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Book Pharmaceutical and Medical Device Compliance Manual

Download or read book Pharmaceutical and Medical Device Compliance Manual written by Ela Bochenek and published by . This book was released on 2019 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Book AHLA Healthcare Compliance Legal Issues Manual  Non Members

Download or read book AHLA Healthcare Compliance Legal Issues Manual Non Members written by and published by . This book was released on 2016 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: As the world of health care compliance continues to evolve, so do the potential ramifications for everyone in the healthcare arena. State and federal governmental agencies continue to pursue large recoveries through litigation and settlements against those who don't have effective compliance plans. In fact, the Federal Government announced it had recovered over $4 billion from healthcare providers for Medicare and Medicaid fraud in 2010 alone.This new edition of Health Care Compliance Legal Issues Manual provides a comprehensive overview of the legal issues that create the foundation for healthcare compliance programs, and affect every aspect of these programs. The Manual addresses important topics such as what a compliance program is, how to conduct internal investigations, audit basics, what to consider prior to deciding on repayments and disclosures, substantive overviews of the false claims act, the Stark and Anti-kickback laws, HIPAA privacy and security, issues in life sciences entities, tax compliance, and many othersHighlights of this new edition include:A discussion of the Sunshine Act's reporting requirements for drug and device companiesHHS' Healthy People 2020 initiativeAnalysis of the fraud and abuse provisions in the Patient Protection and Affordable Care Act (ACA)Compliance program requirements for all providers and suppliers as a condition of enrollment in MedicareChanges to the Federal Sentencing GuidelinesNew HIPAA security and privacy enforcement measuresSarbanes-Oxley compliance standards

Book AHLA Health Care Compliance Legal Issues Manual  Non members

Download or read book AHLA Health Care Compliance Legal Issues Manual Non members written by American Health Lawyers Association and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Book Fundamentals of Health Law

Download or read book Fundamentals of Health Law written by Barry D. Alexander and published by . This book was released on 2011-01-01 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: This specialized and complex field of health law requires a thorough grounding in the basics, and Fundamentals of Health Law, 5th Edition, provides that grounding like no other book on the market does. This new edition has been thoroughly revised and made current to cover the basic issues of health law practice, from patient to facility issues, from permits and regulation issues to compliance and investigation issues, and includes issues raised by new laws, regulations and guidelines promulgated since the fourth edition in 2008, including the Affordable Care Act (ACA). This publication covers fundamental legal principles and issues to assist: * New Practitioners or experienced attorneys entering their first years of health-law practice; * Professors of health law searching for a comprehensive text for their students; and * Users of any law library looking for answers on the health law resource shelf.

Book Health Care Transactions Manual

Download or read book Health Care Transactions Manual written by Kim Harvey Looney and published by . This book was released on 2020 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book The Law of Digital Health

Download or read book The Law of Digital Health written by Bernadette M. Broccolo and published by . This book was released on 2018 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book AHLA Representing Physicians Handbook  AHLA Members

Download or read book AHLA Representing Physicians Handbook AHLA Members written by and published by . This book was released on 2016 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The American Health Lawyers Association is pleased to bring you the Fourth Edition of our best selling Representing Physicians Handbook.Since the Third Edition was published, there has been continued expansion of the healthcare laws and regulations applicable to physicians. This updated edition of the Handbook addresses the issues that confront those who represent physicians in the increasingly complex physician practice world. The authors have provided their expertise to provide insight and guidance on issues of compliance, business, reimbursement, and many other issues.The eBook versions of this title feature links to Lexis Advance for further legal research options.

Book Antitrust and Health Care

Download or read book Antitrust and Health Care written by Christine L. White (Lawyer) and published by . This book was released on 2017 with total page 750 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book AHLA Healthcare Compliance Legal Issues Manual  AHLA Members

Download or read book AHLA Healthcare Compliance Legal Issues Manual AHLA Members written by and published by . This book was released on 2016 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: As the world of health care compliance continues to evolve, so do the potential ramifications for everyone in the healthcare arena. State and federal governmental agencies continue to pursue large recoveries through litigation and settlements against those who don't have effective compliance plans. In fact, the Federal Government announced it had recovered over $4 billion from healthcare providers for Medicare and Medicaid fraud in 2010 alone.This new edition of Health Care Compliance Legal Issues Manual provides a comprehensive overview of the legal issues that create the foundation for healthcare compliance programs, and affect every aspect of these programs. The Manual addresses important topics such as what a compliance program is, how to conduct internal investigations, audit basics, what to consider prior to deciding on repayments and disclosures, substantive overviews of the false claims act, the Stark and Anti-kickback laws, HIPAA privacy and security, issues in life sciences entities, tax compliance, and many othersHighlights of this new edition include:A discussion of the Sunshine Act's reporting requirements for drug and device companiesHHS' Healthy People 2020 initiativeAnalysis of the fraud and abuse provisions in the Patient Protection and Affordable Care Act (ACA)Compliance program requirements for all providers and suppliers as a condition of enrollment in MedicareChanges to the Federal Sentencing GuidelinesNew HIPAA security and privacy enforcement measuresSarbanes-Oxley compliance standards

Book Fraud and Abuse Investigations Handbook for the Health Care Industry

Download or read book Fraud and Abuse Investigations Handbook for the Health Care Industry written by Paul W. Shaw and published by . This book was released on 2021 with total page 775 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Book Telehealth Law Handbook

Download or read book Telehealth Law Handbook written by Jennifer R. Breuer and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Vaccine  Vaccination  and Immunization Law

Download or read book Vaccine Vaccination and Immunization Law written by Brian Dean Abramson and published by . This book was released on 2021 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book The Health Care Compliance Professional s Manual

Download or read book The Health Care Compliance Professional s Manual written by Hcca and published by Aspen Publishers. This book was released on 2007 with total page 1080 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Book Risk Management Handbook for Health Care Organizations

Download or read book Risk Management Handbook for Health Care Organizations written by American Society for Healthcare Risk Management (ASHRM) and published by John Wiley & Sons. This book was released on 2009-04-27 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Book The Cambridge Handbook of the Law of the Sharing Economy

Download or read book The Cambridge Handbook of the Law of the Sharing Economy written by Nestor M. Davidson and published by Cambridge University Press. This book was released on 2018-11-22 with total page 952 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Handbook grapples conceptually and practically with what the sharing economy - which includes entities ranging from large for-profit firms like Airbnb, Uber, Lyft, Taskrabbit, and Upwork to smaller, non-profit collaborative initiatives - means for law, and how law, in turn, is shaping critical aspects of the sharing economy. Featuring a diverse set of contributors from many academic disciplines and countries, the book compiles the most important, up-to-date research on the regulation of the sharing economy. The first part surveys the nature of the sharing economy, explores the central challenge of balancing innovation and regulatory concerns, and examines the institutions confronting these regulatory challenges, and the second part turns to a series of specific regulatory domains, including labor and employment law, consumer protection, tax, and civil rights. This groundbreaking work should be read by anyone interested in the dynamic relationship between law and the sharing economy.

Book Pharmaceuticals  Corporate Crime and Public Health

Download or read book Pharmaceuticals Corporate Crime and Public Health written by Graham Dukes and published by Edward Elgar Publishing. This book was released on 2014-06-27 with total page 419 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the pr

Book Health Care Antitrust

    Book Details:
  • Author : Aspen Health Law Center
  • Publisher : Jones & Bartlett Learning
  • Release : 1998
  • ISBN : 9780834212275
  • Pages : 158 pages

Download or read book Health Care Antitrust written by Aspen Health Law Center and published by Jones & Bartlett Learning. This book was released on 1998 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: Antitrust laws touch upon a wide range of conduct and business relationships in the delivery of health care services, and the issues that should be of concern to health care organizations are described. Health Care Antitrust provides practical overviews of the principal legal issues relating to health care antitrust, as well as a general understanding of antitrust analysis as applied to contractual relationships and business strategies that present antitrust risks in a managed care environment.