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Authored by experts with years of health care compliance experience, this new edition integrates changes in regulation, trends in enforcement, and the reasoning of the courts to help you navigate emerging and unsettled areas of compliance risk, such as self-disclosure obligations, risks associated with opioid use, and the impact of statistical sampling.Highlights of this edition include:All new glossary of health care compliance terms, including key statutes, acronyms, governing agencies, and moreExpanded civil monetary penalty and exclusion authorities under 2017 final rulesDiscussion of core elements of compliance programs for Medicare Advantage Plans and Part D Plans as established by federal regulationsExpanded whistleblower protections under federal and state law, false claims based on lack of medical necessity, materiality after Escobar, and recent enforcement activityExpanded discussion of determinations of medical necessity, CMS review of medical necessity terminations, consequences, and appeals processesRecent health information privacy and security developments, including new guidance, risks associated with innovative technologies, and trends in Health Insurance Portability and Accountability Act (HIPAA) enforcement activityNew chapters:Chapter 1, Glossary of Key TermsChapter 10, The Relationship between Enforcement and ComplianceChapter 17, Health Care Civil Rights and Nondiscrimination Under Section 1557 of the Affordable Care ActChapter 19, Behavioral Health
An immensely practical resource, Health Care Fraud and Abuse Compliance Manual provides a comprehensive overview of legislative and regulatory restrictions that affect the way health care providers conduct business and how they structure relationships among themselves. This treatise helps providers determine the boundaries of permissible conduct under the myriad statutes and regulations that relate to health care fraud and abuse at both the federal and state levels. Specific coverage includes: The statutory language in the Medicare/Medicaid civil money penalties and false claims statutes The Medicare/Medicaid antikickback statute The Stark andquot;self-referralandquot; law The numerous safe harbors and exceptions contained with these prohibitions And more! This authoritative resource will make you aware of your crucial obligations and options. Each chapter of the Health Care Fraud and Abuse Compliance Manual describes what the law requires, how it applies in a health care context, and what the penalties are for failure to comply. With Health Care Fraud and Abuse Compliance Manual: You'll receive coverage of all the critical laws and considerations, including: false claims and fraudulent billings, civil and criminal penalties, the antikickback statute, the safe harbor regulations, the Stark Law, and state statutes You'll get practical advice on developing a corporate compliance program that can help you stay on the right side of the law You'll learn about the structures, goals, and procedures of agencies that investigate health care fraud You'll get an in-depth understanding of what goes into a fraud and abuse investigation - and how you can respond to an investigation to best defend your organization And much, much more! Health Care Fraud and Abuse Compliance Manual has been updated to include: Updated nationwide health care fraud and abuse enforcement statistics OIG Work Plan for FY 12 (Medicaid projects) Enforcement actions involving billing for services of unlicensed personnel Enforcement actions involving billing without proper documentation Enforcement actions involving illegal inducements to beneficiaries Hospital liability for submission of false cost reports Cases involving maximum hospital liability for EMTALA violations Criminal false claims liability for unsolicited telemarketing by a DME supplier Managed care provider liability for cherry-picking, retaining overpayments, and other practices Hospice liability for providing services to ineligible patients Pharmaceutical manufacturer liability for pricing-related false claims violations Enforcement actions involving federal research grant fraud Criminal kickback liability for sham consulting arrangements Self-referral liability for office lease agreements and independent contractor relationships inconsistent with fair market value or not memorialized in writing Updated Medicaid Fraud Control Unit performance standards (MFCU) False claims laws of Massachusetts, Montana, and Nevada OIG evaluation of Massachusetts, Montana, and Nevada false claims laws
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 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
An indispensable resource for doctors, community hospitals, and group practices struggling to understand the law and ethical standards on interactions with pharmaceutical and device companies, this title is the first summary of the law and ethics on physician relationships with industry.
This work discusses the legal implications of the decision to withhold or withdraw medical treatment by someone other than the patient. It addresses such issues as clinical and judicial approaches to decision making, determining the decision making capacity of the patient, standards for surrogate decision makers, drafting and administering living wills and other advance directives, and other topics.
The Right to Die, Third Edition analyzes the statutory and case law
Stepped-up efforts to ferret out health care fraud have put every provider on the alert. The HHS, DOJ, state Medicaid Fraud Control Units, even the FBI is on the case -- and providers are in the hot seat! in this timely volume, you'll learn about the types of provider activities that fall under federal fraud and abuse prohibitions as defined in the Medicaid statute and Stark legislation. And you'll discover what goes into an effective corporate compliance program. With a growing number of restrictions, it's critical to know how you can and cannot conduct business and structure your relationships -- and what the consequences will be if you don't comply.
Learn how the Anti-Kickback Statute protects the healthcare system and beneficiaries from the influence of money on referral decisions.