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Health benefit of anthocyanins from apples and berries noted for men

Posted in Glycobiology: Biopharmaceutical Production, Pharmacodynamics and Pharmacokinetics, Health Economics and Outcomes Research, Healthcare costs and reimbursement, Indigent Nutrition, Inferential analysis, Innovations in Neurophysiology & Neuropsychology, Metabolomics, Molecular Genetics & Pharmaceutical, Neurodegenerative Diseases, Neurohumoral Transmission, Nutrigenomics, Nutrition, Nutritional Supplements: Atherogenesis, lipid metabolism, Personalized and Precision Medicine & Genomic Research, Population Health Management, Nutrition and Phytochemistry, Signaling, Skilled Nursing Facilities, Systemic Inflammatory Response Related Disorders, Translational Effectiveness, Translational Research, Translational Science, Uninsured and Underinsured, tagged , , , , on July 6, 2014| Leave a Comment »

Larry H Bernstein, MD, FCAP, Curator

http://pharmaceuticalintelligence.com/6/7/2014/Health benefit of anthocyanins from apples and berries noted for men

After significant studies have been completed, particularly on a relationship between anthocyanins consumption and decreasd risk of Parkinson’s Disease in men, it is unclear why a comparable effect is not seen in women.  This would lead one to ask questions about predominant time course of development in relationship to androgen activity.  Pre- and postmenopausal status would seem to make no difference. It is reported that the anthocyanins cross the blood brain barrier.  There are other questions that need to be raised.  There is a decline in the production of transthyretin by the choroid plexus in the elderly – not sex related – with an elevation of homocysteine that is reciprocal to decline in transthyretin-RBP complex, that is related to AD.  This is mediated by cystathionine-beta synthase, and involves matrix metalloproteinases.  A mechanism for Parkinson’s Disease has been postulated to be related to Parkin gene expression, but how does this work, and why do we see the sex assymetry?

Eating flavonoids protects men against Parkinson’s disease

General Diet, Missed – Medical Breakthroughs • Tags: Anthocyanin, Flavonoid, Harvard University,Health, Neurology, Parkinson, Parkinson Disease, University of East Anglia

http://healthresearchreport.me/       07 Apr 2012

Men who eat flavonoid-rich foods such as berries, tea, apples and red wine significantly reduce their risk of developing Parkinson’s disease, according to new research by Harvard University and the University of East Anglia (UEA).

Published today in the journal Neurology ®, the findings add to the growing body of evidence that regular consumption of some flavonoids can have a marked effect on human health. Recent studies have shown that these compounds can offer protection against a wide range of diseases including heart disease, hypertension, some cancers and dementia.

This latest study is the first study in humans to show that flavonoids can protect neurons against diseases of the brain such as Parkinson’s.

Around 130,000 men and women took part in the research. More than 800 had developed Parkinson’s disease within 20 years of follow-up. After a detailed analysis of their diets and adjusting for age and lifestyle, male participants who ate the most flavonoids were shown to be 40 per cent less likely to develop the disease than those who ate the least. No similar link was found for total flavonoid intake in women.

The research was led by Dr Xiang Gao of Harvard School of Public Health in collaboration with Prof Aedin Cassidy of the Department of Nutrition, Norwich Medical School at UEA.

“These exciting findings provide further confirmation that regular consumption of flavonoids can have potential health benefits,” said Prof Cassidy.

“This is the first study in humans to look at the associations between the range of flavonoids in the diet and the risk of developing Parkinson’s disease and our findings suggest that a sub-class of flavonoids called anthocyanins may have neuroprotective effects.”

Prof Gao said: “Interestingly, anthocyanins and berry fruits, which are rich in anthocyanins, seem to be associated with a lower risk of Parkinson’s disease in pooled analyses. Participants who consumed one or more portions of berry fruits each week were around 25 per cent less likely to develop Parkinson’s disease, relative to those who did not eat berry fruits. Given the other potential health effects of berry fruits, such as lowering risk of hypertension as reported in our previous studies, it is good to regularly add these fruits to your diet.”

Flavonoids are a group of naturally occurring, bioactive compunds found in many plant-based foods and drinks. In this study the main protective effect was from higher intake of anthocyanins, which are present in berries and other fruits and vegetables including aubergines, blackcurrants and blackberries. Those who consumed the most anthocyanins had a 24 per cent reduction in risk of developing Parkinson’s disease and strawberries and blueberries were the top two sources in the US diet.

The findings must now be confirmed by other large epidemiological studies and clinical trials.

Parkinson’s disease is a progresssive neurological condition affecting one in 500 people, which equates to 127,000 people in the UK. There are few effective drug therapies available.  Dr Kieran Breen, director of research at Parkinson’s UK said: “This study raises lots of interesting questions about how diet may influence our risk of Parkinson’s…   there are still a lot of questions to answer and much more research to do before we really know how important diet might be for people with Parkinson’s.”

 

Eating berries may lower risk of Parkinson’s

Missed – Medical Breakthroughs • Tags: Berry, Doctor of Philosophy, Flavonoid, Parkinson,Parkinson Disease, Xiang Gao

http://healthresearchreport.me/    Public release date: 13-Feb-2011

ST. PAUL, Minn. –New research shows men and women who regularly eat berries may have a lower risk of developing Parkinson’s disease, while men may also further lower their risk by regularly eating apples, oranges and other sources rich in dietary components called flavonoids. The study was released today and will be presented at the American Academy of Neurology’s 63rd Annual Meeting in Honolulu April 9 to April 16, 2011.

Flavonoids are found in plants and fruits and are also known collectively as vitamin P and citrin. They can also be found in berry fruits, chocolate, and citrus fruits such as grapefruit.

The study involved 49,281 men and 80,336 women. Researchers gave participants questionnaires and used a database to calculate intake amount of flavonoids. They then analyzed the association between flavonoid intakes and risk of developing Parkinson’s disease. They also analyzed consumption of five major sources of foods rich in flavonoids: tea, berries, apples, red wine and oranges or orange juice. The participants were followed for 20 to 22 years.

During that time, 805 people developed Parkinson’s disease. In men, the top 20 percent who consumed the most flavonoids were about 40 percent less likely to develop Parkinson’s disease than the bottom 20 percent of male participants who consumed the least amount of flavonoids. In women, there was no relationship between overall flavonoid consumption and developing Parkinson’s disease. However, when sub-classes of flavonoids were examined, regular consumption of anthocyanins, which are mainly obtained from berries, were found to be associated with a lower risk of Parkinson’s disease in both men and women.

“This is the first study in humans to examine the association between flavonoids and risk of developing Parkinson’s disease,” said study author Xiang Gao, MD, PhD, with the Harvard School of Public Health in Boston. “Our findings suggest that flavonoids, specifically a group called anthocyanins, may have neuroprotective effects. If confirmed, flavonoids may be a natural and healthy way to reduce your risk of developing Parkinson’s disease.”
May 10, 2013

Could eating peppers prevent Parkinson’s?

Missed – Medical Breakthroughs • Tags: American Neurological Association, Annals of Neurology,Group Health Cooperative, Nicotine, Parkinson, Parkinson’s disease, Solanaceae, University of Washington

Contact: Dawn Peters sciencenewsroom@wiley.com 781-388-8408 Wiley

Dietary nicotine may hold protective key

New research reveals that Solanaceae—a flowering plant family with some species producing foods that are edible sources of nicotine—may provide a protective effect against Parkinson’s disease. The study appearing today inAnnals of Neurology, a journal of the American Neurological Association and Child Neurology Society, suggests that eating foods that contain even a small amount of nicotine, such as peppers and tomatoes, may reduce risk of developing Parkinson’s.

Parkinson’s disease is a movement disorder caused by a loss of brain cells that produce dopamine. Symptoms include facial, hand, arm, and leg tremors, stiffness in the limbs, loss of balance, and slower overall movement. Nearly one million Americans have Parkinson’s, with 60,000 new cases diagnosed in the U.S. each year, and up to ten million individuals worldwide live with this disease according to the Parkinson’s Disease Foundation. Currently, there is no cure for Parkinson’s, but symptoms are treated with medications and procedures such as deep brain stimulation.

Previous studies have found that cigarette smoking and other forms of tobacco, also a Solanaceae plant, reduced relative risk of Parkinson’s disease. However, experts have not confirmed if nicotine or other components in tobacco provide a protective effect, or if people who develop Parkinson’s disease are simply less apt to use tobacco because of differences in the brain that occur early in the disease process, long before diagnosis.

For the present population-based study Dr. Susan Searles Nielsen and colleagues from the University of Washington in Seattle recruited 490 patients newly diagnosed with Parkinson’s disease at the university’s Neurology Clinic or a regional health maintenance organization, Group Health Cooperative. Another 644 unrelated individuals without neurological conditions were used as controls. Questionnaires were used to assess participants’ lifetime diets and tobacco use, which researchers defined as ever smoking more than 100 cigarettes or regularly using cigars, pipes or smokeless tobacco.

Vegetable consumption in general did not affect Parkinson’s disease risk, but as consumption of edible Solanaceae increased, Parkinson’s disease risk decreased, with peppers displaying the strongest association. Researchers noted that the apparent protection from Parkinson’s occurred mainly in men and women with little or no prior use of tobacco, which contains much more nicotine than the foods studied.

“Our study is the first to investigate dietary nicotine and risk of developing Parkinson’s disease,” said Dr. Searles Nielsen. “Similar to the many studies that indicate tobacco use might reduce risk of Parkinson’s, our findings also suggest a protective effect from nicotine, or perhaps a similar but less toxic chemical in peppers and tobacco.” The authors recommend further studies to confirm and extend their findings, which could lead to possible interventions that prevent Parkinson’s disease.

###

This study is published in Annals of Neurology. Media wishing to receive a PDF of this article may contact sciencenewsroom@wiley.com.

Full citation: “Nicotine from Edible Solanaceae and Risk of Parkinson Disease.” Susan Searles Nielsen, Gary M. Franklin, W.T. Longstreth Jr, Phillip D. Swanson and Harvey Checkoway. Annals of Neurology; Published May 9, 2013 (DOI:10.1002/ana.23884).

URL Upon Publication: http://doi.wiley.com/10.1002/ana.23884

Author Contact: To arrange an interview with Dr. Susan Searles Nielsen, please contact Leila Gray with the University of Washington Health Sciences News Office at +1 206-685-0381 or at leilag@uw.edu.

About the Journal

Annals of Neurology, the official journal of the American Neurological Association and the Child Neurology Society, publishes articles of broad interest with potential for high impact in understanding the mechanisms and treatment of diseases of the human nervous system. All areas of clinical and basic neuroscience, including new technologies, cellular and molecular neurobiology, population sciences, and studies of behavior, addiction, and psychiatric diseases are of interest to the journal. The journal is published by Wiley on behalf of the
American Neurological Association and Child Neurology Society. For more information, please visit http://onlinelibrary.wiley.com/journal/10.1002/ana.

Flavonoids from berries shown to protect men against Parkinson’s disease

December 19, 2013 · by MrT

by: John Phillip, John is a Certified Nutritional Consultant and Health Researcher

(NaturalNews) Past research bodies have confirmed the health-protective effect of a natural diet rich in flavonoids to protect against a wide range of diseases including heart disease, hypertension, some cancers, and dementia. Researchers from Harvard University and the University of East Anglia have published the result of a study in the journalNeurology that demonstrates how these plant-based phytonutrients can significantly lower the risk of developing Parkinson’s disease, especially in men.

Flavonoids from healthy foods such as berries, tea, apples, and red wine cross the delicate blood-brain barrier to protect neurons against neurologic diseases such as Parkinson’s. This large scale study included more than 130,000 men and women participants that were followed for a period of twenty years. During this time, more than 800 individuals developed Parkinson’s disease.

A diet high in flavonoids from berries lowers Parkinson’s disease risk by forty percent

After a detailed analysis of their diets and adjusting for age and lifestyle, male participants who ate the most flavonoids were shown to be forty percent  less likely to develop the disease than those who ate the least. No similar link was found for total flavonoid intake in women.

”This was the first study to examine the connection between flavonoid consumption and the development of Parkinson’s disease. The findings suggest that a sub-class of flavonoids called anthocyanins may exhibit neuroprotective effects. Participants consuming one or more portions of berry fruits each week were around twenty-five percent less likely to develop Parkinson’s disease, relative to those who did not eat berry fruits.

Flavonoids are the bioactive, naturally occurring chemical compounds found in many plant-based foods and drinks.

This study demonstrated the main protective effect was from the consumption of anthocyanins, which are present in berries and other fruits and vegetables including aubergines, blackcurrants, and blackberries. Strawberries and blueberries are the two most common sources of flavonoids in the US diet, contributing to a twenty-four percent lowered risk in this research.

Parkinson’s disease is among a group of chronic diseases presently affecting one in 500 people, with new cases on the rise. Drug therapies are ineffective and bear significant side effects.

Nutrition experts recommend adding a minimum of three to five servings of flavonoids to your diet each week. Include all varieties of berries, apples, and green tea to guard against Parkinson’s disease and other neurodegenerative illnesses.

 

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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 , , , , , , 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.

  1. Where has the reason gone?
  2. Justice Ginsberg written dissent
  3. The physicians’ view of Supreme Court on an issue of public health
  4.  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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Can Mobile Health Apps Improve Oral-Chemotherapy Adherence? The Benefit of Gamification.

Posted in Bio Instrumentation in Experimental Life Sciences Research, CANCER BIOLOGY & Innovations in Cancer Therapy, Cancer Prevention: Research & Programs, Curation, Diabetes Mellitus, FDA Regulatory Affairs, Health Economics and Outcomes Research, Healthcare costs and reimbursement, HealthCare IT, Interviews with Scientific Leaders, ISO 10993 for Product Registration: FDA & CE Mark for Development of Medical Devices and Diagnostics, Medical Device Therapies for Altzheimer’s Disease, Medical Devices R&D Investment, Personal Health Applications: Tech Innovations serves HealhCare, Translational Effectiveness, tagged , , , , , , , , , , , , , on June 17, 2014| Leave a Comment »

Can Mobile Health Apps Improve Oral-Chemotherapy Adherence? The Benefit of Gamification.

Reporter: Stephen J. Williams, PhD

Article ID #144: Can Mobile Health Apps Improve Oral-Chemotherapy Adherence? The Benefit of Gamification. Published on 6/17/2014

WordCloud Image Produced by Adam Tubman

A report on how gamification mobile applications, like CyberDoctor’s PatientPartner, may improve patient adherence to oral chemotherapy.

(includes interviews with CyberDoctor’s CEO Akhila Satish and various oncologists)

 

Writer/Curator: Stephen J. Williams, Ph.D.

UPDATE 5/15/2019

Please see below for an UPDATE on this post including results from the poll conducted here on the value of a gamification strategy for oral chemotherapy patient adherence as well as a paper describing a well designed development of an application specifically to address this clinical problem.

Studies have pointed to a growing need to monitor and improve medical adherence, especially with outpatient prescription drugs across many diseases, including cancer.

The trend to develop oral chemotherapies, so patients can take their medications in the convenience of their home, has introduced produced a unique problem concerning cancer patient-medication adherence. Traditionally, chemotherapies were administered by a parental (for example intravenous) route by clinic staff, however, as noted by Jennifer M Gangloff in her article Troubling Trend: Medication Adherence:

 

with the trend of cancer patients taking their oral medication at home, the burden of adherence has shifted from clinicians to the patients and their families.

 

A few highlights from Jennifer Gangloff’s article highlight the degree and scope of the problem:

 

  1. There is a wide range of adherence for oral chemo– as low as 16% up to 100% adherence rates have been seen in multiple studies
  2. High cost in lives and money: estimates in US of 125,000 deaths and $300 billion in healthcare costs due to nonadherence to oral anticancer medications
  3. Factors not related to the patient can contribute to nonadherence including lack of information provided by the healthcare system and socioeconomic factors
  4. Numerous methods to improve adherence issues (hospital informative seminars, talking pill bottles, reminder phone calls etc.) have met with mixed results.

 

A review by Steve D`Amato of published literature also highlights the extent of problems with highly variable adherence rates including

  • 17-27% for hematologic malignancies
  • 53-98% for breast cancer
  • 97% for ovarian cancer

More strikingly, patient adherence rates can drastically decline over treatment, with one study showing an adherence rate drop from 87% to 50% over 4 years of adjuvant tamoxifen therapy.

 

Tackling The Oral Chemotherapy-Patient Adherence Problem

 

Documented factors leading to non-adherence to oral oncology medications include

  1. Patient feels better so stop taking the drug
  2. Patient feels worse so stops taking the drug
  3. Confusing and complicated dosing regimen
  4. Inability to afford medications
  5. Poor provider-patient relationships
  6. Adverse effects of medication
  7. Cognitive impairment (“chemo fog”; mental impairment due to chemotherapy
  8. Inadequate education/instruction of discharge

There are many examples of each reason why a patient stopped taking medication. One patient was prescribed capecitabine for her metastatic breast cancer and, upon feeling nausea, started to use antacids, which precipitated toxicities as a result of increased plasma levels of capecitabine.

In a white paper entitled Oral Oncology Treatment Regimens and the Role of Medication Therapy Management on Patient Adherence and Compliance, David Reese, Vice President Oncology at Tx Care Advantage discus how Medication Therapy Management (MTM) programs could intervene to improve medical adherence in both the oncology and non-oncology setting.

This review also documented the difficulties in accurately measuring patient adherence including:

  • Inaccuracy of self-reporting
  • Lack of applicability of external measurements such as pill counts
  • Hawthorne effect: i.e. patient pill documentation reminds them to take next dose

The group suggests that using MTM programs, especially telephony systems involving oncology nurses and pharmacists and utilizing:

  • Therapy support (dosing reminders)
  • Education
  • Side effect management

 

may be a cost-efficient methodology to improve medical adherence.

 

Although nurses are important intermediary educating patients about their oral chemotherapies, it does not appear that solely relying on nurses to monitor patient adherence will be sufficient, as indicated in a survey-based Japanese study.

As reported in May 12, 2014 | Oncology Nursing By Leah Lawrence

 

Systematic Nurse Involvement Key as Oral Chemotherapy Use Grows– at: http://www.cancernetwork.com/oncology-nursing/systematic-nurse-involvement-key-oral-chemotherapy-use-grows

 

Survey results indicated that 90% of nurses reported asking patients on oral chemotherapy about emergency contacts, side effects, and family/friend support. Nurses also provided patients with education materials on their assigned medication.

However, less than one-third of nurses asked if their patients felt confident about managing their oral chemotherapy.

“Nurses were less likely to ask adherence-related questions of patients with refilled prescriptions than of new patients,” the researchers wrote. “Regarding unused doses of anticancer agents, 35.5% of nurses reported that they did not confirm the number of unused doses when patients had refilled prescriptions.”

From the Roswell Park Cancer Institute blog post Making Mobile Health Work

https://www.roswellpark.org/partners-practice/white-papers/making-mobile-health-work

US physicians are recognizing the need for the adoption of mobile in their practice but choice of apps and mobile strategies must be carefully examined before implementation. In addition, most physicians are using mobile communications as a free-complementary service and these physicians are not being reimbursed for their time.

 

Some companies are providing their own oncology-related mobile app services:

CollabRx Announces Oncology-Specific Mobile App with Leading Site for Healthcare Professionals, MedPage Today

(http://www.collabrx.com/collabrx-announces-oncology-specific-mobile-app-with-leading-site-for-healthcare-professionals-medpage-today/)

San Francisco, August 13, 2013 – CollabRx, Inc. (NASDAQ: CLRX), a healthcare information technology company focused on informing clinical decision making in molecular medicine, today announced a multi-year agreement with Everyday Health’s MedPage Today. The forthcoming app, which will target oncologists and pathologists, will focus on the molecular aspects of laboratory testing and therapy development. Over time, the expectation is that this app will serve as a comprehensive point of care resource for physicians and patients to obtain highly credible, expert-vetted and dynamically updated information to guide cancer treatment planning.

The McKesson Foundation’s Mobilizing for Health initiative

has awarded a grant to Partners HealthCare’s Center for Connected Health to develop a mobile health program that uses a smartphone application to help patients with cancer adhere to oral chemotherapy treatments and monitor their symptoms, FierceMobileHealthcare reports.

 

CancerNet announces mobile application (from cancer.net)

http://www.cancer.net/navigating-cancer-care/managing-your-care/mobile-applications

 

However, there is little evidence that the plethora of cancer-based apps is providing any benefit with regard to patient outcome or adherence, as reported in to an article in the Journal of Medical Internet Research, reported at FierceMobileHealthcare (Read more: Cancer smartphone apps for consumers lack effectiveness – FierceMobileHealthcare http://www.fiercemobilehealthcare.com/story/cancer-smartphone-apps-consumers-lack-effectiveness/2013-12-26#ixzz34ucdxVcU )

The report suggests that there are too many apps either offering information, suggesting behavior/lifestyle changes, or measuring compliance data but little evidence to suggest any of these are working the way they intended. The article suggests the plethora of apps may just be adding to the confusion.

Johnson&Johnson’s Wellness & Prevention unit has launched a health-tracking app Track Your Health. Although the company considers it a “gamification“ app, Track Your Health© operates to either feed data from other health tracking apps or allow the user to manually input data.
Read more: J&J launches ‘quantified self’ app to game patients into better behavior – FiercePharmaMarketing http://www.fiercepharmamarketing.com/story/jj-launches-quantified-self-app-game-patients-better-behavior/2014-05-28#ixzz34uhFDJr2

Even ASCO has a list of some oncology-related apps (http://connection.asco.org/commentary/article/id/3123/favorite-hematology-oncology-apps.aspx) and

NIH is offering grants for oncology-related app development (https://www.linkedin.com/groupItem?view=&gid=72923&type=member&item=5870221695683424259&qid=dbf53031-dd21-443c-9152-fad87f85d200&trk=groups_most_popular-0-b-ttl&goback=.gmp_72923)
As reports and clinicians have stated, we need health outcome data and clinical trials to determine the effective of these apps.

MyCyberDoctor™, a True Gamification App, Shows Great Results in Improving Diabetics Medical Adherence and Health Outcome

 

Most of the mobile health apps discussed above, would be classified as tracking apps, because the applications simply record a patient’s actions, whether filling a prescription, interacting with a doctor, nurse, pharmacist, or going to a website to gain information. However, as discussed before, there is no hard evidence this is really impacting health outcomes.

 

Another type of application, termed gamification apps, rely on role-playing by the patient to affect patient learning and ultimately behavior.

An interested twist on this method was designed by Akhila Satish, CEO and developer of CyberDoctor and a complementary application PatientPartner.

Akhila Satish Picture

 

 

Ms. Akhila Satish, CEO CyberDoctor

 

 

 

 

 

 

 

Please watch video of interview with Akhila Satish, CEO of CyberDoctor at the Health 2.0 conference http://vimeo.com/51695558

 

And a video of the results of the PatientPartner clinical trial here: http://vimeo.com/79537738

 

As reported here, the PatientPartner application was used in the first IRB-approved mhealth clinical-trial to see if the gamification app could improve medical adherence and outcomes in diabetic patients. PatientPartner is a story-driven game in changing health behavior and biomarkers (blood glucose levels in this trial). In the clinical trial, 100 non-adherent patients with diabetes played the PatientPartner game for 15 minutes. Results were amazing, as the trial demonstrated an increase in patient adherence, with only 15 minutes of game playing.

Results from the study

Patients with diabetes who used PatientPartner showed significant improvement in three key areas – medication, diet, and exercise:

  • Medication adherence increased by 37%, from 58% to 95% – equivalent to three additional days of medication adherence per week.
  • Diet adherence increased by 24% – equivalent to two days of additional adherence a week.
  • Exercise adherence increased by 14% – equivalent to one additional day of adherence per week.
  • HbA1c (a blood sugar measure) decreased from 10.7% to 9.7%.

As mentioned in the article:

The unique, universal, non-disease specific approach allows PatientPartner to be effective in improving adherence in all patient populations.

PatientPartner is available in the iTunes store and works on the iPhone and iPod Touch. For information on PatientPartner, visit www.mypatientpartner.com.

Ms. Satish, who was named one of the top female CEO’s at the Health Conference, gratuitously offered to answer a few questions for Leaders in Pharmaceutical Business Intelligence (LPBI) on the feasibility of using such a game (role-playing) application to improve medical adherence in the oncology field.

LPBI: The results you had obtained with patient-compliance in the area of diabetes are compelling and the clinical trial well-designed.  In the oncology field, due to the increase in use of oral chemotherapeutics, patient-compliance has become a huge issue. Other than diabetes, are there plans for MyCyberDoctor and PatientPartner to be used in other therapeutic areas to assist with patient-compliance and patient-physician relations?

Ms. Satish: Absolutely! We tested the application in diabetes because we wanted to measure adherence from an objective blood marker (hbA1c). However, the method behind PatientPartner- teaching patients how to make healthy choices- is universal and applicable across therapeutic areas. 

LPBI: Recently, there have been a plethora of apps developed which claim to impact patient-compliance and provide information. Some of these apps have been niche (for example only providing prescription information but tied to pharmacy records and company databases). Your app seems to be the only one with robust clinical data behind it and approaches from a different angle, namely adjusting behavior using a gamefying experience and teaching the patient the importance of compliance. How do you feel this approach geared more toward patient education sets PatientPartner apart from other compliance-based apps?

Ms. Satish: PatientPartner really focuses on the how of patient decision making, rather than the specifics of each decision that is made. It’s a unique approach, and part of the reason PatientPartner works so effectively with such a short initial intervention! We are able to achieve more with less “app” time as a result of this method.  

LPBI: There have been multiple studies attempting to correlate patient adherence, decision-making, and health outcome to socioeconomic status. In some circumstances there is a socioeconomic correlation while other cases such as patient-decision to undergo genetic testing or compliance to breast cancer treatment in rural areas, level of patient education may play a bigger role. Do you have data from your diabetes trial which would suggest any differences in patient adherence, outcome to any socioeconomic status? Do you feel use of PatientPartner would break any socioeconomic barriers to full patient adherence?

Ms. Satish: Within our trial, we had several different clinical sites. This helped us test the product out in a broad, socioeconomically diverse population. It is our hope that with a tool as easy to scale and use as PatientPartner we have the opportunity to see the product used widely, even in populations that are traditionally harder to reach.  

LPBI: There has been a big push for the development of individual, personalized physician networks which use the internet as the primary point of contact between a primary physician and the patient. Individuals may sign up to these networks bypassing the traditional insurance-based networks. How would your application assist in these types of personalized networks?

Ms. Satish: PatientPartner can easily be plugged into any existing framework of communication between patient and provider. We facilitate patient awareness, engagement and accountability- all of which are important regardless of the network structure.

LBPI: Thank you Akhila!

A debate has begun about regulating mobile health applications, and although will be another post, I would just like to summarize a nice article in May, 2014 Oncology Times by Sarah Digiulo “Mobile Health Apps: Should They be Regulated?

In general, in the US there are HIPAA regulations about the dissemination of health related information between a patient and physician. Most of the concerns are related to personal health information made public in an open-access platform such as Twitter or Facebook.

In addition, according to Dr. Don Dizon M.D., Director of the Oncology Sexual Health Clinic at Massachusetts General Hospital, it may be more difficult to design applications directed against a vast, complex disease like cancer with its multiple subtypes than for diabetes.

 

Mobile Health Applications on Rise in Developing World: Worldwide Opportunity

 

According to International Telecommunication Union (ITU) statistics, world-wide mobile phone use has expanded tremendously in the past 5 years, reaching almost 6 billion subscriptions. By the end of this year it is estimated that over 95% of the world’s population will have access to mobile phones/devices, including smartphones.

This presents a tremendous and cost-effective opportunity in developing countries, and especially rural areas, for physicians to reach patients using mHealth platforms.

Drs. Clara Aranda-Jan Neo Mohutsiwa and Svetla Loukanova had conducted a systematic review of the literature on mHealth projects conducted in Africa[1] to assess the reliability of mobile phone and applications to assist in patient-physician relationships and health outcomes. The authors reviewed forty four studies on mHealth projects in Africa, determining their:

  • strengths
  • weaknesses
  • opportunities
  • threats

to patient outcomes using these mHealth projects. In general, the authors found that mHealth projects were beneficial for health-related outcomes and their success related to

  • accessibility
  • acceptance and low-cost
  • adaptation to local culture
  • government involvement

while threats to such projects could include

  • lack of funding
  • unreliable infrastructure
  • unclear healthcare system responsibilities

Dr.Sreedhar Tirunagari, an oncologist in India, agrees that mHealth, especially gamification applications could greatly foster better patient education and adherencealthough he notes that mHealth applications are not really used in India and may not be of much use for those oncology patients living in rural areas, as  cell phone use is not as prevalent as in the bigger inner cities such as Delhi and Calcutta.

 

Dr. Louis Bretes, an oncologist from Portugal, when asked

1) do you see a use for such apps which either track drug compliance or use gamification systems to teach patients the importance of continuing their full schedule of drug therapy

2) do you feel patient- drug compliance issues in the oncology practice is due to lack of information available to the patient or issues related to drug side effects?

“I think that Apps could help in this setting, we are in
Informatics era but..
The main question is that chronic patients are special ones.
Cancer patients have to deal with prognosis, even in therapies
with curative intent such as aromatase inhibitors are potent
Drugs that can cure; only in the future the patients know.
But meanwhile he or she has to deal with side-effects every day. A PC can help but suffer this symptoms…it. Is a real problem believe me!”

“The main app is his/her doctor”

I would like to invite all oncologists to answer the poll question ABOVE about the use of such gamification apps, like PatientPartner, for improving medical adherence to oral chemotherapy.

UPDATE 5/15/2019

The results of the above poll, although limited, revealed some interesting insights.  Although only five oncologists answered the poll whether they felt gamification applications could help with oral chemotherapy patient adherence, all agreed it would be worthwhile to develop apps based on gamification to assist in the outpatient setting.  In addition, one oncologist felt that the success of mobile patient adherence application would depend on the type of cancer.  None of the oncologist who answered the survey thought that gamification apps would have no positive effect on patient adherence to their chemotherapy.  With this in light, a recent paper by Joel Fishbein of University of Colorado and Joseph Greer from Massachusetts General Hospital, describes the development of a mobile application, in clinical trial, to promote patient adherence to their oral chemotherapy.

 

Mobile Applications to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development

 

Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development. Fishbein JN, Nisotel LE, MacDonald JJ, Amoyal Pensak N, Jacobs JM, Flanagan C, Jethwani K Greer JA. JMIR Res Protoc. 2017 Apr 20;6(4):e62. doi: 10.2196/resprot.6198. 

 

Abstract 

BACKGROUND:

Oral chemotherapy is increasingly used in place of traditional intravenous chemotherapy to treat patients with cancer. While oral chemotherapy includes benefits such as ease of administration, convenience, and minimization of invasive infusions, patients receive less oversight, support, and symptom monitoring from clinicians. Additionally, adherence is a well-documented challenge for patients with cancer prescribed oral chemotherapy regimens. With the ever-growing presence of smartphones and potential for efficacious behavioral intervention technology, we created a mobile health intervention for medication and symptom management.

OBJECTIVE:

The objective of this study was to develop and evaluate the usability and acceptability of a smartphone app to support adherence to oral chemotherapy and symptom management in patients with cancer.

METHODS:

We used a 5-step development model to create a comprehensive mobile app with theoretically informed content. The research and technical development team worked together to develop and iteratively test the app. In addition to the research team, key stakeholders including patients and family members, oncology clinicians, health care representatives, and practice administrators contributed to the content refinement of the intervention. Patient and family members also participated in alpha and beta testing of the final prototype to assess usability and acceptability before we began the randomized controlled trial.

RESULTS:

We incorporated app components based on the stakeholder feedback we received in focus groups and alpha and beta testing. App components included medication reminders, self-reporting of medication adherence and symptoms, an education library including nutritional information, Fitbit integration, social networking resources, and individually tailored symptom management feedback. We are conducting a randomized controlled trial to determine the effectiveness of the app in improving adherence to oral chemotherapy, quality of life, and burden of symptoms and side effects. At every stage in this trial, we are engaging stakeholders to solicit feedback on our progress and next steps.

CONCLUSIONS:

To our knowledge, we are the first to describe the development of an app designed for people taking oral chemotherapy. The app addresses many concerns with oral chemotherapy, such as medication adherence and symptom management. Soliciting feedback from stakeholders with broad perspectives and expertise ensured that the app was acceptable and potentially beneficial for patients, caregivers, and clinicians. In our development process, we instantiated 7 of the 8 best practices proposed in a recent review of mobile health app development. Our process demonstrated the importance of effective communication between research groups and technical teams, as well as meticulous planning of technical specifications before development begins. Future efforts should consider incorporating other proven strategies in software, such as gamification, to bolster the impact of mobile health apps. Forthcoming results from our randomized controlled trial will provide key data on the effectiveness of this app in improving medication adherence and symptom management.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02157519; https://clinicaltrials.gov/ct2/show/NCT02157519 (Archived by WebCite at http://www.webcitation.org/6prj3xfKA).

In this paper, Fishbein et al. describe the  methodology of the developoment of a mobile application to promote oral chemotherapy adherence.   This mobile app intervention was named CORA or ChemOtheRapy Assistant.

Of the approximately 325,000 health related apps on the market (as of 2017), the US Food and Drug Administration (FDA) have only reviewed approximately 20 per year and as of 2016 cleared only about 36 health related apps.

According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications.  However, there is not much scientific literature providing a framework for design and creation of quality health related mobile applications.

Methods

The investigators separated the app development into two phases: Phase 1 consisted of the mobile application development process and initial results of alpha and beta testing to determine acceptability among the major stakeholders including patients, caregivers, oncologists, nurses, pharmacists, pharmacologists, health payers, and patient advocates.  Phase 1 methodology and results were the main focus of this paper.  Phase 2 consists of an ongoing clinical trial to determine efficacy and reliability of the application in a larger number of patients at different treatment sites and among differing tumor types.

The 5 step development process in phase 1 consisted of identifying features, content, and functionality of a mobile app in an iterative process, including expert collaboration and theoretical framework to guide initial development.

There were two distinct teams: a research team and a technical team. The multidisciplinary research team consisted of the principal investigator, co-investigators (experts in oncology, psychology and psychiatry), a project director, and 3 research assistants.

The technical team consisted of programmers and project managers at Partners HealthCare Connected Health.  Stakeholders served as expert consultants including oncologists, health care representatives, practice administrators, patients, and family members (care givers).  All were given questionaires (HIPAA compliant) and all involved in alpha and beta testing of the product.

There were 5 steps in the development process

  1. Implementing a theoretical framework: Patients and their family caregivers now bear the primary responsibility for their medical adherence especially to oral chemotherapy which is now more frequently administered in the home setting not in the clinical setting.  Four factors were identified as the most important barriers to oral chemotherapy adherence: complexity of medication regimes, symptom burden, poor self-management of side effects, and low clinical support.  These four factors were integral in the design of the mobile app and made up a conceptual framework in its design.
  1. Conducting Initial Focus Group Interviews with key stakeholders: Stakeholders were taken from within and outside the local community.  In all 32 stakeholders served as study collaborators including 8 patient/families, 8 oncologists/clinicians, 8 cancer practice administrators, and 8 representatives of the health system, community, and overall society.   The goal of these focus groups were to obtain feedback on the proposed study and design included perceived importance of monitoring of adherence to oral chemotherapy, barriers to communication between patients and oncology teams regarding side effects and medication adherence, potential role of mobile apps to address barriers of quality of cancer care, potential feasibility, acceptability, and usage and feedback on the overall study design.
  1. Creation of Wireframes (like storyboards or page designs) and Collecting Initial Feedback:  The research and design team, in conjunction with stakeholder input, created content wireframes, or screen blueprints) to provide a visual guide as to what the app would look like.  These wireframes also served as basis for what the patient interviews would look like on the application.  A total of 10 MGH (Massachusetts General Hospital) patients (6 female, 4 male) and most with higher education (BS or higher) participated in the interviews and design of wireframes.  Eight MGH clinicians participated in this phase of wireframe design.
  1. Developing, Programming, and Refining the App:  CORA was designed to be supported by PHP/MySQL databases and run on LAMP hosts (Linux, Apache, MySQL, Perl/PHP/Python) and fully HIPAA compliant.  Alpha testing was conducted with various stakeholders and the app refined by the development team (technical team) after feedback.
  1. Final beta testing and App prototype for clinical trial: The research team considered the first 5 participants enrolled in the subsequent clinical trial for finalization of the app prototype.

There were 7 updated versions of the app during the initial clinical trial phase and 4 updates addressed technical issues related to smartphone operating system upgrades.

Finally, the investigators list a few limitations in their design and study of this application.  First the patient population was homogenous as all were from an academic hospital setting.   Second most of the patients were of Caucasian ethnic background and most were highly educated, all of which may introduce study bias.  In addition, CORA was available on smartphone and tablet only, so a larger patient population who either have no access to these devices or are not technically savvy may experience issues related to this limitation.

In addition other articles on this site related to Mobile Health applications and Health Outcomes include

Medical Applications and FDA regulation of Sensor-enabled Mobile Devices: Apple and the Digital Health Devices Market

How Social Media, Mobile Are Playing a Bigger Part in Healthcare

E-Medical Records Get A Mobile, Open-Sourced Overhaul By White House Health Design Challenge Winners

Qualcomm Ventures Qprize Regional Competition: MediSafe, an Israeli start-up in the personal health field, is the 2014 Winner of a $100,000 Prize

Friday, April 4 8:30 am- 9:30 am Science Track: Mobile Technology and 3D Printing: Technologies Gaining Traction in Biotech and Pharma – MassBio Annual Meeting 2014, Royal Sonesta Hotel, Cambridge, MA

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

Post Acute Care – Driver of Variation in Healthcare Costs

Kaiser data network aims to improve cancer, heart disease outcomes

 

Additional references

  1. Aranda-Jan CB, Mohutsiwa-Dibe N, Loukanova S: Systematic review on what works, what does not work and why of implementation of mobile health (mHealth) projects in Africa. BMC public health 2014, 14:188.

 

 

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Transcatheter Mitral Valve (TMV) Procedures: Centers for Medicare & Medicaid Services (CMS) proposes to cover transcatheter mitral valve repair (TMVR)

Posted in Accountable Care Organizations, Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Health Law & Patient Safety, Healthcare costs and reimbursement, Healthcare Reform, Medical Devices R&D and Inventions, Mitral Valve: Repair and Replacement, Valves & Tools on May 19, 2014| Leave a Comment »

Transcatheter Mitral Valve (TMV) Procedures: Centers for Medicare & Medicaid Services (CMS) proposes to cover Transcatheter Mitral Valve Repair (TMVR)

Reporter: Aviva Lev-Ari, PhD, RN

Proposed Decision Memo for Transcatheter Mitral Valve (TMV) Procedures (CAG-00438N)

The Centers for Medicare & Medicaid Services (CMS) proposes to cover transcatheter mitral valve repair (TMVR) under Coverage with Evidence Development (CED) with the following conditions:

A. TMVR is covered for the treatment of significant symptomatic mitral regurgitation when furnished according to an FDA approved indication and when all of the following conditions are met.

1. The procedure is furnished with a complete transcatheter mitral valve repair system that has received FDA premarket approval (PMA) for that system’s FDA approved indication.

2. Both a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease have independently examined the patient face-to-face and evaluated the patient’s suitability for mitral valve surgery and determination of prohibitive risk; and both physicians have documented the rationale for their clinical judgment and the rationale is available to the heart team.

3. The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals.  The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care.

  1. TMVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to:
    1. On-site heart valve surgery program,
    2. Cardiac catheterization lab or hybrid operating room/catheterization lab equipped with a fixed radiographic imaging system with flat-panel fluoroscopy offering catheterization laboratory-quality imaging,
    3. Non-invasive imaging including expertise in transthoracic and transesophageal echocardiography,
    4. Sufficient space, in a sterile environment, to accommodate necessary equipment for cases with and without complications,
    5. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
    6. Appropriate volume requirements per the applicable qualifications below.

    Outlined below are qualification requirements for hospital surgical programs wishing to perform TMVR procedures.

    The hospital surgical program must have the following:

    1. ≥ 25 total mitral valve procedures in the previous year of which at least 10 must be mitral valve repairs;
    2. ≥1000 catheterizations per year, including ≥ 400 percutaneous coronary interventions (PCIs) per year;
    3. Interventionalist with: ≥ 50 structural procedures per year including atrial septal defects (ASD) and patent foramen ovale (PFO) and trans-septal punctures; and
    4. Additional members of the heart team including echocardiographers, other imaging specialists, heart valve and heart failure specialists, electrophysiologists, cardiac anesthesiologists, intensive care and cardiac imaging departments, congenital heart disease specialists and surgeons, nurse practitioners, data/research coordinators and a dedicated administrator; and device-specific training as required by the manufacturer.
    1. The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TMVR.
  1. The heart team and hospital are participating in a prospective, national, audited registry that:  1) consecutively enrollsTMVR patients; 2) accepts all manufactured devices; 3) follows the patient for at least one year; and 4) complies with relevant regulations relating to protecting human research subjects, including 45CFR Part 46 and 21CFR Parts 50 & 56.  The following outcomes must be tracked by the registry; and the registry must be designed to permit identification and analysis of patient, practitioner and facility level variables that predict each of these outcomes:
    1. Quality of Life (QoL);
    2. Functional capacity
    3. Stroke;
    4. All-cause mortality;
    5. Transient ischemic events (TIAs);
    6. Major vascular events;
    7. Renal complications;
    8. Repeat mitral valve surgery or other mitral procedures;
    9. Worsening mitral regurgitation.

    The registry should collect all data necessary and have a written executable analysis plan in place to address the following questions (to appropriately address some questions, Medicare claims or other outside data may be necessary):

    • When performed outside a controlled clinical study, how do outcomes and adverse events compare to the pivotal clinical studies?
    • How do outcomes and adverse events in subpopulations compare to patients in the pivotal clinical studies?
    • What is the long term (≥ 5 year) durability of the device?
    • What are the long term (≥ 5 year) outcomes and adverse events?
    • How do the demographics of registry patients compare to the pivotal studies?

    Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions.

B. TMVR is covered for uses that are not expressly listed as an FDA approved indication when performed within a FDA-approved randomized clinical trial that fulfills all of the following:

    1. The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TMVR.
  1. As afully-described, written part of its protocol, the clinical research study must critically evaluate the following questions:
    • What is the patient’s post-TMVR quality of life (compared to pre-TMVR) at one year?
    • What is the patient’s post-TMVR functional capacity (compared to pre-TMVR) at one year?
  2. In addition, the clinical research study must address all of the following questions at one year post procedure:
    • What is the incidence of stroke?
    • What is the rate of all-cause mortality?
    • What is the incidence of transient ischemic attacks (TIAs)?
    • What is the incidence of major vascular events?
    • What is the incidence of renal complications?
    • What is the incidence of subsequent mitral valve surgery or other mitral valve procedures?
    • What is the incidence of worsening mitral regurgitation?

C.   All CMS-approved clinical studies and registries must adhere to the following standards of scientific integrity and relevance to the Medicare population:

  1. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants’ health outcomes.
  2. The research study is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
  3. The research study does not unjustifiably duplicate existing studies.
  4. The research study design is appropriate to answer the research question being asked in the study.
  5. The research study is sponsored by an organization or individual capable of executing the proposed study successfully.
  6. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46.  If a study is regulated by the Food and Drug Administration (FDA), it also must be in compliance with 21 CFR Parts 50 and 56.
  7. All aspects of the research study are conducted according to appropriate standards of scientific integrity.
  8. The research study has a written protocol that clearly addresses, or incorporates by reference; the standards listed as Medicare coverage requirements.
  9. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals.  Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life threatening as defined in 21 CFR §312.81(a) and the patient has no other viable treatment options.
  10. The clinical research studies and registries are registered on the http://www.ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject.  Registries are also registered in the Agency for Healthcare Quality (AHRQ) Registry of Patient Registries (RoPR).
  11. The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early.  The results must be made public within 12 months of the study’s primary completion date, which is the date the final subject had final data collection for the primary endpoint,   even if the trial does not achieve its primary aim.  The results must include number started/completed, summary results for primary and secondary outcome measures, statistical analyses, and adverse events. Final results must be reported in a publicly accessibly manner; either in a peer-reviewed scientific journal (in print or on-line), in an on-line publicly accessible registry dedicated to the dissemination of clinical trial information such as ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g., for studies with negative or incomplete results).
  12. The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria affect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial.  If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.
  13. The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention.  Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.
Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions.
The principal investigator must submit the complete study protocol, identify the relevant CMS research question(s) that will be addressed and cite the location of the detailed analysis plan for those questions in the protocol, plus provide a statement addressing how the study satisfies each of the standards of scientific integrity (a. through m. listed above), as well as the investigator’s contact information, to the address below.  The information will be reviewed, and approved studies will be identified on the CMS website.
Director, Coverage and Analysis Group
Re: TMVR CED
Centers for Medicare & Medicaid Services (CMS)
7500 Security Blvd., Mail Stop S3-02-01
Baltimore, MD 21244-1850

CMS is seeking comments on our proposed decision.  We will respond to public comments in a final decision memorandum, as required by §1862(l)(3) of the Social Security Act.

 SOURCE
http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=273

Other related articles on Mirtal Valve DIsease covered in this Open Access Online Scientific Journal Include the following:

Cardiovascular Medical Devices: Cardiac Surgery, Cardiothoracic Surgical Procedures and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty

 

Lev-Ari, A. 1/26/2014. Transcatheter Valve Competition in the United States: Medtronic CoreValve infringes on Edwards Lifesciences Corp. Transcatheter Device Patents

http://pharmaceuticalintelligence.com/2014/01/26/transcatheter-valve-competition-in-the-united-states-medtronic-corevalve-infringes-on-edwards-lifesciences-corp-transcatheter-device-patents/

 

Lev-Ari, A. 1/26/2014. Developments on the Frontier of Transcatheter Aortic Valve Replacement (TAVR) Devices

http://pharmaceuticalintelligence.com/2014/01/26/developments-on-the-frontier-of-transcatheter-aortic-valve-replacement-tavr-devices/

 

Larry H. Bernstein and
Aviva Lev-Ari 6/23/2013 Survivals Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty

http://pharmaceuticalintelligence.com/2013/06/23/comparison-of-cardiothoracic-bypass-and-percutaneous-interventional-catheterization-survivals/

 

Larry H Bernstein and Lev-Ari, A. 6/23/2013 First case in the US: Valve-in-Valve (Aortic and Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices.

http://pharmaceuticalintelligence.com/2013/06/23/valve-in-valve-replacements-with-transapical-transcatheter-implants/

Larry H Bernstein and  Lev-Ari, A. 6/17/2013 Transcatheter Aortic Valve Replacement (TAVR): Postdilatation to Reduce Paravalvular Regurgitation During TAVR with a Balloon-expandable Valve

http://pharmaceuticalintelligence.com/2013/06/17/postdilatation-to-reduce-paravalvular-regurgitation-during-transcatheter-aortic-valve-replacement/



Larry H Bernstein and Lev-Ari, A. 6/17/2013 Trans-apical Transcatheter Aortic Valve Replacement in a Patient with Severe and Complex Left Main Coronary Artery Disease (LMCAD)

http://pharmaceuticalintelligence.com/2013/06/17/management-of-difficult-trans-apical-transcatheter-aortic-valve-replacement-in-a-patient-with-severe-and-complex-arterial-disease/



Larry H Bernstein and Lev-Ari, A. 6/18/2013 Ventricular Assist Device (VAD): A Recommended Approach to the Treatment of Intractable Cardiogenic Shock

http://pharmaceuticalintelligence.com/2013/06/18/a-recommended-approach-to-the-treatmnt-of-intractable-cardiogenic-shock/

Larry H Bernstein and Lev-Ari, A.6/20/2013 Phrenic Nerve Stimulation in Patients with Cheyne-Stokes Respiration and Congestive Heart Failure

http://pharmaceuticalintelligence.com/2013/06/20/phrenic-nerve-stimulation-in-patients-with-cheyne-stokes-respiration-and-congestive-heart-failure/

Lev-Ari, A. 2/12/2013 Clinical Trials on transcatheter aortic valve replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons

http://pharmaceuticalintelligence.com/2013/02/12/american-college-of-cardiologys-and-the-society-of-thoracic-surgeons-entrance-into-clinical-trials-is-noteworthy-read-more-two-medical-societies-jump-into-clinical-trial-effort-for-tavr-tech-f/

Lev-Ari, A. 12/31/2012 Renal Sympathetic Denervation: Updates on the State of Medicine

http://pharmaceuticalintelligence.com/2012/12/31/renal-sympathetic-denervation-updates-on-the-state-of-medicine/

Lev-Ari, A. 9/2/2012 Imbalance of Autonomic Tone: The Promise of Intravascular Stimulation of Autonomics

http://pharmaceuticalintelligence.com/2012/09/02/imbalance-of-autonomic-tone-the-promise-of-intravascular-stimulation-of-autonomics/

Lev-Ari, A. 8/13/2012 Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stentshttp://pharmaceuticalintelligence.com/2012/08/13/coronary-artery-disease-medical-devices-solutions-from-first-in-man-stent-implantation-via-medical-ethical-dilemmas-to-drug-eluting-stents/

Lev-Ari, A. 7/18/2012 Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia

http://pharmaceuticalintelligence.com/2012/07/18/percutaneous-endocardial-ablation-of-scar-related-ventricular-tachycardia/

Lev-Ari, A. 6/13/2012 Treatment of Refractory Hypertension via Percutaneous Renal Denervation

http://pharmaceuticalintelligence.com/2012/06/13/treatment-of-refractory-hypertension-via-percutaneous-renal-denervation/

Lev-Ari, A. 6/22/2012 Competition in the Ecosystem of Medical Devices in Cardiac and Vascular Repair: Heart Valves, Stents, Catheterization Tools and Kits for Open Heart and Minimally Invasive Surgery (MIS)

http://pharmaceuticalintelligence.com/2012/06/22/competition-in-the-ecosystem-of-medical-devices-in-cardiac-and-vascular-repair-heart-valves-stents-catheterization-tools-and-kits-for-open-heart-and-minimally-invasive-surgery-mis/

Lev-Ari, A. 6/19/2012 Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market

http://pharmaceuticalintelligence.com/2012/06/19/executive-compensation-and-comparator-group-definition-in-the-cardiac-and-vascular-medical-devices-sector-a-bright-future-for-edwards-lifesciences-corporation-in-the-transcatheter-heart-valve-replace/

Lev-Ari, A. 6/22/2012 Global Supplier Strategy for Market Penetration & Partnership Options (Niche Suppliers vs. National Leaders) in the Massachusetts Cardiology & Vascular Surgery Tools and Devices Market for Cardiac Operating Rooms and Angioplasty Suites

http://pharmaceuticalintelligence.com/2012/06/22/global-supplier-strategy-for-market-penetration-partnership-options-niche-suppliers-vs-national-leaders-in-the-massachusetts-cardiology-vascular-surgery-tools-and-devices-market-for-car/

Lev-Ari, A. 7/23/2012 Heart Remodeling by Design: Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

http://pharmaceuticalintelligence.com/2012/07/23/heart-remodeling-by-design-implantable-synchronized-cardiac-assist-device-abiomeds-symphony/

Lev-Ari, A. (2006b). First-In-Man Stent Implantation Clinical Trials & Medical Ethical Dilemmas. Bouve College of Health Sciences, Northeastern University, Boston, MA 02115

 

 

 

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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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Post Acute Care – Driver of Variation in Healthcare Costs

Posted in Accountable Care Organizations, Affordable Care Act, Curation methodology, Health Economics and Outcomes Research, Healthcare costs and reimbursement, Healthcare Reform, tagged , , , , , on February 21, 2014| Leave a Comment »

Post Acute Care – Driver of Variation in Healthcare Costs

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

and

Curator and Editor: Aviva Lev-Ari, PhD, RN

The following is a report summarizing the findings of two major articles in the New England J Med by Robert Mechanic, MBA, on the findings of the Institute of Medicine study of drivers of Medical Care cost variation.  This is a seminal piece of work that is already creating a roadmap for hospital cost reduction and hospital evaluation based on reduction of readmissions combined with appropriate discharges not exceeding expected length of stay.  This type of study is not new, but it has taken a new direction.  The studies 25 years ago directed at regional variation in physician practices contributed to the studies at the Yale School of Business Administration by Robert Fetter’s group that developed the Diagnosis Related Groups (DRG) model formulation, pioneering in the engineering design of healthcare management.  The study was the first of its kind, and it was implemented as a demonstration project in New Jersey and then became the current basis for reimbursement.  At the same time, there are numerous studies of practice variation and variation in hospital costs, most prominently carried out at Dartmouth, University of Pennsylvania, and at the Intermountain Healthcare System, which made huge and continuing contributions to improvements in healthcare quality and efficiency.

cost1 per capita costs and life expectancy across all 34 OECD member countries using OECD data from 2009.

hhs_medicare_docs participating in and billing Medicare

obamacare-political-cartoon

1. Post-Acute Care — The Next Frontier for Controlling Medicare Spending

Robert Mechanic, M.B.A.

N Engl J Med 2014; 370:692-694 February 20, 2014 DOI: 10.1056/NEJMp1315607

 

2. Post-Acute Care Reform — Beyond the ACA

D. Clay Ackerly, M.D., and David C. Grabowski, Ph.D.

N Engl J Med 2014; 370:689-691 February 20, 2014 DOI: 10.1056/NEJMp1315350

 

Post-Acute Care — The Next Frontier for Controlling Medicare Spending

 Introduction

A striking conclusion from the Institute of Medicine’s recent report on geographic variation in Medicare spending is that post-acute care is the largest driver of overall variation.1 Medicare pays for post-acute care — short-term skilled nursing and therapy services for patients recovering from acute illness (typically after a hospitalization), provided by home health agencies, skilled nursing facilities (SNFs), inpatient rehabilitation hospitals, and long-term care hospitals. In 2012, Medicare spending for these services exceeded $62 billion. For patients who are hospitalized for exacerbations of chronic conditions such as congestive heart failure, Medicare spends nearly as much on post-acute care and readmissions in the first 30 days after a patient is discharged as it does for the initial hospital admission

(see graph in

http://www.nejm.org/na101/home/literatum/publisher/mms/journals/content/nejm/2014/nejm_2014.370.issue-8/nejmp1315607/20140214/images/small/nejmp1315607_f1.gif

30-day episodes

Medicare Acute and Post-Acute Care Payments for 30-Day Episodes That Began with a Hospitalization, 2008)

Post-acute care spending for surgical episodes is somewhat lower but still substantial. Medicare payments for post-acute care have grown faster than most other categories of spending. For example, total Medicare spending for patients hospitalized with myocardial infarction, congestive heart failure, or hip fracture grew by 1.5 to 2.0% annually between 1994 and 2009, while spending on post-acute care for those patients grew by 4.5 to 8.5% per year.2

Under fee-for-service reimbursement, acute care providers have had little financial incentive to invest in systems to ensure effective transitions to post-acute care or to support post-acute care providers when recently hospitalized patients have complications. Medicare’s recent readmission penalties have begun focusing hospitals’ attention on these issues. But Medicare’s new bundled-payment and shared-savings programs provide much stronger incentives to integrate acute and post-acute care.

Hospital and Post-Acute Care Facility Coordination

Hospitals and physicians participating in bundled-payment or shared-savings programs will need to establish meaningful partnerships with all types of post-acute care providers. Partnerships with SNFs are particularly important, since they account for about half of Medicare’s post-acute care spending. Apart from geographic location, hospitals will focus on three basic characteristics when considering SNF partners:

  • capacity to effectively care for Medicare patients with complex needs,
  • ability to provide high-quality care efficiently, and
  • willingness to actively collaborate on care coordination.

Hospitals will favor SNFs with a proven record of performance and should assess each nursing home in the context of the complexity of its cases. Under bundled payments, one relevant measure of both quality and efficiency is rehospitalization. In 2011, a quarter of nursing homes had risk-adjusted rehospitalization rates of 23% or greater for five potentially avoidable conditions, while a quarter had rates below 15%.4

Equally important for new partnerships is a willingness to actively collaborate on quality improvement and care coordination. Establishment of a clinical point person at both the hospital and the nursing homes would help facilitate rapid responses to unexpected changes in patient status. Finally, such partnerships will need to establish regular and transparent performance reporting.  In order to achieve the next level of performance, physician groups and hospitals will increasingly establish preferred networks of post-acute care providers. Although they cannot require patients to use these providers, they may be able to make a convincing case based on the quality, service level, and continuity of care that a strong partnership can offer.

It is ironic that an extended admission prior to discharge may be advantageous in the emerging bundled payment system.  Other steps hospitals can take to reduce post-acute care spending under a bundled-payment system don’t preclude those with extra bed capacity keeping some Medicare patients in the hospital longer and discharging them to home health care rather than a nursing home or rehabilitation facility; the extra cost of extending a hospital stay by an additional day or two is far less than the average cost of a nursing home admission. According to one study involving 12,000 patients, the incremental cost incurred on the last full day of hospitalization was just 2.4% of the average total cost per admission.5

Post-acute care providers need to make a compelling case for their value, and those that establish preferred relationships with major hospitals and physician groups will generate additional volume and thus be able to maintain revenue levels as they shorten lengths of stay.

REFERENCES

  1. Newhouse JP, Garber AM. Geographic variation in Medicare services. N Engl J Med2013;368:1465-1468
  2. Chandra A, Dalton MA, Holmes J. Large increases in spending on postacute care in Medicare point to the potential for cost savings in these settings. Health Aff (Millwood)2013;32:864-872
  3. Gage B, Morley M, Ingber M, Smith L. Post-acute care episodes: expanded analytic file. Waltham, MA: RTI International, June 2011.
  4. Kramer A, Fish R, Min S. Community discharge and rehospitalization outcome measures (fiscal year 2011). A report by staff from Providigm, LLC, for the Medicare Payment Advisory Commission, April 2013

http://medpac.gov/documents/Apr13_CommunityDischarge_CONTRACTOR.pdf.

5.  Taheri PA, Butz DA, Greenfield LJ. Length of stay has minimal impact on the cost of hospital admission. J Am Coll Surg 2000;191:123-130

Post-Acute Care Reform — Beyond the ACA

 The Case of Mrs. T

Mrs. T. is an 88-year-old woman who lives alone, has a history of congestive heart failure and osteoarthritis. She was found lethargic and sent to the emergency department, where she was discovered to be in renal failure and was admitted to the hospital for fluids and monitoring. Her hospitalist concluded that she had accidentally overdosed on Lasix (furosemide). On hospital day 2, Mrs. T. was having difficulty ambulating, although her cognition and renal function had improved and she felt “back to her old self” and was eager to go home.

The hospitalist had two primary options. He could keep Mrs. T. in the hospital another night, although she was medically stable and had no further diagnostic or medical needs. That would cost the hospital money under Medicare’s system of fixed payments for diagnosis-related groups, but it would give Mrs. T. more time to recover her strength and extend her stay to the 3 days required to qualify her for a stay in a Medicare skilled nursing facility (SNF) if needed.1

Alternatively, the hospitalist could send Mrs. T. home, holding the Lasix to prevent a repetition of the cause of this admission and arranging for a follow-up evaluation by a visiting nurse. Home health agencies are expected to provide an admission visit within 48 hours after discharge, and they receive a fixed payment from Medicare for a 60-day episode of care.  This option presented a higher risk of falls and further medication errors, but it served the hospital’s interest in limiting lengths of stay and Mrs. T.’s desire to return home.

Both options presented a high likelihood of readmission, and neither one encouraged the provision of a high-quality, high-value mix of acute and post-acute care services. Why were there no better options?

This presents a conundrum because Medicare has paid hospitals and post-acute care providers separately, without regard to the quality and efficiency achieved across an entire episode of care. When patients’ discharge plans made without adequate factoring in of clinical reasons, it contributes to the inefficient use of post-acute care and the high rate of readmissions.2,3  A significant factor in this anomaly is that the decrease in length of hospital stay and the increase in use of post-acute care after the implementation of Medicare’s hospital inpatient prospective payment system (see graph

http://www.nejm.org/na101/home/literatum/publisher/mms/journals/content/nejm/2014/nejm_2014.370.issue-8/nejmp1315350/20140214/images/small/nejmp1315350_f1.gif

length of hospital stay and the increase in use of post-acute care

Use of Hospital Care and Post-Acute Care over Time.).

Demonstrations currently being evaluated under the Affordable Care Act (ACA) incentivize a more efficient mix of acute and post-acute care services. For example, under a bundled-payment system, hospitals and post-acute care providers are paid for a fixed “bundle” of services around a hospital episode, including post-hospitalization care. In an accountable care organization (ACO) with risk-based payment, networks of providers can share in savings if they reduce the total cost of care for a defined patient population and meet a series of quality metrics. Under both approaches, provider systems have incentives to deliver cost-effective acute and post-acute care services and prevent costly readmissions.

 Three issues may impede the delivery of high-value services over an entire episode of care.

First, the ACA reforms retain some burdensome payment regulations and rules that will hinder the delivery of the highest-value mix of services. ACOs cannot change most of Medicare’s fee-for-service payment regulations in purchasing post-acute care. These regulations include

  • the 3-day rule for qualifying for Medicare-covered SNF care;
  • fixed payment for a 60-day episode of home health care, which hinders flexibility in tailoring services to patients’ needs; and
  • a rule for inpatient rehabilitation facilities requiring that 75% of cases fall within 13 diagnostic categories, which limits the number and types of patients admitted to these facilities.4

Second, merely aligning financial incentives between providers of acute and post-acute care will not improve quality and reduce costs for episodes of care. True coordination of care — defined as the organization of services among the hospital, physicians, post-acute care provider, and patient to encourage the delivery of the highest-value services — is required to ensure the best possible outcomes. Potential models for coordinated acute and post-acute care might encompass team-based care and transition programs, cross-continuum case-management interventions, improved patient and family engagement, communication protocols for providers across settings to share both clinical and social information by means of interoperable health information technologies, and focused investments in clinical coverage in post-acute care settings (e.g., telemedicine or transitional medicine teams). Most of these on-the-ground activities, however, are in their infancy.

Third, even with payment changes and improved coordination, providers are often “flying blind” when attempting to tailor a care plan to a patient’s and family’s needs. Simply put, we have insufficient understanding about which post-acute care setting (e.g., home with or without services, SNF, or other care facility) benefits which types of patient — which makes it impossible to match patients to the setting that best suits their needs and maximizes the likelihood of the best outcomes. This lack of knowledge is attributable to both insufficient data and poor quality measures. Optimizing post-acute care delivery will require a common data instrument but also new quality measures for such care. For example, one important measure of quality would be the risk-adjusted rate of rehospitalization in a given post-acute care setting.5

 A look backward and forward

In the case described above, the hospitalist was left with our system’s only two discharge options. Imagine how Mrs. T.’s care might have been different. With her care covered under an ACO or as part of a bundled-payment program, her providers would have financial incentives to provide the right care, in the right place, at the right time. If the additional efforts we’ve described above had been successfully implemented, the hospitalist could have used evidence on the comparative value of alternative post-discharge options to choose the most suitable mix of inpatient and post-acute care services without worrying about payment rules and with the support of organizational tools for coordinated care.

REFERENCES

  1. Lipsitz LA. The 3-night hospital stay and Medicare coverage for skilled nursing care. JAMA2013;310:1441-1442
  2. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med 2009;360:1418-1428[Erratum, N Engl J Med 2011;364:1582.]
  3. Institute of Medicine. Variation in health care spending: target decision making, not geography. Washington, DC: National Academies Press, 2013.
  4. Medicare Payment Advisory Commission. Medicare post-acute care reforms. Washington, DC: Statement of Mark E. Miller before the Subcommittee on Health, Committee on Ways and Means, U.S. House of Representatives June 14, 2013.
  5. Mor V, Intrator O, Feng Z, Grabowski DC. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood) 2010;29:57-64

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“Sudden Cardiac Death,” SudD is in Ferrer inCode’s Suite of Cardiovascular Genetic Tests to be Commercialized in the US

Posted in Acute Myocardial Infarction, Atherogenic Processes & Pathology, Bio Instrumentation in Experimental Life Sciences Research, Biological Networks, Gene Regulation and Evolution, Biomarkers & Medical Diagnostics, Biomedical Measurement Science, CANCER BIOLOGY & Innovations in Cancer Therapy, Cardiomyopathy, Cardiovascular Research, Cell Biology, Signaling & Cell Circuits, Chemical Biology and its relations to Metabolic Disease, Chemical Genetics, Computational Biology/Systems and Bioinformatics, Congenital Heart Disease, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Genome Biology, Genomic Testing: Methodology for Diagnosis, Healthcare costs and reimbursement, Human Immune System in Health and in Disease, Imaging-based Cancer Patient Management, Immunodiagnostics, Innovation in Immunology Diagnostics, Interviews with Scientific Leaders, Medical and Population Genetics, Metabolomics, Molecular Genetics & Pharmaceutical, Myocardial metabolism, Myocardial ischemia, myocardial perfusion, Myocardial adenine nucleotide metabolism, Nanotechnology for Drug Delivery, Nutrigenomics, Origins of Cardiovascular Disease, Personalized and Precision Medicine & Genomic Research, Pharmacogenomics, Pharmacologic toxicities, Population Health Management, Genetics & Pharmaceutical, Population Health Management, Nutrition and Phytochemistry, Proteomics, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Scientist: Career considerations, Technology Capital Expenses, Translational Research, Translational Science on February 10, 2014| Leave a Comment »

“Sudden Cardiac Death,” SudD is in Ferrer inCode’s Suite of Cardiovascular Genetic Tests to be Commercialized in the US

Curator: Aviva Lev-Ari, PhD, RN

Article ID #111: “Sudden Cardiac Death,” SudD is in Ferrer inCode’s Suite of Cardiovascular Genetic Tests to be Commercialized in the US. Published on 2/10/2014

WordCloud Image Produced by Adam Tubman

Uncertainty around reimbursement for targeted NGS tests is faced by Molecular Diagnostic and Genomics Services companies

VIEW VIDEO

Democratization of Genomic Medicine: Michael Bolick @ TEDxTalks

Ferrer inCode’s Suite of Cardiovascular Genetic Tests included the following tests: 

  • SudD inCode (Sudden Cardiac Death)
  • Cardio inCode,
  • Thrombo inCode, and
  • Nutri inCode

Selah Genomics, Ferrer inCode to Offer NGS-based Cardiovascular Test in US

2014/02/06

Selah Genomics, a Greenville, S.C.-based molecular diagnostic and genomics services company, has partnered with Spanish pharmaceutical company Ferrer inCode to commercialize Ferrer inCode’s suite of cardiovascular genetic tests in the US.

Selah will first validate Ferrer’s next-generation sequencing-based test for sudden cardiac death, SudD inCode, on Illumina’s MiSeq system to run out of its CLIA-certified laboratory.

Meantime, Selah plans to validate three other Ferrer inCode PCR-based cardiovascular tests — Cardio inCode, Thrombo inCode, and Nutri inCode — in its own lab using PCR, but may eventually combine the tests into one comprehensive panel to run on an NGS system, Selah CEO Michael Bolick told Clinical Sequencing News.

Selah already offers its PrecisionPath targeted Cancer Test in collaboration with the Greenville Health System’s Institute for Translational Oncology Research. All consenting cancer patients at ITOR receive the PrecisionPath test, which runs on Life Technologies’ Ion Torrent PGM and uses the Ion AmpliSeq technology.

Currently, Selah receives between 10 and 20 samples per week for PrecisionPath, and it plans to roll the test out nationwide later this year.

Bolick said that the company is also developing Hepatitis C and HIV assays for the MiSeq, and that the firm will likely purchase Illumina’s MiSeqDx, which recently received clearance from the US Food and Drug Administration.

Selah also collaborates with pharmaceutical companies to develop companion diagnostic tests. Bolick anticipates that the firm will use the MiSeqDx for those tests since they will “ultimately need [pre-market approval].” Having an FDA-cleared platform on which to develop the tests will be helpful in gaining a PMA designation, he said.

Selah also offers Exome Sequencing Services on the Ion Proton for research use only. In addition, it has a

  • Pacific Biosciences RS II and
  • Roche’s 454 GS FLX in house.

Bolick said that the company is currently using the PacBio machine for discovery work in infectious disease.

Ferrer inCode’s SudD inCode Test

currently assesses 55 genes related to structural heart problems that cause sudden cardiac arrest, Robert Jenkins, who manages Ferrer inCode’s UK and Americas groups, told CSN. However, the company is planning to

  • expand the test to 104 genes and also to include
  • genes related to conductive myopathy,
  • sudden infant death, and
  • aneurysms.

While the test sequences the entire genes, only well-known causative variants are reported, Jenkins said. However, the firm has been collecting all the sequenced variants, so it could potentially add content to the test if enough evidence is gathered to validate any of those variants as clinically significant.

Ferrer inCode currently runs SudD inCode on the MiSeq as an LDT, which is how Selah will validate and market the test in the US.

Jenkins said that for now, Ferrer plans to keep the Cardio, Nutri, and Thrombo inCode tests PCR-based.

  • Cardio inCode looks at around 125 variants involved in genetic risk for cardiac disease.

When it is used with traditional markers such as

  • lipid profiling, an individual’s
  • smoking and drinking habits, and
  • body mass index,

Jenkins said the genetic test helps to reclassify around 20 percent to 25 percent of individuals deemed in the intermediate risk category as either high or low risk.

Thrombo inCode Test

is an approximately 20-variant thrombosis test for individuals that have had a thrombotic event or who have had a history of unsuccessful pregnancies. Often, the cause of thrombosis can go unexplained via testing from serological workups, Jenkins said.

Nutri inCode Test

is a nutrigenomics test that looks at around 90 SNPs. In combination with lifestyle factors, it helps individuals develop a tailored genetics-based plan to reduce obesity, Jenkins said.

Bolick said that while Selah will validate and develop each of these tests individually out of its laboratory, it is also deciding whether to combine the tests into one next-gen sequencing-based test.

Jeremy Stuart, Selah’s VP of genomic services, told CSN that one option would be to incorporate the individual SNPs assessed in the Thrombo, Cardio, and Nutri tests into the SudD test.

Bolick said that the company is now in discussions with third party payors about reimbursement for the tests and is readying a regional pilot program to offer the sequencing-based cardiovascular test as part of a corporate wellness program. The pilot will help Selah figure out a pricing structure and will also demonstrate a “return on investment to the corporation, by allowing for better determination of risk of heart disease,” Bolick said.

Currently, Selah’s other NGS test, PrecisionPath, is being paid for by ITOR. However, Bolick said that initial conversations with third party payors about launching the assay outside of the Greenville Health System have been positive.

Reimbursement success will play a role in determining how the company expands beyond its current tests. For instance, while Selah is interested in moving into

  • clinical exome sequencing,

Stuart said that right now there is a “lot of uncertainty around reimbursement for targeted NGS tests, let alone exome sequencing.” Selah will first “establish reimbursement for those and then may expand into what’s possible for exome sequencing,” Stuart said. But currently, the exome market is research use only.

SOURCE

http://www.ferrerincode.com/en/node/98

Selah Genomics

SELAH GENOMICS: HARNESS THE POWER OF PRECISION FOR MORE PERSONALIZED TREATMENT

Selah Genomics is a clinical diagnostic specialist supporting healthcare providers and the pharmaceutical industry with advanced molecular and genomic diagnostic services. Selah’s services add value to early stage drug development, clinical trials and regulatory processes in the pharmaceutical industry and helps clinicians and healthcare providers treat and monitor patients, thereby improving patient outcomes.

With the Power of Precision, Selah Genomics provides the best in molecular diagnostic testing, assay validation and genomic profiling that all leads to one common goal: to provide better outcomes for patients.

Michael Bolick, CEO

Michael is a serial entrepreneur with 25 years of experience in the life science and healthcare industries. Most recently, he led a management buyout of Lab21 Ltd’s US-based operations to form Selah Genomics Inc. Prior to co-founding Selah Genomics, Michael served as President of Lab21 Inc which was formed following Lab21 Ltd’s acquisition of his prior company, Selah Technologies LLC. He founded Selah Technologies LLC to commercialize nanotechnologies licensed from Clemson University. Selah focused these nanotechnologies to enable doctors to see cancer during surgery. Prior to founding Selah Technologies, Michael’s career included roles of increasing responsibility in the pharmaceutical sector.

Michael is a Fellow in the Liberty Fellowship Class of 2011. Liberty Fellowship is a program designed specifically for emerging state leaders to reinforce values necessary to lead an exemplary life both personally and professionally. Michael serves as Immediate Past Chair of SCBIO, South Carolina’s Life Sciences Industry Association. Michael earned his bachelor’s degree in Chemical Engineering from North Carolina State University.

  • Selah Genomics specializes in supporting healthcare providers and the pharmaceutical industry with advanced molecular and genomic diagnostic services.

    read more »

    Latest News

    Find out what the buzz is about

    • Greenville Health System, Roswell Park Adopt Targeted Sequencing in Cancer Treatment

      8 May 2013

    • Selah, GHS expand personalized medicine

      2 May 2013

    • The Democratization of Genomic Medicine: Michael Bolick at TEDxGreenville

      21 Apr 2013

    • Greenville Magazine features Selah Genomics

      1 Apr 2013

    • Upstate Biotech Firm Expands to Columbia

      14 Mar 2013

    • Genetic Engineering and Biotechnology News; “Selah Genomics Establishes Second Clinical Genomics Center”

      20 Feb 2013

    • Selah Genomics Forms Second Clinical Genomic Center

      19 Feb 2013

  • Clinical Laboratory

    Helping physicians by applying our scientific expertise and skills in advanced molecular diagnostic assay development in a CLIA-certified laboratory.

    read more »

  • PrecisionPath™

    Genomic profiling of solid tumors, identifying actionable targets today and enabling the discovery of clinically relevant genes for tomorrow.

    read more »

  • Genomic Services


    Selah Genomics provides a suite of services focused on support of molecular biomarker discovery, assay validation and prospective/retrospective clinical trial testing in support of companion diagnostic development and commercialization.

    read more »

 SOURCE

THE FAST-TRACK TO DISCOVERY AND CLINICAL UTILIZATION

Selah Genomics provides a suite of services focused on support of molecular biomarker discovery, assay validation and prospective/retrospective clinical trial testing in support of companion diagnostic development and commercialization. Selah operates NGS platforms from Life Technologies, Illumina, Roche and PacBio as well as an array of real time PCR and other supporting instrumentation systems. We help you select the best platform for each Project in support of your particular goals. Our prime focus – to help fast-track the clinical utilization and commercialization of your biomarker.

Selah enjoys a key corporate relationship with the Greenville Health System’s (GHS) Institute of Translational Oncology Research (ITOR) conducting multiple clinical trials and identification of new oncology biomarkers.

GHS is the 13th largest public hospital in the United States and ITOR has the largest Phase 1 clinical trial program in South Carolina, including a track record of 16 first-in-human trials. The close relationship with ITOR is an enormous asset for Selah. Not only does it allow Selah to provide state-of-the-art molecular diagnostics support for ITOR clinical studies but it leads to first-hand daily interaction with cancer physicians. This interaction stimulates early identification and development of new biomarker panels.

Selah’s Clinical Genomics Center at ITOR is physically located within GHS & ITOR. In addition, Selah operates a Clinical Genomics Center at Innovista on the campus of the University of South Carolina.

SOURCE

http://selahgenomics.com/genomic-services/

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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:

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

group opinionsThe 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

Obama signing the ACAWith 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)

Fotolia_52964211_Subscription_Monthly_XXLThe 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

President Barack Obama and First Lady Michelle Obama discuss the Affordable Care Act with mothersLast 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

Obama healthcare law supporters rally during the third and final day of legal arguments over the Patient Protection and Affordable Care Act at the Supreme Court in Washington, March 28, 2012Whether 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.

RESEARCH BRIEF

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

Fotolia_48436515_Subscription_Monthly_XLFor 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

Fotolia_51436665_Subscription_Monthly_XLLarge 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.

PERIODICAL

Ramifications of Health Reform — Nov 26, 2013

doctor listens to a heartbeat of a 5-year-old patient 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.

COMMENTARY

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

health insurance claim form, pen, calculatorAs 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

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

Fotolia_52973064_Subscription_Monthly_XLACA 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

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

U.S. President Barack Obama talks about the Affordable Care Act in the Brady Press Briefing Room at the White House in Washington, November 14, 2013David 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.

BLOG

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

Fotolia_52420884_Subscription_Monthly_XXLIn “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.

COMMENTARY

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

Fotolia_44089855_Subscription_Monthly_XXLThe 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

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

blonde boy getting checkupExpanding 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

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

male patient wearing white shirt talking to psychiatristAmerica’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

Understanding the Affordable Care Act — Oct 2, 2013

Fotolia_54387258_Subscription_Monthly_XLOne 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

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

Fotolia_49599013_Subscription_Monthly_XXLOut-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.

BLOG

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

Fotolia_56040470_Subscription_Monthly_XLAs 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.

REPORT

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

a middle aged woman checking out at a medical reception counterThe 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.

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

group opinionsThe 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

Obama signing the ACAWith 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)

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

Fotolia_48335019_Subscription_Monthly_XXLThe 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

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

health insurance policy and reading glassesThe 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.

REPORT

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

calculator, pills, and stethoscopeAn 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

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

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.

REPORT

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

stethoscope and clockA 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.

MULTIMEDIA

The Math of State Medicaid Expansion — Jul 17, 2013

Carter PriceMathematician 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

illustration of weighing medical costsResolving 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.

REPORT

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

A stethoscope atop a United States flagThe 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

stethoscope on American flagRAND’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

ear exam on senior patientAlignment 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.

REPORT

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

Harrisburg, Pennsylvania panoramaWhile 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

Doctor with young womanBecause 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.

RESEARCH BRIEF

The Math of State Medicaid Expansion — Jun 7, 2013

Fotolia_45672516_Subscription_Monthly_XXLRAND 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

A woman is wheeled through an emergency department on a gurney.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

U.S. state map with stethoscopeSome 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.

JOURNAL ARTICLE

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

Nuns On The Bus rally and Texas Capitol visit about MedicaidStates 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.

REPORT

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

machine_shop_workerA 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.

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.

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

group opinionsThe 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

Obama signing the ACAWith 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.

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

Pennsylvania capitol buildingThis 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

6170068425_b192a9d867_bWhile 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.

RESEARCH BRIEF

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

Arkansas state quarterThis 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

a health insurance claim form and a silver penMultistate 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.

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.

REPORT

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

Pennsylvania state flagIf 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

blue and pink pillsThe 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.

REPORT

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

pediatrician with patient and motherPublic 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.

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

patients sitting in waiting roomThe 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

Arkansas flagFor 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

pills and coinsIn 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

money and pillsRegardless 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

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

birth control pillsAs 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.

PERIODICAL

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

stethoscope on 50 dollar billsWhether 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.

CONTENT

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

man getting his arm wrappedRetail 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.

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

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.

CONTENT

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

Supreme Court pillarsNow 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

pills and moneySwitching 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.

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.

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.

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

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.

CONTENT

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

doctor showing patient xrayThe 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

health insurance formRules 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

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.

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.

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

Fotolia_54591532_Subscription_Monthly_XXLCalifornia, 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

bill payment calculatorMedicare’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

thermometer graphPolicymakers 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

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

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

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

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.

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

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 Texas 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 California: 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 California 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 Montana: 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 Montana 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 Connecticut: 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 Connecticut through 2020.

REPORT

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

stethoscope chartHealth 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.

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

PEOPLE

Christine Eibner

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

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

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

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

PEOPLE

Kristin R. Van Busum

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

SOURCE

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

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Genomics and Medicine: The Physician’s View

Posted in Best evidence, Bio Instrumentation in Experimental Life Sciences Research, Biomarkers & Medical Diagnostics, Biomedical Measurement Science, CANCER BIOLOGY & Innovations in Cancer Therapy, Cardiomyopathy, Cardiovascular Pharmacogenomics, Cardiovascular Research, Cerebrovascular and Neurodegenerative Diseases, Coagulation Therapy and Internal Bleeding, Evidence-based decision-making, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Genome Biology, Genomic Expression, Genomic Testing: Methodology for Diagnosis, Health Economics and Outcomes Research, Health Law & Patient Safety, Healthcare costs and reimbursement, HealthCare IT, Hematopoiesis, Infectious Disease & New Antibiotic Targets, Infectious Disease Immunodiagnostics, Innovation in Immunology Diagnostics, Liver & Digestive Diseases Research, Medical and Population Genetics, Molecular Genetics & Pharmaceutical, Myelodysplasia, Myelofibrosis, Neurodegenerative Diseases, Origins of Cardiovascular Disease, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Analytics, Pharmaceutical R&D Investment, Pharmacogenomics, Pharmacologic toxicities, Population Health Management, Genetics & Pharmaceutical, Pre-Clinical Animal Model Development, Prescription Drugs Costs, Regenerative Biology and Medicine, Stem Cells for Regenerative Medicine, Translational Effectiveness, Translational Science, tagged , , , , , , , , , , , , on January 3, 2014| Leave a Comment »

Genomics and Medicine: The Physician’s View

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

 

Genomics has had a rapid growth of research into variability of human genetics in both healthy populations in the study of population migration, and in the study of genetic sequence alterations that may increase the risk of expressed human disease.  This is the case for cardiology, cancer, inflammtory conditions, and gastrointestinal diseases. For the most part, genomics research in the last decade has shed light on potential therapeutic targets, but the identification of drug toxicities in late phase trials has been associated with a 70 percent failure rate in bringing new drugs to the market.   Despite good technologies for investigative studies, initial work is carried out on animals and then the transferrability of the work from a “model” to man has to be assured.  That is the first issue of concern.

Secondly, there is a well considered reluctance on the part of experienced and well prepared physicians to be “early” adopters to newly introduced drugs, with the apprehension that unidentified clinical problems can be expected to be unmasked.  It is, however, easier to consider when a new drug belongs to an established class of medications, and it has removed known adverse effects.  In this case, the adverse effects are known side effects, but not necessarily serious drug reactions that would preclude use.

A third consideration is the cost of drug development, and the cost of development is passed on to the healthcare organization in the purchasing cost. We can rest assured that the Pharmacy and Therapeutics Review Committee will not cease meeting on a regular schedule anytime soon.  Further, how do the drug failures become embedded in the cost of the pharmaceutical budget passed on to the recipient.  Historically, insurance is an actuarial discipline.  But in the lifetime of an individual, they are bound to see a physician for acute or chronic medical attention.  Only the timing cannot be predicted.  As a result, dealing with the valid introduction of new medications is a big concern for both the public and the private insurer.

How does this compute for the physician provider.  The practice of medicine is not quickly adaptive, as the physician’s primary concern is to do no harm.   Genomics testing is not widely available, and it is for the most part not definitive for diagnostic purposes as things stand today.  It may provide assessment of risk, or of survival expectation.  The physician uses a step by step assessment, using the patient and family history, a focused physical exam, laboratory and radiology, proceeding to other more specialized exams.  Much of the laboratory testing is based on the appearance in the circulation of changes in blood chemistry of the nature of electrolytes, circulating cells in the blood and of the blood forming organ, proteins, urea and uric acid.  They are not exquisitely sensitive, but they might be sufficient for their abnormal concentrations appearing at the time the patient presents with a complaint. What tests are ordered is determioned by a need for relevant information to make a medical decision.

The relevant questions are:

1. acuity of symptoms and signs.
2. actions to be taken.
3. tests that are needed to clarify the examination findings.

once a provisional diagnosis is obtained, referrals, additional testing, and medication orders are provided based on the assessment.

Where does genetic testing fit into this? At this point, it will only be used

  1. to confirm a restricted list of diagnoses that have a high association with the condition, and
  2. only with the participation of a medical geneticist, when
  3. profiling the patient and other members of the family is required.

10d0de1 Vitruvian Man by Leonardo da Vinci

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Curation, HealthCare System in the US, and Calcium Signaling Effects on Cardiac Contraction, Heart Failure, and Atrial Fibrillation, and the Relationship of Calcium Release at the Myoneural Junction to Beta Adrenergic Release

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Curation, HealthCare System in the US, and Calcium Signaling Effects on Cardiac Contraction, Heart Failure, and Atrial Fibrillation, and the Relationship of Calcium Release at the Myoneural Junction to Beta Adrenergic Release

Curator and e-book Contributor: Larry H. Bernstein, MD, FCAP
Curator and BioMedicine e-Series Editor-in-Chief: Aviva Lev Ari, PhD, RN

and 

Content Consultant to Six-Volume e-SERIES A: Cardiovascular Diseases: Justin Pearlman, MD, PhD, FACC

This portion summarises what we have covered and is now familiar to the reader.  There are three related topics, and an extension of this embraces other volumes and chapters before and after this reading.  This approach to the document has advantages over the multiple authored textbooks that are and have been pervasive as a result of the traditional publication technology.  It has been stated by the founder of ScoopIt, that amount of time involved is considerably less than required for the original publications used, but the organization and construction is a separate creative process.  In these curations we amassed on average five articles in one curation, to which, two or three curators contributed their views.  There were surprises, and there were unfulfilled answers along the way.  The greatest problem that is being envisioned is the building a vision that bridges and unmasks the hidden “dark matter” between the now declared “OMICS”, to get a more real perspective on what is conjecture and what is actionable.  This is in some respects unavoidable because the genome is an alphabet that is matched to the mino acid sequences of proteins, which themselves are three dimensional drivers of sequences of metabolic reactions that can be altered by the accumulation of substrates in critical placements, and in addition, the proteome has functional proteins whose activity is a regulatory function and not easily identified.  In the end, we have to have a practical conception, recognizing the breadth of evolutionary change, and make sense of what we have, while searching for more.

We introduced the content as follows:

1. We introduce the concept of curation in the digital context, and it’s application to medicine and related scientific discovery.

Topics were chosen were used to illustrate this process in the form of a pattern, which is mostly curation, but is significantly creative, as it emerges in the context of this e-book.

  • Alternative solutions in Treatment of Heart Failure (HF), medical devices, biomarkers and agent efficacy is handled all in one chapter.
  • PCI for valves vs Open heart Valve replacement
  • PDA and Complications of Surgery — only curation could create the picture of this unique combination of debate, as exemplified of Endarterectomy (CEA) vs Stenting the Carotid Artery (CAS), ischemic leg, renal artery stenosis.

2. The etiology, or causes, of cardiovascular diseases consist of mechanistic explanations for dysfunction relating to the heart or vascular system. Every one of a long list of abnormalities has a path that explains the deviation from normal. With the completion of the analysis of the human genome, in principle all of the genetic basis for function and dysfunction are delineated. While all genes are identified, and the genes code for all the gene products that constitute body functions, there remains more unknown than known.

3. Human genome, and in combination with improved imaging methods, genomics offers great promise in changing the course of disease and aging.

4. If we tie together Part 1 and Part 2, there is ample room for considering clinical outcomes based on individual and organizational factors for best performance. This can really only be realized with considerable improvement in information infrastructure, which has miles to go.

Curation

Curation is an active filtering of the web’s  and peer reviewed literature found by such means – immense amount of relevant and irrelevant content. As a result content may be disruptive. However, in doing good curation, one does more than simply assign value by presentation of creative work in any category. Great curators comment and share experience across content, authors and themes.
Great curators may see patterns others don’t, or may challenge or debate complex and apparently conflicting points of view.  Answers to specifically focused questions comes from the hard work of many in laboratory settings creatively establishing answers to definitive questions, each a part of the larger knowledge-base of reference. There are those rare “Einstein’s” who imagine a whole universe, unlike the three blindmen of the Sufi tale.  One held the tail, the other the trunk, the other the ear, and they all said this is an elephant!
In my reading, I learn that the optimal ratio of curation to creation may be as high as 90% curation to 10% creation. Creating content is expensive. Curation, by comparison, is much less expensive.  The same source says “Scoop.it is my content marketing testing “sandbox”. In sharing, he says that comments provide the framework for what and how content is shared.

Healthcare and Affordable Care Act

We enter year 2014 with the Affordable Care Act off to a slow start because of the implementation of the internet signup requiring a major repair, which is, unfortunately, as expected for such as complex job across the US, and with many states unwilling to participate.  But several states – California, Connecticut, and Kentucky – had very effective state designed signups, separate from the federal system.  There has been a very large rush and an extension to sign up. There are many features that we can take note of:

1. The healthcare system needed changes because we have the most costly system, are endowed with advanced technology, and we have inexcusable outcomes in several domains of care, including, infant mortality, and prenatal care – but not in cardiology.

2. These changes that are notable are:

  • The disparities in outcome are magnified by a large disparity in highest to lowest income bracket.
  • This is also reflected in educational status, and which plays out in childhood school lunches, and is also affected by larger class size and cutbacks in school programs.
  • This is not  helped by a large paralysis in the two party political system and the three legs of government unable to deal with work and distraction.
  • Unemployment is high, and the banking and home construction, home buying, and rental are in realignment, but interest rates are problematic.

3.  The  medical care system is affected by the issues above, but the complexity is not to be discounted.

  •  The medical schools are unable at this time to provide the influx of new physicians needed, so we depend on a major influx of physicians from other countries
  • The technology for laboratories, proteomic and genomic as well as applied medical research is rejuvenating the practice in cardiology more rapidly than any other field.
  • In fields that are imaging related the life cycle of instruments is shorter than the actual lifetime use of the instruments, which introduces a shortening of ROI.
  • Hospitals are consolidating into large consortia in order to maintain a more viable system for referral of specialty cases, and also is centralizing all terms of business related to billing.
  • There is reduction in independent physician practices that are being incorporated into the hospital enterprise with Part B billing under the Physician Organization – as in Partners in Greater Boston, with the exception of “concierge” medical practices.
  • There is consolidation of specialty laboratory services within state, with only the most specialized testing going out of state (Quest, LabCorp, etc.)
  • Medicaid is expanded substantially under the new ACA.
  • The federal government as provider of services is reducing the number of contractors for – medical devices, diabetes self-testing, etc.
  • The current rearrangements seeks to provide a balance between capital expenses and fixed labor costs that it can control, reduce variable costs (reagents, pharmaceutical), and to take in more patients with less delay and better performance – defined by outside agencies.

Cardiology, Genomics, and calcium ion signaling and ion-channels in cardiomyocyte function in health and disease – including heart failure, rhythm abnormalities, and the myoneural release of neurotransmitter at the vesicle junction.

This portion is outlined as follows:

2.1 Human Genome: Congenital Etiological Sources of Cardiovascular Disease

2.2 The Role of Calcium in Health and Disease

2.3 Vasculature and Myocardium: Diagnosing the Conditions of Disease

Genomics & Genetics of Cardiovascular Disease Diagnoses

actin cytoskeleton

wall stress, ventricular workload, contractile reserve

Genetic Base of Atherosclerosis and Loss of Arterial Elasticity with Aging

calcium and actin skeleton, signaling, cell motility

hypertension & vascular compliance

Genetics of Conduction Disease

Ca+ stimulated exostosis: calmodulin & PKC (neurotransmitter)

complications & MVR

disruption of Ca2+ homeostasis cardiac & vascular smooth muscle

synaptotagmin as Ca2+ sensor & vesicles

atherosclerosis & ion channels


It is increasingly clear that there are mutations that underlie many human diseases, and this is true of the cardiovascular system.  The mutations are mistakes in the insertion of a purine nucleotide, which may or may not have any consequence.  This is why the associations that are being discovered in research require careful validation, and even require demonstration in “models” before pursuing the design of pharmacological “target therapy”.  The genomics in cardiovascular disease involves very serious congenital disorders that are asserted early in life, but the effects of and development of atherosclerosis involving large and medium size arteries has a slow progression and is not dominated by genomic expression.  This is characterized by loss of arterial elasticity. In addition there is the development of heart failure, which involves the cardiomyocyte specifically.  The emergence of regenerative medical interventions, based on pleuripotent inducible stem cell therapy is developing rapidly as an intervention in this sector.

Finally, it is incumbent on me to call attention to the huge contribution that research on calcium (Ca2+) signaling has made toward the understanding of cardiac contraction and to the maintenance of the heart rhythm.  The heart is a syncytium, different than skeletal and smooth muscle, and the innervation is by the vagus nerve, which has terminal endings at vesicles which discharge at the myocyte junction.  The heart specifically has calmodulin kinase CaMK II, and it has been established that calmodulin is involved in the calcium spark that triggers contraction.  That is only part of the story.  Ion transport occurs into or out of the cell, the latter termed exostosis.  Exostosis involves CaMK II and pyruvate kinase (PKC), and they have independent roles.  This also involves K+-Na+-ATPase.  The cytoskeleton is also discussed, but the role of aquaporin in water transport appears elsewhere, as the transport of water between cells.  When we consider the Gibbs-Donnan equilibrium, which precedes the current work by a century, we recall that there is an essential balance between extracellular Na+ + Ca2+ and the intracellular K+ + Mg2+, and this has been superceded by an incompletely defined relationship between ions that are cytoplasmic and those that are mitochondrial.  The glass is half full!

 

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