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A robust compliance program is essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. The second edition of the Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies develop a compliance program tailored to today's complex enforcement and business environment. Study of this Manual will enable compliance professionals and lawyers to understand the government's expectations of an effective compliance program and ethical business practices, as well as:how the government discovers potential enforcement actions,its approach to pursuing such actions,what behaviors can constitute mitigating factors for a company in the event of a legal violation.Coverage includes new chapters covering:Pharmaceutical industry interactions with patient organizationsCompliance 2.0: compliance analytics in the era of big dataThe art and science of health care compliance in the pharmaceutical and medical device industries The Manual will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry.
A robust compliance program is essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. The second edition of the Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies develop a compliance program tailored to today's complex enforcement and business environment. Study of this Manual will enable compliance professionals and lawyers to understand the government's expectations of an effective compliance program and ethical business practices, as well as: how the government discovers potential enforcement actions, its approach to pursuing such actions, what behaviors can constitute mitigating factors for a company in the event of a legal violation. Coverage includes new chapters covering:Pharmaceutical industry interactions with patient organizations Compliance 2.0: compliance analytics in the era of big dataThe art and science of health care compliance in the pharmaceutical and medical device industries The Manual will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry
The authors examine each stage of a fraud and abuse investigation, beginning with an overview of federal and state enforcement agencies, and concluding with a discussion of the potential collateral consequences of an investigation. They have supplemented their analysis extensively with sample documents, including indictments, requests for records, subpoenas, internal response memoranda, and responses to auditors, prosecutors, and more. Taken together, the materials in this book provide a true Handbook for anyone who needs to quickly and thoroughly understand the complex nature of a government fraud and abuse investigation.-Preface.
The Health Care Compliance Professional's Manual gives you all the tools you need to plan and execute a customized compliance program that meets federal standards. It walks you through the entire process, start to finish, showing you how to draft compliance policies, build a strong compliance infrastructure in your organization, document your efforts, apply self-assessment techniques, create an effective education program, pinpoint areas of risk, conduct internal probes and much more. The Health Care Compliance Professional's Manual is used by the Health Care Compliance Association (HCCA) as the basic text for its Compliance Academy - the program that prepares compliance professionals for the CHC (Certificate in Healthcare Compliance) certification exam. The Health Care Compliance Professional's Manual will help you to: Use OIG publications and Federal Sentencing Guidelines to help plan and execute a customized compliance strategy that meets tough federal standards Perform risk assessment to pinpoint areas within your company that pose compliance and operational risks Draft compliance policies that form the foundation for a strong compliance program Build a strong infrastructure for compliance to work, including hiring the right personnel Create an effective education and training program that instills in employees the value of legal compliance Conduct internal probes that uncover legal violations before the federal government does - and mitigate possible penalties Stay up-to-date on all the latest legal and regulatory requirements affecting your facility, including HIPAA, EMTALA, fraud and abuse reimbursement, privacy, security, patient safety and much more! Packed with tools to make your job easier, The Health Care Compliance Professional's Manual will provide: Practical coverage of federal and state laws governing your facility Document efforts and apply self assessment techniques Insight into helpful federal standards on effective compliance programs Step-by-step guidance on implementing a sound compliance program Time-saving sample compliance policies, forms, checklists, and chart The Health Care Compliance Professional's Manual will protect your company if violations do occur: Learn how to apply auditing, monitoring, and self-assessment techniques Discover how to successfully follow the OIG's voluntary disclosure program to resolve overpayment problems and avoid exclusion from Medicare Find out how to enter into a corporate integrity agreement to settle with the federal government and mitigate FCA-related penalties Document your compliance efforts so you leave a protective paper trail that shields you from liability And much more
Risk Management Handbook for Health Care Organizations, Student Edition This comprehensive textbook provides a complete introduction to risk management in health care. Risk Management Handbook, Student Edition, covers general risk management techniques; standards of health care risk management administration; federal, state and local laws; and methods for integrating patient safety and enterprise risk management into a comprehensive risk management program. The Student Edition is applicable to all health care settings including acute care hospital to hospice, and long term care. Written for students and those new to the topic, each chapter highlights key points and learning objectives, lists key terms, and offers questions for discussion. An instructor's supplement with cases and other material is also available. American Society for Healthcare Risk Management (ASHRM) is a personal membership group of the American Hospital Association with more than 5,000 members representing health care, insurance, law, and other related professions. ASHRM promotes effective and innovative risk management strategies and professional leadership through education, recognition, advocacy, publications, networking, and interactions with leading health care organizations and government agencies. ASHRM initiatives focus on developing and implementing safe and effective patient care practices, preserving financial resources, and maintaining safe working environments.