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Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget
Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget
Seattle University Law Review
Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …
Medicare's Prospective Payment System At Age Eight: Mature Success Or Midlife Crisis?, Bruce C. Vladeck
Medicare's Prospective Payment System At Age Eight: Mature Success Or Midlife Crisis?, Bruce C. Vladeck
Seattle University Law Review
This Article is necessarily a rather selective (for reasons of brevity and reader tolerance) and even subjective attempt to summarize the experience under PPS to date and to suggest some lessons that might be drawn from that experience for the future reform of PPS itself and of payment systems generally. No attempt will be made here to be comprehensive, to explain all the technical details of an inherently and increasingly complex system, nor even to systematically survey the rapidly growing body of literature. But the few issues and themes that clearly stand out will be the focus of most of …
Policing Cost Containment: The Medicare Peer Review Organization Program, Timothy Stoltzfus Jost
Policing Cost Containment: The Medicare Peer Review Organization Program, Timothy Stoltzfus Jost
Seattle University Law Review
This Article will first examine the problem of health care cost inflation and the payment strategies the Medicare program has adopted to address that problem. It will then discuss the perverse incentives that these payment strategies create, and the role of the PRO program in addressing harmful provider behavior encouraged by those perverse incentives. The Article examines evidence on whether the PRO program is succeeding or failing in this mission, and suggests possible means of improving the effectiveness of the PRO program in policing cost containment. Specifically, it recommends clarifying and strengthening the deterrent role of the PROs, crafting PRO …