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The Arnold Relman Challenge: US HealthCare Costs vs US HealthCare Outcomes

Posted in Academic Publishing, Federal Budget Appropriations, Health Economics and Outcomes Research, Health Law & Patient Safety, Healthcare costs and reimbursement, HealthCare IT, Healthcare Reform, tagged health care spending, review on August 5, 2014| Leave a Comment »

The Arnold Relman Challenge: US HealthCare Costs vs US HealthCare Outcomes

Reviewer and Curator: Larry H. Bernstein, MD, FCAP and

Curator: Aviva Lev-Ari, PhD, RN

About Arnold Relman

Arnold Relman (1923–2014) was Professor Emeritus of Medicine and Social Medicine at Harvard Medical School and a contributor of many articles and essays to The New York Review. Marcia Angell is a Senior Lecturer in Social Medicine at Harvard Medical School. Arnold Relman was her husband.

The American Health Care Paradox: Why Spending More Is Getting Us Less

The US spends much more per person on medical care than any other country. And yet,

by commonly accepted measures of the quality of its national health system, it ranks only in the middle of the other advanced countries

belonging to the Organization for Economic Cooperation and Development (OECD).

Elizabeth Bradley and Lauren Taylor argue that

this “American health care paradox” is resolved when expenditures on other social services that undoubtedly contribute to improved national and personal health are taken into account.

These expenditures include support for such services as housing, education, maternal and child care, disease prevention, nutrition, environmental safety, and unemployment benefits. They also involve subsidies for the very poor, the disabled, and the elderly.

The US spends a much smaller percentage of its GDP on these programs than other OECD countries. Thus,

when these expenditures are added to what is spent for medical care, the total, expressed as a percentage of GDP, places our country in the middle of the other OECD countries.

That is consistent with the ranking of our health care system, and so the authors claim

the “paradox” is resolved.

To increase the quality of our health care system to the level now achieved by France, Germany, Switzerland, and Sweden,

we would need not only to expand our investment in other social services, but also
to practice what Bradley and Taylor call “a more holistic approach” to the medical care of each patient.

That means more attention to preventing illness and to modifying patients’ behavior in ways that promote health.

Their argument has intuitive appeal, made even stronger by the warm endorsement given by Dr. Harvey Fineberg, outgoing president of the Institute of Medicine (IOM) of the National Academy of Sciences, in the foreword he has written for the book, and by recent reports from committees of the IOM. It is generally agreed that

poor and disadvantaged populations, such as teenaged single mothers and their children, or
unemployed, uneducated, and ill-housed minorities,

suffer relatively poor health.

So it might seem entirely reasonable to conclude with the authors

that the answer to what ails our national health system lies in paying more attention to
social welfare programs, preventive measures, and education.

Relman dissatisfied:

Their argument is made more attractive by their clear prose and by their many helpful descriptions and historical explanations of US health care policy. Nevertheless, it does not persuade me, and
I don’t believe it will satisfy many critics who look closely at the issues.

In the first place, Bradley and Taylor pay insufficient attention to the great value Americans place on

the immediate diagnosis and treatment of personal illnesses and injuries, as compared with
public measures to enhance national health such as disease prevention and nutrition.

In the US, prompt medical care is given

far greater priority than improved public health, and
it commands much greater resources.

Research on personal medical care is also given a high priority, but (political reality)

new large investments in social welfare programs are not a legislative or political necessity now or in the foreseeable future,
so long as conservative Republican opposition to governmental spending of this sort persists.

Moreover, the long-range economic benefits of social welfare and preventive measures are generally misunderstood. For example,

prevention of heart attacks in early life through exercise, better diet, and elimination of smoking would extend life into later decades.

That is certainly a desirable goal, but then the multiple

incurable disabilities of old age and the need for long-term care after retirement begin to increase total health costs.

Second, the evidence presented by Bradley and Taylor to support their claim of resolving the American health care “paradox” is not as strong as their rhetoric implies. This is well illustrated by their Figure 1.3, which shows

aggregate health care and social welfare spending in OECD countries for 2007, and

is supposed to demonstrate that when all costs are considered,

the US is no longer as inferior to European countries as many have claimed.

The figure shows that American total expenditures place it just about

in the middle of all the countries shown, in accord with the quality of its health care system.

Nevertheless, while total expenditures on health and social welfare in France, Sweden, Switzerland, and Germany exceed those in the US (which would be expected given their generally superior health systems), the figure shows

total expenditures for Canada, New Zealand, and Australia to be well below those in the US, even though
these countries are widely acknowledged to have better health systems than the US.
Similarly, total expenditures in Norway are roughly equal to those in the US, although the Norwegian national health system is generally recognized to be of much higher quality.

Their Table 4.1 (see below) also illustrates this lack of congruence between health care outcomes such as

infant mortality and life expectancy in selected countries and
their ranking in total expenditures (as shown in Figure 1.3).

In short, total expenditures (social welfare plus medical care) do not seem to be as consistently related to health outcomes as Bradley and Taylor would have us believe. But they are certainly correct in arguing that in general, more attention to welfare programs would improve the quality of life in the US.

American Health Care Paradox

My final reason for skepticism is the authors’ dependence on personal interviews with

a selected and limited number of sources for much of their original data on attitudes about health care.

Bradley, the senior author, is a professor of public health at Yale; Taylor was trained in public health and medical ethics. They would therefore be expected to use

the methods of descriptive social science in developing their arguments.

They state that they conducted interviews with “more than eighty health and social policy experts, researchers, practitioners, and consumers.” Anyone who has been involved in such interviews knows how variably the results can be interpreted. Bradley and Taylor were commendably diligent in recording and transcribing their interviews, but

they took a relatively small sample, and
much of it was limited to Scandinavian countries,
which are very different from the US, for example

in their levels of taxation and their guarantees of medical care and public welfare generally.

As a result, the reader can never be quite sure how comprehensive and balanced a picture this book presents of the American health system, when compared with other OECD countries.

Nevertheless, it is hard to deny two basic and fairly obvious points the authors want to make.

First, inadequate social services in the US contribute to our poor national health.

Second, adding welfare expenditures to those of medical care does help to some extent to resolve the American “paradox” of high medical expenditures and relatively poor health outcomes. But the resolution

is not as complete or convincing as claimed, and
there is no evidence that expanding welfare programs,

as Bradley and Taylor argue,

would more effectively improve national health than directly reforming the payment and organization of medical services.

In fact, the evidence suggests the contrary. The US currently

wastes vastly more resources on a dysfunctional medical care system than it would ever consider spending on social welfare, so
the likelihood of bettering national health through major expansion of welfare programs is remote.

As difficult as it may be, trying to reform the medical system is a better bet;

this would free up resources that could be used to improve other social services.

In addition, most Americans will inevitably become ill or injured at some time in their lives, no matter how adequate the US social services, and for them at that time,

a good medical care system is essential. Therefore, it makes sense to consider

how reforming the payment and organization of medical care could reduce the heavy burden of

unnecessary waste, fraud, and bureaucratic overhead on our medical care system.

This looks like the best way to begin to resolve this book’s “paradox.”

There is widespread and growing recognition that the best way of improving the delivery of medical service and reducing its costs would be

a shift away from fee-for-service payment for medical care after it is received
to prepayment for comprehensive care.

The Affordable Care Act (ACA) attempts to move in this direction by establishing “accountable care organizations” that are paid

small bonuses for bettering the treatment of Medicare patients (as defined by government guidelines). However,
these organizations work mainly through private insurance plans, which, despite these intentions,
still pay for the more expensive special procedures and services by fee-for-service.

The ACA is therefore not likely to control national health expenditures in the long term. Government actuaries and budget officers

predict that these expenditures will continue to rise at an unsustainable rate unless there is major reform.

To achieve better quality at lower costs, I believe we will have to progress beyond the ACA, and

the needed reforms will require more participation by the medical profession.

Physicians will have to join medical groups that accept a single payment for comprehensive care and

are willing to be paid mainly by salaries rather than the fees they bill and collect.

Although insurance companies will lobby hard to maintain their power, such a system does not need private insurance plans; it would be much better without them. Vast overhead expenditures would be saved if payment were to come from a single tax-supported agency. That’s why single-payer plans are getting increasing attention these days.

Recent changes in the medical care system have created forces that

both favor and inhibit the development of a single-payer arrangement.

Physicians who would formerly have started practicing solo or in small partnerships are rapidly becoming employees of large groups

in order to avoid the daunting economic risks of managing their own practices. Unfortunately,
most of these large groups are owned by hospitals that are primarily interested in furthering their own financial goals.

They use their physician employees to generate

more admissions and greater use of hospital-based procedures.

They want to defend the status quo and their own income, rather than press for reform.

An awakening interest in political affairs and a recent trend toward a preference for Democratic political candidates suggest that

the medical profession may soon wish to turn national health policy in a different direction.
(this is a period of transition between generations)

No large-scale health reform is likely without broad support by physicians, so

their political awakening may be the most important factor in bringing about major change.

A united profession could influence the views of its patients, and this in turn could

influence legislators even more than the money of an army of lobbyists.
(army of lobbyists is supported by an exhorbitant wealth disproportion unknown in history, or at least since reconstruction)

Legislators need votes most of all, and patients are the voters they need.
(assumes that patients are a homogeneous group; and thee is no difference between rural and municipalities)

Another recent change that may favor the arrival of single-payer health care is

the rapid increase in the number of women in active medical practice.

They will soon equal or outnumber men. Women physicians seem to be more interested in the

social services that are available in multispecialty medical group practices,
among them adequate child care and parental leaves.
They want to share practice responsibilities, and
they tend to have more liberal political views than most men.

This major demographic shift in the physician population, as well as its political movement toward more progressive policies, might put the profession in the forefront of health reform instead of the sidelines where it has usually been.

Without leadership by physicians, it is unlikely that we will see any major change in the system for payment and organization of medical care within the next decade or two. And

without such change, the future of the American health system is bleak;
either market forces or intrusive government regulations (or both)
will control how physicians practice their profession.

Financial responsibility for health care coverage will increasingly fall on individuals, because

‘neither government nor business employers will be able to afford the rising costs.

The greatest opportunities for reducing unnecessary costs and improving the quality of the American health system are to be found in

reforming the payment and organization of medical care
rather than in expanding social welfare programs.

Although these programs are of enormous importance for many reasons not only related to health, and well worth expanding, they cannot substitute for improving the effectiveness and efficiency of medical care for the sick and injured. That is where we are likely to see the most hopeful future development.

Epicrisis:

In my reading of Arnold Relman, I find that there is validity and unrealistic assumptions in his criticism. It will take a generational change in the profession, which is currently avolving and making some of the changes he notes.

1. There is at least two generations of physicians who entered the profession in the post WWII era, when the Flexner model was in full force, and exemplified by William Osler, the Oslerian model..

Over a century ago, the Quaker merchant Johns Hopkins did more than provide in his will for the construction of a university, a hospital and a medical school. He provided a vision of a unique university-based health center, one with a vital mission: to create a learning, training and caring environment where the quest for new knowledge would continuously yield more effective and compassionate care for all. Today, after a century of progress that even its founder could not have envisioned, the quest for new knowledge leading to better health care remains the defining mission of Johns Hopkins Medicine.

The original faculty of The Johns Hopkins University School of Medicine, including such pioneers of modern medicine as William H. Welch, William S. Halsted, William Osler and Howard A. Kelly, created a revolutionary new medical curriculum that integrated a rigorous program of basic science education with intensive clinical mentoring. With the opening of The Johns Hopkins Hospital in 1889, followed four years later by the School of Medicine, these founding physicians ushered in a new era in medical education marked by rigid entrance requirements for students, a vastly upgraded curriculum with emphasis on the scientific method, the incorporation of bedside teaching and laboratory research as part of the instruction, and integration of the School of Medicine with the Hospital through joint appointments.

Notable faculty have included: John Jacob Abel – Pharmacologist, John Shaw Billings – Civil War surgeon, pioneering leader in hygiene, Alfred Blalock – Developed field of cardiac surgery, Max Brödel – Acclaimed medical illustrator, William R. Brody – Radiologist, President of the Salk Institute, former President of Johns Hopkins University, Ben Carson – Pediatric Neurosurgeon, awarded the Presidential Medal of Freedom, Denton Cooley – Renowned Cardiovascular surgeon, Harvey Cushing – Father of modern neurosurgery, Catherine Clarke Fenselau – Biochemist and mass spectrometrist, William Halsted – Father of modern surgery, Leo Kanner – Father of child psychiatry, Albert L. Lehninger – Biochemist, Victor McKusick – Developed field of medical genetics, William Osler – Father of modern medicine, Wilder Penfield – Pioneer of epilepsy neurosurgery; developed the cortical homunculus, Peter Pronovost – Anesthesiologst, MacArthur Fellow, Julie A. Freischlag, M.D., the director of the Department of Surgery

2. The large inroads in genetics, genomics and the Human Genome Project attests to the incredible growth in the knowledge base required from which physicians make decisions. But despite the huge competition for entry, a shortage of primary care physicians, and a brain drain for less developed countries, the multicultural profession has had to adjust to a multicultural society into which it has to be integrated. As much as a half century ago, candidates competed for entry on the basis of correlation with their undergraduate performance in organic chemistry.

3. A half century ago, the poor could obtain emergency room care as a primary root of admission, which was likely late in the progression of the illness. This was not then, and is not now an acceptable system.

4. When Medicare came in, physicians accepted it as a reliable source for patients. The same had to be true for hospitals.

5. Managed care began with the building of the Golden Gate Bridge, finished early, and supported by physicians employed by Henry Kaiser. This became a model taken seriously by Eastman Kodak and IBM.

6. It appears be be difficult to predict what will be in place a decade from now. The Republican party is in default mode, and the Supreme Court has appointments that have not earned a lifetime appointment.

7. I can’t see how the reorganizing of medicine, even with NPs and PAs can deal with the healthcare burden without attending to..

children in broken families
a substantial population in prison confinement
dealing with white collar corruption
supporting a minimum standard of living
an improvement in education at a very young age (with parental involvement)
a population that is more than 70% literate

8. There is a young physician population that has a dream and life style that is larger than the ALL MEDICINE and early to rise, late to bed than I have seen for so many years, and compassion has become important, as we don’t have all the answers, or all of the control.

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Proteins and cellular adaptation to stress

Posted in Curation, De novo synthesis, Discovery process, Evolutionary cognition, Experimental validation, Federal Budget Appropriations, Genome Biology, Healthcare costs and reimbursement, Historical relevance, Innovations in Neurophysiology & Neuropsychology, Medicare and Medicaid, Metabolomics, Molecular Genetics & Pharmaceutical, Neurodegenerative Diseases, Nitric Oxide in Health and Disease, Pharmaceutical R&D Investment, Prescription Drugs Costs, Proteomics, Regenerative Biology and Medicine, Translational Science, tagged Alzheimers Disease, Apoptosis, CHOP, ER stress, neurodegeneration, pERK, proapoptotic RD5, Protein folding, REST, TF-XBP1, UPR, UPR-IRE1a on July 8, 2014| Leave a Comment »

Larry H Bernstein, MD, FCAP, Curator

http://pharmaceuticalintelligence/7/8/2014/Proteins and cellular adaptation to stress

There are two recent articles that are, if not interesting, possibly important in the direction of cellular regulation, adaptation, and decline. One deals with apoptosis, or cell death, which is synchronized with recovery of membrane and protein breakdown for reuse in synthesis and maintenance. The other is a new perspective to Alzhemier’s Disease, for which there is no effective pharmacotherapy. In both cases, the stresses of the cell are critical to the responce to the environment. This is not just about the classical transcriptomics story. This is a perfect followup to the just posted research on the regulatory role of a small RNA that is related to, but distinct from silencing RNA, and also the revelations about lncRNA.

Protein Helps Cells Adapt—or Die

Scientists show how cell stress both prevents and promotes cell suicide in a study that’s equally divisive.

By Ruth Williams | July 3, 2014

A cellular stress pathway called the unfolded-protein-response (UPR) both activates and degrades death receptor 5 protein (DR5), which can promote or prevent cell suicide, according to a paper published in Science today (July 3). The theory is that initial stress blocks cell suicide, or apoptosis, to give the cell a chance to adapt, but that if the stress persists, it eventually triggers apoptosis.

“This work has made the most beautiful simplification of all this big complex mess. Basically, they identified and pinpointed the specific protein involved in the switching decision and explain how the decision is made,” said Alexei Korennykh, a professor of molecular biology at Princeton University, who was not involved in the work.

But Randal Kaufman of the Sanford-Burnham Medical Research Institute in La Jolla, California, was not impressed. He questioned the physiological relevance of the experiments supporting the authors’ main conclusions about this key cellular process.

Protein folding in a cell takes place largely in the endoplasmic reticulum (ER), but if the process goes awry, unfolded proteins accumulate, stressing the ER. This triggers the UPR, which shuts down translation, degrades unfolded proteins, and increases production of protein-folding machinery. If ER stress is not resolved, however, the UPR can also induce apoptosis.

Two main factors control the UPR—IRE1a and PERK. IRE1a promotes cell survival by activating the transcription factor XBP1, which drives expression of cell-survival genes. PERK, on the other hand, activates a transcription factor called CHOP, which in turn drives expression of the proapoptotic factor DR5.

Peter Walter of the University of California, San Francisco, and his colleagues have now confirmed that CHOP activates DR5, showing that it is a cell-autonomous process. But they have also found that IRE1a suppresses DR5, directly degrading its mRNA through a process called regulated IRE1a-dependent degradation (RIDD). Inhibition of IRE1a in a human cancer cell line undergoing ER stress both prevented DR5 mRNA decay and increased apoptosis.

However, in an e-mail to The Scientist, Kaufman expressed concern that “the significance of RIDD has not been demonstrated in a physiologically-relevant context.”

Walter insisted that the evidence for RIDD’s existence is “crystal clear.” His only concession was that “the effects aren’t 100 percent,” he said, because “RIDD degrades mRNA by a few-fold,” making it difficult to measure.

This RIDD debate aside, the researchers have also sparked a rumpus with their finding that IRE1a expression switches off just 24 hours after ER stress initiation, leaving PERK to drive the cell toward apoptosis. “We and others have evidence that suggests another model,” said Scott Oakes, a professor of pathology at the University of California, San Francisco, “which is that both PERK and IRE1a under high stress will send out death signals.”

Whether IRE1a promotes or inhibits apoptosis under extreme stress “is controversial,” said Ira Tabas, a professor at Columbia University in New York City. But it’s essential that scientists figure it out. Cell death from ER stress is a pathological process in many major diseases, Tabas said, and there are IRE1a inhibitors in pharmaceutical development. “It is very important because under high stress you have two different views here,” said Oakes. “One is that you want to keep IRE1a on, the other is that you want to shut it off.”

Because ER stress is central to many diseases, “a lot of people are passionate about it,” said Tabas, explaining the polemic views. “Who’s right? . . . I think it depends on the context in which the experiments are done—one pathway may be important in some settings, and another pathway may be important in different settings,” he suggested. What might help to resolve the issues, he said, will be “in vivo causation studies using actual disease models.”

Researchers will continue to debate. So, said Walter, “we’ll have to see what holds-up five years from now.”

M. Lu et al., “Opposing unfolded-protein-response signals converge on death receptor 5 to control apoptosis,” Science, 345:98-101, 2014.

Tags stress response, protein folding, disease/medicine, cell & molecular biology and apoptosis

Protein May Hold the Key to Who Gets Alzheimer’s

By PAM BELLUCK MARCH 19, 2014

It is one of the big scientific mysteries of Alzheimer’s disease: Why do some people whose brains accumulate the plaques and tangles so strongly associated with Alzheimer’s not develop the disease?

Now, a series of studies by Harvard scientists suggests a possible answer, one that could lead to new treatments if confirmed by other research.

The memory and thinking problems of Alzheimer’s disease and other dementias, which affect an estimated seven million Americans, may be related to a failure in the brain’s stress response system, the new research suggests. If this system is working well, it can protect the brain from abnormal Alzheimer’s proteins; if it gets derailed, critical areas of the brain start degenerating.

“This is an extremely important study,” said Li-Huei Tsai, director of the Picower Institute for Learning and Memory at the Massachusetts Institute of Technology, who was not involved in the research but wrote a commentary accompanying the study. “This is the first study that is really starting to provide a plausible pathway to explain why some people are more vulnerable to Alzheimer’s than other people.”

An image of tau tangles in the brain, often a hallmark of Alzheimer’s disease.

The research, published on Wednesday in the journal Nature, focuses on a protein previously thought to act mostly in the brains of developing fetuses. The scientists found that the protein also appears to protect neurons in healthy older people from aging-related stresses. But in people with Alzheimer’s and other dementias, the protein is sharply depleted in key brain regions.

Experts said if other scientists could replicate and expand upon the findings, the role of the protein, called REST, could spur development of new drugs for dementia, which has so far been virtually impossible to treat. But they cautioned that much more needed to be determined, including whether the decline of REST was a cause, or an effect, of brain deterioration, and whether it was specific enough to neurological diseases that it could lead to effective therapies.

“You’re going to see a lot of papers now following up on it,” said Dr. Eric M. Reiman, executive director of the Banner Alzheimer’s Institute in Phoenix, who was not involved in the study. “While it’s a preliminary finding, it raises an avenue that hasn’t been considered before. And if this provides a handle on which to understand normal brain aging, that will be great, too.”

REST, a regulator that switches off certain genes, is primarily known to keep fetal neurons in an immature state until they develop to perform brain functions, said Dr. Bruce A. Yankner, a professor of genetics at Harvard Medical School and the lead author of the new study. By the time babies are born, REST becomes inactive, he said, except in some areas outside the brain like the colon, where it seems to suppress cancer.

While investigating how different genes in the brain change as people age, Dr. Yankner’s team was startled to find that REST was the most active gene regulator in older brains. The researchers have found that this protein, normally active in fetuses, may also protect the neurons in older people. It is not yet possible to measure the levels of this protein that is a gene regulator called REST, in living people.

“Why should a fetal gene be coming on in an aging brain?” he wondered. He hypothesized that it was because in aging, as in birth, brains encounter great stress, threatening neurons that cannot regenerate if harmed.

His team discovered that REST appears to switch off genes that promote cell death, protecting neurons from normal aging processes like energy decrease, inflammation and oxidative stress.

Analyzing brains from brain banks and dementia studies, the researchers found that brains of young adults ages 20 to 35 contained little REST, while healthy adults between the ages of 73 and 106 had plenty. REST levels grew the older people got, so long as they did not develop dementia, suggesting that REST is related to longevity.

But in people with Alzheimer’s, mild cognitive impairment, frontotemporal dementia and Lewy body dementia, the brain areas affected by these diseases contained much less REST than healthy brains.

This was true only in people who actually had memory and thinking problems. People who remained cognitively healthy, but whose brains had the same accumulation of amyloid plaques and tau tangles as people with Alzheimer’s, had three times more REST than those suffering Alzheimer’s symptoms. About a third of people who have such plaques will not develop Alzheimer’s symptoms, studies show.

REST levels dropped as symptoms worsened, so people with mild cognitive impairment had more REST than Alzheimer’s patients. And only key brain regions were affected. In Alzheimer’s, REST steeply declined in the prefrontal cortex and hippocampus, areas critical to learning, memory and planning. Other areas of the brain not involved in Alzheimer’s showed no REST drop-off.

It is not yet possible to analyze REST levels in the brains of living people, and several Alzheimer’s experts said that fact limited what the new research could prove.

John Hardy, an Alzheimer’s researcher at University College London, cautioned in an email that information from post-mortem brains could not prove that a decline in REST caused dementia because death might produce unrelated damage to brain cells.

To investigate further, the team conducted what both Dr. Tsai and Dr. Reiman called a “tour de force” of research, examining REST in mice, roundworms and cells in the lab.

“We wanted to make sure the story was right,” Dr. Yankner said. “It was difficult to believe at first, to be honest with you.”

Especially persuasive was that mice genetically engineered to lack REST lost neurons as they aged in brain areas afflicted in Alzheimer’s.

Dr. Yankner said REST appeared to work by traveling to a neuron’s nucleus when the brain was stressed. In dementia, though, REST somehow gets diverted, traveling with toxic dementia-related proteins to another part of the neuron where it is eventually destroyed.

Experts said the research, while intriguing, left many unanswered questions. Bradley Wise of the National Institute on Aging’s neuroscience division, which helped finance the studies, said REST’s role needed further clarification. “I don’t think you can really say if it’s a cause of Alzheimer’s or a consequence of Alzheimer’s” yet, he said.

Dr. Samuel E. Gandy, an Alzheimer’s researcher at Mount Sinai Medical Center, wondered if REST figured only in neurodegenerative diseases or in other diseases, too, which could make it difficult to use REST to develop specific treatments or diagnostic tests for dementia.

“My ambivalence is, is this really a way that advances our understanding of the disease or does this just tell us this is even more complicated than we thought?” he said.

Dr. Yankner’s team is looking at REST in other neurological diseases, like Parkinson’s. He also has thoughts about a potential treatment, lithium, which he said appears to stimulate REST function, and is considered relatively safe.

But he and other experts said it was too early. “I would hesitate to start rushing into lithium treatment” unless rigorous studies showed that it could forestall dementia, said Dr. John C. Morris, an Alzheimer’s researcher at Washington University in St. Louis.

Still, Dr. Morris said, the REST research the team conducted so far is “very well done, and certainly helps support this idea that we’ve all tried to understand about why Alzheimer’s is age-associated and why, while amyloid is necessary for the development of Alzheimer’s disease, it certainly is not sufficient.”

He added, “There have to be some other processes and triggers that result in Alzheimer’s.”

Correction: March 19, 2014
Because of an editing error, an earlier version of this article misstated the gender of Dr. Li-Huei Tsai. Dr. Tsai is a woman.

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Reason in Hobby Lobby

Posted in Affordable Care Act, Curation, Federal Budget Appropriations, Genome Biology, Health Economics and Outcomes Research, Health Law & Patient Safety, Healthcare costs and reimbursement, Healthcare Reform, Law and Medicine Conflicts, Leadership, Power, Social Interlocking Connections, Personal Health Applications: Tech Innovations serves HealhCare, Personalized and Precision Medicine & Genomic Research, Prescription Drugs Costs, Regenerative Biology and Medicine, Reproductive Andrology, Embryology, Genomic Endocrinology, Preimplantation Genetic Diagnosis and Reproductive Genomics, Reproductive Biology & Bio Instrumentation, Uninsured and Underinsured, tagged aca, autonomy, Hobby Lobby, physician-patient relationship, religion and medicine, Supreme Court of the United States, womens' health on July 8, 2014| Leave a Comment »

Reason in Hobby Lobby

Curator: Larry H. Bernstein, MD, FCAP

This is a Part 4 followup of the Hobby Lobby legal precedent.

Where has the reason gone?

http://pharmaceuticalintelligence.com/2014/07/07/where-has-reason-gone-2/

Justice Ginsberg written dissent – Third Part

http://pharmaceuticalintelligence.com/2014/07/08/justice-ginsberg-written-dissent/

The physicians’ view of Supreme Court on an issue of public health

http://pharmaceuticalintelligence.com/2014/07/08/the-physicians-view-of-supreme-court-on-an-issue-of-public-health/

Reason in Hobby Lobby

http://pharmaceuticalintelligence.com/2014/07/08/reason-in-hobby-lobby/

Reason in Hobby Lobby

Reason #1 SCOTUS Will Regret Hobby Lobby byMan from Wasichustan

After oral arguments in the Hobby Lobby case, I wrote a very misnamed but widely read diary in which I echoed Attorney and Ring of Fire radio host Mike Papantonio’s argument that the SCOTUS would never rule in favor of Hobby Lobby for a really Big Business reason: It pierces the corporate veil. If Hobby Lobby’s owners can give their Corporation religion, their religion gives Hobby Lobby’s owners–and any other owner, shareholder, officer, whatever–liability for the actions of the corporation. Mr. Papantonio, who happens to be one of America’s preeminent trial lawyers, sees it as an opportunity to sue owners for the company’s negligence. Some other people, it turns out, agree with his assessment and expand on what it means….

That separation is what legal and business scholars call the “corporate veil,” and it’s fundamental to the entire operation. Now, thanks to the Hobby Lobby case, it’s in question. By letting Hobby Lobby’s owners assert their personal religious rights over an entire corporation, the Supreme Court has poked a major hole in the veil. In other words, if a company is not truly separate from its owners, the owners could be made responsible for its debts and other burdens. So says Alex Park, writing in Salon today.

“If religious shareholders can do it, why can’t creditors and government regulators pierce the corporate veil in the other direction?” Burt Neuborne, a law professor at New York University, asked in an email. That’s a question raised by 44 other law professors, who filed a friends-of-the-court brief that implored the Court to reject Hobby Lobby’s argument and hold the veil in place. Here’s what they argued: Allowing a corporation, through either shareholder vote or board resolution, to take on and assert the religious beliefs of its shareholders in order to avoid having to comply with a generally-applicable law with a secular purpose is fundamentally at odds with the entire concept of incorporation.

Creating such an unprecedented and idiosyncratic tear in the corporate veil would also carry with it unintended consequences, many of which are not easily foreseen. This is definitely going to complicate things for the religious extremists on the SCOTUS and empire wide as these lawsuits inevitably proliferate. Putting on the popcorn….now.

George Takei’s blistering response to #HobbyLobby: Could a Muslim Corp impose Sharia Law?

(O)ne wonders,” he said, “whether the case would have come out differently if a Muslim-run chain business attempted to impose Sharia law on its employees.” “Hobby Lobby is not a church. It’s a business — and a big one at that,” he continued. “Businesses must and should be required to comply with neutrally crafted laws of general applicability.

Your boss should not have a say over your healthcare. Just as Justice Ginsberg and Mr Takei have suggested, the Hyper-Religious are already attempting to capitalize on the SCOTUS new granting of the rights of an individual to a corporate entity. In this decision the SCOTUS Majority opinion claimed that they were not granting the equal legitimacy of such follow on requests, but they’ve kicked open the door. Takei – bless his soul – also pointed out the basic hypocrisy of Hobby Lobby’s business practices in regards to religion. Noting that… …Hobby Lobby has invested in multiple companies that manufacture abortion drugs and birth control. The company receives most of its merchandise from China, a country where overpopulation has led to mandatory abortions and sterilizations for women who try to have more than one child.

What the battle over birth control is really about byteacherken

in a 2012 piece at Alternet by Sara Robinson. Conservative bishops and Congressmen are fighting a rear-guard action against one of the most revolutionary changes in human history. Robinson suggests 500 years from now looking back, the three great achievements of the 20th Century are likely to be the invention of the integrated circuit (without which the internet does not exist), the Moon landing (which she thinks will carry the same impact as Magellan’s circumnavigation of the globe), and the mass availability of nearly 100% effective contraception.

Free Birth Control is Emerging Standard for Women RICARDO ALONSO-ZALDIVAR, Associated Press 07/07/2014

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Justice Ginsberg Written Dissent

Posted in Affordable Care Act, Evidence-based decision-making, Federal Budget Appropriations, Health Law & Patient Safety, Healthcare costs and reimbursement, Healthcare Reform, Law and Medicine Conflicts, Personal Health Applications: Tech Innovations serves HealhCare, Population Health Management, Genetics & Pharmaceutical, Regenerative Biology and Medicine, Reproductive Andrology, Embryology, Genomic Endocrinology, Preimplantation Genetic Diagnosis and Reproductive Genomics, Reproductive Biology & Bio Instrumentation, Technology Transfer: Biotech and Pharmaceutical, Translational Science, tagged aca, Hobby Lobby, Justice Ginsberg, minority opinion, RFRA, United States Supreme Court, womens' health on July 8, 2014| Leave a Comment »

Justice Ginsberg Written Dissent

Curator and Reporter: Larry H. Bernstein, MD, FCAP

This is the third of a series of four articles on Hobby Lobby and the consequences.

Where has the reason gone?

http://pharmaceuticalintelligence.com/2014/07/07/where-has-reason-gone-2/

Justice Ginsberg written dissent – Third Part

http://pharmaceuticalintelligence.com/2014/07/08/justice-ginsberg-written-dissent/

The physicians’ view of Supreme Court on an issue of public health

http://pharmaceuticalintelligence.com/2014/07/08/the-physicians-view-of-supreme-court-on-an-issue-of-public-health/

Reason in Hobby Lobby

http://pharmaceuticalintelligence.com/2014/07/08/reason-in-hobby-lobby/

Justice Ginsberg Written Dissent

The dissenters deride as unfounded the Court’s new recognition of religious rights for for-profit corporations: Until this litigation, no decision of this Court recognized a for-profit corporation’s qualification for a religious exemption from a generally applicable law, whether under the Free Exercise Clause or RFRA.

The absence of such precedent is just what one would expect, for the exercise of religion is characteristic of natural persons, not artificial legal entities. As Chief Justice Marshall observed nearly two centuries ago, a corporation is “an artificial being, invisible, intangible, and existing only in contemplation of law.

” Trustees of Dartmouth College v. Woodward, 4 Wheat. 518, 636 (1819). Corporations, Justice Stevens more recently reminded, “have no consciences, no beliefs, no feelings, no thoughts, no desires.” Citizens United v. Federal Election Comm’n, 558 U. S. 310, 466 (2010) (opinion concurring in part and dissenting in part). The First Amendment’s free exercise protections, the Court has indeed recognized, shelter churches and other nonprofit religion-based organizations. “For many individuals, religious activity derives meaning in large measure from participation in a larger religious community,” and “furtherance of the autonomy of religious organizations often furthers individual religious freedom as well.” The Court’s “special solicitude to the rights of religious organizations,” however, is just that. No such solicitude is traditional for commercial organizations.

Indeed, until today, religious exemptions had never been extended to any entity operating in “the commercial, profit-making world.” The reason why is hardly obscure. Religious organizations exist to foster the interests of persons subscribing to the same religious faith. Not so of for-profit corporations. Workers who sustain the operations of those corporations commonly are not drawn from one religious community. Indeed, by law, no religion-based criterion can restrict the work force of for-profit corporations.

The distinction between a community made up of believers in the same religion and one embracing persons of diverse beliefs, clear as it is, constantly escapes the Court’s attention. One can only wonder why the Court shuts this key difference from sight. But even if these for-profit corporations can maintain religious beliefs, this doesn’t really burden them: Undertaking the inquiry that the Court forgoes, (dissent) would conclude that

the connection between the families’ religious objections and the contraceptive coverage requirement is too attenuated to rank as substantial. The requirement carries no command that Hobby Lobby or Conestoga purchase or provide the contraceptives they find objectionable.

Instead, it calls on the companies covered by the requirement to direct money into undifferentiated funds that finance a wide variety of benefits under comprehensive health plans. Those plans, in order to comply with the ACA, must offer contraceptive coverage without cost sharing, just as they must cover an array of other preventive services.

Importantly, the decisions whether to claim benefits under the plans are made not by Hobby Lobby or Conestoga, but by the covered employees and dependents, in consultation with their health care providers.

Should an employee of Hobby Lobby or Conestoga share the religious beliefs of the Greens and Hahns, she is of course under no compulsion to use the contraceptives in question. But “[n]o individual decision by an employee and her physician—be it to use contraception, treat an infection, or have a hip replaced—is in any meaningful sense [her employer’s] decision or action.”

It is doubtful that Congress, when it specified that burdens must be “substantia[l],” had in mind a linkage thus interrupted by independent decisionmakers (the woman and her health counselor) standing between the challenged government action and the religious exercise claimed to be infringed. Any decision to use contraceptives made by a woman covered under Hobby Lobby’s or Conestoga’s plan will not be propelled by the Government, it will be the woman’s autonomous choice, informed by the physician she consults.

And let’s be clear: these are truly compelling governmental interests: To recapitulate, the mandated contraception coverage enables women to avoid the health problems unintended pregnancies may visit on them and their children.The coverage helps safeguard the health of women for whom pregnancy may be hazardous, even life threatening. See Brief for American College of Obstetricians and Gynecologists et al. as Amici Curiae 14–15. And the mandate secures benefits wholly unrelated to pregnancy, preventing certain cancers, menstrual disorders, and pelvic pain. …

It bears note in this regard that the cost of an IUD is nearly equivalent to a month’s full-time pay for workers earning the minimum wage; that almost one-third of women would change their contraceptive method if costs were not a factor; and that only one-fourth of women who request an IUD actually have one inserted after finding out how expensive it would be. See also Eisenberg, supra, at S60 (recent study found that women who face out-of-pocket IUD costs in excess of $50 were “11-times less likely to obtain an IUD than women who had to pay less than $50”); Postlethwaite, Trussell, Zoolakis, Shabear, & Petitti, A Comparison of Contraceptive Procurement Pre- and Post-Benefit Change, 76 Contraception 360, 361–362 (2007) (when one health system eliminated patient cost sharing for IUDs, use of this form of contraception more than doubled).

As for the “let the government pay” alternative, the dissenters find it lacking: Impeding women’s receipt of benefits “by requiring them to take steps to learn about, and to sign up for, a new [government funded and administered] health benefit” was scarcely what Congress contemplated. Ibid. More-over, Title X of the Public Health Service Act “is the nation’s only dedicated source of federal funding for safety net family planning services … Safety net programs like Title X are not designed to absorb the unmet needs of . . . insured individuals.”

And where is the stopping point to the “let the government pay” alternative? Suppose an employer’s sincerely held religious belief is offended by health coverage of vaccines, or paying the minimum wage, or according women equal pay for substantially similar work? Does it rank as a less restrictive alternative to require the government to provide the money or benefit to which the employer has a religion-based objection?… Conestoga suggests that, if its employees had to acquire and pay for the contraceptives (to which the corporation objects) on their own, a tax credit would qualify as a less restrictive alternative.

A tax credit, of course, is one variety of “let the government pay.” In addition to departing from the existing employer-based system of health insurance, Conestoga’s alternative would require a woman to reach into her own pocket in the first instance, and it would do nothing for the woman too poor to be aided by a tax credit.

In sum, in view of what Congress sought to accomplish, i.e., comprehensive preventive care for women furnished through employer-based health plans, none of the proffered alternatives would satisfactorily serve the compelling interests to which Congress responded. And, in conclusion, the dissenters warn about what’s next: Hobby Lobby and Conestoga surely do not stand alone as commercial enterprises seeking exemptions from generally applicable laws on the basis of their religious beliefs.

See, e.g.,Newman v. Piggie Park Enterprises, Inc., 256 F. Supp. 941, 945 (SC 1966) (owner of restaurant chain refused to serve black patrons based on his religious beliefs opposing racial integration); In re Minnesota ex rel. McClure, 370 N. W. 2d 844, 847 (Minn. 1985) (born-again Christians who owned closely held, for-profit health clubs believed that the Bible proscribed hiring or retaining an “individua[l] living with but not married to a person of the opposite sex,”

“a young, single woman working without her father’s consent or a married woman working without her husband’s consent,” and any person “antagonistic to the Bible,” including “fornicators and homosexuals” (internal quotation marks omitted)), appeal dismissed, 478 U. S. 1015 (1986) ; Elane Photography, LLC v. Willock, 2013–NMSC–040, _ N. M. _, 309 P. 3d 53 (for-profit photography business owned by a husband and wife refused to photograph a lesbian couple’s commitment ceremony based on the religious beliefs of the company’s owners), cert. denied, 572 U. S. _ (2014).

Would RFRA require exemptions in cases of this ilk? And if not, how does the Court divine which religious beliefs are worthy of accommodation, and which are not? Isn’t the Court disarmed from making such a judgment given its recognition that “courts must not presume to determine . . . the plausibility of a religious claim”? Would the exemption the Court holds RFRA demands for employers with religiously grounded objections to the use of certain contraceptives extend to employers with religiously grounded objections to blood transfusions (Jehovah’s Witnesses); antidepressants (Scientologists); medications derived from pigs, including anesthesia, intravenous fluids, and pills coated with gelatin (certain Muslims, Jews, and Hindus); and vaccinations (Christian Scientists, among others)?

According to counsel for Hobby Lobby, “each one of these cases . . . would have to be evaluated on its own . . . apply[ing] the compelling interest-least restrictive alternative test.” Not much help there for the lower courts bound by today’s decision. … There is an overriding interest, I believe, in keeping the courts “out of the business of evaluating the relative merits of differing religious claims,” or the sincerity with which an asserted religious belief is held. Indeed, approving some religious claims while deeming others unworthy of accommodation could be “perceived as favoring one religion over another,” the very “risk the Establishment Clause was designed to preclude.”

The Court, I fear, has ventured into a minefield by its immoderate reading of RFRA. I would confine religious exemptions under that Act to organizations formed “for a religious purpose,” “engage[d] primarily in carrying out that religious purpose,” and not “engaged . . . substantially in the exchange of goods or services for money beyond nominal amounts.” ORIGINALLY POSTED TO ADAM B ON MON JUN 30, 2014 AT 09:05 AM PDT. TAGS 1st Amendment Affordable Care Act contraceptive mandate Health Care Hobby Lobby Religious Freedom SCOTUS Supreme Court

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Physicians’ View of Supreme Court on an Issue of Public Health

Posted in Affordable Care Act, Curation, Dialectic, Evolutionary cognition, Federal Budget Appropriations, Health Economics and Outcomes Research, Health Law & Patient Safety, Healthcare costs and reimbursement, Healthcare Reform, Historical relevance, Law and Medicine Conflicts, Leadership, Power, Social Interlocking Connections, Medical Devices R&D Investment, Personal Health Applications: Tech Innovations serves HealhCare, Reproductive Biology & Bio Instrumentation, tagged blood transfusion, closely-held corporations, Medical Ethics, medicine, physician-patient relationship, Public health, Religion, reproductive medicine, RFDA, science and religion conflicts, United States Supreme Court, womens' health on July 8, 2014| Leave a Comment »

Physicians’ View of Supreme Court on an Issue of Public Health

Curator: Larry H. Bernstein, MD, FCAP

Where has the reason gone?

http://pharmaceuticalintelligence.com/2014/07/07/where-has-reason-gone-2/

Justice Ginsberg written dissent – Third Part

http://pharmaceuticalintelligence.com/2014/07/08/justice-ginsberg-written-dissent/

The physicians’ view of Supreme Court on an issue of public health

http://pharmaceuticalintelligence.com/2014/07/08/the-physicians-view-of-supreme-court-on-an-issue-of-public-health/

Reason in Hobby Lobby

http://pharmaceuticalintelligence.com/2014/07/08/reason-in-hobby-lobby/

Physicians’ View of Supreme Court on an Issue of Public Health

The physicians are under considerable stress. They have a minimum of 8 years of post graduate university education to practice as a generalist or in a medical, pediatric, gynecological or surgical related specialty. A significant loss is incurred in the cost of loans for education to many. A significant sacrifice is made in time for family. A primary obligation is incurred toward the wellbeing of the patient, and the community that has to be respected and protected by civil law.

Supreme Court Issues Hobby Lobby Decision

By Joyce Frieden, News Editor, MedPage Today Published: Jun 30, 2014

The Supreme Court has struck down the Affordable Care Act requirement that employers must include no-cost contraceptive coverage in employee health insurance plans. The 5-4 decision decision issued today in the Hobby Lobby case (Burwell v. Hobby Lobby Stores, Inc.) follows conflicting appellate court rulings in cases involving businesses that objected to the ACA’s birth control requirement on religious grounds. The businesses said the ACA stepped on their religious freedoms.

The 2010 health law mandates that all health plans provide preventive services — including birth control — free of cost-sharing. But some corporations — most notably arts-and-crafts giant Hobby Lobby and its sister company Mardel, a Christian bookstore chain — sued the Department of Health and Human Services to be exempted from having to comply with the mandate. In its 5-4 decision, written by Justice Samuel Alito, the Court ruled that the mandate violates the Religious Freedom Restoration Act of 1993, “which prohibits the ‘Government [from] substantially burden[ing] a person’s exercise of religion’” unless it shows that doing so is “in furtherance of a compelling governmental interest” and “is the least restrictive means” of doing do. The decision summary also notes that the Department of Health and Human Serivces (HHS) “argues that the companies cannot sue because they are for-profit corporations, and that the owners cannot sue because the regulations apply only to the companies, but that would leave merchants with a difficult choice:

give up the right to seek judicial protection of their religious liberty or forgo the benefits of operating as corporations.

RFRA’s text shows that Congress designed the statute to provide very broad protection for religious liberty and did not intend to put merchants to such a choice.” Donna Harrison, MD, executive director of the American Association of Pro-Life Obstetricians & Gynecologists (AAPLOG), noted that Hobby Lobby was in particular objecting to very specific contraceptives — the emergency contraceptive Ella and intrauterine devices, which she noted are capable of killing embryos, either by preventing their implantation or killing them after they have been implanted.

Art Caplan, PhD, director of the medical ethics division at the NYU Langone Medical Center in New York City, oberved “decision could have a very negative impact” on women’s ability to obtain contraception, and “it could affect many women even if only a small percentage of companies followed suit.” “The other problem,” he told MedPage Today in a video interview, “is that if your employer says ‘I’m not covering contraception,’ you may decide to go with methods that don’t involve pharmaceutical control, or you may rely on something like emergency contraception” — decisions that could lead to more abortions, which would be

an ironic outcome since many employers’ objections to contraception revolve around their objections to abortion.

Harrison, of AAPLOG, noted that the decision should be reassuring to physicians who object to prescribing particular forms of contraception that they see as abortifacients, since insurers may have been considering excluding such doctors from their provider networks if the mandate had been upheld. “This will help incentivize insurers to not exclude ‘conscientious doctors’ from their networks,” she said.

More Physician Groups Weigh In

Many of the other physician groups issuing statements today expressed disappointment in the ruling.

“Allowing for-profit employers to exclude coverage for contraception is itself deeply concerning because of the demonstrated adverse impact it will have on women’s health,” David Fleming, MD, president of the American College of Physicians, said in a statement. “And, “the ruling clearly does not preclude for-profit employers from challenging such mandates (vaccinations), or the courts from granting further coverage exemptions.”

Rebecca Sokol, MD, president of the American Society for Reproductive Medicine in Washington, said in a statement that her organization “profoundly disagrees” with the decision. “Allowing an employer to impose their beliefs about reproduction on their staff is simply wrong, particularly when those beliefs are

so clearly misinformed on the scientific and medical facts,” Sokol said.

“In no other field of medicine do we allow employers to substitute their judgment for that of patients and physicians; it should not be allowed just because the subject matter is reproduction.”

Between Women and Their Physicians

Lin-Fan Wang, MD, reproductive health advocacy fellow at Physicians for Reproductive Health in New York City, said in a video interview that

“decisions about contraception should really be made between a woman and her doctor, and not by her employer.”

Wang recounted the story of one of her own patients, a woman who had recently had a baby and then went back to work, and was having trouble remembering to take her birth control pills. “She chose one of the intrauterine devices … because it was one of the most effective forms of contraception and she didn’t have to think about it every day,” she said. “Luckily her insurance plan covered the cost of this very expensive form of contraception, but

under the ruling today, patients like [her] might not be able to choose that method

and she may end up having to choose a method that is hard for her to take or she’s not happy with.” Reproductive rights groups also expressed their concerns. Bebe Anderson, JD, director of the U.S. Legal Program at the Center for Reproductive Rights in New York City, called the decision “an affront to women of this country.”

“As Justice [Ruth Bader] Ginsburg recognized in her dissent, this decision makes it very difficult for women to get some of the best long-acting reversible forms of contraception,” Anderson told MedPage Today in a video interview. “For example, IUDs are as expensive as 1 month’s pay for someone working at minimum wage.”

Cecile Richards, president of the Planned Parenthood Action Fund, called the ruling “stunning.” On a call with reporters she said it was no coincidence that the majority opinion was decided by five male justices. “It is endlessly frustrating for women that decisions about their healthcare are being made by people who never need to use birth control, and it is no coincidence that all three women on the court signed today’s dissent,” Richards said. On the same call, Marcia Greenberger, co-president of the National Women’s Law Center, said the decision was “a bitter pill for women to swallow …These [plaintiffs] and other closely held companies

will now have license to harm their female employees in the name of the company’s religion, and
ignore the moral and practical considerations of women themselves.”

Other Implications

Several commenters noted that, although the majority opinion specifically states that this ruling does not apply to religious objections to other healthcare benefits such as vaccinations and blood transfusions, this opens up the way for plaintiffs to sue about those as well. “Regardless of what they said, they’ve opened Pandora’s box and set a precedent,” said Ilyse Hogue, president of NARAL Pro-Choice America. The Tenth Circuit Court of Appeals in Denver ruled in June 2013 that

Hobby Lobby should be given the opportunity to show its religious beliefs would be violated by either complying with the law or being forced to pay large fines.

Hobby Lobby faced penalties amounting to $1.3 million a day starting in the summer of 2013 if it didn’t provide FDA-approved contraceptive methods in its self-insured health plans, which cover 13,000 employees. But a court issued an injunction in July that prevented the penalty from taking effect.

A rule from HHS finalized last summer exempted churches and other nonprofit religious organizations that object to contraceptive coverage. But private businesses such as Hobby Lobby weren’t exempt. UPDATE: This article, originally published on June 30 at 10:18 EDT, was updated with new material at 19:12 EDT.

When Religious Freedom Clashes with Access to Care

Glenn Cohen, J.D., Holly Fernandez Lynch, J.D., M.Bioethics, and Gregory D. Curfman, M.D.

July 2, 2014 DOI: 10.1056/NEJMp1407965

At the tail end of this year’s Supreme Court term, religious freedom came into sharp conflict with the government’s interest in providing affordable access to health care. In a consolidated opinion inBurwell v. Hobby Lobby Stores and Conestoga Wood Specialties Corp. v. Burwell (collectively known as Hobby Lobby) delivered on June 30, the Court sided with religious freedom, highlighting the limitations of our employment-based health insurance system.

Hobby Lobby centered on the contraceptives-coverage mandate, which derived from the Affordable Care Act (ACA) mandate that many employers offer insurance coverage of certain “essential” health benefits, including coverage of “preventive” services without patient copayments or deductibles. The ACA authorized the Department of Health and Human Services (HHS) to define the scope of those preventive services, a task it delegated to the Institute of Medicine, whose list included all 20 contraceptive agents approved by the Food and Drug Administration. HHS articulated various justifications for the resulting mandate, including the fact that many Americans have difficulty affording contraceptives despite their widespread use and

the goal of avoiding a disproportionate financial burden on women.

Under the regulation, churches are exempt from covering contraception for their employees, and nonprofit religious organizations may apply for an “accommodation,” which shifts to their insurance companies (or other third parties) the responsibility for providing free access. However,

HHS made no exception for for-profit, secular businesses with religious owners.

Hobby Lobby, a craft-store chain with more than 13,000 employees, is a closely held, for-profit corporation owned by a Protestant family that operates the business in accordance with its Christian principles — for example, donating a portion of proceeds to Christian missions and remaining closed on Sundays. The family does not object to providing coverage for some contraceptives, but

it challenged the mandate because it includes contraceptive methods that the family believes cause abortion by preventing implantation of a fertilized egg.

The challenge in Hobby Lobby was not about the Constitution or its First Amendment. Rather, it hinged on the Religious Freedom Restoration Act of 1993 (RFRA), which was Congress’s response to a Supreme Court decision holding that

even if a law in fact burdened religion, it could stand as long as it was not intended to burden religion (was “neutral”),
applied without regard to religious beliefs or practices (was “generally applicable”), and
was rationally related to a legitimate government interest — a low bar.

RFRA applies when a federal law is deemed to “substantially” burden a person’s exercise of religion, even if it is neutral and generally applicable. Such laws may be enforced against religious objectors only when they further a compelling government interest using the least restrictive means available. This is the most demanding standard of judicial review, and few laws meet its requirements. In a 5-to-4 decision the Court found that the contraceptives-coverage mandate did not.

In its RFRA analysis, the Court had to address several key questions:

Are closely held, for-profit corporations “persons” for the purposes of RFRA protection?
Can corporations exercise religion?
Does the contraceptives-coverage mandate substantially burden religion?
Does the mandate advance a compelling government interest? And
are there less restrictive alternatives that would achieve the same result?

In a ruling in which Justice Samuel Alito wrote for the majority (joined by Chief Justice John Roberts and Justices Antonin Scalia, Anthony Kennedy, and Clarence Thomas), the mandate came up short. The majority concluded that RFRA was intended to protect even for-profit corporations and that

corporations may exercise religion,
rejecting as unreasonable any definition of “person” that would include some but not all corporations.

The majority also concluded that the mandate did place a substantial burden on the companies’ religious beliefs, given the dramatic financial consequences of noncompliance (for example, Hobby Lobby would have faced a fine of $475 million per year) and

the fact that the government had extended other exemptions and accommodations in recognition of that burden.

The majority assumed that the government has a compelling interest in promoting free access to contraceptive agents, but it held that

the government had failed to advance that interest in the least restrictive way, given
the possibility of extending its existing exemptions and accommodations to for-profit corporations

Thus, the Court held that as applied to closely held, for-profit corporations with religious objections, the mandate violates RFRA. It was careful, however, to restrict the decision to the case before it, refraining from opining on the implications for other types of employers or objections to other health care services, which it cautioned must be addressed on a case-by-case basis. Nonetheless, the case may have broad practical impact, since

approximately 90% of all U.S. companies are closely held, and
“closely held” is not synonymous with “small.”

Justice Ruth Bader Ginsburg issued a sharp dissent, in which she was joined by Justice Sonia Sotomayor and in large part by Justices Elena Kagan and Stephen Breyer. Delivering her opinion from the bench, Justice Ginsburg underscored the burden that the majority decision would allow to be placed on women in favor of religious objectors:

“Today’s potentially sweeping decision . . . discounts the disadvantages religion-based opt outs impose on others, in particular, employees who do not share their employer’s religious beliefs.”

Hobby Lobby‘s outcome is of concern to U.S. health care professionals because

our health insurance system is still largely dependent on employers.
Employers and employees may have fundamentally different perspectives on which medical interventions are acceptable,
particularly when the employer’s fundamental mission is not to advance specific religious beliefs and
- its employees are therefore unlikely to be drawn exclusively from its own religious group.

The Court’s decision allows the beliefs of employers of various sizes and corporate forms to trump the beliefs and needs of their employees, potentially influencing the types of care that will be affordable and accessible to individuals and permitting employers to intrude on clinician–patient relationships.

The case also has important implications for efforts to achieve compromise between religious freedom and health care access. The Obama administration’s attempts to compromise on the contraceptives-coverage mandate ultimately backfired, since its efforts were used to demonstrate that

applying the mandate even to secular employers was not necessarily the only way to achieve the government’s interests.

In the future, regulators may be less willing to seek compromise lest their efforts be similarly used against them — and it is bad news for all of us if health policy can be made only through polarization and rancor rather than compromise. On the other hand, in other contraceptives-mandate cases working their way through the courts, nonprofit religious employers argue that the government’s accommodations do not go far enough in protecting their religious freedom, essentially requiring them to deputize a third party to commit what they think is a sin on their behalf.

Finally, in the wake of Hobby Lobby, we may anticipate challenges to other medical services that some religions find objectionable, such as vaccinations, infertility treatments, blood transfusions, certain psychiatric treatments, and even hospice care. Hobby Lobby‘s implications may also extend into civil rights law, with employers asking to “opt out” of laws intended to protect people from employment and housing discrimination based on religion, race, sex, national origin, or pregnancy status. Although the majority deemed these slippery-slope concerns unrealistic, the dissent expressed serious concerns.

Though the decision applies only to closely held, for-profit corporations, it sets a precedent for religious exemptions that could have sweeping implications — and reflects the Supreme Court’s great potential impact on U.S. health care. Yet the Court was applying Congress’s statute, and

Congress could, if it chose, scale back the protection offered to religious objectors — a good reason to share public reactions to the decision with our elected representatives.

BUFFER ZONES, BUBBLE ZONES, AND ABORTION CLINICS — ANOTHER WOMEN’S HEALTH CASE

In 2000, concerned about clashes between antiabortion protesters and women seeking abortions, the Massachusetts legislature established an 18-ft radius around the entrances and driveways of facilities providing abortions and specified that within that area, no person could, without consent, approach within 6 ft of another person (a so-called “bubble zone”) for the purpose of protesting, leafleting, counseling, or education. In 2007, the legislature concluded that law was not effective enough and increased its stringency, imposing a 35-ft fixed buffer zone with few exceptions. The law was challenged on free-speech grounds in a case called McCullen v. Coakley, and on June 26, 2014, the U.S. Supreme Court unanimously struck it down as unconstitutional.

The lead opinion by Chief Justice John Roberts, joined by four other justices, noted that sidewalks and public ways hold a “special position in terms of First Amendment protection because of their historic role as sites for discussion and debate.” Although it was abortion that had motivated the statute, the Court held that the law was content- and viewpoint-neutral: it did not focus on what was said but on where it was said, and it burdened all speech, not merely disfavored speech.

On this point, the four remaining justices disagreed. Nevertheless, the Court held that the statute failed the second part of the relevant constitutional test because it was not “narrowly tailored to serve a significant governmental interest.” In particular, though the Court recognized that the buffer zones furthered the state’s interests in “ensuring public safety” on streets and sidewalks and in “preserving access to adjacent healthcare facilities,” it determined that

the law problematically criminalized not only protests,
but also sidewalk counseling, which could not be done at a distance of 35 ft.
It also found that the buffer zones burdened “substantially more speech than necessary to achieve” the state’s interest

and suggested a plethora of less intrusive means the state could have used instead, some of which are used in other states.

Although the decision deals another blow to abortion rights, that blow is not as substantial as some had feared: the finding that the law was content- and viewpoint-neutral allows for the possibility that Massachusetts and other states could pass similar but narrower laws. Moreover, the Court left open the future of the floating “bubble zone” around women approaching clinics for abortions — the strategy that Massachusetts had used from 2000 to 2007 and one that the Court upheld in a Colorado case in 2000. Several justices, however, indicated a willingness to revisit that decision in future litigation.

See §§2000bb–1(a), (b) (requiring the Government to “demonstrat[e] that application of [a substantial] burden to the person . . . is the least restrictive means of furthering [a] compelling governmental interest” (emphasis added)).

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Immune activation, immunity, antibacterial activity

Posted in Biological Networks, Gene Regulation and Evolution, Federal Budget Appropriations, Genome Biology, Health Economics and Outcomes Research, Healthcare costs and reimbursement, Human Immune System in Health and in Disease, Infectious Disease & New Antibiotic Targets, Molecular Genetics & Pharmaceutical, Neutrophilia, Pharmaceutical Analytics, Pharmaceutical Discovery, Pharmaceutical Drug Discovery, Pharmaceutical R&D Investment, Pharmacogenomics, Platelet count disorder, Population Health Management, Genetics & Pharmaceutical, Prescription Drugs Costs, Proteomics, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Systemic Inflammatory Response Related Disorders, Technology Transfer: Biotech and Pharmaceutical, Translational Effectiveness, Translational Research, Translational Science, tagged 8-OXO dG, antimicrobial therapy, autoimmunity, cGAMP, DAMP, immune activation, innate immunity, microbiota, PAMPs, ribonuclease TREX1 on July 6, 2014| Leave a Comment »

Larry H. Bernstein, MD, FCAP, Curator

http://pharmaceuticalintelligence.com/6/7/2014/Immune activation, immunity, antibacterial activity

This segment is an update on activation of innate immunity, which has had a great amount of basic science resurgence in the last several decades. It also addresses the issue of antibiotic resistance, which shall be covered more fully in later segments. Antimicrobial resistance is a growing threat, and a challenge to the pharmaceutical industry. Moreover, worldwide travel increases the possibility of transfer of strains of virus and microbiota to distant communities.

8-OH-dG: A novel immune activator.

Innate immunity against viral or pathogenic infection involves sensing of non-self-molecules, otherwise known at pathogen-associated molecular patterns (PAMPs). This same sensing mechanism can be applied to damaged self-molecules, which are called damage-associated molecular patterns (DAMPs). One type of molecular pattern, for both groups, is cytosolic or extracellular DNA. However, there is not an extensive amount of research showing specifically what type of DAMP DNA molecule is best at activating this immune sensing response. A recent study investigated the mechanism behind how oxidized DNA from UV damage activates an immune sensing response.

A group of researchers found that, compared to a variety of types of cellular damage, damage from UV irradiation created a strong immune response (type I IFN response), seen across different types of immune regulatory cells. This was compared with freeze/thaw, physical damage and nutritional deprivation, each of which did not produce a noticeable immune response. Additionally, this immune response was seen when DNA was exposed to UV-A and UV-B (the type of radiation produced by our sun) and UV-C radiation.

DNA can be damaged by UV light directly, or through reactive oxygen species (ROS) caused by UV light. A well-known mark of DNA damaged by ROS is the oxidation of guanine to create 8-hydroxyguanine (8-OH-dG). These researchers saw an increase in 8-OH-dG dependant on the level of UV dose, and this also correlated with an increase in immune response; showing that DNA damage created by UV light in the form of 8-OH-dG is sufficient to activate an immune response. This study shows that 8-OH-dG can be classified at a DAMP.

Next, this group wanted to place a mechanism to these observations. They found that the ability of oxidation-damaged DNA to activate an immune response was dependant on cGAS and STING. Free DNA in the cytosol binds cGAS, a cGAMP synthase. This action produces a messenger molecule which proceeds to bind to and activate STING, an endoplasmic reticulum protein. STING activation will ultimately stimulate a type I IFN response.

When a cell’s own DNA is damaged, the cell’s machinery does all it can to repair it. This sometimes involves erasing, or degrading, the DNA that has been damaged. The enzyme, TREX1 exonuclease, has this job in a cell. However, this group found that when DNA was modified with an 8-OH-dG, it was resistant to this degradation by TREX1. This implies that the observed increase in immune response due to the presence of 8-OH-dG occurred because of an accumulation of damaged DNA, because it was not being degraded by TREX1 and could therefore sufficiently activate cGAS and STING.

This type of study has important implications for autoimmune diseases like lupus erythematosus (LE), which is characterized by its abnormally high number of autoantibodies against DNA. It is possible that this uncontrollable immune response is activated by oxidation-damaged DNA. Studies in this area, therefore, hold great importance.

– See more at: http://www.stressmarq.com/Blog/November-2013/8-OH-dG-A-novel-immune-activator.aspx#sthash.CvSdK0H1.dpuf

Oxidative Damage of DNA Confers Resistance to Cytosolic Nuclease TREX1 Degradation and Potentiates STING-Dependent Immune Sensing

Nadine Gehrke, Christina Mertens, Thomas Zillinger, Jörg Wenzel,…,Winfried Barchet

DOI: http://dx.doi.org/10.1016/j.immuni.2013.08.004

Highlights

•UV or ROS damage potentiates immunorecognition of DNA via cGAS and STING
•The oxidation product 8-OHG in DNA is sufficient for enhanced immunorecognition
•Oxidized self-DNA acts as a DAMP and induces skin lesions in lupus-prone mice
•Oxidized DNA is resistant to cytosolic nuclease TREX1-mediated degradation

Summary

Immune sensing of DNA is critical for antiviral immunity but can also trigger autoimmune diseases such as lupus erythematosus (LE). Here we have provided evidence for the involvement of a damage-associated DNA modification in the detection of cytosolic DNA. The oxidized base 8-hydroxyguanosine (8-OHG), a marker of oxidative damage in DNA, potentiated cytosolic immune recognition by decreasing its susceptibility to 3′ repair exonuclease 1 (TREX1)-mediated degradation. Oxidizative modifications arose physiologically in pathogen DNA during lysosomal reactive oxygen species (ROS) exposure, as well as in neutrophil extracellular trap (NET) DNA during the oxidative burst. 8-OHG was also abundant in UV-exposed skin lesions of LE patients and colocalized with type I interferon (IFN). Injection of oxidized DNA in the skin of lupus-prone mice induced lesions that closely matched respective lesions in patients. Thus, oxidized DNA represents a prototypic damage-associated molecular pattern (DAMP) with important implications for infection, sterile inflammation, and autoimmunity.

ribonuclease TREX1 and immunity

Immunity 19 Sep 2013;39(3), p482–495,

New Weapon in Fight Against ‘Superbugs’

Some harmful bacteria are increasingly resistant to treatment with antibiotics. A discovery might be able to help the antibiotics treat the disease.

By ANN LUKITS June 30, 2014 8:47 p.m. ET

Some harmful bacteria are increasingly resistant to treatment with antibiotics. This common fungus found in soil might be able to help the antibiotics combat diseases. Corbis

A soil sample from a national park in eastern Canada has produced a compound that appears to reverse antibiotic resistance in dangerous bacteria.

Scientists at McMaster University in Ontario discovered that the compound almost instantly turned off a gene in several harmful bacteria that makes them highly resistant to treatment with a class of antibiotics used to fight so-called superbug infections. The compound, called aspergillomarasmine A, or AMA, was extracted from a common fungus found in soil and mold.

Antibiotic resistance is a growing public-health threat. Common germs such asEscherichia coli, or E. coli, are becoming harder to treat because they increasingly don’t respond to antibiotics. Some two million people in the U.S. are infected each year by antibiotic-resistant bacteria and 23,000 die as a result, according to the Centers for Disease Control and Prevention. The World Health Organization has called antibiotic resistance a threat to global public health.

The Canadian team was able to disarm a gene—New Delhi Metallo-beta-Lactamase-1, or NDM-1—that has become “public enemy No. 1” since its discovery in 2009, says Gerard Wright, director of McMaster’s Michael G. DeGroote Institute for Infectious Disease Research and lead researcher on the study. The report appears on the cover of this week’s issue of the journal Nature.

“Discovery of a fungus capable of rendering these multidrug-resistant organisms incapable of further infection is huge,” says Irena Kenneley, a microbiologist and infectious disease specialist at Frances Payne Bolton School of Nursing at Cleveland’s Case Western Reserve University. “The availability of more treatment options will ultimately save many more lives,” says Dr. Kenneley, who wasn’t involved in the McMaster research.

The McMaster team plans further experiments to determine the safety and effective dosage of AMA. It could take as long as a decade to complete clinical trials on people with superbug infections, Dr. Wright says.

The researchers found that AMA, extracted from a strain of Aspergillus versicolor and combined with a carbapenem antibiotic, inactivated the NDM-1 gene in three drug-resistant superbugs—Enterobacteriaceae, a group of bacteria that includes E. coli;Acenitobacter, which can cause pneumonia and blood infections; and Pseudomonas, which often infect patients in hospitals and nursing homes. The NDM-1 gene encodes an enzyme that helps bacteria become resistant to antibiotics and that requires zinc to survive. AMA works by removing zinc from the enzyme, freeing the antibiotic to do its job, Dr. Wright says. Although AMA was only tested on carbapenem-resistant bacteria, he expects the compound would have a similar effect when combined with other antibiotics.

AMA was first identified in the 1960s in connection with leaf wilt in plants and later investigated as a potential drug for treating high blood pressure. The compound turned up in Dr. Wright’s lab a few years ago during a random screening of organisms derived from 10,000 soil samples stored at McMaster. The sample that produced AMA was collected by one of Dr. Wright’s graduate students during a visit to a Nova Scotia park. It was the only sample of 500 tested that inhibited NDM-1 in cell cultures.

“It was a lucky hit,” says Dr. Wright. “It tells us that going back to those environmental organisms, where we got antibiotics in the first place, is a really good idea.”

The McMaster team developed a purified form of AMA for experiments on mice injected with a lethal form of drug-resistant pneumonia. Treatment with either AMA or a carbapenem antibiotic alone proved ineffective. But combining the substances resulted in more than 95% of the mice still being alive after five days. The combination was also tested on 229 cell cultures from human patients infected with resistant superbugs. The treatment resensitized 88% of the samples to carbapenem.

Still, bacteria could someday find a way to outwit AMA. “I can’t imagine anything we could make where resistance would never be an issue,” he says. “At the end of the day, this is evolution and you can’t fight evolution.”

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Where has reason gone?

Posted in Accountable Care Organizations, Affordable Care Act, Federal Budget Appropriations, Health Economics and Outcomes Research, Health Law & Patient Safety, Healthcare costs and reimbursement, Law and Medicine Conflicts, Population Health Management, Genetics & Pharmaceutical, Reproductive Biology & Bio Instrumentation, tagged Closely held, Definition of Corporate entity, Hobby Lobby, Individual protection, Religion, Science and belief, Supreme Court on July 5, 2014| Leave a Comment »

Larry H. Bernstein, MD, FCAP, Wtiter and Curator

http:///pharmaceuticalintelligence.com/5/7/2014/where_has_reason_gone?

Update 8 July 2014

This will be a series of presentations on the Supreme Court decision on Hobby Lobby, it’s impact, and the distamce it places on Chief Justic Roberts’ decision to go with a 5-4 majority after this year achieving a direction of concensus largely undivided decisions. Both Justice Kennedy and Chief Justice Roberts could have taken a different position with a much appreciated decision, or the alternative was to send the case back to the lower court. That did not happen, and the consequences are unfolding.

Where has the reason gone?
Justice Ginsberg written dissent
The physicians’ view of Supreme Court on an issue of public health
Reason in Hobby Lobby

We are in a period of widespread instability that is bereft of comprehensibility, not just in Asia, the Middle East, and Africa, but also imposing constrainsts on our constitutional government. This web sight is concerned with science and also health. Science is challenged to figure out the complexity of biology and the physical world. But it has been challenged for centuries by an uncompromizing view of how to organize a society, driven by hatred and violence, and excused by fanatical views. We have a most advanced society in the US, self selected to be the leader of nations. Yet we have a separation of powers in the presidency, two houses of Congress, and a judiciary that cannot function for the good of the people. The Congress is at war within itself , unable to carry out its obligations, and only functioning to blockade the presidential authority.

But most disconcerting is a third branch, the judiciary, with Supreme Court Justices, all of whom are political appointmnt for LIFE, and half of who have shown sufficient incompetence to wonder how they can stay in office. Perhaps, what we don’t have to keep them in line is a periodic review of performance by the American Association of Legal Constitutional Scholars. What we have is as good as it gets, but not good enough. I refrain from saying more, and proceed to the most recent ABSURD events. In the Hobby Lobby case, the Court’s conservative majority held that closely held corporations are entitled to some of the same religious rights as people. That means corporations can decide whether or not birth control is covered in the health plans of female employees. Corporations are not people, period. A boss’s religious views should not trump a physician’s medical judgement or a woman’s considered need .

The White House must move fast on expanding contraception coverage.

One proposal…would assign companies’ insurers or health plan administrators for contraceptive coverage… Another would give the administration itself a larger role.” Robert Pear and Adam Liptak in The New York Times.

A rare but potentially important dissent?

“Dissents to Supreme Court orders are rare, and a 17-page dissent to a curt, four-paragraph order is extraordinary. But Sotomayor is on to something: What the majority did in Hobby Lobby, was to allow the plaintiff also to determine what constitutes a ‘substantial burden’ upon it.” Daniel Fisher in Forbes.

Here’s what everyone has been missing in this debate.

“Ginsburg, in her scathing dissent…made an important point about women’s health that’s been almost entirely overlooked elsewhere: For many American women, the birth-control pill has nothing to do with controlling births. It’s a life-saving medicine….The decision…may affect millions of women who suffer from a variety of medical conditions. These women depend on the pill to regulate their hormones and do everything from ease pain to reduce the risk of cancer. These medical benefits have nothing to do with sex or the prevention of pregnancy….Even if these women never have sex once in their lives, they need to be on birth control.” Lucia Graves in National Journal.

“The share of privately insured women who got their birth control pills without a copayment jumped to 56 percent, from 14 percent in 2012. The law’s requirement that most health plans cover birth control as prevention, at no additional cost to women, took full effect in 2013. The average annual saving for women was $269.” Ricardo Alonso-Zaldivar in the Associated Press.

In Hobby Lobby, Supremes grant religious objection rights to for-profit corporations.

by Adam B In a widely-awaited-but-still-85 percent-as-sucky-as-you-feared 5-4 decision this morning,the Supreme Court of the United States has held that for-profit corporations are “persons” for purposes of the Religious Freedom Restoration Act, and that their religious rights were unduly burdened by the contraceptive mandate provisions of the Affordable Care Act. Because the contraceptive mandate was not the least restrictive means available for the government to provide such coverage—in the Court’s mind, the Government could just assume the costs itself, and already provided an opt-out for religious non-profit employers—the mandate on private employers violates the law. The Court was careful to limit its opinion (in theory) to these facts.

It applies only to closely held corporations, and not publicly traded ones.
It applies to the contraceptive mandate and
not religious objections to all laws in general,

believing that the “compelling interest” struck a sensible balance between religious liberty and competing prior governmental interests. But … we’ll see about that. Justice Ginsburg, writing for the four dissenting Justices, refers to the decision thusly:

In a decision of startling breadth, the Court holds that commercial enterprises, including corporations, along with partnerships and sole proprietorships, can opt out of any law (saving only tax laws) they judge incompatible with their sincerely held religious beliefs.

Compelling governmental interests in uniform compliance with the law, and disadvantages that religion-based opt-outs impose on others, hold no sway, the Court decides,

at least when there is a “less restrictive alternative.”

And such an alternative, the Court suggests, there always will be whenever, in lieu of tolling an enterprise claiming a religion-based exemption, the government, i.e., the general public, can pick up the tab….

Religious organizations exist to serve a community of believers.

For-profit corporations do not fit that bill.

Moreover, history is not on the Court’s side. Recognition of the discrete characters of “ecclesiastical and lay” corporations dates back to Blackstone, see 1 W. Blackstone, Commentaries on the Laws of England 458 (1765), and was reiterated by this Court centuries before the enactment of the Internal Revenue Code. See Terrett v. Taylor, 9 Cranch 43, 49 (1815) (describing religious corporations); Trustees of Dartmouth College, 4 Wheat., at 645 (discussing “eleemosynary” corporations, including those “created for the promotion of religion”). To reiterate,

“for-profit corporations are different from religious non-profits in that they use labor to make a profit, rather than to perpetuate [the] religious value[s] [shared by a community of believers].”

Let’s be clear, explains Justice Alito for the five majority opinion, corporations are people too (in aggregate) (for purposes of this statute): As we will show,

Congress provided protection for people like the Hahns and Greens by employing a familiar legal fiction: It included corporations within RFRA’s definition of “persons.”

It is important to keep in mind that the purpose of this fiction is to provide protection for human beings. A corporation is simply a form of organization used by human beings to achieve desired ends. An established body of law specifies the rights and obligations of the people (including shareholders, officers, and employees) who are associated with a corporation in one way or another. When rights, whether constitutional or statutory, are extended to corporations, the purpose is to protect the rights of these people. For example, extending Fourth Amendment protection to corporations protects the privacy interests of employees and others associated with the company. Protecting corporations from government seizure of their property without just compensation protects all those who have a stake in the corporations’ financial well-being. And … protecting the free-exercise rights of corporations like Hobby Lobby, Conestoga, and Mardel protects the religious liberty of the humans who own and control those companies…

This statement extends the rights beyond the statement above in that it cannot apply to a closely held corporation with only the owner having fiduciary interest

Indeed, the opinion claims, you can go back over 50 years and find the Court not questioning that a for-profit corporation’s had religious rights— in that 1961 case, a kosher supermarket seeking the right to be open on Sundays despite Massachusetts blue laws. [To which the dissent counters, “The suggestion is barely there. True, one of the five challengers to the Sunday closing law … was a corporation owned by four Orthodox Jews. The other challengers were human individuals, not artificial, law-created entities, so there was no need to determine whether the corporation could institute the litigation.”]

The Court insists that this isn’t something publicly traded companies are going to get involved in. We could use corporate law principles to suss out what their religious beliefs are: HHS contends that Congress could not have wanted RFRA to apply to for-profit corporations because it is difficult as a practical matter to ascertain the sincere “beliefs” of a corporation. HHS goes so far as to raise the specter of “divisive, polarizing proxy battles over the religious identity of large, publicly traded corporations such as IBM or General Electric.” These cases, however, do not involve publicly traded corporations, and it seems unlikely that the sort of corporate giants to which HHS refers will often assert RFRA claims. HHS has not pointed to any example of a publicly traded corporation asserting RFRA rights, and numerous practical restraints would likely prevent that from occurring. For example,

the idea that unrelated shareholders—including institutional investors with their own set of stakeholders—would agree to run a corporation under the same religious beliefs seems improbable. In any event, we have no occasion in these cases to consider RFRA’s applicability to such companies.
The companies in the cases before us are closely held corporations, each owned and controlled by members of a single family, and no one has disputed the sincerity of their religious beliefs.

HHS has also provided no evidence that the purported problem of determining the sincerity of an asserted religious belief moved Congress to exclude for-profit corporations from RFRA’s protection…. HHS and the principal dissent express concern about the possibility of disputes among the owners of corporations, but that is not a problem that arises because of RFRA or that is unique to this context. The owners of closely held corporations may—and sometimes do—disagree about the conduct of business. Even if RFRA did not exist, the owners of a company might well have a dispute relating to religion…. Courts will turn to that structure and the underlying state law in resolving disputes.

So, what about the contraceptive mandate?

Interestingly, the Court concedes for sake of argument that it serves a compelling state interest. But, still, that’s not enough. By requiring the Hahns and Greens and their companies to arrange for such coverage, the HHS mandate demands that they engage in conduct that seriously violates their religious beliefs. If the Hahns and Greens and their companies do not yield to this demand, the economic consequences will be severe. If the companies continue to offer group health plans that do not cover the contraceptives at issue, they will be taxed $100 per day for each affected individual. For Hobby Lobby, the bill could amount to $1.3 million per day or about $475 million per year; for Conestoga, the assessment could be $90,000 per day or $33 million per year; and for Mardel, it could be $40,000 per day or about $15 million per year. These sums are surely substantial. … Are their religious beliefs loony? The Court’s not going to look into that.

The sincerity is what counts, and that creates a burden: …If I may ask—how do you measure sincerity?

How much it will spend on litigating its case!

The Hahns and Greens believe that providing the coverage demanded by the HHS regulations is connected to the

destruction of an embryo in a way that is sufficient to make it immoral for them to provide the coverage.

This belief implicates a difficult and important question of religion and moral philosophy, namely, the circumstances under which it is wrong for a person to perform an act that is innocent in itself but that has the effect of enabling or facilitating the commission of an immoral act by another.

Arrogating the authority to provide a binding national answer to this religious and philosophical question, HHS and the principal dissent in effect tell the plaintiffs

that their beliefs are flawed. …
we have repeatedly refused to take such a step.

See, e.g., Smith, 494 U. S., at 887 (“Repeatedly and in many different contexts, we have warned that courts must not presume to determine . . . the plausibility of a religious claim”)

Incredible!! So, RFRA applies, there’s a burden, and the contraceptive mandate fails the test.

The least-restrictive-means standard is exceptionally demanding, and it is not satisfied here. HHS has not shown that it lacks other means of achieving its desired goal without imposing a substantial burden on the exercise of religion by the objecting parties in these cases. See §§2000bb–1(a), (b) (requiring the Government to “demonstrat[e] that application of [a substantial] burden to the person . . . is the least restrictive means of furthering [a] compelling governmental interest” (emphasis added)).

The most straightforward way of doing this would be for the Government to assume the cost of providing the four contraceptives at issue to any women who are unable to obtain them under their health-insurance policies due to their employers’ religious objections. This would certainly be less restrictive of the plaintiffs’ religious liberty, and HHS has not shown that this is not a viable alternative. HHS has not provided any estimate of the average cost per employee of providing access to these contraceptives, two of which, according to the FDA, are designed primarily for emergency use. Nor has HHS provided any statistics regarding the number of employees who might be affected because they work for corporations like Hobby Lobby, Conestoga, and Mardel. Nor has HHS told us that it is unable to provide such statistics. It seems likely, however, that the cost of providing the forms of contraceptives at issue in these cases (if not all FDA-approved contraceptives) would be minor when compared with the overall cost of ACA.

According to one of the Congressional Budget Office’s most recent forecasts, ACA’s insurance-coverage provisions will cost the Federal Government more than $1.3 trillion through the next decade. If, as HHS tells us, providing all women with cost-free access to all FDA-approved methods of contraception is a Government interest of the highest order, it is hard to understand HHS’s argument that it cannot be required under RFRA to pay anything in order to achieve this important goal.

HHS contends that RFRA does not permit us to take this option into account because “RFRA cannot be used to require creation of entirely new programs.” But we see nothing in RFRA that supports this argument, and drawing the line between the “creation of an entirely new program” and the modification of an existing program (which RFRA surely allows) would be fraught with problems. And don’t worry, Justice Alito insists! This is a really, really narrow holding, and doesn’t create religious exemptions to good laws: HHS and the principal dissent argue that a ruling in favor of the objecting parties in these cases will

lead to a flood of religious objections regarding a wide variety of medical procedures and drugs, such as vaccinations and blood transfusions,

but HHS has made no effort to substantiate this prediction. HHS points to no evidence that insurance plans in existence prior to the enactment of ACA excluded coverage for such items. Nor has HHS provided evidence that any significant number of employers sought exemption, on religious grounds, from any of ACA’s coverage requirements other than the contraceptive mandate. …

What are the credentials for Alito and associates in the domain of medical therapies? None!

[O]ur decision in these cases is concerned solely with the contraceptive mandate.

Our decision should not be understood to hold that an insurance-coverage mandate must necessarily fall if it conflicts with an employer’s religious beliefs. Other coverage requirements, such as immunizations, may be supported by different interests (for example, the need to combat the spread of infectious diseases) and may involve different arguments about the least restrictive means of providing them. The principal dissent raises the possibility that discrimination in hiring, for example on the basis of race, might be cloaked as religious practice to escape legal sanction. Our decision today provides no such shield. The Government has a compelling interest in providing an equal opportunity to participate in the workforce without regard to race, and prohibitions on racial discrimination are precisely tailored to achieve that critical goal. Justice Kennedy adds an additional concurrence to remind everyone that Justice Kennedy believes in the Court, America, and his own importance:

In our constitutional tradition, freedom means that all persons have the right to believe or strive to believe in a divine creator and a divine law. For those who choose this course, free exercise is essential in preserving their own dignity and in striving for a self-definition shaped by their religious precepts. Free exercise in this sense implicates more than just freedom of belief. It means, too, the right to express those beliefs and to establish one’s religious(or nonreligious) self-definition in the political, civic, and economic life of our larger community.

But in a complex society and an era of pervasive governmental regulation, defining the proper realm for free exercise can be difficult. … “[T]he American community is today, as it long has been, a rich mosaic of religious faiths.” Town of Greece v. Galloway, 572 U. S. _, _ (2014) (Kagan, J., dissenting) (slip op., at 15). Among the reasons the United States is so open, so tolerant, and so free is that no person may be restricted or demeaned by government in exercising his or her religion. Yet neither may that same exercise unduly restrict other persons, such as employees, in protecting their own interests, interests the law deems compelling.

In these cases the means to reconcile those two priorities are at hand in the existing accommodation the Government has designed, identified, and used for circumstances closely parallel to those presented here. RFRA requires the Government to use this less restrictive means. Justice Ginsburg writes the principal dissent, and begins by reminding us of the importance of sexual autonomy, and the economic stakes for women in this litigation: “The ability of women to participate equally in the economic and social life of the Nation has been facilitated by their ability to control their reproductive lives.” Planned Parenthood of Southeastern Pa. v. Casey, 505 U. S. 833, 856 (1992).Congress acted on that understanding when, as part of a nationwide insurance program intended to be comprehensive, it called for coverage of preventive care responsive to women’s needs.

… The [ACA] had a large gap, however; it left out preventive services that “many women’s health advocates and medical professionals believe are critically important.” 155 Cong. Rec. 28841 (2009) (statement of Sen. Boxer). To correct this oversight, Senator Barbara Mikulski introduced the Women’s Health Amendment, which added to the ACA’s minimum coverage requirements a new category of preventive services specific to women’s health…Women paid significantly more than men for preventive care, the amendment’s proponents noted; in fact, cost barriers operated to block many women from obtaining needed care at all. See, e.g., id., at 29070 (statement of Sen. Feinstein) (“Women of childbearing age spend 68 percent more in out-of-pocket health care costs than men.”); id., at 29302 (statement of Sen. Mikulski) (“copayments are [often] so high that [women] avoid getting [preventive and screening services] in the first place”). And increased access to contraceptive services, the sponsors comprehended, would yield important public health gains. See, e.g., id., at 29768 (statement of Sen. Durbin) (“This bill will expand health insurance coverage to the vast majority of [the 17 million women of reproductive age in the United States who are uninsured] . . . . This expanded access will reduce unintended pregnancies.”). And the dissenters deride as unfounded the Court’s new recognition of religious rights for for-profit corporations: Until this litigation, no decision of this Court recognized a for-profit corporation’s qualification for a religious exemption from a generally applicable law, whether under the Free Exercise Clause or RFRA.

George Takei’s blistering response to #HobbyLobby: Could a Muslim Corp impose Sharia Law?

byVyan THU JUL 03, 2014 AT 09:12 AM PDT “The ruling elevates the rights of a FOR-PROFIT CORPORATION over those of its women employees and opens the door to all manner of claims that a company can refuse services based on its owner’s religion,” Takei wrote. (O)ne wonders,” he said, “whether the case would have come out differently if a Muslim-run chain business attempted to impose Sharia law on its employees.” “Hobby Lobby is not a church. It’s a business — and a big one at that,” he continued. “Businesses must and should be required to comply with neutrally crafted laws of general applicability. Your boss should not have a say over your healthcare. Just as Justice Ginsberg and Mr Takei have suggested, the Hyper-Religious are already attempting to capitalize on the SCOTUS new granting of the rights of an individual to a corporate entity. In this decision the SCOTUS Majority opinion claimed that they were not granting the equal legitimacy of such follow on requests, but they’ve kicked open the door. Takei – bless his soul – also pointed out the basic hypocrisy of Hobby Lobby’s business practices in regards to religion. Noting that… …Hobby Lobby has invested in multiple companies that manufacture abortion drugs and birth control. The company receives most of its merchandise from China, a country where overpopulation has led to mandatory abortions and sterilizations for women who try to have more than one child.

What the battle over birth control is really about

byteacherken in a 2012 piece at Alternet by Sara Robinson. Conservative bishops and Congressmen are fighting a rear-guard action against one of the most revolutionary changes in human history. Robinson suggests 500 years from now looking back, the three great achievements of the 20th Century are likely to be the invention of the integrated circuit (without which the internet does not exist), the Moon landing (which she thinks will carry the same impact as Magellan’s circumnavigation of the globe), and the mass availability of nearly 100% effective contraception. Far from being a mere 500-year event, we may have to go back to the invention of the wheel or the discovery of fire to find something that’s so completely disruptive to the way humans have lived for the entire duration of our remembered history.

Free Birth Control is Emerging Standard for Women

Mon, 07/07/2014 – 8:47am

RICARDO ALONSO-ZALDIVAR, Associated Press

WASHINGTON (AP) — More than half of privately insured women are getting free birth control under President Barack Obama’s health law, a major coverage shift that’s likely to advance. This week the Supreme Court allowed some employers with religious scruples to opt out, but most companies appear to be going in the opposite direction. Recent data from the IMS Institute document a sharp change during 2013. The share of privately insured women who got their birth control pills without a copayment jumped to 56 percent, from 14 percent in 2012. The law’s requirement that most health plans cover birth control as prevention, at no additional cost to women, took full effect in 2013. The average annual saving for women was $269. “It’s a big number,” said institute director Michael Kleinrock. The institute is the research arm of IMS Health, a Connecticut-based technology company that uses pharmacy records to track prescription drug sales. The core of Obama’s law — taxpayer-subsidized coverage for the uninsured — benefits a relatively small share of Americans. But free preventive care— from flu shots to colonoscopies —is a dividend of sorts for the majority with employer coverage. Expanded preventive coverage hasn’t gotten as much attention as another bonus for the already insured: the provision that allows young adults to remain on their parents’ policy until they turn 26. That may start to change with all the discussion of birth control. Business groups and employee benefits consultants say they see little chance that employers will roll back contraceptive coverage as a result of the Supreme Court ruling. The court carved out a space for “closely held” companies whose owners object on religious grounds. Most companies don’t fit that niche.

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Information Security and Privacy in Healthcare is part of the 2nd Annual Medical Informatics World, April 28-29, 2014, World Trade Center, Boston, MA

Posted in Accountable Care Organizations, Affordable Care Act, Federal Budget Appropriations, Healthcare costs and reimbursement, HealthCare IT, Healthcare Reform, Medicare and Medicaid, Prescription Drugs Costs, Technology Capital Expenses, Uninsured and Underinsured on March 26, 2014| Leave a Comment »

Information Security and Privacy in Healthcare is part of the 2nd Annual Medical Informatics World, April 28-29, 2014, World Trade Center, Boston, MA

Reporter: Aviva Lev-Ari, PhD

Concurrent Tracks

Provider-Payer-Pharma Cross-Industry Data Collaboration
Coordinated Patient Care Engagement and Empowerment
Population Health Management and Quality Improvement
Information Security and Privacy in Healthcare

Dinner Workshop

Advancing the Use of EHR/EMR for Clinical Research and Drug Development

About the Conference

Cambridge Healthtech Institute and Bio-IT World’s Second Annual Medical Informatics World builds upon last year’s successful inaugural launch by delivering timely programming focused on the cross-industry connections and innovative solutions needed to take biomedical research and healthcare delivery to the next level.

The 2014 meeting will bring together more than 300 senior level executives and industry leaders from each side of the discussion – providers, payers and pharma – in the fields of healthcare, biomedical sciences, health informatics, and IT. Over two days of insightful discussions and engaging presentations, leading experts will share emerging trends and solutions in population health management, payer-provider-pharma data collaborations, optimizing patient care and engagement, leveraging mobile technologies, sustaining innovation within the rapidly changing care delivery models, enhancing clinical decision support, controlling costs and improving quality, and maintaining security-privacy in healthcare. Led by key decision makers and senior executives at the forefront of healthcare information technology, the conference is a must-attend for all involved in this evolving industry.

Co-located with CHI’s flagship Bio-IT World Expo, a premier event showcasing the myriad applications of IT and informatics to the life sciences enterprise, Medical Informatics World completes the week of scientific content by bridging the healthcare and life science worlds. As Bio-IT World Expo attracts more than 2,500 delegates from dozens of countries as well as more than 130 exhibiting companies, networking opportunities abound at the two events.

KEY NOTES

John Halamka, M.D., MS, CIO, Beth Israel Deaconess Medical Center
Bryan Sivak, CTO & EIR, U.S. Department of Health and Human Services
Roy Beveridge, M.D., Senior Vice President and CMO, Humana
Mark Davies, M.D., Executive Medical Director, Health & Social Care Information Centre, National Health Service
Sachin Jain, M.D., MBA, Vice President and Chief Medical Information & Innovation Officer, Merck & Co.
Jacob Reider, M.D., Acting Principle Deputy National Coordinator, Office of the National Coordinator for Health Information Technology (ONC), U.S. Department of Health and Human Services

AGENDA

http://www.medicalinformaticsworld.com/

PROGRAM in PDF

http://www.medicalinformaticsworld.com/uploadedFiles/Medical_Informatics_World/Agenda/14/2014-Medical-Informatics-World-Conference-Brochure.pdf

2014 Agenda at a Glance

REAL CHALLENGES OF UNAUTHORIZED DISCLOSURE OF PHI Patient Privacy and Security: What Recent Benchmarks of Healthcare Providers Revealed Larry Ponemon, Chairman and Founder, Ponemon Institute Fair Information Practice for Cyber ID Adrian Gropper, M.D., CTO, Patient Privacy Rights Should I Trust You With My Patient’s Data? Rick Moore, CIO, National Committee for Quality Assurance (NCQA)

HITECH REGULATIONS AND THE FUTURE OF TRANSPARENCY A Practical Look at the HITECH Proposed Regulations and Federal Information Transparency Policies: The Payer Perspective Marilyn Zigmund Luke, Senior Counsel and Compliance Officer, America’s Health Insurance Plans (AHIP) Just Added! Omnibus HIPAA Rulemaking and a New Era of Privacy and Security: Don’t be an Ostrich Lassaad Fridhi, Information Privacy & Security Officer, Commonwealth Care Alliance

PUTTING HEALTHCARE DATA IN THE CLOUD Can PHI and the Cloud Coexist? Paul Connelly, Vice President, CISO, Hospital Corporation of America (HCA) Just Added! U Mass Medical College-NIH Case Study: A Privacy Solution for Sharing and Analyzing Healthcare Data Luvai Motiwalla, Ph.D., Professor, Operations and Information Systems (OIS), Manning School of Business, U Mass Lowell

BYOD: BALANCING PRIVACY, SECURITY AND FLEXIBILITY BYOD: Job Security for Privacy and Information Security Professionals Marti Arvin, Chief Compliance Officer, David Geffen School of Medicine, UCLA Health System

BYOD: BRING YOUR OWN DEVICE OR BRING YOUR OWN DISASTER? Mobile Security and BYOD in a Large Hospital System Jennings Aske, CISO, Partners HealthCare System Just Added! A Modern CISO’s Role is More than Tech: Achieving the Elusive Balance Between Information Security and Human Factors SumitSehgal, Chief Information Security & Privacy Officer, Boston Medical Center Can a Company with More than Two Million Employees Successfully Implement BYOD? Anthony Martin, Senior Associate General Counsel, Privacy & Information Security, Walmart

OVERCOMING THE INTEROPERABILITY-PRIVACY STANDOFF “Mind the Gap”: Lessons from London on Using Information to Improve English Healthcare Samantha Meikle, Director, London Connect Overcoming the Interoperability-Privacy Standoff Peter Madras, M.D., Senior Staff, Lahey Health and Hospitals; Founder, Medical Record Bank

KEYNOTE SESSION: CONNECTING PATIENTS, PROVIDERS, AND PAYERS Health Delivery Reform and the Future of Health IT-Enabled Quality Improvement Jacob Reider, M.D., Acting Principle Deputy National Coordinator, Office of the National Coordinator for Health Information Technology (ONC), U.S. Department of Health and Human Services Healthcare IT Innovations that are Connecting Patients, Providers, and Payers John Halamka, M.D., MS, CIO, Beth Israel Deaconess Medical Center Three Patients: How Health Information Technology Will Enable the Pharmaceutical Industry to Improve Patient Care Sachin Jain, M.D., MBA, Vice President and Chief Medical Information & Innovation Officer, Merck & Co. Keynote Panel: Deploying Information Technology to Enable Innovation within the Future State of Care Susan Dentzer, Senior Policy Adviser, Robert Wood Johnson Foundation

KEYNOTE SESSION: TRANSFORMING GOVERNMENT & HEALTHCARE THROUGH INNOVATION Startup Mentality: Transforming Government & Health Bryan Sivak, Chief Technology Officer & EIR, U.S. Department of Health and Human Services Humana’s Approach to Medicare Advantage Roy Beveridge, M.D., Senior Vice President and Chief Medical Officer, Humana The English Patient, a Story of NHS Informatics Mark Davies, M.D., Executive Medical Director, Health & Social Care Information Centre, National Health Service Keynote Panel: What are the Remaining Policy and Technology Barriers to Information Sharing with Patients? Daniel Sands, M.D., MPH, Assistant Clinical Professor, Harvard Medical School; Co-Founder, Society for Participatory Medicine To learn more, view the brochure or visit MedicalInformaticsWorld.com/Information-Security-Privacy.

————————————————————————

Information Security and Privacy in Healthcare is part of the Second Annual Medical Informatics World, to be held April 28-29, 2014 at the World Trade Center in Boston, MA. The event builds upon last year’s successful inaugural launch by delivering timely programming focused on the cross-industry connections and innovative solutions needed to take biomedical research and healthcare delivery to the next level. The 2014 meeting will bring together more than 300 senior level executives and industry leaders from each side of the discussion – providers, payers and pharma – in the fields of healthcare, biomedical sciences, health informatics, and IT. Medical Informatics World Conference Tracks Provider-Payer-Pharma Cross-Industry Data Collaboration Coordinated Patient Care, Engagement and Empowerment Population Health Management and Quality Improvement Information Security and Privacy in Healthcare Also Available On-Site, A Dinner Workshop Advancing the Use of EHR/EMR for Clinical Research and Drug Development: A Platform that Reuses EHRs across Hospitals to Support Clinical Research supported by Sustainability Measures* (Details) > Download the full program. > For the latest speaker additions and presentation updates, visit MedicalInformaticsWorld.com. > Register now to join 300+ colleagues! > Learn more about sponsorship and exhibit opportunities.

SOURCE

From: Medical Informatics World 2014 <jaimeh@healthtech.com>
Date: Wed, 26 Mar 2014 11:59:00 -0400
To: <avivalev-ari@alum.berkeley.edu>
Subject: Just Added! NIH Health Privacy Case Study, Balancing Security & Human Factors, Omnibus HIPAA Rulemaking

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Tycho Brahe, where art thou? Today’s Renaissance of the Self-Funded Scientist!

Posted in Academic Publishing, Bio Instrumentation in Experimental Life Sciences Research, Federal Budget Appropriations, Health Economics and Outcomes Research, Interviews with Scientific Leaders, Open Access Journals, Scientist: Career considerations, Technology Transfer: Biotech and Pharmaceutical, tagged biohacker, bioincubator, bioresearch, crowd-funding, crowdscourcing, Funding, Grants, Innovation, medicine, research, research funding on February 24, 2014| Leave a Comment »

Tycho Brahe, where art thou? Today’s Renaissance of the Self-Funded Scientist!

Curator: Stephen J. Williams, Ph.D.

Article ID #114: Tycho Brahe, where art thou? Today’s Renaissance of the Self-Funded Scientist!. Published on 2/24/2014

WordCloud Image Produced by Adam Tubman

Every scientist usually can describe an event or an admired historical figure as their pivotal point of inspiration which led them to embark on a scientific career.

I will admit there were two points of inspiration: the first was Jacques Cousteau while watching his program Undersea World of Jacques Cousteau.

The other (and please don’t laugh) was reading about the intellectual duel and collaboration between two of the greats in astronomy and mathematics: Tycho Brahe and Johannes Kepler, two historical figures responsible for our modern-day understanding of the universe and planetary motion. For some reason I had romanticized the study of science, envisioning days in the laboratory wearing renaissance garb while striking medieval vogue poses (just kidding). But back then, accurately determining planetary motions and mapping the stars was a real big deal, as trade ships would rely on the positioning of stars as their heavenly GPS system. Otherwise you might be trying to establish a new trade route to India and wind up somewhere… say America.

Tycho Brahe (1546-1601; born Tyge Ottesen Brahe) was a Danish nobleman and scientist who made the most accurate measurement of planetary motion and positioning of the stars, which enabled another great astronomer, Johannes Kepler, to deduce the laws of planetary orbits. His measurements allowed Kepler to prove Copernicus’s sun centered theory (Earth revolves around the sun). An interesting history of Brahe, The crazy life and crazier death of Tycho Brahe, history’s strangest astronomer, gives some in-depth look at this intriguing historical figure.

Now back then science, as is the case now, costs money; and the two ways to get that money was either find a wealthy backer (like a king) or have a rich uncle who leaves a great inheritance. Well Tycho did have a rich uncle who left him a lot of money, but instead of just sitting around spending it on jewelry, he used a great portion of his inheritance to build his 1st observatory to make his important measurements and also discover a supernova (published in De Nova Stella), breaking the dogma at the time that stars never changed their appearance or position.

(Photo Credit: Wikipedia)

There have been other examples of self-funded scientists including:

i. Luther Burbank (b:1845) who led the way for plant genetics. After developing the Burbank potato he used the money from his nursery business to buy a farm to conduct plant breeding experiments

ii. Dr. Edward Jenner who used his own funds to develop the first smallpox vaccine and later awarded money from Parliament for his development

iii. Ritu Levi Montalcini, M.D.: Dr. Montalcini discovered nerve growth factor together with Stanley Cohen (both awarded Nobel Prize). After earning an MD in Turin, Italy in 1938 she was unable to work as Mussolini banned Jews from holding professional positions. So she moved to Belgium but when the Nazi’s took over she fled back to Turin and made a secret lab to study the development of neurons in chick embryos.

Now as many government science budgets are tightening some scientist are returning to self-funding and alternative models in order to continue their research.

The Ronin Institute

One such example is the Ronin Institute, founded by Dr. Jon Wilkins, Ph.D., where scientists who may not have institutional support, band together in a sort of virtual Institute which supports publication and grantsmanship. The mission and values of the Ronin Institute (which can be found here) includes creating new models for the conducting, funding, collaboration, and dissemination of scholarly research to get researchers back to what they do best: RESEARCH.

A wonderful and inspiring article, written by Samuel Arbesman and co-authored by Jon Wilkens, can be found in Wired magazine.

The following is an excerpt from the article about independent researchers:

“

One of us (Jon Wilkins), has set out to promote and support independent scholarly research through the founding of the Ronin Institute. The Ronin Institute acts as an aggregator for the fractional scholars of the world, providing an institutional affiliation, connection with other fractional scholars, and support for conference travel and grant applications.

When people are doing something that they are passionate about, they work harder and produce a better product. Thus, underemployed scholars represent in some sense a good that is currently trading well below its actual value. By providing a mechanism for those who wish to conduct research, we can allow these people to engage in their passions while growing the base of scholarly knowledge, which in turn has the potential to create further economic growth.

Through the Ronin Institute, we will be harnessing the skills and talents of thousands of underemployed researchers.

“

Some more articles on the Ronin Institute can be found on their site at http://ronininstitute.org/press/

Two other great articles on “gentlemen scientists” or self-funding scientists can be found at the Singular Scientist blog post entitled “Self-Funding in Science” and a 1998 Science article by Jon Cohen entitled Scientists Who Fund Themselves. In each case, scientists felt freed up from the financial overhead accompanied with big institutions and realized more time for their research.

Alternate Funding Source: CROWDSOURCING

The passage of the JOBS act has relieved some of the pressures off obtaining funding for companies through crowdfunding mechanisms. Scientists are also turning to crowdsourcing mechanisms to fund their research. An article in the Washington Times (Scientists discover ‘crowdfunding’ as a way of replacing research grants) highlights some of the successes and science-related crowdfunding sites that exist.

Science-related Crowdfunding sites include:

i. Rockethub

ii. SciFund Challenge

iii. Microryza

iv. Kickstarter

v. Petridish.org

Digital Tools and Lab Space for the Self-Funding Scientist

Dr. Elizabeth Iorns, breast cancer researcher and founder and CEO of Science Exchange, an online marketplace for ordering science experiments from various nationwide and worldwide labs, explains in a three-part Nature blog post “Research 2.0.1: The future of research funding” how the traditional government-based grant-funding model may transition into a more crowdfunding model. For example Science Exchange allows you to order common laboratory procedures (for example immunohistochemistry or bioinformatics analysis or gene sequencing) from a list of participating labs in the marketplace. Prices are usually reasonably priced.

Finding Lab Space: Biohacker Labs

The last piece of the puzzle is finding rented space and equipment to do research. A new type of laboratory space, small, nimble, and priced and equipped to fit the independent researcher is cropping up. Termed biohacker labs or hackubators, these small rented communal spaces are different from the traditional bio-incubators or science centers which sprang up decades ago to foster the biotech revolution. This phenomenon is explained quite nicely in a Science article by Virginia Gewen “Biotechnology: Independent Streak”. These spaces can go for $100-400 a month, much less than $900 a month for incubator space. Most of the investigators highlighted in the article get funds through crowdsourcing.

One such hackubator lab is Bio, Tech and Beyond, a DIY lab in San Diego which supports numerous projects using 3D printing, cell culture, and sequencing. These type of DIY biolabs are springing up all over, based on the idea from tech hacker DIY labs, although before the expense seemed to be the limiting factor. Now it appears the internet is once again revolutionizing another industry, namely that of the independent bio researcher

…. Sans the 16^th century fashion (what a shame!)

Patient Protection and Affordable Care Act Featured at RAND

Posted in Accountable Care Organizations, Affordable Care Act, Federal Budget Appropriations, Healthcare costs and reimbursement, Healthcare Reform, Medicare and Medicaid, Uninsured and Underinsured on January 7, 2014| Leave a Comment »

Patient Protection and Affordable Care Act Featured at RAND

Reporter: Aviva Lev-Ari, PhD, RN

Below the reader will find a compilation of all the articles related to Affordable Care Act Featured at RAND

The Patient Protection and Affordable Care Act (ACA)—the sweeping health care reform sometimes known as “Obamacare”—was enacted in 2010. The law aims to expand access to health coverage for uninsured Americans.

The ACA does this through several provisions: an individual mandate requiring adults to have health insurance or pay a fine; an employer mandate requiring firms with 50 or more employees to offer coverage or pay a fine; a requirement that each state establish a health insurance exchange or accept a federally established exchange in which individuals and small businesses can buy coverage; an expansion of Medicaid eligibility to cover greater numbers of lower-income people. (A 2012Supreme Court decision held that states could not be required to expand Medicaid, thus leaving expansion up to the states.)

In addition, the ACA makes changes to Medicare intended to cut costs, shore up the program’s fiscal solvency, and improve delivery of care.

What’s Next for the ACA

With most of the ACA’s provisions taking full effect in 2014, the complex process of implementing the law is underway across the country. RAND research is tracking the progress of implementation and assessing the potential consequences of choices facing decisionmakers at many levels: federal and state governments, employers, families, and individuals.Our recent work has examined the likely impact of the ACA in four key policy areas:

http://www.rand.org/health/aca.html

Patient Protection and Affordable Care Act

Through a number of provisions — such as individual and employer mandates, health insurance exchanges, and the expansion of Medicaid — the Patient Protection and Affordable Care Act (ACA) aims to expand access to health care for uninsured Americans. RAND has examined implementation challenges, cost and coverage implications, Medicaid expansion, state health insurance exchanges, and reforms to both care delivery and payment.

Featured at RAND

The RAND Health Reform Opinion Study

The RAND Health Reform Opinion Study tracks public opinion of the Affordable Care Act by surveying the same people over time. This allows us to observe true changes in public opinion, rather than changes based on who was surveyed randomly.

The Affordable Care Act: Four Key Policy Areas

With the complex process of implementing the ACA underway, RAND research is tracking the progress of implementation and assessing the potential consequences of choices facing federal and state governments, employers, families, and individuals.

All Items (123)

RAND Health Reform Opinion Study Update: Positive Opinion on the ACA Continues to Rise — Dec 30, 2013

The latest data from the RAND Health Reform Opinion Study indicates that positive opinion of the ACA continues to increase. The overall favorable rating is now as high as it was in late September, prior to the opening of the health insurance exchanges.

BLOG

RAND Health Reform Opinion Study Update: Positive Opinion on ACA Grows, Negative Opinion Stabilizes— Dec 23, 2013

Last week we introduced the RAND Health Reform Opinion Study, a new way to measure public opinion of the Affordable Care Act. Negative opinion about the ACA seems to be stabilizing, while positive opinion is increasing. Those undecided about the ACA are decreasing.

COMMENTARY

A New Way to Measure Public Opinion of Health Reform — Dec 18, 2013

Whether the public will begin to settle on an overall positive or negative perception of the Affordable Care Act (ACA) is very much an open question. But understanding how opinion of the law evolves over time could offer valuable insight into Americans’ appetite both for the ACA and for health reform more broadly.

Commentary

RESEARCH BRIEF

Will the Affordable Care Act Make Health Care More Affordable? — Dec 11, 2013

For most lower-income people who obtain coverage as a result of the Affordable Care Act, health care spending will fall. But spending by some newly insured higher-income people will increase because they will be now paying insurance premiums.

COMMENTARY

Is There Really a Physician Shortage? — Dec 5, 2013

Large coverage expansions under the ACA have reignited concerns about physician shortages. These estimates result from models that forecast future supply and demand for physicians based on past trends and current practice. While useful exercises, they do not necessarily imply that intervening to boost physician supply would be worth the investment.

Commentary

PERIODICAL

Ramifications of Health Reform — Nov 26, 2013

2014 will be an important year for the Patient Protection and Affordable Care Act. Health insurance exchanges will offer people new ways to buy insurance. Medicaid will expand in many states. And people without “minimum essential coverage” may have to pay a fee.

Full Document

COMMENTARY

Employer-Provided Health Insurance: Why Does It Persist, and Will It Continue after 2014? — Nov 25, 2013

As the ACA is implemented, policy makers should be attuned to potential inefficiencies and inequities created by a system with different regulatory and tax rules for small employers, large employers, and individual health plans. Attempts to equalize the playing field may be difficult.

Commentary

COMMENTARY

Can the Affordable Care Act Help Asthma Sufferers Breathe Easier? — Nov 20, 2013

ACA reforms can potentially address barriers that get in the way of individuals with asthma getting the care they need. At the population level, the law has the potential to improve outcomes and efficiency and equity of services for chronic conditions such as asthma for which cost-effective preventive treatments exist.

Commentary

COMMENTARY

Four Questions on Canceled Insurance Policy Fix — Nov 14, 2013

David Mastio, Forum editor at USA TODAY, asked RAND’s Christine Eibner four questions about President Obama’s plan to fix the problem with people getting their insurance canceled.

Commentary

BLOG

The Future of the Health Care Workforce: RAND Researchers Well Represented in Health Affairs Special Issue— Nov 7, 2013

In “Redesigning the Health Care Workforce,” a new special issue of the journal Health Affairs, RAND researchers contribute to several timely examinations of challenges, opportunities, and potential solutions relating to the future of health care staffing in the U.S. and abroad.

Blog Post

COMMENTARY

Quick Takes: Health Literacy and ACA Enrollment — Nov 7, 2013

The Affordable Care Act (ACA) expands coverage to millions of Americans. But the newly eligible may face challenges enrolling if they lack understanding of how the health care system itself works. Laurie Martin explains the role of health literacy in determining how successful the ACA will be in providing coverage for America’s uninsured.

Commentary

COMMENTARY

Quick Takes: The Math of Medicaid Expansion — Oct 21, 2013

Expanding Medicaid under the Affordable Care Act (ACA) is both contentious and complicated. RAND mathematician Carter Price has been using the COMPARE model to help those making decisions understand what their choices mean for their budgets and population health.

Commentary

COMMENTARY

Medicaid Access for the Formerly Incarcerated Under the ACA: Helping the Oft-Forgotten — Oct 3, 2013

America’s prison population tends to be sicker than the general population. While Medicaid eligibility under the ACA offers an historic opportunity, enrolling the formerly incarcerated into the health exchanges or Medicaid will be neither simple nor straightforward.

Commentary

COMMENTARY

Understanding the Affordable Care Act — Oct 2, 2013

One of the chief aims of the Affordable Care Act (ACA) is the expansion of insurance coverage to individuals who at present either cannot afford it or choose not to purchase it. Unfortunately, many Americans lack the financial literacy needed to navigate the numerous and complex options thrust upon them by the ACA.

Commentary

COMMENTARY

Will the Affordable Care Act Make Health Care More Affordable? — Oct 1, 2013

Out-of-pocket spending on health care will decrease for both the newly insured as well as for those changing their source of insurance. These decreases will be largest for those who would otherwise be uninsured.

Commentary

BLOG

Ask Me Anything: Carter Price on the Affordable Care Act — Oct 1, 2013

As of October 1, many Americans can now shop for health insurance through state exchanges created as part of the Affordable Care Act (ACA)—the sweeping health care reform often referred to as “Obamacare.” To provide some insight into the ACA, RAND’s Carter Price hosted an “Ask Me Anything” session on Reddit today.

NEWS RELEASE

Affordable Care Act Will Reduce Out-of-Pocket Medical Spending for Many Americans — Oct 1, 2013

The Affordable Care Act will have a varied impact on health spending by individuals and families, depending primarily on their income and whether they would have been uninsured in 2016 without the program.

News Release

REPORT

Affordable Care Act Will Reduce Out-of-Pocket Medical Spending for Many Americans — Oct 1, 2013

Patient Protection and Affordable Care Act

Featured at RAND

The RAND Health Reform Opinion Study

The Affordable Care Act: Four Key Policy Areas

All Items (123)

Will ACA Implementation Lead to a Spike in Demand for Care? — Sep 26, 2013

The growing number of Americans newly-insured under the ACA will undoubtedly lead to a surge in demand for care, whether through Medicaid or insurance exchanges. But, if predictions hold, the increase won’t be as dramatic as some may fear, writes David I. Auerbach.

Commentary

COMMENTARY

Data Points: Why Delay of the Employer Mandate May Not Actually Mean That Much — Aug 29, 2013

The bottom line is that the employer mandate does not provide a large inducement for firms to change their health insurance offerings, but it does raise a substantial amount of money to pay for the ACA’s coverage provisions over time.

Commentary

REPORT

No Widespread Increase in Cost of Individual Health Insurance Policies Under Affordable Care Act— Aug 29, 2013

An analysis of 10 states and the United States overall predicts that there will be no widespread premium increase in the individual health insurance market under the ACA. However, the cost of policies will vary among states and will be influenced by individual factors such as a person’s age and whether they smoke.

NEWS RELEASE

No Widespread Increase in Cost of Individual Health Insurance Policies Under Affordable Care Act— Aug 29, 2013

News Release

NEWS RELEASE

Delay of Employer Insurance Mandate Will Not Cause Major Problems for Affordable Care Act — Aug 19, 2013

A one-year delay in requiring large employers to provide health insurance to their workers will not significantly hurt the goals of the Affordable Care Act, but a repeal of the requirement would seriously undermine financial support for the law.

News Release

REPORT

Delay of Employer Insurance Mandate Will Not Cause Major Problems for Affordable Care Act — Aug 19, 2013

MULTIMEDIA

The Math of State Medicaid Expansion — Jul 17, 2013

$Carter Price$ Mathematician Carter Price discusses the potential impacts to low-income populations and local economies in states that choose not to expand Medicaid under the Affordable Care Act.

COMMENTARY

Health Care Spending: What’s in Store? — Jul 16, 2013

Resolving the question of whether or not the U.S. has finally gotten a handle on health care spending is vitally important, because the choices we make going forward will have profound implications for our economy, the financial wellbeing of millions of American families, and ultimately America’s standing in the world.

Commentary

REPORT

Helping Decisionmakers Implement the ACA’s Medicaid Provisions — Jun 26, 2013

The Affordable Care Act (ACA) contains many Medicaid-related provisions. RAND is working closely with decisionmakers at the federal and state levels to help resolve challenges associated with implementing the ACA’s sweeping reforms.

CONTENT

The Impact of RAND’s Work for the Centers for Medicare & Medicaid Services (CMS) — Jun 26, 2013

RAND’s work for the Centers for Medicare & Medicaid Services reflects the diverse, widespread nature of CMS’s programs. Major topics examined by our health policy experts include improving Medicare payment policies, implementation of the ACA’s Medicaid provisions, Medicare demonstration projects, measuring quality of care, and assessing patients experience.

JOURNAL ARTICLE

How Well Do Medicare’s Pay-for-Performance (P4P) Programs Match Desirable P4P Design Criteria?— Jun 25, 2013

Alignment with best P4P practices varies across Medicare programs; the program for Medicare Advantage aligns most strongly. It is unclear which P4P design elements are critical for quality improvement. Unintended consequences of design features are poorly understood.

Abstract

REPORT

Revenue, Spending Reductions Will Offset Costs of Expanding Medicaid in PA — Jun 24, 2013

While the expansion of Medicaid under the Affordable Care Act will require additional spending by the Commonwealth of Pennsylvania, these costs will be more than offset by additional revenue or reductions in other spending in the 2014-2020 timeframe.

COMMENTARY

Will Small Firms Self-Insure After Jan. 1, 2014? — Jun 17, 2013

Because of the ACA’s regulations, some smaller employers with young and healthy workers are considering avoiding the purchase of health care coverage in the regulated market, opting instead to self-insure their employees.

Commentary

RESEARCH BRIEF

The Math of State Medicaid Expansion — Jun 7, 2013

RAND researchers have analyzed how opting out of Medicaid expansion would affect insurance coverage and spending and whether alternative policy options—such as partial Medicaid expansion—could cover as many people at lower costs to states.

BLOG

Covering Emergency Care for Young Adults: Is the ACA Doing Its Job? — Jun 5, 2013

The dependent coverage provision of the Affordable Care Act is working as intended, say Andrew Mulcahy and Katherine Harris. In 2011, it spared individuals and hospitals from $147 million in emergency room costs.

CONTENT

Should States Expand Medicaid Under the ACA? — Jun 3, 2013

Some governors have stated publicly that their states will not participate in Medicaid expansion. A recent RAND study explores how this could affect government costs and coverage.

NEWS RELEASE

Expanding Medicaid Is Best Financial Option for States — Jun 3, 2013

States that choose not to expand Medicaid under federal health care reform will leave millions of their residents without health insurance and increase spending on the cost of treating uninsured residents, at least in the short term.

News Release

JOURNAL ARTICLE

Expanding Medicaid Is Best Financial Option for States — Jun 3, 2013

REPORT

Labor Market Outcomes of Health Shocks and Dependent Coverage Expansions — Jun 1, 2013

A series of studies on sources of variation in individual valuation of employer-provided group health care found that the effects of bundling health insurance with employment in the U.S. can vary significantly within different population groups.

Full Document

NEWS RELEASE

Health Reform Shields Young Adults from Emergency Medical Costs — May 29, 2013

A new federal law allowing young adults to remain on their parents’ medical insurance through age 25 has shielded them, their families, and hospitals from the full financial consequences of serious medical emergencies.

News Release

Featured at RAND

The RAND Health Reform Opinion Study

The Affordable Care Act: Four Key Policy Areas

Infographic: How Pennsylvania May Fare Under the ACA — May 15, 2013

This infographic presents findings from a RAND analysis of the economic and other effects of Medicaid expansion on the commonwealth of Pennsylvania.

COMMENTARY

Governors Missing the Point on Medicaid — Apr 29, 2013

While a governor or legislator may disagree with Medicaid expansion for philosophical reasons, the claims that the expansion will be a burden on states’ economies seem misguided given the full range of projected economic impacts on the states, writes Carter C. Price.

Commentary

RESEARCH BRIEF

Infographic: How Arkansas May Fare Under the Affordable Care Act — Apr 8, 2013

This infographic presents findings from a RAND analysis of the economic and other effects of the Affordable Care Act on the state of Arkansas.

COMMENTARY

Helping Obama—and Other Americans—Weigh Which Health Insurance Exchange to Pick — Apr 1, 2013

Multistate plans are most likely to appeal to out-of-state students, interstate migrants, out-of-state workers, seasonal movers (e.g., “snowbirds”), and similar groups that require improved access to health care across state lines.

Commentary

NEWS RELEASE

Expanding Medicaid in Pennsylvania Would Sharply Increase Federal Revenue to State — Mar 28, 2013

Expanding Medicaid in Pennsylvania under the Affordable Care Act would boost federal revenue to the state by more than $2 billion annually and provide 340,000 residents with health insurance.

News Release

REPORT

The Economic Impact of Medicaid Expansion on Pennsylvania — Mar 28, 2013

If Pennsylvania opts into Medicaid expansion under the Affordable Care Act, more residents would have health coverage and the state would enjoy a positive economic effect. However, benefits would have a long-term cost, with uneven regional results.

REPORT

Multistate Health Plans in the ACA’s State Insurance Exchanges — Mar 20, 2013

The ACA requires the government to work with insurance issuers to establish at least two multistate plans (MSPs) in each state’s health insurance exchange. MSPs may be especially attractive to those interested in issuers that operate in multiple states, such as out-of-state students or temporary workers.

Full Document

REPORT

Efforts to Reform Physician Payment by Tying Payment to Performance — Feb 14, 2013

Public and private sector purchasers are actively working to design value-based payment programs to achieve the goals of improved quality and more efficient use of health care resources. How these programs are designed is a complex undertaking and one that will determine the likelihood of their success.

Testimony

BLOG

In Brief: Amelia M. Haviland on Consumer-Directed Health Plans — Jan 23, 2013

In this video, Amelia Haviland presents the results of several new RAND studies on cost and quality in consumer-directed health plans, and explores how switching plans affects the quality of care.

BLOG

Modeling the Effects of the Affordable Care Act in Arkansas — Jan 7, 2013

The Medicaid expansion under the ACA will result in about 400,000 people newly insured in Arkansas by 2016. Of these, about 190,000 would be newly enrolled in Medicaid and the rest would be newly insured through the new insurance exchanges. The state is likely to save about $67 million for reduced uncompensated care costs for the uninsured.

REPORT

The Economic Impact of the ACA on Arkansas — Jan 3, 2013

For Arkansas, the Affordable Care Act will result in an increase in GDP of around $550 million and the creation of about 6,200 jobs. The new law will also increase health insurance coverage by 400,000 newly insured individuals.

JOURNAL ARTICLE

Implications of New Insurance Coverage for Access to Care, Cost-Sharing, and Reimbursement — Jan 1, 2013

Many physician practices will face a set of critical decisions in the coming years that may contribute to the ultimate success or failure of the ACA.

CONTENT

Four Strategies to Contain America’s Growing Health Care Spending — Nov 15, 2012

In its second term, the Obama Administration can restrain further health care spending growth—without compromising quality—by employing four broad strategies: fostering efficient and accountable providers, engaging and empowering consumers, promoting population health, and facilitating high-value innovation.

COMMENTARY

Health Care Costs Must Be Curbed, No Matter Who Wins — Oct 16, 2012

Regardless of which candidate wins in November, and regardless of whether “Obamacare” is repealed, amended, or defended by the next Congress, the next president will have to contend with the spiraling cost of health care in the United States—a problem that is growing more acute with each passing year, writes Arthur Kellermann.

Commentary

COMMENTARY

California Improves on Affordable Care Act by Letting RNs Dispense Birth Control — Oct 8, 2012

As we look for ways to provide efficient, high-quality and cost-effective healthcare to more Americans, states may study California as a potential model for how to do more to deliver on what the Affordable Care Act has to offer women, while saving money at the same time, writes Chloe Bird.

Commentary

PERIODICAL

The Fate of ACA Is a Major Issue in Upcoming Congressional and Presidential Elections — Sep 21, 2012

Whether the Affordable Care Act is repealed, defended, or weakened will hinge on who holds the balance of power next January. Regardless of what happens with the ACA, the spiraling cost of health care in the United States will remain a huge challenge.

Full Document

CONTENT

Retail Clinics Play Growing Role in Health Care Marketplace — Sep 11, 2012

Retail health care clinics provide treatment for acute conditions like bronchitis as well as vaccinations and other preventive care. With the role of retail clinics expanding and U.S. health care entering a dynamic period of change, it is important to consider what we know about this emerging health care setting.

COMMENTARY

Supporting Comprehensive Healthcare for Women Makes Dollars, and Sense — Sep 5, 2012

As we look for ways to provide efficient, high-quality, and cost-effective health care to more Americans, we can’t afford to ignore women’s health issues, including reproductive health care and the cost savings that contraceptive access provides, writes Chloe Bird.

Commentary

JOURNAL ARTICLE

Medicare Postacute Care Payment Reforms Have Potential To Improve Efficiency Of Care, But May Need Changes To Cut Costs — Sep 1, 2012

ACA-mandated payment reforms need to achieve more than a one-time cost saving.

COMMENTARY

Will More Employers Drop Coverage Under the ACA? Don’t Bet on It — Jul 27, 2012

A problem with using surveys to predict behavior is that they measure employer sentiment toward the ACA today, rather than the economic decisions employers typically make when the time comes, writes Art Kellermann.

Commentary

COMMENTARY

Time to Focus on Healthcare Costs — Jun 29, 2012

The bottom line is this: With or without the Affordable Care Act, the nation can no longer kick the can down the road on costs, writes Arthur Kellermann.

Commentary

CONTENT

Supreme Court Upholds the Affordable Care Act: What the Experts Are Saying — Jun 28, 2012

Now that the Supreme Court has upheld key provisions of the Affordable Care Act, what lies ahead for health care in America? RAND experts sound off in the wake of this momentous decision.

COMMENTARY

Time to Shift Talk to Health Care Costs — Jun 28, 2012

The U.S. Supreme Court’s ruling on the Affordable Care Act is unquestionably historic, but there is a critical aspect of health care reform that still needs to be fixed. The nation needs to take decisive action to address the rising costs of health care, writes Arthur Kellermann.

RESEARCH BRIEF

Consumer-Directed Plans Could Cut Health Costs Sharply, but Also Discourage Preventive Care — Jun 28, 2012

Switching to a consumer-directed health plan (CDHP) could save families 20 percent or more on their health care costs. Families with CDHPs initiate less episodes of care and spend less per episode, however, they also tend to scale back on high-value preventive care, such as child vaccinations.

PERIODICAL

Eliminating Individual Mandate Would Decrease Coverage, Increase Spending — May 11, 2012

If the individual mandate requiring all Americans to have health insurance were eliminated, it would sharply reduce the number of people gaining coverage and slightly increase the cost for those who do buy policies through the new insurance exchanges.

Full Document

JOURNAL ARTICLE

Expanding Consumer-Directed Health Plans Could Help Cut Overall Health Care Spending — May 7, 2012

If consumer-directed health plans grow to account for half of all employer-sponsored insurance in the United States, health costs could drop by $57 billion annually—about 4 percent of all health care spending among the nonelderly.

BLOG

Would the Affordable Care Act Lead to Reductions in Employer-Sponsored Coverage? — May 4, 2012

As the U.S. Supreme Court considers the constitutionality of the Affordable Care Act’s (ACA) individual mandate, one of the questions being debated is what effect the mandate would have on employer-sponsored health insurance coverage. A factor to consider in this is the effect the ACA would have on small businesses, which employ the majority of America’s private-sector workforce.

COMMENTARY

What Happens Without the Individual Mandate? — Mar 21, 2012

If the individual mandate were ruled unconstitutional, subsidies and the age structure of premiums should keep enough healthy people in the insurance exchanges to prevent huge spikes in premiums, write Carter C. Price and Christine Eibner.

Commentary

PAST EVENT

The Affordable Care Act’s Individual Mandate in Play — Mar 20, 2012

RAND economist Christine Eibner spoke at a Bloomberg Government and RAND Corporation event in Washington, D.C. Eibner briefed the attendees on the results of her recent study, How Would Eliminating the Individual Mandate Affect Health Coverage and Premium Costs?

PROJECT

Will Health Care Reform Impact Applications for Disability Benefits? — Mar 12, 2012

As the Affordable Care Act expands health insurance coverage in the U.S., the “cost” of applying for SSDI will decline for many. Studying the effect of Massachusetts health care reform in 2006 may provide insights into the impact the ACA may have on SSDI applications and awards.

NEWS RELEASE

Ending Individual Mandate Would Cut Health Coverage, but Not Dramatically Hike Insurance Price— Feb 16, 2012

Eliminating a key part of health care reform that requires all Americans to have health insurance would sharply lower the number of people gaining coverage, but would not dramatically increase the cost of buying policies through new insurance exchanges.

News Release

RESEARCH BRIEF

How Would Eliminating the Individual Mandate Affect Health Coverage and Premium Costs? — Feb 16, 2012

An analysis of the effects of implementing the Affordable Care Act without an individual mandate found that over 12 million people who would have otherwise signed up for coverage will be uninsured and premium prices will increase by 2.4 percent.

REPORT

Ending Individual Mandate Would Cut Health Coverage, but Not Dramatically Hike Insurance Price— Feb 16, 2012

CONTENT

How Will Eliminating the Individual Mandate Affect Health Coverage and Premium Costs? — Feb 15, 2012

The individual mandate of the Patient Protection and Affordable Care Act of 2010 (ACA) requires that most Americans either obtain health coverage or pay an annual fine. How much will overturning the individual mandate affect costs and coverage?

JOURNAL ARTICLE

Rules Allowing Small Businesses to Opt Out of Health Reform Should Have Minor Impact on Insurance Cost— Feb 8, 2012

Rules that allow some small employers to avoid regulation under the federal Affordable Care Act are unlikely to have a major impact on the future cost of health insurance unless those rules are relaxed to allow more businesses to opt out.

NEWS RELEASE

Rules Allowing Small Businesses to Opt Out of Health Reform Should Have Minor Impact on Insurance Cost— Feb 8, 2012

News Release

COMMENTARY

How Will the Effects of the Affordable Care Act Be Monitored? — Jan 4, 2012

Most will agree with the undeniable fact that a new era in US medicine and US health care begins in less than two years. The key question is what potential measures should be monitored to determine both anticipated and unanticipated effects of the new law on the health of the US population, writes Robert H. Brook.

Commentary

OURNAL ARTICLE

Two Years and Counting: How Will the Effects of the Affordable Care Act Be Monitored? — Jan 1, 2012

The Affordable Care Act marks a new era in US health care and US medicine. This commentary suggests ways to monitor the act’s effect on the health of the US population.

RESEARCH BRIEF

How Does Health Reform Affect the Health Care Workforce? Lessons from Massachusetts — Dec 13, 2011

Since Massachusetts enacted health reform legislation in 2006, health care employment in the state has grown more rapidly than in the rest of the United States, primarily in administrative positions.

CONTENT

What Are the Public Health Implications of Prisoner Reentry in California? — Dec 1, 2011

California, the state with the nation’s largest prison population, is releasing increased numbers of inmates under its 2011 Public Safety Realignment Plan. RAND was asked to study the public health implications of returning prisoners for the communities they return to and has found both challenges and opportunities.

REPORT

Addressing Medicare Payment Differentials Across Ambulatory Settings — Oct 12, 2011

Medicare’s payment for physician work and malpractice liability expenses is the same regardless of where a service is provided, but payments differ for facility-related components of care.

REPORT

Power to the People: The Role of Consumer-Controlled Personal Health Management Systems in the Evolution of Employer-Based Health Care Benefits — Sep 13, 2011

The Patient Protection and Affordable Care Act has piqued employers’ interest in new benefit designs. This paper reviews consumer-controlled personal health management systems that could help individuals control and manage their health care.

JOURNAL ARTICLE

Health Care Reform and the Health Care Workforce — The Massachusetts Experience — Sep 1, 2011

Analysis of the Massachusetts Health Care Reform Plan suggests national health care reform may require larger numbers of support personnel, rather than requiring greater numbers of physicians and nurses themselves.

PROJECT

Comprehensive Assessment of Reform Efforts (COMPARE) — Jul 20, 2011

Policymakers are facing new challenges as they implement the Patient Protection and Affordable Care Act (ACA). RAND COMPARE is a modeling tool that simulates the impact of implementation decisions on insurance coverage, premiums, and health care spending.

REPORT

Employer Self-Insurance Decisions and the Implications of the Patient Protection and Affordable Care Act as Modified by the Health Care and Education Reconciliation Act of 2010 (ACA) — May 25, 2011

Implications of the Patient Protection and Affordable Care Act of 2010 (as Modified by the Health Care and Education Reconciliation Act) for small firms’ decisions to offer self-insured health plans and consequences of self-insurance for enrollees.

REPORT

How Community and Faith-Based Organizations Can Help Improve Community Well-Being — May 9, 2011

Content for a toolkit was designed to help community and faith-based organizations take advantage of opportunities presented in the Patient Protection and Affordable Care Act and engage leaders in promoting health in their communities.

NEWS RELEASE

How National Health Reform Will Affect a Variety of States — Apr 5, 2011

A series of new reports by the RAND Corporation outlines the impact that national health care reform will have on individual states, estimating the increased costs and coverage that are expected in five diverse states once reform is fully implemented in 2016.

NEWS RELEASE

Health Reform Will Add Coverage for 6 Million Californians; State Health Spending to Grow by 7 Percent— Apr 5, 2011

National health care reform will help 6 million California residents obtain health insurance and increase health care spending by state government by about 7 percent when it is fully implemented in 2016.

News Release

NEWS RELEASE

Health Reform Will Add Coverage for 170,000 in Connecticut; State Health Spending to Drop by 10 Percent— Apr 5, 2011

National health care reform will help 170,000 Connecticut residents obtain health insurance and decrease health care spending by state government by about 10 percent when it is fully implemented in 2016.

News Release

NEWS RELEASE

Health Reform Will Add Coverage for 1.3 Million in Illinois; State Health Spending to Grow by 10 Percent— Apr 5, 2011

National health care reform will help 1.3 million Illinois residents obtain health insurance and increase health care spending by state government by about 10 percent when it is fully implemented in 2016.

News Release

NEWS RELEASE

Health Reform Will Add Coverage for 125,000 in Montana; State Health Spending to Grow by 3 Percent— Apr 5, 2011

National health care reform will help 125,000 Montana residents obtain health insurance and increase health care spending by state government by about 3 percent when it is fully implemented in 2016.

News Release

NEWS RELEASE

Health Reform Will Add Coverage for 5 Million in Texas; State Health Spending to Grow by 10 Percent— Apr 5, 2011

National health care reform will help 5 million Texas residents obtain health insurance and increase health care spending by state government by about 10 percent when it is fully implemented in 2016.

News Release

RESEARCH BRIEF

High-Deductible Health Plans Cut Spending but Also Reduce Preventive Care — Apr 5, 2011

High-deductible plans significantly reduce health care spending but also lead consumers to cut back on their use of preventive health care — even though high-deductible plans waive the deductible for such care.

RESEARCH BRIEF

How Will Health Care Reform Affect Costs and Coverage? Examples from Five States — Apr 1, 2011

Projects how the coverage-related provisions of the Patient Protection and Affordable Care Act will affect health insurance coverage and state government spending on health care in five states.

REPORT

The Impact of the Coverage-Related Provisions of the Patient Protection and Affordable Care Act on Insurance Coverage and State Health Care Expenditures in Illinois: An Analysis from RAND COMPARE — Apr 1, 2011

Projects how the coverage-related provisions of the Patient Protection and Affordable Care Act will affect health insurance coverage and state government spending on health care in Illinois through 2020.

REPORT

The Impact of the Coverage-Related Provisions of the Patient Protection and Affordable Care Act on Insurance Coverage and State Health Care Expenditures in Texas: An Analysis from RAND COMPARE — Apr 1, 2011

REPORT

The Impact of the Coverage-Related Provisions of the Patient Protection and Affordable Care Act on Insurance Coverage and State Health Care Expenditures in California: An Analysis from RAND COMPARE — Apr 1, 2011

REPORT

The Impact of the Coverage-Related Provisions of the Patient Protection and Affordable Care Act on Insurance Coverage and State Health Care Expenditures in Montana: An Analysis from RAND COMPARE — Apr 1, 2011

REPORT

The Impact of the Coverage-Related Provisions of the Patient Protection and Affordable Care Act on Insurance Coverage and State Health Care Expenditures in Connecticut: An Analysis from RAND COMPARE — Apr 1, 2011

REPORT

Investment in New Health Care Quality Measures Needed as Cost-Cutting Strategies Grow — Feb 23, 2011

Health care spending reforms should be met with new efforts to develop and refine quality of care and other performance measures in order to assure that any changes will improve medical care and not harm patients.

JOURNAL ARTICLE

Small Firms’ Actions in Two Areas, and Exchange Premium and Enrollment Impact — Feb 1, 2011

An analysis of two rules that allow small businesses to avoid participating in health reform concludes they will have only a minor impact because relatively few businesses are likely to take advantage of the options.

RESEARCH BRIEF

How Will the Affordable Care Act Affect Employee Health Coverage at Small Businesses? — Sep 8, 2010

Finds that the Affordable Care Act will increase the percentage of employers that offer health coverage to workers: from 57 percent to 80 percent for firms with 50 or fewer workers, and from 90 percent to 98 percent for firms with 51 to 100 workers.

JOURNAL ARTICLE

The Effects of the Affordable Care Act on Workers’ Health Insurance Coverage — Sep 1, 2010

The nature of employer-sponsored coverage may change substantially after implementation of the Patient Protection and Affordable Care Act, with an increase in the number of workers offered coverage through the health insurance exchanges.

REPORT

Establishing State Health Insurance Exchanges: Implications for Health Insurance Enrollment, Spending, and Small Businesses — Aug 11, 2010

The Patient Protection and Affordable Care Act will increase insurance offer rates at small businesses. By 2016, rates would increase from 53 to 77 percent at firms with ten or fewer workers and from 71 to 90 percent at firms with 11 to 25 workers.

REPORT

Grandfathering in the Small Group Market Under the Patient Protection and Affordable Care Act: Effects on Offer Rates, Premiums, and Coverage — Jun 2, 2010

To avoid changes in current health coverage, the Patient Protection and Affordable Care Act exempts existing plans from some regulations. These exemptions may lead to higher employer-sponsored insurance enrollment and lower government spending.

JOURNAL ARTICLE

Patient Protection and Affordable Care Act: Laying the Infrastructure for National Health Reform — Jun 1, 2010

This article discusses the range of health information technology initiatives included in the 2009 economic stimulus legislation that collectively are known as the Health Information Technology for Economic and Clinical Health (HITECH) initiative; these include proposed regulations on

RESEARCH BRIEF

RAND COMPARE Analysis of President Obama’s Proposal for Health Reform — Mar 3, 2010

Compares President Obama’s Proposal for Health Reform, the U.S. House and Senate health care reform bills, and the status quo on changes in number of uninsured and government and national costs, as estimated by the RAND COMPARE microsimulation model.

RESEARCH BRIEF

Coverage, Spending, and Consumer Financial Risk: How Do the Recent House and Senate Health Care Bills Compare? — Feb 12, 2010

Compares how two health care reform bills, HR. 3962 and H.R. 3590, passed by the U.S. House and Senate, respectively, in late 2009 compare on a variety of projections made using the RAND COMPARE microsimulation model.

RESEARCH BRIEF

Analysis of the Patient Protection and Affordable Care Act (H.R. 3590) — Feb 11, 2010

Using the COMPARE microsimulation model, estimates the effects of the Patient Protection and Affordable Care Act (H.R. 3590) on the number of uninsured, the costs to the federal government and the nation, and consumers’ health care spending.

NEWS RELEASE

The Potential Impact of House Health Reform Legislation — Jan 8, 2010

Health reform as set forth in legislation passed by the U.S. House of Representatives in November would cut the number of uninsured Americans to 24 million by 2019 (a 56 percent decrease) and increase personal spending on health care by about 3.3 percent cumulatively between 2013 and 2019.

News Release

RESEARCH BRIEF

Analysis of the Affordable Health Care for America Act (H.R. 3962) — Jan 7, 2010

Using the COMPARE microsimulation model, estimates proposed health care reform legislation’s effects on the number of uninsured, the costs to the federal government and the nation, revenues from penalty payments, and consumers’ health care spending.

JOURNAL ARTICLE

Bending the Curve Through Health Reform Implementation — Jan 1, 2010

Cost savings can be achieved while improving health care quality by speeding payment reforms, implementing insurance reforms, and reforming coverage.

JOURNAL ARTICLE

Could We Have Covered More People at Less Cost? Technically, Yes; Politically, Probably Not — Jan 1, 2010

Using the COMPARE (Comprehensive Assessment of Reform Efforts) microsimulation model, this study evaluated how the recently enacted health reform law performed compared with alternative designs on measures of effectiveness and efficiency and found that only a few different approaches would cover more individuals at a lower cost to the government; however, these appeared politically untenable because they included substantially higher penalties, lower subsidies, or less generous Medicaid expansion.

JOURNAL ARTICLE

The Science of Health Care Reform — Jun 17, 2009

Another health policy window has opened; through it will stream proposals to reform the US health care system. President Obama has demanded that reform proposals improve both coverage and quality of care and make health care more affordable for all Americans. Extending coverage without worrying about costs would be relatively easy. Improving quality of care without worrying about costs might also be achievable. But extending coverage and improving quality while also making coverage more affordable will be difficult.

PEOPLE

David I. Auerbach

Policy Researcher; Professor, Pardee RAND Graduate School
Ph.D. in health economics, Harvard University; M.S. in environmental science & policy, MIT; M.S. in chemistry, University of California, Berkeley; B.S. in chemistry, MIT

Staff Profile

PEOPLE

Christine Eibner

Economist
Ph.D. in economics, University of Maryland, College Park

Staff Profile

PEOPLE

Peter S. Hussey

Policy Researcher; Professor, Pardee RAND Graduate School
Ph.D. in health policy and management, Johns Hopkins Bloomberg School of Public Health

Staff Profile

PEOPLE

Sarah A. Nowak

Associate Physical Scientist; Professor, Pardee RAND Graduate School
Ph.D. and M.S. in biomathematics, University of California, Los Angeles; B.S. in physics, MIT

Staff Profile

PEOPLE

Jeanne S. Ringel

Director, Public Health Systems and Preparedness Initiative, RAND Health; Senior Economist; Professor, Pardee RAND Graduate School
Ph.D. in economics, University of Maryland, College Park; M.A. in economics, University of Maryland, College Park

Staff Profile

PEOPLE

Kristin R. Van Busum

Project Associate, Behavioral & Policy Sciences
M.P.A. in health policy analysis, New York University; B.A., Butler University

Staff Profile

SOURCE

http://www.rand.org/topics/patient-protection-and-affordable-care-act.all.0.html

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Archive for the ‘Federal Budget Appropriations’ Category

The Arnold Relman Challenge: US HealthCare Costs vs US HealthCare Outcomes

Other articles of Arnold Relman in the New York REVIEW of Books

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Reason in Hobby Lobby

Reason in Hobby Lobby

What the battle over birth control is really about byteacherken

Free Birth Control is Emerging Standard for Women RICARDO ALONSO-ZALDIVAR, Associated Press 07/07/2014

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Justice Ginsberg Written Dissent

Justice Ginsberg written dissent – Third Part

Justice Ginsberg Written Dissent

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Physicians’ View of Supreme Court on an Issue of Public Health

Physicians’ View of Supreme Court on an Issue of Public Health

Supreme Court Issues Hobby Lobby Decision

More Physician Groups Weigh In

Between Women and Their Physicians

Other Implications

When Religious Freedom Clashes with Access to Care

BUFFER ZONES, BUBBLE ZONES, AND ABORTION CLINICS — ANOTHER WOMEN’S HEALTH CASE

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8-OH-dG: A novel immune activator.

Oxidative Damage of DNA Confers Resistance to Cytosolic Nuclease TREX1 Degradation and Potentiates STING-Dependent Immune Sensing

New Weapon in Fight Against ‘Superbugs’

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Where has the reason gone?

Religious organizations exist to serve a community of believers.

For-profit corporations do not fit that bill.

So, what about the contraceptive mandate?

Incredible!! So, RFRA applies, there’s a burden, and the contraceptive mandate fails the test.

[O]ur decision in these cases is concerned solely with the contraceptive mandate.

Free Birth Control is Emerging Standard for Women

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Information Security and Privacy in Healthcare is part of the 2nd Annual Medical Informatics World, April 28-29, 2014, World Trade Center, Boston, MA

Concurrent Tracks

About the Conference

KEY NOTES

AGENDA

PROGRAM in PDF

2014 Agenda at a Glance

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Tycho Brahe, where art thou? Today’s Renaissance of the Self-Funded Scientist!

Alternate Funding Source: CROWDSOURCING

Digital Tools and Lab Space for the Self-Funding Scientist

Finding Lab Space: Biohacker Labs

Other posts on this site about Science Funding, Crowdsourcing, and Open Innovation include:

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Patient Protection and Affordable Care Act Featured at RAND

What’s Next for the ACA

Featured at RAND

All Items (123)

RAND Health Reform Opinion Study Update: Positive Opinion on ACA Grows, Negative Opinion Stabilizes— Dec 23, 2013

A New Way to Measure Public Opinion of Health Reform — Dec 18, 2013

Will the Affordable Care Act Make Health Care More Affordable? — Dec 11, 2013

Is There Really a Physician Shortage? — Dec 5, 2013

Ramifications of Health Reform — Nov 26, 2013

Employer-Provided Health Insurance: Why Does It Persist, and Will It Continue after 2014? — Nov 25, 2013

Can the Affordable Care Act Help Asthma Sufferers Breathe Easier? — Nov 20, 2013

Four Questions on Canceled Insurance Policy Fix — Nov 14, 2013

The Future of the Health Care Workforce: RAND Researchers Well Represented in Health Affairs Special Issue— Nov 7, 2013

Quick Takes: Health Literacy and ACA Enrollment — Nov 7, 2013

Quick Takes: The Math of Medicaid Expansion — Oct 21, 2013

Medicaid Access for the Formerly Incarcerated Under the ACA: Helping the Oft-Forgotten — Oct 3, 2013

Understanding the Affordable Care Act — Oct 2, 2013

Will the Affordable Care Act Make Health Care More Affordable? — Oct 1, 2013

Ask Me Anything: Carter Price on the Affordable Care Act — Oct 1, 2013

Affordable Care Act Will Reduce Out-of-Pocket Medical Spending for Many Americans — Oct 1, 2013

Affordable Care Act Will Reduce Out-of-Pocket Medical Spending for Many Americans — Oct 1, 2013

Patient Protection and Affordable Care Act