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Hemoglobin levels and the dose of erythropoiesis-stimulating agents (ESAs) have risen over time in hemodialysis patients within the United States. There are concerns that these trends may be driven by reimbursement policies that provide potential incentives to increase this use. To determine this we studied trends in the use of ESA and hemoglobin levels in hemodialysis patients and the relationship of these trends to the mode of reimbursement. Using the Dialysis Outcomes and Practice Patterns Study (DOPPS) database of hemodialysis we analyzed facility practices in over 300 randomly selected dialysis units in 12 countries. At each of three phases (years 1996–2001, 2002–2004, and 2005–present), we randomly selected over 7500 prevalent hemodialysis, hemofiltration, or hemodiafiltration patients. ESA usage rose significantly in every country studied except Belgium. All but Sweden demonstrated a substantial increase in hemoglobin levels. In 2005 more than 40% of patients had hemoglobin levels above the KDOQI upper target limit of 120g/l in all but Japan. These trends appeared to be independent of the manner of reimbursement even though the United States is the only country with significant financial incentives promoting increased use of these agents. Thus, our study found that prescribing higher doses of ESAs and achieving higher hemoglobin levels by physicians reflects a broad trend across DOPPS countries regardless of the reimbursement policies.

Safety-net hospitals provide essential care to patients regardless of their insurance coverage, financial circumstances, or immigration status, and they often operate with thin margins. But the lack of a clear definition for safety-net hospitals presents challenges.

This report marks the fifth anniversary of the Affordable Care Act. The authors discuss the ACA's effects on health care access, quality, and cost resulting from the law's expansion of health insurance coverage and reforms of the U.S. health care delivery system. Just over 5 years ago, on March 23, 2010, President Barack Obama signed the Affordable Care Act (ACA) into law. Its enactment may constitute the most important event of the Obama presidency and could fundamentally affect the future of health care in the United States. From a historical perspective, 5 years is a very short time, far too short to assess definitively the effects of the ACA. Still, the 5-year mark seems to be a logical point to pause and take stock of how the ACA has fared to date — to review what we know now of its effect . . .

For a substantial minority of older adults, a stay in a post-acute care facility is the gateway into a cycle between the hospital and the nursing home that spans the final months of life. Certain Medicare and Medicaid policies perpetuate this cycle.

Somatic gene editing (SGE) holds great promise for making genetic therapy possible for many monogenic conditions very soon. Is our current system of European market authorization and reimbursement ready for the expected tsunami of gene therapies? At a recent workshop of the Netherlands ZonMw consortium on ethical, legal, and social implications of personalized medicine, we discussed the current possibilities for bringing new gene therapies to the clinic. In Europe, it is not yet clear whether the route via the European medicines agency as an advanced therapy medicinal product is the most appropriate for evaluation of highly personalized SGE applications, although this may optimally guarantee safety and effectiveness. Compassionate use may ensure faster access than the centralized procedure but does not stimulate the commercial development of products. Prescription to named patients may only provide adequate access for single patients. Temporary authorization of use may allow access to medication half a year before formal market authorization has been granted, but may also have large budget impacts. Magistral compounding under a hospital exemption may be an attractive solution for rare, tailor-made applications at an acceptable price. To approve local experimental use of a therapy on a case-by-case basis may be fast, but does not guarantee optimal safety, effectiveness, and broad implementation. We argue that alternative routes should be considered for products developed for a market of large groups of patients versus unique personalized treatments. A balance between scientific evidence for safety and effectiveness, affordability, and fast access may demand a range of alternative solutions.

The Patient-Centered Outcomes Research Institute . . . shall not develop or employ a dollars per quality adjusted life year (or similar measure that discounts the value of a life because of an individual's disability) as a threshold to establish what type of health care is cost effective or recommended. The Secretary shall not utilize such an adjusted life year (or such a similar measure) as a threshold to determine coverage, reimbursement, or incentive programs under title XVIII. — The Patient Protection and Affordable Care Act 1 In 1996, after 2 years of deliberation, the U.S. Panel on Cost-Effectiveness in Health and Medicine, . . .

CMS is considering whether and under what circumstances Medicare will pay for aducanumab for Alzheimer’s disease. A restrictive coverage determination could save the federal government money, but it would also shift substantial costs to states.

The Patient Protection and Affordable Care Act (the ACA, for short) became law with President Obama’s signature on March 23, 2010. It represents the most significant transformation of the American health care system since Medicare and Medicaid. It is argued that it will fundamentally change nearly every aspect of health care, from insurance to the final delivery of care. The length and complexity of the legislation and divisive and heated debates have led to massive confusion about the impact of ACA. It also became one of the centerpieces of 2010 congressional campaigns. Essentials of ACA include: 1) a mandate for individuals and businesses requiring as a matter of law that nearly every American have an approved level of health insurance or pay a penalty; 2) a system of federal subsidies to completely or partially pay for the now required health insurance for about 34 million Americans who are currently uninsured – subsidized through Medicaid and exchanges; 3) extensive new requirements on the health insurance industry; and 4) numerous regulations on the practice of medicine. The act is divided into 10 titles. It contains provisions that went into effect starting on June 21, 2010, with the majority of provisions going into effect in 2014 and later. The perceived major impact on practicing physicians in the ACA is related to growing regulatory authority with the Independent Payment Advisory Board (IPAB) and the Patient Centered Outcomes Research Institute (PCORI). In addition to these specifics is a growth of the regulatory regime in association with further discounts in physician reimbursement. With regards to cost controls and projections, many believe that the ACA does not fix the finances of our health care system – neither public nor private. It has been suggested that the Congressional Budget Office (CBO) and the administration have used creative accounting to arrive at an alleged deficit reduction; however, if everything is included appropriately and accounted for, we will be facing a significant increase in deficits rather than a reduction. When posed as a global question, polls suggest that public opinion continues to be against the health insurance reform. The newly elected Republican congress is poised to pass a bill aimed at repealing health care reform. However, advocates of the repeal of health care reform have been criticized for not providing a meaningful alternative approach. Those criticisms make clear that it is not sufficient to provide vague arguments against the ACA without addressing core issues embedded in health care reform. It is the opinion of the authors that while some parts of the ACA may be reformed, it is unlikely to be repealed. Indeed, the ACA already is growing roots. Consequently, it will be extremely difficult to repeal. In this manuscript, we look at reducing the regulatory burden on the public and providers and elimination of IPAB and PCORI. The major solution lies in controlling the drug and durable medical supply costs with appropriate negotiating capacity for Medicare, and consequently for other insurers. Key words: Affordable Care Act, health care costs, health care regulation, health care reform, Patient Centered Outcomes Research Institute, health exchanges, health care subsidies, health insurance premiums, uninsured, Medicare, cost control

With the Merit-Based Incentive Payment System, Medicare shifts from payment based on macroeconomic indicators to relying on physician- or group-level indicators of cost and quality — and could create a large fee differential between high- and low-performing physicians. The “doc fix” — a permanent replacement for the unworkable sustainable growth rate formula (SGR) enacted in 1997 for calculating Medicare's physician fees — had been a long time coming when it emerged from Congress this past spring. The law that did away with the SGR was an elegant compromise from a political point of view, crafted to end the tyranny of annual delays in physician-payment reductions but also to balance the need for public accountability against the profession's interest in implementing a reasonable and predictable payment system. 1 At the heart of the legislation is the new Merit-Based Incentive Payment . . .

This Health Policy Report describes major reforms to physician payment that are under way in the United States as a result of the Affordable Care Act and the Medicare Access and CHIP Reauthorization ACT of 2015.