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New England Journal of Medicine 08/2012; 367(5):396-7. · 53.30 Impact Factor
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Mark A Hall
Journal of Health Politics Policy and Law 06/2011; 36(3):521-6. · 0.87 Impact Factor
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Mark A Hall
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ABSTRACT: This descriptive study assesses the access to care provided by five model and diverse safety net programs that enroll uninsured adults in a coordinated system offering primary care, hospital care, prescription drugs, and most specialist services. Physician use by safety net program members was similar to insured groups. However, there was less use of hospitals in the two programs that relied on uncompensated charity care. Considering access measures commonly used in population-based surveys, the uninsured in these five communities fared no better than uninsured elsewhere. However, respondents may consider enrollment in a well-structured safety net program to be equivalent to insurance. If so, population surveys may be least accurate in identifying uninsured people in the very communities that have the best safety net programs. On balance the five safety net systems profiled here meet the needs of low-income uninsured residents at a level that is roughly similar to that for people with insurance.
Medical Care Research and Review 05/2011; 68(4):441-61. · 2.96 Impact Factor
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Mark A Hall
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ABSTRACT: To achieve the aims of the Affordable Care Act, state and federal regulators must construct an effective system of risk adjustment, one that protects health insurers that attract a disproportionate share of patients with poor health risks. This brief, which summarizes a Commonwealth Fund–supported conference of leading risk adjustment experts, explores the challenges regulators will face, considers the consequences of the law's risk adjustment provisions, and analyzes the merits of different risk adjustment strategies. Among other recommendations, the brief suggests that regulators use diagnostic rather than only demographic risk measures, that they allow states some but limited flexibility to tailor risk adjustment methods to local circumstances, and that they phase in the use of risk transfer payments to give insurers more time to predict and understand the full effects of risk adjustment.
Commonwealth Fund Issue Briefs 05/2011; 7:1-12.
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Mark A Hall
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ABSTRACT: National health insurance reform will pose considerable challenges to the core missions of safety net organizations that serve the uninsured. Those who currently donate money or time will, rightly or wrongly, view uninsured recipients as less deserving on the whole. Nevertheless, safety net organizations can serve several critical functions that continue to justify their existence and support.One important mission is to maintain access for low-income uninsured until all elements of insurance reform are fully in place. Second, once the reform is implemented, people will need a great deal of assistance and encouragement to determine what they are supposed to do and where they are supposed to sign up. Third, substantial portions of the remaining uninsured will continue to lack affordable insurance options, and large numbers of people eligible for coverage will unavoidably undergo temporary gaps in coverage as their family and financial circumstances change. Finally, not all people with insurance will have affordable access to all needed care. Market conditions will continue pushing higher levels of patient cost-sharing through deductibles and co-payments.To serve these multiple needs, safety net organizations should consider adapting their missions and business models so that they accept both insured and uninsured patients under a sliding fee scale that varies charges according to ability to pay.
Journal of General Internal Medicine 03/2011; 26(7):802-5. · 2.83 Impact Factor
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Mark A Hall
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ABSTRACT: This week's decision by federal district Judge Roger Vinson in Pensacola, Florida, declaring the Affordable Care Act (ACA) unconstitutional is far and away the most prominent decision issued to date in this ongoing litigation. Because this lawsuit involves about half the states, it has received the most attention. But it is only one of about two dozen legal challenges across the country. Two other federal judges (in Detroit and in Lynchburg, Virginia) have upheld the law, and one other (in Richmond, Virginia) sided with Judge Vinson on the unconstitutionality of the individual mandate to obtain health insurance.(1) Of the remaining . . .
New England Journal of Medicine 02/2011; 364(9):793-5. · 53.30 Impact Factor
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Mark A Hall
New England Journal of Medicine 01/2011; 364(4):295-7. · 53.30 Impact Factor
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Mark A Hall
New England Journal of Medicine 01/2011; 364(1):7-9. · 53.30 Impact Factor
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Mark A Hall
Yale journal of health policy, law, and ethics 01/2011; 11(1):9-19.
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ABSTRACT: Paying more for clinical research than the cost of doing the work may create a conflict of interest that could lead to overzealous recruitment, putting participants and scientific integrity at risk. Thus, although various policies prohibit "finder's fees" simply for recruiting patients, paying the actual costs for research is permissible. Whereas industry-sponsored research routinely pays for the costs of each patient enrolled, the line between reasonable and excessive costs merits more attention. In academic medical centers (AMCs), institutional review boards and conflict of interest committees usually are not involved in reviewing research budgets to determine whether per capita payments are excessive. Also, the costs for clinical services in research are not standardized. Instead, budgets are negotiated both internally, among departments within research institutions, and externally, between researchers and sponsors. Sometimes, rates paid by sponsors exceed what researchers usually receive or are actually paid for particular services, generating a surplus. Nevertheless, the authors see only limited cause for concern because, at the AMCs with which the authors are familiar, any monetary surplus generally remains within the research enterprise to cover unanticipated budget shortfalls or to support research staff in the future during lean times. In addition, the surplus from research budgets is not shared directly with individual investigators. However, further investigation is needed to determine whether practices outside AMCs pose greater concerns.
Academic medicine: journal of the Association of American Medical Colleges 10/2010; 85(10):1554-6. · 2.34 Impact Factor
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Mark A Hall
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ABSTRACT: The Patient Protection and Affordable Care Act contains three different forms of reinsurance, covering individual insurers, small-group insurers, and employers that insure early retirees. Each reinsurance program has a distinctive structure that serves a unique purpose. Each also has predecessors in various forms of public reinsurance implemented previously by state and federal governments. This article explains the structure of and purpose for each reinsurance provision and why it should no longer be needed once reinsurance helps launch health reform safely.
Health Affairs 06/2010; 29(6):1168-72. · 4.31 Impact Factor
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ABSTRACT: Although the informed consent process is supposed to help potential research participants make informed and voluntary decisions about participating in research, little is known about how participants react to language in the informed consent document and whether their reactions are related to their willingness to enroll in clinical trials. We examined the relationship between patients' reactions to standard informed consent language and their willingness to participate in a hypothetical clinical trial.
We simulated the consent process for a hypothetical cardiology clinical trial with 470 patients in an outpatient cardiovascular medicine clinic at a large academic medical center. We analyzed the spontaneous comments and questions that participants made during the interviews about each section of the informed consent document. Few participants made positive comments. Participants made the most negative comments about the sections on risks, study purpose or protocol, and payment for injury. Having a negative reaction to any section was associated with a lower likelihood of participating in the clinical trial. Using a multivariable model, we found that negative reactions in the patient rights, financial disclosure, and confidentiality sections predicted willingness to participate (P<0.001).
Recognizing elements of informed consent that elicit questions and concerns from potential research participants may help investigators design clinical research trials and model language in a way that reduces concerns or increases participant understanding, thereby enhancing informed consent for research.
Circulation Cardiovascular Quality and Outcomes 03/2010; 3(2):151-8. · 4.91 Impact Factor
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ABSTRACT: Studies of conflicts of interest in clinical research have focused on academic centers, but most clinical research takes place in nonacademic settings.
To compare oversight and management of investigators' financial relationships in academic and nonacademic research settings.
Survey of officials at 199 sites that contributed participants to commercially sponsored phase 3 clinical trials published in JAMA or the New England Journal of Medicine in 2006 and 2007.
Response rates were 66% for academic medical centers, 37% for nonacademic medical centers (inpatient), and 27% for outpatient nonacademic sites. Almost all academic medical centers (97%) and most nonacademic medical centers (87%) followed written conflict-of-interest policies, whereas 44% of outpatient nonacademic sites had written policies (P < 0.001). Academic and nonacademic medical centers relied mainly on internal institutional review boards (69% and 71%, respectively); outpatient nonacademic sites relied primarily on independent institutional review boards (59%; P < 0.001).
Nonacademic sites have substantially different approaches to the oversight and management of financial relationships in commercially sponsored clinical research than academic medical centers. These differences warrant more attention to how financial relationships are monitored in community research settings.
Journal of General Internal Medicine 02/2010; 25(5):460-4. · 2.83 Impact Factor
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Mark A Hall
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ABSTRACT: Many measures to reform health insurance markets include various types of government-sponsored reinsurance. This article explains the purposes and types of private and public reinsurance, and reviews available evidence about their performance. The author concludes that government-sponsored reinsurance inherently cannot reduce total costs, but it can shift costs from the private to the public sector. Also, reinsurance can help transition to a new government program or market structure that creates uncertain risks. Whether reinsurance is the best way to accomplish these goals depends greatly on the details.
Annals of health law / Loyola University Chicago, School of Law, Institute for Health Law 01/2010; 19(3):465-78, 1 p preceding i.
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ABSTRACT: When employees without group health insurance buy individual coverage, they do so using after-tax income--costing them from 20% to 50% more than others pay for equivalent coverage. Prior to the passage of the Patient Protection and Affordable Care Act (PPACA), several states promoted a potential solution that would allow employees to buy individual insurance through tax-sheltered payroll deduction. This technical but creative approach would allow insurers to combine what is known as "list-billing" with a Section 125 "cafeteria plan." However, these state-level reform attempts have failed to gain significant traction because state small-group reform laws and federal restrictions on medical underwriting cloud the legality of tax-sheltered list-billing. Several authorities have taken the position that insurance paid for through a cafeteria plan must meet the nondiscrimination requirements of the Health Insurance Portability and Accountability Act with respect to eligibility, premiums, and benefits. The recently enacted Patient Protection and Affordable Care Act addresses some of the legal uncertainty in this area, but much remains. For health reform to have its greatest effect, federal regulators must clarify whether individual health insurance can be purchased on a pre-tax basis through a cafeteria plan.
Inquiry: a journal of medical care organization, provision and financing 01/2010; 47(3):252-61. · 0.83 Impact Factor
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ABSTRACT: and
This article describes several ethical, legal, and social issues typical of international genetics biobanking, as encountered in the Type 1 Diabetes Genetics Consortium (T1DGC).
By studying the examples set and lessons learned from other international biobanking studies and by devoting considerable time and resources to identifying, addressing, and continually monitoring ethical and regulatory concerns, T1DGC was able to minimize the problems reported by some earlier studies.
Several important conclusions can be drawn based on the experience in this study: (1) Basic international standards for research ethics review and informed consent are broadly consistent across developed countries. (2) When consent forms are adapted locally and translated into different languages, discrepancies are inevitable and therefore require prompt central review and resolution before research is initiated. (3) Providing separate 'check-box' consent for different elements of a study creates confusion and may not be essential. (4) Creating immortalized cell lines to aid future research is broadly acceptable, both in the US and internationally. (5) Imposing some limits on the use of stored samples aids in obtaining ethics approvals worldwide. (6) Allowing potential commercial uses of donated samples is controversial in some Asian countries. (7) Obtaining government approvals can be labor-intensive and time-consuming, and can require legal and diplomatic skills.
Clinical Trials 01/2010; 7(1 Suppl):S33-45. · 1.92 Impact Factor
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The Journal of family practice 11/2009; 58(11):E1-E4. · 0.61 Impact Factor
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New England Journal of Medicine 09/2009; 361(9):916-21. · 53.30 Impact Factor
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JAMA The Journal of the American Medical Association 04/2009; 301(12):1282-4. · 30.03 Impact Factor
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ABSTRACT: The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's health policy watchword. This article evaluates consumerism and the regulatory mechanism of which it is essentially an example -- legally mandated disclosure of information. We do so by assessing the crucial assumptions about human nature on which consumerism and mandated disclosure depend. Consumerism operates in a variety of contexts in a variety of ways with a variety of aims. To assess so protean a thing, we ask what a patient's life would really be like in a consumerist world. The literature abounds in theories about how medical consumers should behave. We look for empirical evidence about how real people actually buy health plans, choose providers, and select treatments. We conclude that consumerism, and thus mandated disclosure generally, are unlikely to accomplish the goals imagined for them. Consumerism's prerequisites are too many and too demanding. First, consumers must have choices that include the coverage, care-takers, and care they want. Second, reliable information about those choices must be available. Third, information must be put before consumers, especially by doctors. Fourth, consumers must receive the information. Fifth, the information must be complete and comprehensible enough for consumers to use it. Sixth, consumers must understand what they are told. Seventh, consumers must be willing to analyze the information. Eighth, consumers must actually analyze the information and do so well enough to make good choices. Our review of the empirical evidence concludes that these prerequisites cannot be met reliably most of the time. At every stage people encounter daunting hurdles. Like so many other dreams of controlling costs and giving patients control, consumerism is doomed to disappoint. This does not mean that consumerist tools should never be used. It means they should not be used unadvisedly or lightly, but discreetly, advisedly, soberly, and in the fear of error.
American journal of law & medicine 02/2009; 35(1):7-65. · 1.44 Impact Factor
