A regional, market oriented governance for disaster management: A new planning approach.

This paper proposes a regional competitive governance and management of response and recovery from disasters. It presents problems experienced in major disasters, analyzes the failures, and suggests how a competitive system that relies on private and volunteer regional leaders, personnel, and capital can improve preparation, response and recovery efforts over the existing government system. A Public Choice approach is adopted to explain why government often fails, and how regional governance may be socially more efficient than the existing federal- state-local funded and managed disaster system. The paper suggests that the federal role might change from both funding and supplying aid in disasters to merely funding disaster recovery efforts. When a disaster occurs, available businesses and government resources in the region can be utilized under a competitive system. These resources could replace existing federal and state inventories and emergency personnel. An independent regionally controlled and managed council, which also develops its own financial resources, and local volunteer leaders are key for success. The paper suggests a new planning method that utilizes the statistical Factor Analysis methodology to derive an efficient organizational and functional model to confront disasters.

The Economics of Medicare Accountable Care Organizations.

BACKGROUND: Accountable care organizations (ACOs) have been created to improve patient care, enhance population health, and reduce costs. Medicare in particular has focused on ACOs as a primary device to improve quality and reduce costs. OBJECTIVE: To examine whether the current Medicare ACOs are likely to be successful. DISCUSSION: Patients receiving care in ACOs have little incentive to use low-cost quality providers. Furthermore, the start-up costs of ACOs for providers are high, contributing to the minimal financial success of ACOs. We review issues such as reducing readmissions, palliative care, and the difficulty in coordinating care, which are major cost drivers. There are mixed incentives facing hospital-controlled ACOs, whereas physician-controlled ACOs could play hospitals against each other to obtain high quality and cost reductions. This discussion also considers whether the current structure of ACOs is likely to be successful. CONCLUSION: The question remains whether Medicare ACOs can achieve the Triple Aim of "improving the experience of care, improving the health of populations, and reducing per capita costs of health care." Care coordination in ACOs and information technology are proving more complicated and expensive to implement than anticipated. Even if ACOs can decrease healthcare costs and increase quality, it is unclear if the current incentives system can achieve these objectives. A better public policy may be to implement a system that encompasses the best practices of successful private integrated systems rather than promoting ACOs.

The health and economic effects of counterfeit drugs.

BACKGROUND: Counterfeit drugs comprise an increasing percentage of the US drug market and even a larger percentage in less developed countries. Counterfeit drugs involve both lifesaving and lifestyle drugs. OBJECTIVE: To review the health and economic consequences of counterfeit drugs on the US public and on the healthcare system as a whole. METHOD: This comprehensive review of the literature encompassed a search of MEDLINE/PubMed, Google Scholar, and ProQuest using the keywords "counterfeit drugs," "counterfeit medicines," "fake drugs," and "fake medicines." A search of the various FiercePharma daily newsletter series on the healthcare market was also conducted. In addition, the US Food and Drug Administration and the World Health Organization websites were reviewed for additional information. DISCUSSION: The issue of counterfeit drugs has been growing in importance in the United States, with the supply of these counterfeit drugs coming from all over the world. Innovation is important to economic growth and US competitiveness in the global marketplace, and intellectual property protections provide the ability for society to prosper from innovation. Especially important in terms of innovation in healthcare are the pharmaceutical and biopharmaceutical industries. In addition to taking income from consumers and drug companies, counterfeit drugs also pose health hazards to patients, including death. The case of bevacizumab (Avastin) is presented as one recent example. Internet pharmacies, which are often the source of counterfeit drugs, often falsely portray themselves as Canadian, to enhance their consumer acceptance. Adding to the problems are drug shortages, which facilitate access for counterfeits. A long and convoluted supply chain also facilitates counterfeits. In addition, the wholesale market involving numerous firms is a convenient target for counterfeit drugs. Trafficking in counterfeits can be extremely profitable; detection of counterfeits is difficult, and the penalties are modest. CONCLUSION: Counterfeit drugs pose a public health hazard, waste consumer income, and reduce the incentive to engage in research and development and innovation. Stronger state licensure supervision of drug suppliers would be helpful. Technological approaches, such as the Radio Frequency Identification devices, should also be considered. Finally, counterfeit drugs may raise concerns among consumers about safety and reduce patient medication adherence.

The economics of biosimilars.

BACKGROUND: The high cost of pharmaceuticals, especially biologics, has become an important issue in the battle to control healthcare costs. The Hatch-Waxman Act encourages generic competition but still provides incentives for pioneers to develop new drugs. The Biologics Price Competition and Innovation Act is intended to do the same for biologics and biosimilars. OBJECTIVE: To examine information related to biosimilars to determine their potential impact on competition in the biologic market. METHOD: Using information concerning the European Union (EU) and the pharmaceutical industry, this article reviews and analyzes the experience of biosimilars in the EU, as well as the obstacles and opportunities that biosimilars face in the United States. Much of the analysis is based on examining current trends in biologic drugs and the potential implications on the future of biosimilars. DISCUSSION: This article reviews the mixed success of biosimilars in the EU and the implications for the United States. Because biologics are produced from living organisms, manufacturing issues are more important than in the chemical drug market. The barriers to biosimilar entry into the marketplace are much more difficult to overcome than challenges generic manufacturers typically face and are similar to obstacles specialty injectable producers encounter. The competitive responses by pioneers are also likely to be more important. The capital costs and risk issues with biosimilars make alliances and partnering arrangements very likely. Biosimilars often enter emerging markets, where the barriers to entry are easier to overcome. Nevertheless, the United States represents the greatest opportunity for biosimilar producers, in part because it is the largest biologics market and has high prices for biologics. As the United States enters the biosimilar market, the pharmaceutical industry is likely to grow at an accelerated pace. Automatic substitution is likely to be slow to develop, because of safety and quality concerns. The beneficial impact of biosimilars is likely to take a long time to be realized and to be fraught with more difficulties than was the case for small-molecule generics. CONCLUSION: Various factors, such as safety, pricing, manufacturing, entry barriers, physician acceptance, and marketing, will make the biosimilar market develop different from the generic market. The high cost to enter the market and the size of the biologic drug market make entry attractive but risky.

Will comparative effectiveness research finally succeed?

Autonomy, innovation, and drug access may be at stake along with personalized medicine. Can all stakeholders be satisfied and should cost be a factor?

Innovation and Competition: Will Biosimilars Succeed?: The creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. But so are efficacy and patient safety.

Biosimilars are here, but there's no clear pathway yet for their approval. Difficult realities about their effect on drug prices, innovation, and competition need to be faced.

Biosimilars and innovation: an analysis of the possibility of increased competition in biopharmaceuticals.

The USA is now developing a process for expedited approval of biosimilars. Biopharmaceuticals are far more complex and costly to develop and produce than chemical drugs. Biosimilars raise greater safety issues owing to possible immune responses, are likely to offer smaller percentage price reductions than chemical generics and will probably obtain smaller market shares. Patents may not be as strong for biopharmaceuticals, which are often made by small firms, suggesting the desirability of greater data exclusivity protection. This article suggests that it is better to err on the side of too much protection than too little, given the uncertainties involved.

Specialty hospitals: the economics and policy issues they pose.

Specialty hospitals are not a new phenomenon. From psychiatric and tuberculosis hospitals to children's and eye hospitals, they have long existed. The current interest lies in the development of single specialty hospitals for certain conditions or illness such as cardiology or orthopedics for which such hospitals were previously uncommon or non-existent. We include physician-owned surgical hospitals in our definition of single specialty hospitals. Some have claimed that these specialty hospitals (hereafter SSH) are an efficient way of producing services by concentrating them in one institution. They argue that SSHs avoid inefficiencies of scheduling and use of facilities not expressly designed for the illness or condition. Critics contend that doctors are simply trying to get the general hospital's profits and the ultimate impact will be a financial weakening of the general hospital. They argue that the cross-subsidy from these procedures and services are necessary to give general hospitals the ability to provide services to the uninsured and the poor. This debate led to a 30-month moratorium on new specialty hospitals which was lifted in August 2006. General acute care hospitals have responded by denying privileges to physicians who own or participate in competing SSHs. The appropriateness of such economic credentialing will be investigated. Further, we shall examine issues associated with Medicare pricing structures that encourage the development of SSHs as well as self-referral rules for physicians involved with SSHs. The real issue which has not been addressed is whether specialty hospitals create more value for the patient than the traditional acute care hospitals.

Biopharmaceuticals: the economic equation.

As more biopharmaceuticals reach the market, more attention will be given to issues such as cost-effectiveness evaluations, biosimilars, and price controls. The value biologic therapies bring to the healthcare system may take years to appreciate in full -perhaps only when policy decisions allow for their economic effects to be understood.

Generic biopharmaceutical drugs: an economic and policy analysis.

Encouraging both generic drug competition and pharmaceutical innovation is difficult, especially in the case of follow-on biologics. Can the U.S. nurture a system that seeks both lower drug prices now and new and improved medications in the future?

Failed hospital mergers.

The spate of hospital mergers in recent years has yielded both substantial increases in market power and many divestitures. These seemingly contradictory results stem from the pressures imposed by stakeholders of merging hospitals and the inability of those stakeholders to exert control over nonprofit institutions prior to the effectuation of a merger. This Article examines several recent mergers, analyses their failures, and recommends that the judiciary and state attorneys general look carefully at merging nonprofits so as to fill the void left by the lack of market control mechanisms.