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In the warped world of prescription drug pricing, generic drugs can cost more than branded ones, old drugs can be relaunched at astronomical prices, and low-cost options are shut out of the market. In Drugs, Money and Secret Handshakes, Robin Feldman shines a light into the dark corners of the pharmaceutical industry to expose a web of shadowy deals in which higher-priced drugs receive favorable treatment and patients are channeled toward the most expensive medicines. At the center of this web are the highly secretive middle players who establish coverage levels for patients and negotiate with drug companies. By offering lucrative payments to these middle players (as well as to doctors and hospitals), drug companies ensure that inexpensive drugs never gain traction. This system of perverse incentives has delivered the kind of exorbitant drug prices - and profits - that everyone loves except for those who pay the bills.
While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
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.
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.
Scientific and technological innovations are forcing the inadequacies of patent law into the spotlight. Robin Feldman explains why patents are causing so much trouble. She urges lawmakers to focus on crafting rules that anticipate future bargaining, not on the impossible task of assigning precise boundaries to rights when an invention is new.
The allure of science -- Internalization of science in modern law -- Externalization in modern law -- The repetitions of history -- The nature of law -- What is science? -- Misunderstanding the limits of science -- Improving the role of science in law.
"Official documents of social security, 1935-65": pages 288-294.
NEW YORK TIMES BESTSELLER • A NEW YORK TIMES NOTABLE BOOK • “A tour de force . . . a comprehensive and suitably furious guide to the political landscape of American healthcare . . . persuasive, shocking.”—The New York Times America’s Bitter Pill is Steven Brill’s acclaimed book on how the Affordable Care Act, or Obamacare, was written, how it is being implemented, and, most important, how it is changing—and failing to change—the rampant abuses in the healthcare industry. It’s a fly-on-the-wall account of the titanic fight to pass a 961-page law aimed at fixing America’s largest, most dysfunctional industry. It’s a penetrating chronicle of how the profiteering that Brill first identified in his trailblazing Time magazine cover story continues, despite Obamacare. And it is the first complete, inside account of how President Obama persevered to push through the law, but then failed to deal with the staff incompetence and turf wars that crippled its implementation. But by chance America’s Bitter Pill ends up being much more—because as Brill was completing this book, he had to undergo urgent open-heart surgery. Thus, this also becomes the story of how one patient who thinks he knows everything about healthcare “policy” rethinks it from a hospital gurney—and combines that insight with his brilliant reporting. The result: a surprising new vision of how we can fix American healthcare so that it stops draining the bank accounts of our families and our businesses, and the federal treasury. Praise for America’s Bitter Pill “An energetic, picaresque, narrative explanation of much of what has happened in the last seven years of health policy . . . [Brill] has pulled off something extraordinary.”—The New York Times Book Review “A thunderous indictment of what Brill refers to as the ‘toxicity of our profiteer-dominated healthcare system.’ ”—Los Angeles Times “A sweeping and spirited new book [that] chronicles the surprisingly juicy tale of reform.”—The Daily Beast “One of the most important books of our time.”—Walter Isaacson “Superb . . . Brill has achieved the seemingly impossible—written an exciting book about the American health system.”—The New York Review of Books
An immensely practical resource, Health Care Fraud and Abuse Compliance Manual provides a comprehensive overview of legislative and regulatory restrictions that affect the way health care providers conduct business and how they structure relationships among themselves. This treatise helps providers determine the boundaries of permissible conduct under the myriad statutes and regulations that relate to health care fraud and abuse at both the federal and state levels. Specific coverage includes: The statutory language in the Medicare/Medicaid civil money penalties and false claims statutes The Medicare/Medicaid antikickback statute The Stark andquot;self-referralandquot; law The numerous safe harbors and exceptions contained with these prohibitions And more! This authoritative resource will make you aware of your crucial obligations and options. Each chapter of the Health Care Fraud and Abuse Compliance Manual describes what the law requires, how it applies in a health care context, and what the penalties are for failure to comply. With Health Care Fraud and Abuse Compliance Manual: You'll receive coverage of all the critical laws and considerations, including: false claims and fraudulent billings, civil and criminal penalties, the antikickback statute, the safe harbor regulations, the Stark Law, and state statutes You'll get practical advice on developing a corporate compliance program that can help you stay on the right side of the law You'll learn about the structures, goals, and procedures of agencies that investigate health care fraud You'll get an in-depth understanding of what goes into a fraud and abuse investigation - and how you can respond to an investigation to best defend your organization And much, much more! Health Care Fraud and Abuse Compliance Manual has been updated to include: Updated nationwide health care fraud and abuse enforcement statistics OIG Work Plan for FY 12 (Medicaid projects) Enforcement actions involving billing for services of unlicensed personnel Enforcement actions involving billing without proper documentation Enforcement actions involving illegal inducements to beneficiaries Hospital liability for submission of false cost reports Cases involving maximum hospital liability for EMTALA violations Criminal false claims liability for unsolicited telemarketing by a DME supplier Managed care provider liability for cherry-picking, retaining overpayments, and other practices Hospice liability for providing services to ineligible patients Pharmaceutical manufacturer liability for pricing-related false claims violations Enforcement actions involving federal research grant fraud Criminal kickback liability for sham consulting arrangements Self-referral liability for office lease agreements and independent contractor relationships inconsistent with fair market value or not memorialized in writing Updated Medicaid Fraud Control Unit performance standards (MFCU) False claims laws of Massachusetts, Montana, and Nevada OIG evaluation of Massachusetts, Montana, and Nevada false claims laws