President Barack Obama’s victory is a strong indication that the Patient Protection and Affordable Health Care Act of 2010 (PPACA) is here to stay. Health care providers and suppliers can no longer delay implementation of PPACA mandated compliance plans.
Before PPACA, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) encouraged health care providers to develop voluntary compliance plans in order to best comply with the complex regulations governing federally funded health care programs such as Medicare. Despite such encouragement and the well-recognized importance of an effective compliance plan, few health care providers developed and actually use compliance plans. Now, the days of voluntary compliance programs are in the past. PPACA requires health care providers and suppliers to establish compliance programs as a condition of enrollment in federally funded health care programs.
PPACA charged HHS with promulgating yet to be released regulations setting forth the “core elements” that must be included in mandatory compliance programs for health care providers and suppliers in each section of the health care industry. In the interim, the HHS has advised that the “core elements” will be based on the core elements of a compliance plan prescribed in the Federal Sentencing Guidelines Manual, which include the following:
- Implementing written compliance policies, procedures and standards of conduct
- Designating a compliance officer and compliance committee responsible for monitoring compliance efforts and enforcing practice standards
- Conducting effective training and education on the compliance policies, procedures and standards of conduct
- Developing effective lines of communication to facilitate communication with staff (updates and training) and allow anonymous reporting mechanisms
- Conducting internal monitoring and auditing by performing periodic self-audits
- Enforcing standards for employees through well-publicized disciplinary guidelines
- Responding promptly to detected offenses and develop corrective action
Health care providers currently without compliance plans meeting the criteria in the Sentencing Guidelines should adopt such a compliance plan as soon as possible. Not only will such a plan be required, an effective compliance program enables a health care provider to avoid or mitigate significant penalties associated with violations of existing health care regulations. Enforcement initiatives against health care providers are ever increasing, particularly with respect to investigations of alleged health care fraud, and an effective compliance program should be a health care provider’s first line of defense.
PPACA brings in a new era where a compliance plan can no longer be an unused binder on a shelf. If you are a health care provider or supplier, you must develop, use, and monitor a compliance program consistent with government mandates.
A well-structured compliance plan can serve as a valuable tool to help your organization successfully navigate the complex and ever changing health care delivery landscape. An experienced health care attorney can assist your facility or practice in structuring a plan to implement a mandatory compliance program.