The Physician Payments Sunshine Act is a 2010 United States healthcare law to increase transparency of financial relationships between health care providers and pharmaceutical or medical device manufacturers.
The Sunshine Act requires manufacturers of drugs, medical devices, biological and medical supplies covered by the three federal health care programs Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) to collect and track all financial relationships with physicians and teaching hospitals and to report these data to the Centers for Medicare and Medicaid Services (CMS). The goal of the law is to increase the transparency of financial relationships between health care providers and pharmaceutical manufacturers and to uncover potential conflicts of interest. [1] The bill allows states to enact "additional requirements", as six states already had industry-pay disclosure laws. [2]
In 2013, the American Medical Association offered physicians training to understand the Sunshine Act. [3]
A recent 2024 analysis suggests nearly 60% of experts who reviewed manuscripts for four major medical journals received at least one payment from the industry over a recent three-year period, with a total exceeding $1 billion. [4] From 2020 to 2022, 1,155 of the 1,962 reviewers for The BMJ , JAMA , The Lancet , and The New England Journal of Medicine received payments. [5] More than half of these reviewers—1,060—accepted general payments for activities like travel, speaking, consulting, and meals, while 623 reviewers (32%) received research-related payments. Of the $1.06 billion in total payments, $1 billion went towards research, including payments to individual physicians and institutions where reviewers served as principal investigators in clinical studies.
The Sunshine Act was first introduced in 2007 by senior US Senator Charles Grassley, a Republican from Iowa and Senator Herb Kohl from Wisconsin, a member of the Democratic Party. [6] The act was introduced independently and failed. After debate by various groups [2] it was enacted along with the 2010 Patient Protection and Affordable Care Act.[ citation needed ]
In 2011, it was proposed to use identification systems on tracked physicians. [7]
On September 30, 2014, the Centers for Medicare and Medicaid Services reported payment information on its Open Payment Program website for the first time, the data from 2012. [8]
In 2012 it was suggested that the act may have a limited effect on prescribing and on expenditures. [9]
A 2015 opinion piece in JAMA stated that the value of transparency was beyond dispute, but "the true value of the database remains uncertain and probably too early to ascertain". [10]
There is no agreement on appropriate standards of disclosure internationally. [11]
Australia was one of the first countries that has, since mid-2007, required reporting of details of every industry-sponsored event. Data are publicly posted, updated every six months and downloadable as pdf only. A 2009 study found modest expenditure at individual events, but high cumulatively, particularly for prescribers of high cost drugs like oncologists, endocrinologists, and cardiologists. It concluded disclosure requirements fell short of what is required and proposed more comprehensive data collections. [11]
In The Netherlands the Transparantieregister Zorg was founded in 2013, that requires full disclosure of payments above 500 euro from pharmaceutical companies and manufacturers of medical devices to healthcare workers, patient organizations et cetera. The effectiveness of this register will be evaluated in 2019.
Resource-based relative value scale (RBRVS) is a schema used to determine how much money medical providers should be paid. It is partially used by Medicare in the United States and by nearly all health maintenance organizations (HMOs).
Prescription drug list prices in the United States continually are among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the American health care reform debate of 2009, and received renewed attention in 2015. One major reason for high prescription drug prices in the United States relative to other countries is the inability of government-granted monopolies in the American health care sector to use their bargaining power to negotiate lower prices, and the American payer ends up subsidizing the world's R&D spending on drugs.
Pharmaceutical marketing is a branch of marketing science and practice focused on the communication, differential positioning and commercialization of pharmaceutical products, like specialist drugs, biotech drugs and over-the-counter drugs. By extension, this definition is sometimes also used for marketing practices applied to nutraceuticals and medical devices.
Dual-eligible beneficiaries refers to those qualifying for both Medicare and Medicaid benefits. In the United States, approximately 9.2 million people are eligible for "dual" status. Dual-eligibles make up 14% of Medicaid enrollment, yet they are responsible for approximately 36% of Medicaid expenditures. Similarly, duals total 20% of Medicare enrollment, and spend 31% of Medicare dollars. Dual-eligibles are often in poorer health and require more care compared with other Medicare and Medicaid beneficiaries.
Medical research, also known as health research, refers to the process of using scientific methods with the aim to produce knowledge about human diseases, the prevention and treatment of illness, and the promotion of health.
Medicare Part D, also called the Medicare prescription drug benefit, is an optional United States federal-government program to help Medicare beneficiaries pay for self-administered prescription drugs. Part D was enacted as part of the Medicare Modernization Act of 2003 and went into effect on January 1, 2006. Under the program, drug benefits are provided by private insurance plans that receive premiums from both enrollees and the government. Part D plans typically pay most of the cost for prescriptions filled by their enrollees. However, plans are later reimbursed for much of this cost through rebates paid by manufacturers and pharmacies.
Fee-for-service (FFS) is a payment model where services are unbundled and paid for separately.
Patient safety is a discipline that emphasizes safety in health care through the prevention, reduction, reporting and analysis of error and other types of unnecessary harm that often lead to adverse patient events. The magnitude of avoidable adverse events, often known as patient safety incidents, experienced by patients was not well known until the 1990s, when multiple countries reported significant numbers of patients harmed and killed by medical errors. After recognizing that healthcare errors impact 1 in every 10 patients around the world, the World Health Organization (WHO) calls patient safety an endemic concern. Indeed, patient safety has emerged as a distinct healthcare discipline supported by an immature yet developing scientific framework. There is a significant transdisciplinary body of theoretical and research literature that informs the science of patient safety with mobile health apps being a growing area of research.
Medication costs, also known as drug costs are a common health care cost for many people and health care systems. Prescription costs are the costs to the end consumer. Medication costs are influenced by multiple factors such as patents, stakeholder influence, and marketing expenses. A number of countries including Canada, parts of Europe, and Brazil use external reference pricing as a means to compare drug prices and to determine a base price for a particular medication. Other countries use pharmacoeconomics, which looks at the cost/benefit of a product in terms of quality of life, alternative treatments, and cost reduction or avoidance in other parts of the health care system. Structures like the UK's National Institute for Health and Clinical Excellence and to a lesser extent Canada's Common Drug Review evaluate products in this way.
Aggregate Spend is the process used in the United States to aggregate and monitor the total amount spent by healthcare manufacturers on individual healthcare professionals and organizations (HCP/O) through payments, gifts, honoraria, travel and other means. Also often referred to as the Physician Payments Sunshine Act, this initiative is a growing body of federal and state legislations intended to collectively address all or some of the following goals:
In the United States, healthcare is largely provided by private sector healthcare facilities, and paid for by a combination of public programs, private insurance, and out-of-pocket payments. The U.S. is the only developed country without a system of universal healthcare, and a significant proportion of its population lacks health insurance. The United States spends more on healthcare than any other country, both in absolute terms and as a percentage of GDP; however, this expenditure does not necessarily translate into better overall health outcomes compared to other developed nations. Coverage varies widely across the population, with certain groups, such as the elderly and low-income individuals, receiving more comprehensive care through government programs such as Medicaid and Medicare.
Funding bias, also known as sponsorship bias, funding outcome bias, funding publication bias, and funding effect, refers to the tendency of a scientific study to support the interests of the study's financial sponsor. This phenomenon is recognized sufficiently that researchers undertake studies to examine bias in past published studies. Funding bias has been associated, in particular, with research into chemical toxicity, tobacco, and pharmaceutical drugs. It is an instance of experimenter's bias.
Unnecessary health care is health care provided with a higher volume or cost than is appropriate. In the United States, where health care costs are the highest as a percentage of GDP, overuse was the predominant factor in its expense, accounting for about a third of its health care spending in 2012.
Pharmaceutical fraud is when pharmaceutical companies engage in illegal, fraudulent activities to the detriment of patients and/or insurers. Examples include counterfeit drugs that do not contain the active ingredient, false claims in packaging and marketing, suppression of negative information regarding the efficacy or safety of the drug, and violating pricing regulations.
Peter B. Bach is a physician and writer in New York City. He is the Chief Medical Officer of DELFI Diagnostics and was previously an attending and researcher at Memorial Sloan-Kettering Cancer Center where he was the Director of the Center for Health Policy and Outcomes. His research focuses on healthcare policy, particularly as it relates to Medicare, racial disparities in cancer care quality, and lung cancer. Along with his scientific writings he is a frequent contributor to The New York Times and other newspapers.
Conflict of interest in the health care industry occurs when the primary goal of protecting and increasing the health of patients comes into conflict with any other secondary goal, especially personal gain to healthcare professionals, and increasing revenue to a healthcare organization from selling health care products and services. The public and private sectors of the medical-industrial complex have various conflicts of interest which are specific to these entities.
Conflicts of interest (COIs) often arise in academic publishing. Such conflicts may cause wrongdoing and make it more likely. Ethical standards in academic publishing exist to avoid and deal with conflicts of interest, and the field continues to develop new standards. Standards vary between journals and are unevenly applied. According to the International Committee of Medical Journal Editors, "[a]uthors have a responsibility to evaluate the integrity, history, practices and reputation of the journals to which they submit manuscripts".
Yuting Zhang is a professor of health economics at the University of Melbourne, and an expert on economic evaluations of health policy and healthcare reforms. She is a journal editor, award recipient, and has written numerous articles in influential journals in her field.
Scott E. Hadland is a Canadian-American physician and scientist who serves as a pediatrician, and addiction specialist at Massachusetts General Hospital and Harvard Medical School, where he is the Chief of the Division of Adolescent and Young Adult Medicine. He previously served as an addiction specialist at the Grayken Center for Addiction at Boston Medical Center.
Kevin G. Volpp is an American behavioral economist and Mark V. Pauly President's Distinguished Professor at the University of Pennsylvania’s Perelman School of Medicine and the Wharton School. He is the Director of the Penn Center for Health Incentives & Behavioral Economics (CHIBE).
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