Federal Reimbursement Policies Research Articles

Biosimilars in the USA: Will New Efforts to Spur Approvals and Access Spur Uptake and Cost Savings?

Unlike in Europe, US healthcare systems and payers are still awaiting significant savings related to biosimilar utilization. Costs related to biologic use continue to rise at double-digit rates, and biosimilars are seen as a major tool to control costs and increase access to biologic drugs. However, one 2018 report indicated that US$3.2 billion (only 3%) of biologic spending is subject to competition from biosimilar products. Although the European Medicines Agency did a great deal of pioneering work in biosimilar regulation, the US Food and Drug Administration is moving at approximately the same pace as the European Medicines Agency, based on the number of approvals at the same time after implementation of its regulatory pathway. Several unique factors in the USA have conspired to limit biosimilar access (e.g. delayed regulatory policies, extended patent litigation activities, federal reimbursement policies, the widespread use of rebate contracting, and limited competition). The US Federal Government is taking the initiative in an attempt to address these factors, and speed both biosimilar development and patient access. To date, the most significant cost savings in the US system associated with the introduction of biosimilars may be their ability to halt price increases of the reference product. The complexity of the healthcare delivery system, and how it is financed, will remain challenging to payers, manufacturers, health providers and patients as they seek ways to manage health expenditure growth.

Telemedicine Applications in Obstetrics and Gynecology.

This article reviews principles to consider when setting up a telemedicine (TM) program to provide care to women in the field of obstetrics and gynecology. There are different types of TM encounters and clinical applications vary widely. The consensus among patients and providers is that TM is convenient to provide needed subspecialty medical care when it is not available locally. These programs are clinically successful, but economic and cost-effectiveness data are lacking. Federal reimbursement policy is limited for TM. State policy on coverage and reimbursement varies significantly from state to state and is the main driver on whether TM programs are successful.

Policy Diffusion across Disparate Disciplines: Private- and Public-Sector Dynamics Affecting State-Level Adoption of the ACA.

The ACA entails a number of provisions that are profoundly changing the way the states ensure access to medical care, including the expansion of Medicaid and the maintenance of health insurance exchanges. Here, we argue that while federal policy is the originating force of whether these provisions are adopted, individual state decisions are made within a larger ecosystem. This ecosystem has two main components: (1) complementary and competing state and federal policies; and (2) medical provision by a variety of suppliers. Specifically, the merits, costs, and uncertainties associated with adopting these provisions cannot be considered by the states in a vacuum-they may interact with a large set of simultaneously launched or existing local, state, and federal policies aimed at ensuring access to medical care. They may also interact with specific state and federal reimbursement policies and other requirements facing local hospitals and medical providers. We illustrate by example how these interactions may have important implications for the diffusion of ACA provisions. One implication of this perspective is that future empirical work on the rate, determinants, and impacts of ACA coverage expansions on individual and aggregate well-being must incorporate systematic study of this complex public-private sector ecosystem.

Report Urges Addressing Barriers to Reimbursement for Mental Health Care

STATE AND FEDERAL REIMBURSEment policies create barriers that prevent many primary care physicians from offering screening and intervention for mental disorders, despite growing evidence suggesting such efforts by frontline clinicians may reduce the burden of mental illness in the United States, according to a recent report by the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Health Resources and Services Administration (HRSA). The report provides an overview of the challenges physicians face in trying to bill for mental health services and recommends steps that federal and state agencies can take to make the process easier (http://download.ncadi.samhsa.gov/ken /pdf/SMA08-4324/SMA08-4324.pdf). The Centers for Medicare & Medicaid Services provided technical guidance to the group that drafted the report. Physician organizations applaud the report’s call to overcome barriers to compensation for mental health services and its emphasis on providing incentives for offering evidence-based care. Some caution, however, that the recommendations will do little to alleviate reimbursement problems stemming from an underfunded system, and that they will do nothing to improve reimbursement for mental health specialists, who, like primary care clinicians, also face substantial barriers to being paid for providing care.

Economic impact on physicians and hospitals of proposed changes in Medicare reimbursement for coronary interventions

Background The federal government is implementing changes in reimbursement for angioplasty and coronary stenting. These include reductions in physician reimbursement and a redesignation of intracoronary stents to a different diagnosis-related group than other methods of intracoronary intervention. Objective The aim of this study was to examine the financial impact on physicians and hospitals of proposed federal reimbursement policies for percutaneous coronary revascularization procedures. Methods We modeled the financial effects of 3 different stenting strategies: strategy I is the most conservative, with stents reserved for addressing lab complications; strategy II stents are used for suboptimal results after attempts at conventional percutaneous transluminal coronary angioplasty (PTCA); strategy III is the most aggressive, with initial stenting of all accessible lesions. We used economic data on PTCA and stent costs from a 1996 dataset and made assumptions about PTCA and stent success rates and restenosis rates based on published data. Results Under current reimbursement policies, physician revenues and profits are approximately equal under all 3 stenting strategies. After the proposed changes, there is a slight financial incentive for physicians to pursue the more aggressive strategy III, but the major financial effect is a substantial overall decline in revenues with any of the 3 strategies. For hospitals, the present situation strongly favors the more conservative strategies, but after the proposed changes the more aggressive stenting strategies will be more profitable, thus realigning physician and hospital incentives. Health care delivery organizations that combine physician and hospital income streams achieve the greatest financial stability. Conclusions Current reimbursement policies for angioplasty and stenting have created misaligned incentives between physicians and hospitals. Proposed changes do not present physicians with large economic incentives to pursue aggressive versus conservative stent strategies but substantially address the current disparity in hospital financial incentives. (Am Heart J 1999;137:258-63.)

The impact of foundation-funded commissions on health policy.

National task forces, commissions, and other ad hoc advisory bodies-both public and pr ivate-have been a prominent feature of the American political landscape since the turn of the century. However, studies of their impact on public policy are relatively recent and have focused primarily on presidential commissions. Privately sponsored bodies have received considerably less attention. This essay reports on a study we conducted with the support of The Commonwealth Fund to learn more about the impact of foundation-funded commissions on national health policy decisions. The study had two main objectives: (1) to assess the policy impact of one of Commonwealth’s own recent commissions (the Task Force on Academic Health Centers), and (2) to extrapolate from the specific experiences of the task force and a small comparison group of commissions some practical lessons about the composition, conduct, and impact of such bodies. Because the sponsorship and funding of commissions is but one way foundations seek to influence public policy, our study cannot settle broader arguments about the policy role of foundations. It can, however, provide useful information for foundations and other sponsors about the design and management of ad hoc advisory bodies. Study methods. We defined foundation-funded commission as (1) an ad hoc, task-oriented advisory body, (2) sponsored (that is, established) by a foundation or other private institution or organization, and (3) funded by one or more foundations to deliberate and formulate recommendations on an issue of public policy. We excluded from this definition all governmental commissions (for example, all ad hoc advisory bodies established by executive or legislative mandate or regulation), even

Federal Legislative Impact on Emergency Medicine Practice

The specialty of emergency medicine has grown rapidly, partially as a result of federal programs providing insurance coverage for large numbers of formerly uninsured individuals. The specialty grew and flourished as a response to improving economic circumstances. Today, however, changes in federal reimbursement policies threaten the future viability of emergency medicine.

Quality assurance in changing times: proposals for reform and research in the clinical laboratory field.

The U.S. Department of Health and Human Services recently commissioned a comprehensive analysis of the effectiveness and appropriateness of federal clinical regulations. The analysis found that many federal regulations are technically obsolescent and many may be operationally unnecessary as a result of changing laboratory technology and changed federal reimbursement policies. Among changes recommended by the HHS-funded analysis are: the regulatory classification system based upon physical location of laboratories is no longer appropriate and should be replaced with a classification system reflecting laboratory functions; a single, uniform set of federal regulations should be developed that covers all civilian laboratories receiving federal reimbursement or operating in interstate commerce; a revised federal regulatory system should emphasize measures of performance such as personnel and inspection requirements; and clinical laboratory regulations should be based upon objective data to the maximum extent possible.

The diffusion of the computed tomography (CT) scanner in the United States.

The rising cost of medical care in the United States is a problem generally familiar to all interested in health care policy. In recent years the contribution of technology to this rising cost has been debated. The computed tomography (CT) scanner has come to exemplify the problem of "technology run wild." The scanner was introduced into the United States in 1973 and has diffused rapidly into virtually every area of the country. However, despite the large number of scanners, they are mal-distributed by institutional setting and geographic location. A number of Federal policies have been developed to deal with medical technology. The case of the CT scanner illustrates the failure of these policies. The CT scanner was not well evaluated before it diffused into practice, and it appears that Federal reimbursement policy facilitated its spread. Federal policies designed to slow diffusion or to assure optimal placement or wise use of scanners have not had demonstrable effects. The case of the CT scanner suggests the need to alter Federal policies toward medical technologies.

Federal Reimbursement Policy for Water Resources and other Programs

Differences in reimbursement requirements among federal programs encourage unwise investment decisions by creating incentives for uneconomical design of individual programs, uneconomical use of existing facilities, uneconomical allocation of budgetary resources among program areas, and uneconomical allocation of national resources to the public sector. In addition, these differing federal subsidies have a tendency to increase the disparity among income groups. Comparison of actual and optimal reimbursement rules for water resource programs indicates that federal reimbursement policy has encouraged overinvestment in these programs and the selection of nonoptimal techniques of production. Analysis of the equity impact of federal cost-sharing policies suggests that subsidies for many federal programs have had an unfavorable effect on the distribution of income.