See generally, Health Care Compliance Association (HCCA)
See also, HCCA Compliance Certification Examination
OIG Compliance Program Guidance for Pharmaceutical Manufacturers - a set of guidelines that pharmaceutical manufacturers should consider when developing and implementing a compliance program or evaluating an existing one. For those manufacturers with an existing compliance program, this guidance may serve as a benchmark or comparison against which to measure ongoing efforts.
PhRMA Code on Interactions with Health Professionals - this Code addresses interactions with
respect to marketed products and related pre-launch activities. It does not address relationships with clinical investigators relating to pre-approval studies.
AdvaMed's Code of Ethics - discusses relationships in which health care professionals work with the medical technology industry as advisors, researchers, students, and teachers to bring innovation to patients and the practice of medicine.
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[Source: HCCA Compliance Information]
Brief overview of health care complianceThe move by many in the health care industry to develop corporate compliance programs came after passage of the Health Insurance Portability and Accountability Act of 1996. This Act gives the Department of Health and Human Services’ Office of Inspector General and the U. S. Department of Justice more investigational funding and authority to increase penalties for health care fraud and abuse. Using these and other enforcement tools the government continues to investigate health care institutions across the U. S. searching for violations of the False Claims Act and other federal laws.
To protect their institutions from liability, health care providers are implementing corporate compliance programs using the seven elements outlined in the U. S. Sentencing Guidelines for Organizations and appointing corporate compliance officers to develop, implement, and manage them.
While law does not require an organization to meet the Guidelines seven elements of a compliance program, these elements provide the backbone of a well-designed compliance program. An organization that is found guilty of violating federal criminal laws and has a compliance program in accord with the Guidelines, may reduce assessed penalties by up to 70% against the fines that the law requires.
The U. S. Sentencing Commission was created by Congress in 1984 to promulgate the U. S. Sentencing Guidelines for Organizations and the U. S. Sentencing Guidelines for Individuals to increase sentencing uniformity for those found guilty of violating federal laws. To encourage good corporate citizenship, the Commission outlined a punishment structure based on the culpability of the organization and the seriousness of the crime.
U.S. Sentencing Guidelines Revisions:
Effective Compliance and Ethics Programs
Click here to download the U.S. Sentencing Guidelines revisions regarding an effective compliance and ethics program.
