Governing Commercial Access to Health Data for Public Benefit: Charity Law Solutions.

There is a growing body of evidence that supports the view that research participants and the public are concerned about commercial access to health data. Evidence also suggests that attitudes are ameliorated when charity organisations are involved and where research promises to deliver 'public benefit'. To a significant extent, therefore, mechanisms that ensure the public benefit are key to sustaining public and participant support for research access to health data. As a regime founded on the concept of public benefit, charity law provides regulatory and governance mechanisms through which the public benefit of a charity is protected and promoted. This article examines the merits of charity law mechanisms and analyses their significance for governance of commercial access to health data for public benefit, using UK Biobank Ltd, a charitable company limited by guarantee, as an example. The article critically analyses three charity law mechanisms that operate to ensure that an organization providing access to data meets its public benefit requirements: charitable purposes; members' and directors' powers and duties; and accountability via the oversight powers of the Charity Commission and charity proceedings in court. The article concludes that there is potential for the charity model to be the benchmark for governing commercial access to health data for public benefit research, but notes the limitations of the model and recommends the appointment of independent data governance committees to further bolster the charity law framework.

Financial Eligibility Criteria and Medication Coverage for Independent Charity Patient Assistance Programs.

Importance: Although independent charity patient assistance programs improve patient access to costly prescription drugs, recent federal investigations have raised questions about their potential to increase pharmaceutical spending and to violate the federal Anti-Kickback Statute. Little is known about the design of the programs, patient eligibility, or drug coverage. Objective: To examine the eligibility criteria of the independent charity patient assistance programs and the drugs covered by them. Design, Setting, and Participants: Descriptive cross-sectional study of the 6 largest independent charities offering patient assistance programs for patients including, but not limited to, Medicare beneficiaries in 2018. These charities offered 274 different disease-specific patient assistance programs. Drugs were identified for subgroup analysis that had any use reported on the Medicare Part D spending dashboard and any off-patent brand-name drugs that incurred more than $10 000 in Medicare spending per beneficiary in 2016. Exposures: Support by independent charity patient assistance programs. Main Outcomes and Measures: The primary outcomes were the characteristics of patient assistance programs, including assistance type, insurance coverage (vs uninsured), and income eligibility. The secondary outcomes were the cost of the drugs covered by the patient assistance programs and the coverage of expensive off-patent brand-name drugs vs substitutable generic drugs. Results: Among the 6 independent charity foundations included in the analysis, their total revenue in 2017 ranged from $24 million to $532 million, and expenditures on patient assistance programs ranged from $24 million to $353 million, representing on average, 86% of their revenue. Of the 274 patient assistance programs offered by these organizations, 168 (61%) provided only co-payment assistance, and the most common therapeutic area covered was cancer or cancer treatment-related symptoms (113 patient assistance programs; 41%). A total of 267 programs (97%) required insurance coverage as an eligibility criterion (ie, excluded uninsured patients). The most common income eligibility limit was 500% of the federal poverty level. The median annual cost of the drugs per beneficiary covered by the programs was $1157 (interquartile range, $247-$5609) compared with $367 (interquartile range, $100-$1500) for the noncovered drugs. Off-patent brand-name drugs (cost: >$10 000) were covered by a mean of 3.1 (SD, 2.0) patient assistance programs, whereas their generic equivalents were covered by a mean of 1.2 (SD, 1.0) patient assistance programs. Conclusions and Relevance: In 2018, among 274 patient assistance programs operated by the 6 independent charity foundations, the majority did not provide coverage for uninsured patients. Medications that were covered by the patient assistance programs were generally more expensive than those that were not covered.

Additional requirements for charitable hospitals; community health needs assessments for charitable hospitals; requirement of a section 4959 excise tax return and time for filing the return. Final regulations and removal of temporary regulations.

This document contains final regulations that provide guidance regarding the requirements for charitable hospital organizations added by the Patient Protection and Affordable Care Act of 2010. The regulations will affect charitable hospital organizations

Government control over health-related not-for-profit organisations: Agency for International Development v. Alliance for Open Society International Inc 570 US_(2013).

The relationship between government and the not-for-profit (NFP) sector has important implications for society, especially in relation to the delivery of public health measures and the protection of the environment. In key health-related areas such as provision of medical services, welfare, foreign aid and education, governments have traditionally preferred for the NFP sector to act as service partners, with the relationship mediated through grants or funding agreements. This service delivery arrangement is intended to provide a diversity of voices, and encourage volunteerism and altruism, in conjunction with the purposes and objectives of the relevant NGO. Under the pretence of "accountability", however, governments increasingly are seeking to impose intrusive conditions on grantees, which limit their ability to fulfil their mission and advocate on behalf of their constituents. This column examines the United States Supreme Court decision, Agency for International Development v Alliance for Open Society International Inc 570 US_(2013), and compares it to the removal of gag clauses in Australian federal funding rules. Recent national changes to the health-related NFP sector in Australia are then discussed, such as those found in the Charities Act 2013 (Cth) and the Not-for-Profit Sector Freedom to Advocate Act 2013 (Cth). These respectively include the establishment of the Australian Charities and Not-For-Profit Commission, the modernising of the definition of "charity" and statutory blocks on "gag" clauses. This analysis concludes with a survey of recent moves by Australian States to impose new restrictions on the ability of health-related NFPs to lobby against harmful government policy Among the responses considered is the protection afforded by s 51l(xxiiiA) of the Australian Constitution. This constitutional guarantee appears to have been focused historically on preventing medical and dental practitioners and related small businesses being practically coerced into government or large-scale private corporate operations. As such, it may prohibit civil conscription arising not only from "gag clauses" in managed care contracts, but also from "gag clauses" in governmental ideological controls over taxpayer-funded, health-related NFPs.

From closed ranks to open doors: Elaine and John Cummings' mental health education experiment in 1950s Saskatchewan.

During late 1951 and early 1952, married couple, social biologist Elaine Cumming and psychiatrist John Cumming, led a mental health education experiment in Indian Head, Saskatchewan. The study, which was intended to inform strategies toward deinstitutionalization, sought to determine if attitudes regarding mental illness could be changed through commonly used educational practices. It was shaped by the shared interests of powerful philanthropic, charitable, psychiatric, academic and governmental bodies to create healthier citizens and a stronger democratic nation through expert knowledge. However, in addition to the disappointing findings indicating that attitudes remained unchanged, the town appeared to close ranks against the research team. Nonetheless, the Cummings' later association with sociologists at Harvard University enabled them to interpret the results in a way that lent the study credibility and themselves legitimacy, thus opening the door to their careers as very successful researchers and policy-makers.

A Form 990 Schedule H conundrum: how much of your bad debt might be charity?

IRS Form 990 Schedule H requires hospitals to estimate the amount of bad debt expense attributable to patients eligible for charity under the hospital's charity care policy. Responses to Schedule H, Part III.A.3 open up the entire patient collection process to examination by the IRS, state officials, and the public. Using predictive analytics can help hospitals efficiently identify charity-eligible patients when answering Part III.A.3.

History of hospital care in São Paulo: State grants to the misericórdia charitable associations. / História da assistência hospitalar em São Paulo: a subvenção do Estado às misericórdias paulistas.

This article investigates how the santas casas de misericórdia charitable associations in the state of São Paulo were subsidized by the municipal, provincial, and state governments at the turn of the twentieth century. Budget appropriations from 1838 to 1915 were examined to evaluate these charitable grants as well as the growth in funding during this period. While a care network created with strong state backing, it was put into action by philanthropic assistance. This network of hospital care retained the same format until at least the first third of the twentieth century, and included misericórdia establishments created within the interior of the state of São Paulo.

O artigo analisa como as santas casas de misericórdia do estado de São Paulo foram subvencionadas pelos governos municipais, provincial e estadual na passagem do século XIX para o XX. Para tanto, são discutidas as dotações orçamentárias realizadas de 1838 a 1915, com o fim de avaliar o repasse e a ampliação de verbas nesse ínterim. É possível notar que foi criada uma rede de assistência fortemente apoiada pelo Estado, mas efetivada pela assistência filantrópica. Essa rede de atendimento hospitalar permanece com o mesmo formato até pelo menos o primeiro terço do século XX, contexto em que se incluíam as misericórdias criadas pelo interior do estado paulista.

When the ophthalmologists turn blind.

The cost of technology is high in ophthalmology but given the increasingly competitive environment and the social demand, there is a pressure to progressively lower the costs to the consumer. To keep costs down there is a tendency to do as many surgeries as possible in an assembly line fashion both in hospitals as well as in the charitable camps. This article provides ophthalmologists an insight into the legal pitfalls in practice of ophthalmology in India and the dangers of the constant lowering of costs of surgery as well as of free service. This lowering of costs would have been ideal in a Utopian world, but times have now changed and there is cost to be paid even for providing free service. In India the prevalent tradition of providing free service, has also resulted in a lowering of guard by the eye surgeons. These mass eye surgery assembly popularly called "free eye camps" has seen millions of people benefited. But recently there is an increase in number of cases where exorbitant penalty has been imposed by the courts, on these philanthropic surgeons for any deficiency in service, and this has destroyed the careers of many ophthalmologists. Time has now come to introspect and to factor the cost of litigation and compensations into the cost of surgeries so that we not only benefit the patients but also safeguard the ophthalmologists and help them fulfill their responsibilities towards their own dependents.

Unlocking the community chest. In 2009, the community benefits debate will again be front and center as Sen. Grassley seeks to nail down its definition.

In the wake of GAO reports that uniformly measuring community benefits is all but impossible, Sen. Chuck Grassley says he'll draft legislation setting up strict rules for measuring charity care and other benefits. While hospitals are leery, others see merit. "You need to have a standard methodology.... Everyone has a self-interest in reporting numbers that make themselves look terrific", says John Colombo, left.

[Birth of the "Social Security" in Alsace-Lorraine]. / Naissance de la Sécurité Sociale en Alsace-Moselle.

For a long time healthy and socially disabled people have been helped by caritative institutions, primarily religious ones, with only occasional involvement of the state. The problem was raised by the economic revolution in the XIXth century, with particular emphasis on the highly industrialized countries, such as Alsace and Lorraine. The development of public healthcare, as well as the help to socially disabled people in these two areas (particularly in the spinning factories of Mulhouse, the iron works and the coal-mines of Moselle) have undoubtedly come before and lead to the social laws that were promulgated between 1883 and 1889 by Bismark and then in France after 1919.

Caracci and the valuation of exempt organizations.

In Caracci v. Commissioner, the Internal Revenue Service faced an important test in its application of Excess Benefit Taxes to disqualified persons of a nonprofit corporation that converted to for-profit status. This Article, written by the taxpayers' valuation expert, details the difficulties in the IRS case and demonstrates the reasons for the Fifth Circuit's reversal of the Tax Court's judgment in favor of the IRS. The author concludes with a number of lessons that taxpayers can take from Caracci.

True to form. The IRS' updated reporting rules for tax-exempt organizations could require full disclosure on community benefits, charity care.

By mid-month, the IRS expects to unveil extensive changes to its Form 990 reporting rules for not-for-profits, which could further affect current disclosure or nondisclosure of tax-exempt hospitals' community benefits and charity care. Most hospitals welcome the revisions, but the legislative process to implement those reforms could be lengthy, says healthcare attorney Bernadette Broccolo, left.