provide additional training and to audit that proper processes are being followed.

To meet the intent of these new regulations, compliance and regulatory officers in healthcare facilities must set new policies and monitor the healthcare staff, management, C-Suite and Board of Directors.  Compliance requires continuous assessment and oversight.  The expanding role of regulatory officers in healthcare facilities seems to be limitless. .