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High prescription drug prices are driving ever-increasing United States healthcare costs, and the federal government is following this alarming trend with ninety-five billion dollars in expenditures for prescription drugs under Medicare Part D. Even accepting arguments that high drug prices are necessary to encourage the development of safe and effective drugs, Medicare Part D is flawed in that it will pay top dollar for ineffective drugs. Because Part D lacks adequate oversight for off-label drug usage, pharmaceutical companies obtain windfall profits for drugs that have not been proven effective for off-label conditions. Permitting companies to reap such profits without incurring the costs of demonstrating efficacy creates a distorted marketplace that leads to excessive Medicare drug expenditures. In addition to the financial burden to taxpayers and the risks to Medicare patients' health, the flaws in Medicare Part D also increase the risk that non-Medicare patients will be prescribed ineffective and expensive drugs. This article proposes a theoretical reimbursement scheme that encourages fairness and restrains excessive off-label drug reimbursement by tying reimbursement rates to competitive products. Fully correcting this systemic problem will require substantial statutory, regulatory, and institutional reforms that are not immediately likely. In the interim, courts and regulators should embrace the civil False Claims Act to begin to correct the incentive problems created under the present off-label reimbursement structure, thereby immediately curbing excessive Medicare spending on prescription drugs.
The intersection of the False Claims Act with the FDA rules restricting the promotion of off-label uses of approved drugs has generated a confusing blend of public and private enforcement, primarily through settlements that provide little hard law. Many question whether this multi-billion dollar enforcement regime achieves its public policy goals. This white paper comprehensively describes how a False Claims Act case evolves, especially with regard to the relationship between the U.S. Department of Justice and the multiple interested federal and state agencies. While the traditional off-label promotion case may be waning, the white paper predicts and analyzes the next frontier of off-label enforcement - the provision of pharmacoeconomics information to pharmacy benefit managers, payers, and provider organizations. The paper draws from a thorough review of the cases, literature and numerous interviews with players in all sectors of the enforcement space, and exhaustively canvasses the challenges for all parties in reaching appropriate policy solutions. It ultimately recommends transparency, both in what is (and is not) "promotion" and in enforcement. The latter recommendations address both government sharing of information with qui tam relators when it does not assume control of a case and disclosure of the government's rationale for the remedies it seeks in negotiating settlements.
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Stepped-up efforts to ferret out health care fraud have put every provider on the alert. The HHS, DOJ, state Medicaid Fraud Control Units, even the FBI is on the case -- and providers are in the hot seat! in this timely volume, you'll learn about the types of provider activities that fall under federal fraud and abuse prohibitions as defined in the Medicaid statute and Stark legislation. And you'll discover what goes into an effective corporate compliance program. With a growing number of restrictions, it's critical to know how you can and cannot conduct business and structure your relationships -- and what the consequences will be if you don't comply.
Managing Legal Compliance in the Health Care Industry is a comprehensive text that prepares students for this increasingly critical field in health care administration. In three sections, this unique title first examines all the key laws and regulations that health care organizations must comply with. In section two, it explores in detail the seven essential ingredients for a good compliance program. In the final section, the book explains how the compliance program must be adapted to the special needs of different types of health care organizations. Designed for graduate level students in programs of public health, health administration, and law, the text is filled with highly practical information about the ways that legal violations occur and how good compliance programs function. Key Features: - Examines in detail the current laws and regulations with which all types of health care organizations must comply - Explore the seven essential ingredients for a good compliance program - Looks at compliance programs within twelve different types of health care organizations - References real world cases of fraud and abuse - Includes Study Questions and Learning Experiences in each chapter that are designed to encourage critical thinking
The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
Sixth edition of the hugely successful, internationally recognised textbook on global public health and epidemiology, with 3 volumes comprehensively covering the scope, methods, and practice of the discipline
If a competent adult refuses medical treatment, physicians and public officials must respect her decision. Coercive medical paternalism is a clear violation of the doctrine of informed consent, which protects patients' rights to make medical decisions even if a patient's choice endangers her health. The same reasons for rejecting medical paternalism in the doctor's office are also reasons to reject medical paternalism at the pharmacy, yet coercive medical paternalism persists in the form of premarket approval policies and prescription requirements for pharmaceuticals. In Pharmaceutical Freedom Jessica Flanigan defends patients' rights of self-medication. Flanigan argues that public officials should certify drugs instead of enforcing prohibitive pharmaceutical policies that disrespect people's rights to make intimate medical decisions and prevent patients from accessing potentially beneficial new therapies. This argument has revisionary implications for important and timely debates about medical paternalism, recreational drug legalization, human enhancement, prescription drug prices, physician assisted suicide, and pharmaceutical marketing. The need for reform is especially urgent as medical treatment becomes increasingly personalized and patients advocate for the right to try. The doctrine of informed consent revolutionized medicine in the twentieth century by empowering patients to make treatment decisions. Rights of self-medication are the next step.