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.
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Health Care Fraud and Abuse: Practical Perspectives, Third Edition, outlines in detail the existing fraud and abuse laws, regulations, case law, and other government activity, and offers attorneys the practical perspectives and guidance they need to protect their clients. This incomparable treatise offers seasoned counsel, as well as those new to health care law, assistance in structuring acceptable business arrangements, avoiding statutory and regulatory pitfalls, defending clients against government investigations and litigation, implementing effective corporate compliance programs, and more.
The Third Edition has been reorganized to include a separate, comprehensive chapter on the Anti-Kickback Statute, full of practical guidance. The Third Edition also includes material on: two key new OIG documents issued in 2013: the OIG Provider Self-Disclosure Protocol and the OIG Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs (both documents superseding prior guidance on these topics); multiple new settlements and other government enforcement actions and initiatives throughout the health care industry; recent Stark Law developments, including the Tuomey case, one of the few Stark Law cases to go to trial; key developments in the False Claims Act prosecution of off-label marketing cases, (e.g., the Caronia case); increasing enforcement in the Part D arena, including CMS’s concern with preferred networks and other Part D-related issues, as evidenced in multiple OIG audits, Work Plan items, CMPs and False Claims Act cases; and developments indicating potential individual liability, particularly for directors and officers of health care organizations, in areas such as anti-trust and the Foreign Corrupt Practices Act.
The 2016 Cumulative Supplement includes:
• An expanded chapter on director and officer liability that addresses the government’s increasing enforcement efforts against individuals, including the Yates Memorandum and related revisions to the US Attorneys’ Manual, as well as recent areas of potential liability related to enforcement of the Foreign Corrupt Practices Act against the directors and officers of health care and pharmaceutical companies
• Analysis of the various regulations related to the rule requiring that overpayments be returned within 60 days of identification (including the separate regulations applicable to Medicare Parts A and B and those applicable to Medicare Parts C and D)
• Assessment of the ramifications of the Supreme Court’s decision in Escobar, particularly the revised “rigorous and demanding” materiality standard to be used in False Claims Act cases
• Discussion in multiple chapters about the amendments to the Stark regulations in the 2016 Medicare Physician Fee Schedule, including several new exceptions (for timeshare arrangements and the recruitment of nonphysician practitioners) and new interpretations of certain key criteria in several existing exceptions (e.g., holdover arrangements, and the signature and written agreement requirements)
• Review of numerous new developments related to fraud and abuse in the managed care context, including CMS audits, enforcement actions and the resulting penalties; and the new Medicaid managed care regulations
• Examination of DOJ’s appointment of a Compliance Counsel and the criteria she plans to use to evaluate the effectiveness of compliance programs
• Descriptions of notable settlements with pharmaceutical companies, hospitals, nursing homes, and others including the $784.6 million Pfizer/Wyeth settlement to resolve False Claims Act allegations related to Medicaid rebates for the drug Protonix; several record-breaking Stark/FCA settlements including $115 million paid by Adventist Health System largely related to its arrangements with 240 employed physicians; and a $125 million settlement with RehabCare and its parent Kindred for causing skilled nursing facilities to submit false claims for rehabilitation therapy that was not reasonable, necessary or that never occurred;
• Updated summary charts of OIG Work Plan topics for the last four years, including eight new topics related to Medicare Parts A and B for 2016
• Discussion of new OIG materials including guidance on physician compensation, permissive exclusion and other topics
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