Monday, October 31, 2011
Michael Carrier, Provigil: A Case Study of Anticompetitive Behavior, SSRN/Hast Sci & Tech L. J.
Jane Baron, Property as Control: The Case of Information, SSRN/Mich. Tel & Tech L.Rev.
Katrice Bridges Copeland, Enforcing Integrity, SSRN/Ind. L.J.
Saturday, October 29, 2011
In Kaiser's October tracking poll, public support for PPACA has reached a new low since the law was passed, with only 34 percent of people expressing a favorable view and 51 percent an unfavorable view. The drop in popularity reflects a decline in enthusiasm among Democrats.
Friday, October 28, 2011
The Robert Wood Johnson Foundation is out this week with a fun new resource for those brave souls trying to explain and help others understand some of the elements of the Affordable Care Act. In a series of brief animated videos, key concepts from the Affordable Care Act are explained in concise, digestible fashion.
Topics covered include:
Thursday, October 27, 2011
A familar argument but very well made by Ezekiel Emanuel in today's New York Times, here.
"The United States, with a population a quarter of the size of China’s, spends just on health care slightly less than half of what China spends on everything."
Wednesday, October 26, 2011
Health Affairs recently had a terrific conference (and new issue) on battling health disparities. I enjoyed listening to the podcast recording of Howard Koh, the assistant secretary for health at the Department of Health and Human Services (HHS), describing his agency's Action Plan for reducing disparities. From the abstract:
The 2011 HHS Action Plan to Reduce Racial and Ethnic Health Disparities not only responds to advice previously offered by stakeholders around the nation, but it also capitalizes on new and unprecedented opportunities in the Affordable Care Act of 2010 to benefit diverse communities. The Action Plan advances five major goals: transforming health care; strengthening the infrastructure and workforce of the nation’s health and human services; advancing Americans’ health and well-being; promoting scientific knowledge and innovation; and upholding the accountability of HHS for making demonstrable progress.
The entire issue is well worth reading.
Help fashion "best practices" with conflicts of interest experts at ASLME's "Conflicts of Interest in the Practice of Medicine: A National Symposium." This one-and-a-half day conference will feature an array of recognized national experts who will discuss, debate, and propose best practices and approaches to the problem of conflicts of interest. The conference will be held on October 27-28, 2011 at the University Club, University of Pittsburg in Pittsburgh, PA.
This conference intends to foster a cross-disciplinary perspective on pertinent issues, and by the end of the conference, attendees will (1) learn about current consensus panel recommendations regarding management of conflicts of interest, (2) be able to describe remaining challenges to regulating conflicts of interest in key areas of research and medical practice, and (3) help fashion recommendations for the key players and identify other key steps in moving forward.
Looking for Continuing Ed Credits? ASLME will be awarding 8.5 CLE and CME credits to conference attendees. Click here to register today! If you would like to learn more about this event, please read the event description or view the conference agenda.
Tuesday, October 25, 2011
Sunday, October 23, 2011
The biggest news in health care last week was the release of the ACO Final Rule, governing accountable care organizations. With a great sense of timing (and some good luck), our law review at Seton Hall is sponsoring a conference this Friday that will bring together some of the leading legal, academic, and medical experts on ACOs. (We’ve even invited an information technology expert who can address the vital role of electronic medical records in promoting quality and efficiency.)
Why care about ACOs? Here’s Jenny Gold from Kaiser Health News:
Accountable care organizations take up only seven pages of the massive new health law yet have become one of the most talked about provisions. This latest model for delivering services offers doctors and hospitals financial incentives to provide good quality care to Medicare beneficiaries while keeping down costs. A cottage industry of consultants has sprung up to help even ordinary hospitals become the first ACOs on the block.
When the draft ACO regulation was released, there were many naysayers. But as Sarah Kliff reports, the concept is now “getting a much more positive reception.” In a familiar Obama Administration pattern, the rule now“marks a victory for hospitals, clinics and large doctors’ practices that have lobbied to alter draft regulations they viewed as too burdensome and financially risky.”
The Seton Hall Law Review symposium will bring together those who are implementing and studying ACOs. For a good run down of presentation topics, check out our posts on the speakers at the Health Reform Watch blog.
Friday, October 21, 2011
I had hoped to blog on a new topic this week, but I’ve emerged from the AALS faculty recruitment conference to find conscience in medicine in the headlines yet again.
Late last week, the House of Representatives passed H.R. 358 by an overwhelming margin. The bill—either the “Protect Life Act” or the “Let Women Die Act,” depending who you ask—both codifies existing provisions for institutional and individual refusal and expands the protection of conscience to emergency situations.
In the name of conscience, the bill seeks to radically change federal law to allow healthcare institutions to refuse care to pregnant women in emergencies. Currently, the Emergency Medical Treatment and Active Labor Act (EMTALA) requires all hospitals to provide stabilizing treatment to patients with emergency medical conditions. As the name suggests, pregnant women’s access to emergency care is specifically protected. Patients with severe symptoms must receive “immediate medical attention” if their health will be seriously damaged without treatment. Under H.R. 358, however, a pregnant woman would no longer receive this protection when an abortion is necessary to save her life or preserve her health.
A majority of Congressmen were heedless to the real world effects of this bill. Women miscarrying, suffering ectopic pregnancies, or experiencing other emergencies could be refused care in any hospital. The problem could be widespread. Catholic hospitals—which would be most likely to take advantage of the change—see 18 million emergency room visits each year. In twenty-two states, over twenty percent of hospital care takes place in Catholic facilities. In some areas, the Catholic hospital is the only provider at all.
These provisions are troubling in their unreflecting adoption of the concept of institutional conscience and their failure to acknowledge the implications for individual conscience. What’s more, the assertion of conscience as an absolute value seems to disregard why our society protects medical conscience in the first place.
Across theories, the strongest rationale for conscience protection is that allowing medical providers to act according to conscience is central to their ability to be whole persons (uniting their professional and personal roles). And, indeed, this concern for the individual physician’s moral integrity has been at the heart of the debates over conscience in medicine.
But in a system premised on respect for integrity, an individual’s moral integrity might be outweighed by the disvalue to the patient or society of protecting conscience. Emergencies present the interests most starkly. When faced with a woman with life-threatening pregnancy complications, how can concern for a conscientious refuser’s psychological unity outweigh the patient’s autonomy (to say nothing of her life)? How can appeals to the well-being of the providers be convincing when a patient’s health is at stake?
The views expressed in this post are those of the author and should not be attributed to the Center for Reproductive Rights or the Health Law Prof Blog.
Emily Morris, The Myth of Generic Pharmaceutical Competition Under the Hatch‐Waxman Act, SSRN/Fordham Intell. Prop. Media & Ent. L.J.
David Orentlicher, Cost Containment and the Patient Protection and Affordable Care Act, SSRN/Fla. Int'l U. L. Rev.
Thursday, October 20, 2011
This week the Obama Administration formally abandoned the CLASS Act, a component of the ACA designed to provide long-term care. Robert Reich explains why it was doomed from the start:
First, it required beneficiaries to receive at least $50 a day if they had a long-term illness or disability (to pay a caregiver or provide other forms of maintenance). That $50 was an absolute minimum. No flexibility on the downside.
Second, insurance premiums had to fully cover these costs. In budget-speak, the program was to be self-financing. Given the minimum benefit, that meant fairly hefty premiums. Third, unlike the rest of the healthcare law, enrollment was to be voluntary. But given the fairly hefty premiums, the only people likely to sign up would know they’d need the benefit because they had or were prone to certain long-term illnesses or disabilities. Healthier people probably wouldn’t enroll.
The failure of CLASS has led to a flurry of proposals for alternatives to long-term care insurance. Some want a purely private sector solution. Maybe a new Rube Goldberg financing scheme could be implemented as a part of 401(k) plans. Perhaps Wall Street could sell disability derivatives and ability default swaps, engineering away the “risk of non-use” that keeps people from enrolling in programs like this.
In thinking about these proposals, my mind turns back to Robert Bork’s Antitrust Paradox. For Bork, antitrust law was “at war with itself” because it professed to promote simultaneously 1) a cutthroat competitive process that would encourage firms to maximize efficiency and 2) the threat of penalties for any firm that succeeded in being so efficient that it outcompeted all or nearly all of its rivals, if its efforts to do so stepped over the line into monopolization. Of course, one could resolve the so-called paradox if one recognized that the Sherman and Clayton Acts were passed not merely to maximize “consumer welfare,” but also to prevent concentrations of economic power from exercising excessive influence. But as the judicial interpretation of antitrust law took on more of the assumptions of the Chicago school, the paradox loomed ever larger in efforts to characterize antitrust as futile in an era of consolidation.
So what’s the CLASS paradox? There are actually several. Those who are not so well off (such as the 50% of American workers who made less than $26,000 last year) are likely to be the most in need of the program, but have the least amount to spare for premiums. Those in the top 1% (that is, those who make over $506,000 annually) will probably want to use their own savings and investments, rather than an insurance program, to pay for LTC. That leaves a middle 49%, making between $26,000 and $506,000, who are the most likely participants. But among that group, the more healthy, well-connected, wealthy, and young you are, the less likely you are to buy in because the benefits are speculative, distant, and/or unneeded. And by and large, the sicker, more isolated, poorer, and older you are, the less likely you are to have the resources to participate now.
The question finally becomes: are we serious about social insurance in this country, or are we content with treating the very frail elderly like possessions in the home, to be insured as need and whim allow? The solution to the LTC crisis is a right to basic care and residence, funded by general tax revenues. Sure, we can have extensive and difficult debates about the obligations of individuals and families to contribute to long-term care, particularly in order to make better-than-basic options available. But the general focus needs to be on redistribution from the currently well-to-do to the currently needy, rather than an ownership society mirage of individuals anticipating distant futures that may never materialize (and that many or even most can’t very well prepare for even if they do materialize).
We should also consider funding more of Medicare out of general tax revenues, rather than from dedicated payroll taxes and premiums. Richard Kaplan has argued that this shift could better serve both equity and cost-control goals:
The use of general tax revenues, moreover, would make clear that financing the health care needs of the Medicare population is a societal undertaking, much like the Medicaid program, which targets low-income individuals of any age. At a minimum, eliminating the separate taxes for Medicare would simplify the lives of employees and employers alike and would additionally reduce the cost to employers of adding new employees. Perhaps changing the financing of the Medicare program along the lines just suggested might also make its beneficiaries less inclined to protest every proposed programmatic restriction and to understand that their benefits are indeed coming from a communal funding source. The resulting change in budgetary debates can only be salutary for the republic as a whole.
Health care finance in general must adopt to a world of massive and growing income and wealth inequality. From 1947-1980, when Americans’ incomes more or less grew together at the same rate, there was some justification for modeling the purchase of long term care as an investment that individuals would manage one by one, to reflect their tastes and preferences. Since 1980, the divergence in fortunes has become so great that such choices far more reflect ability-to-pay rather than taste for risk or comfort. It is unfair to expect struggling middle and lower class individuals to continue with such burdens. And to the extent tough choices need to be made, they ought to better reflect the collective wealth of the nation, rather than the tragic choices that can befall an individual forced to choose between preparing for bleak penury in old age or investing in present purchases that could make that neediness less likely.
X-Posted: Health Reform Watch.
Major changes include providing better, and more timely, information to ACOs at the outset of the performance year through preliminary prospective alignment of beneficiaries (while retaining a retrospective reconciliation to ensure that ACOs are measured on the basis of the patients they actually care for during the year); retaining a strong monitoring and quality-measurement mechanism while streamlining the metrics to focus on what matters most, including reducing the total number of quality measures by about half; allowing start-up ACOs to choose a “savings only” track without financial risk during their initial contract period; sharing savings with successful ACOs on a “first dollar” basis when the ACO achieves meaningful savings for the Medicare program and improves care or provides high-quality care; and creating a pathway for full participation of federally qualified health centers and rural health clinics that provide a primary care safety net for Medicare beneficiaries in underserved areas.
Wednesday, October 19, 2011
CMS's latest proposed regulatory roll-backs are summarized here. The most far-reaching proposals appear to be the changes to the Medicare and Medicaid Conditions of Participation, here, affecting Governing body, Patient’s rights, Medical staff, Nursing services, Medical record services, Infection control, Outpatient services, and Transplant Center Process Requirements. [NPT]
According to "Why Not the Best? Results from the National Scorecard on U.S. Health System Performance, 2011," a new report from The Commonwealth Fund, here, the US continues to lag behind other countries in access, affordability and most quality measures. In short, "Other advanced countries are outpacing the U.S. in providing timely access to primary care, reducing premature mortality, and extending healthy life expectancy, all while spending considerably less on health care and administration… The U.S. health system continues to perform suboptimally relative to what is achievable and relative to the large resources invested by the nation. The ... Scorecard documents that there are significant human and economic costs attached to our failure to address the problems in the health care system. As rising costs put family, business, and government budgets under stress, access to care and financial protection are eroding for middle-income and low-income families alike." [NPT]
Tuesday, October 18, 2011
Last month, Senator Rand Paul introduced a bill, S.J. Res. 27, that would overturn the Environmental Protection Agency's Cross-State Air Pollution Rule (CSAPR) that was proposed in July. CSAPR requires 27 states to significantly improve air quality by reducing power plant emissions that contribute to ozone and/or fine particle pollution in other states.
Supporters of the bill, such as the conservative group Americans for Prosperity and Tea Party Patriots, oppose CSAPR because it would dramatically increase the costs of power generation, allegedly harming the economy. Environmental groups, on the other hand, have been adamant that the rule must be upheld since it protects public health. The Environmental Defense Fund claims it is a life-saving rule "that would save up to 34,000 lives every year."
It's not just environmental groups are concerned about S.J Res. 27. The League of Women Voters wrote a recent letter urging Senators to oppose the bill, maintaining that CSAPR will "prevent 15,000 heart attacks, 400,000 aggravated asthma attacks and hundreds of thousands of cases of other respiratory ailments every year."
All clean air rules arguably "harm" the economy, if harm is defined as higher costs for energy producers and consumers. However, it is disturbing that the costs of diseases and the benefits of disease prevention are not factored in by the interests advancing economic arguments. In this case, the costs and benefits probably balance out, but interests of people affected by future diseases are not well represented in Congress. As a result this ill-advised bill may become law.
Friday, October 14, 2011
PPACA's effort to deal with long-term care insurance died yesterday when the Obama Administration announced it will not be able to implement the CLASS Act provisions of PPACA. Projections indicated that not enough young, healthy individuals would sign up to ensure affordable premiums.
Michelle Mello & Noah Messing, Restrictions on the Use of Prescribing Data for Drug Promotion, NEJM
Ashish Jha et al, Low-Quality, High-Cost Hospitals, Mainly In South, Care For Sharply Higher Shares Of Elderly Black, Hispanic, And Medicaid Patients, Health Affairs
Anne Beal, High-Quality Health Care: The Essential Route To Eliminating Disparities And Achieving Health Equity, Health Affairs
Lorian Hardcastle et al, Improving the Population’s Health: The Affordable Care Act and the Importance of Integration, SSRN/JLME
Thursday, October 13, 2011