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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HHS 2013 omnibus amendments to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules; FDA 2014 draft guidance on drug and biologic manufacturer regulatory obligations in the context of social media marketing; USPTO-promulgated guidelines for determining subject matter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 the following: 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.
An essential reference 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; class action lawsuits and arbitration, settlement, and discovery issues; and much more.
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 equips transactional health care attorneys to adequately advise clients on fraud-and-abuse risks unique to this submarket of the health care industry. It breaks down the full legal and regulatory context of: off-label marketing; antitrust, securities law, and other compliance violations; reimbursement; civil and regulatory liability under securities and antitrust laws; compliance and corporate governance issues; 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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