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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.

Prescription Drugs

United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment

Published: 1999

Total Pages: 138


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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.
To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.