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This essential treatise offers practitioners clear guidance on the full range of today’s e-health business and transactional law issues, focusing particularly on the ethical issues associated with the increased use of health information technology, social media, and electronic health records.
The 2014 Cumulative Supplement adds discussion of: Medicare and Medicaid reimbursement for telemedicine; HHS 2013 omnibus amendments to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules; FDA 2014 draft guidance on drug and biologic manufacturer regulatory obligations in the context of social media marketing; USPTO-promulgated guidelines for determining subject matter eligibility in view of the Supreme Court’s holdings in Mayo Collaborative Servs. v. Prometheus Labs. Inc. and Association for Molecular Pathology v. Myriad Genetics, Inc.; and more.
This treatise offers both health care law practitioners and generalists insights on existing health care fraud and abuse laws, regulations, case law and government standards. Attorneys will find guidance on structuring acceptable business arrangements, avoiding regulatory pitfalls, defending clients against government investigations and litigation, implementing effective corporate compliance programs, and more.
The 2014 Supplement covers fraud and abuse enforcement actions at the federal and state levels, new sets of rules including those from the Office of Inspector General, Part D-related developments including False Claims Act cases and settlements, Recovery Audit Program amendments, and much more.
This essential reference is written specifically for practitioners who handle managed care disputes to help them rapidly focus on key issues and expertly advise their clients. The treatise covers typical disputes, reimbursement issues, state regulations, health plan liability laws, external review laws and health insurance exchanges, and class action lawsuits and arbitration, settlement, and discovery issues.
The 2014 Supplement offers discussion of ERISA statute of limitations and ERISA prompt payment laws, the ACA and legal challenges, HHS “transitional policy”, unanswered questions after the Supreme Court’s Actavis decision, the Filed Rate Doctrine, and more.
This resource provides transactional health care attorneys the information they need to effectively advise clients on the complex health care law issues unique to the pharmaceutical industry. It examines the interaction between pharmaceutical companies and health care delivery systems, insurers, and regulators, including fraud and abuse risks. It also covers off-label marketing issues, antitrust, securities law, and other compliance violations, as well as Part D reimbursement, and more.
The 2014 Cumulative Supplement discusses the New Drug Application process, FDA’s 2013 final guidance recommending risk-based approaches to clinical investigations monitoring by trial sponsors, the Drug Quality and Security Act of 2013, Department of Justice 2013 and 2014 settlements in pharmaceutical cases, Anderson v. Peregrine Pharms., Inc., and other new developments.
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