Justices Appear Skeptical About Patenting Of Human Genes.

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The Supreme Court on Monday heard arguments in a key case about whether or not human DNA could be patented by biomedical firms. Media coverage portrayed the justices as skeptical about the assertions of Utah-based Myriad Genetics Inc., which holds patents on two genes.

        The AP (4/15, Holland) reports that the Supreme Court "seemed worried" during Monday arguments "about the idea of companies patenting human genes." Noting that the US Patent and Trademark Office "has been awarding patents on human genes for almost 30 years," the AP adds that "opponents of Myriad Genetics Inc.'s patents on two genes linked to an increased risk of breast and ovarian cancer say such protection should not be given to something that can be found inside the human body." Myriad argues that "the company's genes can be patented because the DNA that Myriad isolated from the body has a 'markedly different chemical structure' from DNA within the body."

        The Wall Street Journal (4/16, Bravin, Subscription Publication) reports that challengers to the Myriad patents, including a medical researchers' group represented by the American Civil Liberties Union, argue the genes themselves, like all natural products, cannot be patented, but methods for isolating them or using them might be.

        The New York Times (4/16, Liptak, Subscription Publication) reports that in "lively" exchanges, the justices "struggled to find a narrow way to rule on the momentous question of whether human genes may be patented." Noting that the court's ruling "will shape the course of scientific research and medical testing," and "may alter the willingness of businesses to invest in the expensive work of isolating and understanding genetic material," the Times adds that the Obama Administration, through Solicitor General Donald Verrilli Jr., "largely supported" the challengers, and argued that the court's ruling last year in Mayo Collaborative Services v. Prometheus Laboratories "suggested that the correct answer in the case argued Monday was that merely isolating a gene was not sufficient for patent protection."

        USA Today (4/16, Wolf) reports, "Using analogies ranging from baseball bats to chocolate chip cookies, a majority of justices said Myriad Genetics' isolation of the breast cancer genes was largely a force of nature, not invention. At the same time, the justices indicated a compromise could be in the works, siding with the company on its patent for a type of DNA that goes beyond merely extracting the BRCA1 and BRCA2 genes from the body."

        The Washington Post (4/16, Barnes) reports, "Even the normally confident justices expressed some trepidation as they considered the complexities of patent law and the mysteries of biochemistry." The Post notes that the justices' "caution is warranted," as the ruling "could shape the future of medical and genetic research and have profound effects on pharmaceuticals and genetically modified crops."

        The Los Angeles Times (4/16, Savage) reports, "During the argument Monday, most of the justices questioned the decision of the U.S. Patent and Trademark Office to grant Myriad Genetics a patent on two isolated gene sequences that signal a high risk of breast or ovarian cancer."

        Bloomberg News (4/16, Stohr, Decker) reports that "the case has ramifications for the growing field of personalized medicine as well as efforts to map the human brain and discover new uses for embryonic stem cells." Challengers to Myriad's patents include the American Medical Association, Association for Molecular Pathology, and the American College of Obstetricians and Gynecologists.

        Politico (4/16, Norman) notes that "much of the research community has bristled against patenting genes for decades, even as the policy at the patent office has consistently favored it. The American Medical Association weighed in against the practice, but some biotech interests argue that outlawing the patenting of genes could discourage companies from investing in genetic research."

        In a second article, the Los Angeles Times (4/15, Brown) reports that, according to Dr. Eric Topol, director of the Scripps Translational Science Institute in La Jolla, "Myriad's patents on the genes 'have really held back the field,' as the company has issued cease-and-desist letters to some academic centers attempting to study the BRCA1 and BRCA2 genes." Topol claimed that "Myriad's patents also have a chilling effect on genomics research because the company's tight control over BRCA1 and BRCA2 test results has prevented scientists from accessing useful data about genes and associated traits."

        Although supporters claim that the "patent only covers isolated molecules that are outside the body," ABC News (4/16, De Vogue) quotes Sandra Park, a senior attorney with the ACLU, as stating: "The patents are framed as covering and claiming the isolated genes. What that means is that the moment the gene is removed from the cell, Myriad owns it. The scope of the patent is incredibly broad." The ACLU argues "that although Myriad has not exercised its authority to stop all research, it has a monopoly on clinical testing in the U.S., and the ability to discourage research because laboratories are dissuaded from pursuing scientific work that requires using patented genes." In an amicus brief on behalf of the American Medical Association and others, Lori B. Andrews, a professor from Chicago-Kent College of Law, claimed that "patents on human genes impede the provision of health care, thwart public health objectives, shackle innovation and violate ethical tenets."

        On its website, NBC News (4/15, Williams) reports that the ACLU claims that Myriad's exclusive patent "creates a monopoly that denies women the ability to seek a second opinion, based on another test of the genetic material, and dissuades other laboratories from pursuing research on the patented genes." The ACLU contends that, because Myriad's breast cancer "test costs roughly $3,000, many women cannot afford it or lack the necessary insurance coverage." Regarding availability of the test, Myriad "says the cost of the test is covered by private insurance, Medicare, and Medicaid."

        The Salt Lake (UT) Tribune (4/16) reports that "one area where ACLU attorney Christopher Hansen seemed to stumble was when justices pressed him on whether invalidating gene-related patents would mean companies and investors would be much less likely to pour money into research and development. Hansen said that a company could get recognition for its work and that money for research would always be available, a statement that Kennedy said wasn't sufficient." The Tribune notes that "the court is expected to rule before the end of the summer."

        BBC News (4/16) reports that "the ramifications of any decision by the Supreme Court are uncertain," but "one thing is certain: A deeper understanding of how genes affect health is already starting to transform medicine. It is helping to deliver targeted drugs to the right patients as well as tests for cancer risk genes."

        Also reporting on the story are Reuters (4/16, Hurley), McClatchy (4/16, Doyle), CNN (4/15, Mears), NPR (4/15, Totenberg), Daily Mail (UK) (4/16, Lawson), HealthDay (4/16, Steele), and MedPage Today (4/16, Pittman).

        More Commentary. In a column for USA Today (4/15, Turley), George Washington University law professor Jonathan Turley writes, "The Myriad case raises fundamental questions on the meaning of property, including the treatment of the human genome as akin to a Hoover vacuum. As the Supreme Court deliberates over the very ownership of our genes, there has never been a national debate over the commoditization of American life. If we do not want to live by the leave of a new property class, we have fight for our rights."

        In his Los Angeles Times (4/15, Healey) column, Jon Healey writes that "the justices were clearly concerned about preserving innovation in medicine and biotechnology," but "the issue presented by Myriad Genetics' patents on the BRCA genes cuts both ways, leading to a potential split among the justices." Healey notes that, "during Monday's oral argument, several justices seemed worried about the implications of allowing patents over something extracted from nature."

        However, in a "Blowback" opinion piece in the Los Angeles Times (4/14, Meldrum), Peter D. Meldrum, president and chief executive of Myriad Genetics, writes in support of Myriad's patents on BRCA1 and BRCA2, which he claims "do not cover human genes from anyone's body." Claiming that the patents were a "product of creative, human ingenuity," Meldrum adds, "Without our patents, our tests could not have been developed." He concludes that "the issue before the Supreme Court is not about Myriad," but rather it "is about the consequences to the life sciences - and for innovation."

        In his column for the Washington Post (4/16) , Dana Milbank writes that "Based on the justices' questioning, there was little doubt that corporations such as Myriad have a legitimate claim to the DNA in our bodies. The argument was mostly about whether corporations own the material itself or merely have the exclusive rights to use our genes for research and commerce."

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High Court To Hear Key Case On Human Gene Patents.

DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning.

The New York Times (4/15, A1, Pollack, Subscription Publication) reports that the Supreme Court "is poised to take up the highly charged question of whether human genes can be patented," but "another question could trump it: Has the field of genetics moved so far so fast that whatever the court decides, it has come too late to the issue?" The Times continues, "The hearing comes as rapid scientific advances are producing an explosion of new information about human genes, as well as those of animals, plants and microbes, yielding new approaches to detecting and combating diseases."

        The Christian Science Monitor (4/14, Richey) reports, "The issue arises in a challenge to patents held by Myriad Genetics, a Utah-based diagnostic testing and research firm that developed a way to detect genetic mutations (called BRCA1 and BRCA2) that scientists associate with a higher risk of breast and ovarian cancer. The process is described by the company's lawyers as akin to locating a particular grain of sand in a space the size of the Empire State Building. The tests have helped over a million patients identify risks and develop treatment strategies," but "the American Civil Liberties Union and the Public Patent Foundation charge that Myriad Genetics is actually hindering scientific innovation and undercutting access to medical care for patients who need it."

        Bloomberg News (4/12, Stohr, Decker) reports that "trade groups for the biotechnology, agriculture and drug industries are siding with Myriad," claiming that "gene patents have led to valuable treatments." Meanwhile, "doctor groups such as the American Medical Association are backing the challengers to the patents. They have partial support from the Obama administration, which is urging the court to uphold parts of Myriad's patents and void other aspects."

        The Philadelphia Inquirer (4/15, Sell) reports that "research groups, patient advocates, and the American Medical Association, among others, argue that Myriad's assertion of patent rights to the genes stifles future research and the use of existing, lower-cost diagnostic tools because they involve those genes. Armed with the patent-induced market exclusivity, Myriad charges about $3,000 for a test for which other labs previously charged $200 or less." According to Myriad, "separating pieces of genes requires skilled human intervention and creates a new entity, worthy of a patent, and that 30 years of patent protocol should not be changed."

        The Salt Lake (UT) Tribune (4/15, Harvey) reports that, "without that patent protection, the company says it is unlikely that kind of money would have been poured into research and development. It also points out that research by others has not been stifled, with 10,000 research papers published about BRCA1 and BRCA2." The Tribune notes that "Myriad officials have said that the patents in question are only a small part of its portfolio, and that a negative decision won't have a significant impact on the publicly traded company's finances."

        Also reporting on the story are the Boston Herald (4/15, Kantor), Boston Business Journal (4/15, Subscription Publication) on its "Bioflash" blog, Reuters (4/15, Begley), The Hill (4/15, Baker) on its "Healthwatch," Atlantic Wire (4/15, Estes), Forbes (4/12, Fisher), McClatchy (4/12, Doyle), and Modern Healthcare (4/13, Subscription Publication).

        More Commentary. The Washington Post (4/15) editorializes, "The legal precedent stresses that products of nature aren't patentable, so the justices may well rule against Myriad. But either way, their ruling shouldn't be the end of it. Balancing the benefits of free-flowing research against the value of mobilizing private money to detangle genetic code is a hard policy call that Congress should make."

        The New York Times (4/15, Subscription Publication) editorializes, "The petitioners in the case - doctors, scientific researchers and women's health organizations - argue that the isolated genes are not materially different from genes before extraction, and that allowing Myriad a patent on them would allow the patenting of nature itself, at untold cost to scientific research, medical treatment and patients. We agree with the petitioners, while recognizing that this case is one of the most important and complex disputes involving the intersection of science, law and commerce in a generation." The Times notes that the Administration is conflicted over the case. "The patent office sees the patents as valid and consistent with its duty to protect and promote invention; Solicitor General Donald Verrilli Jr. and the Justice Department oppose them on grounds that what nature makes cannot be patented and Myriad's isolation of DNA did not change it enough to alter nature and be eligible for a patent."

        USA Today (4/14) editorializes, "By locking up the BRCA genes and making its $3,340 test the only one doctors can use without the company's permission, Myriad stifles independent scientific inquiry and the sort of competition that might produce better or cheaper tests. Myriad says it spent hundreds of millions of dollars developing its test, and no one could reasonably object if the company patented only its test. But the gene patents go too far."

        In an op-ed for USA Today (4/14) Peter D. Meldrum, president and CEO of Myriad Genetics, Inc., writes, "To create tests for hereditary breast cancer and ovarian cancer, our company and its investors spent more than $500 million over 17 years before we were able to recoup this investment." Meldrum continues, "Our tests have been used by more than 1 million women to determine whether they are at increased risk of developing hereditary breast, colon, uterine and ovarian cancer. We think it is right for a company to be able to own its findings, just as pharmaceutical and other companies do all the time."

        In an opinion piece in the Dallas Morning News (4/12), Jeffrey A. Rosenfeld, assistant professor of medicine at the New Jersey Medical School, writes about how "DNA belongs not to you but rather to many companies and institutions that have patents on the DNA from your cells. Forty-one percent of the genes in your genome are not legally yours, according to a long list of gene patents granted since the 1980s." Referring to the Myriad Genetics case, Rosenfeld concludes: "Fortunately, the Supreme Court has a chance to rectify this genetic injustice."

        Despite the controversy surrounding the case, columnist Bradley J. Fikes writes in the U-T San Diego (4/13, Fikes), "No matter which way the Supreme Court rules on the Myriad Genetics BRCA breast cancer gene test patenting case, the importance of such patents is diminishing over time. Biotechnology is moving beyond patents derived from naturally occurring gene sequences. The most important biotech patents nowadays are becoming synthetic gene and RNA sequences, proteins and other indisputable contrivances of human ingenuity."

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High Court To Consider Settlements That Slow Entry Into Generic Drug Market.

USA Today (3/25, Wolf) reports, "Consumers will have billions of dollars on the line today when the Supreme Court hears the government's case charging antitrust collusion between brand-name and generic drugmakers. What's in dispute, though, is whether the questionable deals cheat consumers - or whether they come out ahead." The Federal Trade Commission "has been on a decade-long crusade to stop settlements in which brand-name drugmakers pay generics to stay out of the $250 billion U.S. drug market for a specified number of years," but drug manufacturers "say that without such settlements, millions of dollars would be wasted in litigation, and when generics lose patent challenges, the lower-cost drugs would remain off the market even longer, until the patent expires."         The New York Times (3/25, Wyatt, Subscription Publication) reports, "The case, Federal Trade Commission v. Actavis, No. 12-416, centers on whether the maker of a brand-name drug can pay a generic-drug company to keep the generic version off the market. Based on antitrust law, the obvious answer would seem to be no, the view voiced by the government and most recently upheld by a federal appeals court. At least three other federal appeals courts have previously said those payments are legal, however, when made under the settlement of a patent infringement lawsuit. Those courts sided with drug company arguments that the payments are what Congress intended in setting up guidelines to encourage the production of generic drugs. The question before the justices pits a company's constitutional right to protect its intellectual property - through reliance on a patent that excludes competitors - against antitrust law, which holds that a company cannot unfairly exclude others from legitimately entering a business with a rival product."         The AP (3/25, Holland, Johnson) reports, "The Obama administration, backed by consumer groups and the American Medical Association, says these so-called 'pay for delay' deals profit the drug companies but harm consumers by adding 3.5 billion annually to their drug bills. But the pharmaceutical companies counter that they need to preserve longer the billions of dollars in revenue from their patented products in order to recover the billions they spend developing new drugs. And both the large companies and the generic makers say the marketing of generics often is hastened by these deals." DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning. Subscribe to the DIA Daily. View archives. iPhone and iPad Apps available! Download "BulletinHC."DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing. If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org.Click here to check your membership status. Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044 Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191

What if Supreme Court is not done with health reform law?

Justices tell a lower court to reconsider a plaintiff’s argument that the requirement for employers to provide insurance covering abortions violates its religious freedoms.

By Alicia Gallegos, amednews staff. Posted Dec. 10, 2012.

Legal analysts said a revived legal challenge against the Affordable Care Act by a Christian university could put the health system reform law back in the hands of the U.S. Supreme Court, even after the high court upheld the bulk of the statute as constitutional.

In a rare move, the Supreme Court on Nov. 26 ordered a federal appeals court to reconsider a constitutional challenge against the ACA that focuses on whether the measure’s employer insurance coverage mandate violates religious freedoms. The 4th U.S. Circuit Court of Appeals previously had dismissed the lawsuit, brought by Liberty University in Virginia, without considering the suit’s merits.

for complete article...

Supreme Court To Decide Whether Companies Can Patent Human Genes.

The AP (12/1) reported the Supreme Court "will decide whether companies can patent human genes, a decision that could reshape medical research." The court said last Friday it would hear the case of the Association for Molecular Pathology v. Myriad Genetics, Inc. The Times said a "decision will likely resolve an ongoing battle between scientists who believe that genes carrying the secrets of life should not be exploited for commercial gain and companies that argue that a patent is a reward for years of expensive research that moves science forward." Myriad Genetics has a test that probes for a gene that indicates a predisposition to breast cancer and is correlated with ovarian cancer. The American Civil Liberties Union (ACLU) has challenged Myriad Genetics' patents, with plaintiffs that include "geneticists who said they were not able to continue their work because of Myriad's patents, as well as breast cancer and women's health groups, patients and groups of researchers, pathologists and laboratory professionals."

The New York Times (12/1, A17, Liptak, Subscription Publication, 1.68M) reported that Myriad argues "that the 'isolated molecules' at issue 'were created by humans, do not occur in nature and have new and significant utilities not found in nature.'" Myriad also argues its work "is worthy of encouragement and that its fruits are worthy of protection."

The Wall Street Journal (12/1, Kendall, Subscription Publication) reported that a lower court had ruled that isolating the gene makes it no longer a product of nature and is therefore subject to patent. The company urged the court not to take the case.

Bloomberg News (12/1, Stohr, Decker) reported, "Biotechnology companies say they have been getting patents on genes for 30 years -- and can't attract investment dollars unless they can protect their research from competitors." But "the challengers say isolated DNA is identical to the coding that exists naturally in the body."

DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

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Copyright © 2012 by BulletinHealthcare | 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191

       

 

Supreme Court Ruling Generates Widespread Reaction During the DIA 2012 48th Annual Meeting

For Immediate Release Supreme Court Ruling Generates Widespread Reaction During the DIA 2012 48th Annual Meeting JUNE 28, 2012—HORSHAM, PA—The Supreme Court today voted 5-4 to uphold President Obama’s Affordable Care Act, affirming the centerpiece of the sweeping 2010 overhaul of the nation’s medical industries. “Today’s Supreme Court decision will impact patient access to medical products and treatments,” explains Paul Pomerantz, DIA Worldwide Executive Director.”It also provides clarity and direction to allow DIA to continue to create forums to exchange vital information and discuss current issues to ensure patient access to safe, effective, and affordable medical products.” In his decision, Chief Justice John Roberts explained that the individual mandate survives because Congress has the power to impose taxes. Today’s announcement came during the DIA 2012 Annual Meeting CDER Town Hall—generating mixed reaction from the 600 people in attendance. "It sure seems like the right thing to do," says Patrick Revelle, MedDRA MSSO. "It seems an odd position for someone to be against. I have health care coverage, but many other people don't." Greg Gogates of CRF Health noted that the Supreme Court considers the individ¬ual mandate to be tax on those who do not have health insurance. "I understand the concept,” he says. “But where are the people who already have no money for health insurance going to come up with the money to pay for this tax?" Starting in 2014, the Affordable Care Act will extend health insurance to approximately 30 million Americans who currently lack coverage. It will also guarantee the availability of insurance for those with pre-existing conditions and ensure those people don’t pay more than healthy people. Anyone earning up to 133% of the federal poverty level will get free coverage through Medicaid and those earning 133% to 400% (but without access to employer or government insurance) will be eligible for federal subsidies to help them buy policies. As a frequent visitor to the US, and also having lived here for a couple years, Thomas Kuhler of Novo Nordisk A/S, Denmark congratulated the Supreme Court’s decision noting, "This [decision] represents a great step forward." Contact: Joe Krasowski DIA Marketing Communications Manager P: 215-293-5812 E: Joe.Krasowski@diahome.org

Why the Constitution matters in the health care case, from Richmond Times Dispatch

Although most of the commentaries on the Affordable Care Act ("Obamacare") have emphasized public policy issues such as the spiraling cost of health care and the burden placed on the health care industry by uninsured or underinsured people, the legal challenge to the law that culminated in three days of hearings before the United States Supreme Court has forced both defenders and critics of the law to give at least some attention to constitutional issues. This is of enormous significance. The message that these hearings should send, and that the American people need to hear loudly and repeatedly, is that the Constitution matters.

Irrespective of how the Supreme Court rules in the health care case, it will be important for the justices to rest their ruling principally on constitutional issues and not public policy issues. While it is impossible to completely disentangle public policy issues from constitutional issues in the field of modern commerce-clause jurisprudence, it is possible to subordinate public policy considerations to constitutional considerations even in this area of the law, and it will be important for the court to do this.

There are several good reasons for the court to resist any temptation to act like a policymaking or public policy institution in the health care case, something that it has done in the past. The temptation to elevate public policy considerations to a position of primacy will be great since virtually everyone concedes that the health care system, from the point of view of access and quality of care as well as affordability, is not meeting the expectations of many Americans.
Indeed, President Obama challenged the court to uphold the law largely on public policy grounds shortly after the conclusion of oral arguments. It would be unfortunate, however, both for constitutional and pragmatic reasons, if the court decides that another foray into the public policy arena makes sense in this case.
* * * * * One the one hand, the court (made up of unelected officials) can best defend its scrutiny of the actions of the elected officials of the coordinate (political) branches of the federal government by falling back on the dictates of the country's constitutional or fundamental law. It was just such a defense, rooted in First Amendment analysis, that the justices invoked in response to President Obama's criticism of their handling of corporate campaign spending (the Citizens United case) in his State of the Union Address in 2010.

There is no better protection for the court when attacked by the political branches or by the people than being able to assert that "the Constitution made us do it." Preserving an independent judiciary, in turn, is critical to protecting the personal liberties associated with limited government.
To paraphrase the Federalist Papers, "the reservation of particular rights and privileges would amount to nothing" in the absence of an independent judiciary, that is, a judiciary that is free to do its work without fear of political pressure or manipulation.

more...
http://www2.timesdispatch.com/news/commentary/2012/apr/22/tdcomm03-why-the-constitution-matters-in-the-healt-ar-1858288/

The Supreme Court’s other business

The intense attention paid to the U.S. Supreme Court’s March 26-28 consideration of the health system reform law overshadowed several other health care cases that have wide-ranging implications on medical care.

In addition to its comprehensive coverage of the health reform oral arguments, American Medical News reported on these recent Supreme Court decisions of great interest to physicians and other health professionals. The justices struck down patents on a medical test that measures patients’ metabolite levels. They sent a lawsuit by California physicians and others against Medicaid pay cuts back to a lower court for further consideration. And justices sided with drugmakers in separate cases involving the sale of physician information and liability for labeling errors.

see AMAnews article for details: http://www.ama-assn.org/amednews/2012/04/09/edsa0409.htm

GAO Sees Gloomy Fiscal Outlook without Health Reform

As the U.S. Supreme Court decides the fate of the Patient Protection and Affordable Care Act, a new report from the Government Accountability Office says that healthcare costs could soar if the law is overturned, further adding to the long-term challenge posed by the federal deficits and debt.

In its latest update of the federal government’s long-term fiscal outlook, the GAO makes projections based on two models, one baseline model that generally reflects current law, and another alternative model that assumes cost-containment mechanisms are not sustained over the long term. Even with the Affordable Care Act implemented as intended, the “structural gap between revenues and spending driven by rising healthcare costs and demographics” would not be closed, according to the GAO.
But spending on healthcare would grow “much more rapidly” in the alternative scenario, causing spending on Medicare and Medicaid to grow to more than 8 percent of GDP by 2030 from 5 percent of GDP in 2010. The baseline model finds Medicare and Medicaid growing to 7 percent under the baseline simulation, it says.

http://www.burrillreport.com/article-gao_sees_gloomy_fiscal_outlook_without_health_reform.html

Court’s Potential to Goad Voters Swings to Democrats

The prospect arises both because of President Obama’s comments this week implicitly warning the court against striking down his signature domestic achievement, the expanded health insurance law, and because of recent court rulings, chiefly the Citizens United campaign finance decision, and looming cases on immigration and affirmative action that incite passions on the left.

“Historically, the court has been a rallying point for the Republican base, and it is now much easier to imagine that it will be a rallying point with the Democratic base just as much if not more, especially if the court overturns the Affordable Care Act,” said Geoff Garin, a Democratic pollster who works with Priorities USA Action, a group supporting the president’s re-election but independent of his campaign.

for full article,

1http://www.nytimes.com/2012/04/05/us/politics/this-election-supreme-court-could-rally-democrats.html?_r=1

The Role of Partisanship in the Health Care Reform Challenge

The large interest shown by the public in the three days of oral arguments devoted to the constitutional challenge to the Affordable Care Act (ACA) should be heartening to any fan of the US Constitution. Americans of all stripes listened to the arguments, learned the precedents and constitutional clauses the arguments relied on and engaged with the rich history and philosophy surrounding the Constitution. I doubt Roscoe Filburn, of Wickard v. Filburn fame, would ever have expected his name to be bandied about by so many people 70 years after his case was decided.

On the second day of argument, in which the Court took up the question of the "individual mandate," the conservative justices each showed extreme skepticism that the commerce power gives Congress the ability to force people to purchase insurance. Some academics and commentators had gone so far to predict that the argument for the constitutionality of the individual mandate was so easy that even conservative stalwarts like Justice Antonin Scalia would kowtow to the government's arguments. This was rapidly proven to be untrue. Justice Scalia in particular assailed the solicitor general with questions that demonstrated he understood the finely tuned arguments and subtle distinctions of the challengers.

The general anti-ACA tenor of the arguments has opponents of the act cautiously optimistic that the Supreme Court might actually strike down all or part of it. An argument that once had more skeptics than believers now may have more believers than skeptics, and five of those believers might be on the Supreme Court.
for full article,
http://jurist.org/hotline/2012/04/trevor-burrus-health-care.php

Unsustainable Health Care System

 “If we are going to fix our ineffective and unsustainable healthcare "system" the only real cure is a vibrant, diverse and independent Primary Care provider base. The only way to get that is to change the way people pay for primary care (giving everyone equal means). Everyone needs primary care and preventive services, not necessarily insurance. I even found SCOTUS making the statement that the only way to buy healthcare was to buy insurance; a false and somewhat scary assumption. By giving everyone the same means to purchase primary care and introducing pricing transparency into primary care, costs will go down and quality will improve. Why? because the patient is now the payer (the only single payer system I agree with) and they can hold the Practitioner/Practice accountable for wait times and interpersonal skills (are they listening to me?) This also alters the economics for the Practitioner; for the better. Reducing the administrative burden thrust upon each practice by the antiquated CPT Code based billing system. We are working diligently in NC (other states are waiting for the template) with all major parties to create the next major "pilot project" for meaningful reform (Medicaid, State Health Plan, Private Payers). This is not a political effort, but an effort by one state to do what is in the best interest of its residents. This is why/how decisions should be made in the political realm.

For more...

http://healthworkscollective.com/gary-levin-md/31067/unsustainable-health-care-system?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+healthworkscollective_allposts+%28Healthworks+Collective%29&utm_content=Google+Reader

Like The U.S., Europe Wrestles With Health Care, NPR Shots

by Corey Flintoff

The U.S. has been absorbed by the Supreme Court case this week on the future of health care. But Americans are not alone.
Several European nations, where universal health care has been the norm for decades, have been waging their own intense debates as they also deal with aging populations and rising costs.
Britain passed a new health care measure earlier this month, after more than a year of rancorous debate. Can the European experience cast some light on the American debate over health care?
"There are some common problems," says British analyst Chris Ham, "but we're coming to this debate from very different starting points. In the States, it's about how to extend coverage to more people, whereas [in Britain], it's about how to get more bang for the buck out of our current system."
  Ham is the chief executive of The King's Fund, an independent health policy think tank in London.

The British Debate
Britain's debate is still going on, with critics charging that the Conservative-led government is trying to privatize the more than 60-year-old system in an effort to cut the nation's budget deficit.
The government says the reforms will trim a bloated health care bureaucracy and give doctors more control over health care management.

for full article:
http://www.npr.org/blogs/health/2012/03/28/149564583/like-the-u-s-europe-wrestles-with-health-care

Obamacare Court fail could hit pharmas with "double whammy"

If the Supreme Court finds the “individual mandate” provision of the Affordable Care Act unconstitutional, as now seems surprisingly possible, the biopharma industry could be looking at a worst possible outcome situation.

The Court's five-justice conservative-libertarian majority was frequently relentless in their questioning of the mandate at last week's marathon hearings, leading many Court Kremlinologists to put the odds in favor of partial or total repeal. The court could void the mandate, which would blow up the rationale on which PhRMA negotiated $100 billion in drug discounts for federal programs, or it could void the entire law. Either of those outcomes was regarded as unlikely before the hearings. Not anymore.

“PhRMA negotiated an excise tax recognizing it was a give-back taking into account that the industry would likely benefit from that,” said Acorda Therapeutics president and CEO Ron Cohen, MD. “If the individual mandate gets struck down, now you've got a double-whammy, because those thirty-million people aren't going to show up and pay for innovator drugs. So we're still paying into the system, but we don't have the benefit of people having access to medication, which would add costs the system.”

Click here for more.

Health IT impact of Supreme Court decision depends on extent of ruling

http://www.fiercehealthit.com/story/health-it-impact-supreme-court-decision-depends-extent-ruling/2012-04-02?utm_medium=nl&utm_source=internal 

When the U.S. Supreme Court heard oral arguments about the constitutionality of the Affordable Care Act (ACA) last week, the news media went a little crazy. Despite the evident skepticism of some justices about the individual mandate to buy insurance, there still is no reason to assume that the High Court will knock down the entire healthcare reform law--or even the individual mandate. One or more swing votes are still in play, and nobody has a crystal ball that can forecast the outcome.

But from the perspective of health IT, whether the court chooses to strike down just the insurance mandate or the entire law is critically important. As the Health Information and Management Systems Society (HIMSS) pointed out recently, the statute includes provisions related to "quality reporting initiatives, pay-for-performance initiatives, adoption of state HIEs, operating rules and standards, and health IT work force development."

That's just the beginning. The business model for accountable care organizations (ACOs) is based partly on the Medicare shared savings program authorized by the law--and ACOs cannot exist without a robust IT infrastructure. The ACA also authorizes a bundled payment pilot that depends on coordination of care between hospitals and post-acute-care facilities. And another ACA provision requires Medicare to levy penalties for excessive readmissions, forcing hospitals to bolster their ability to communicate with other providers and patients.

Read more: Health IT impact of Supreme Court decision depends on extent of ruling - FierceHealthIT http://www.fiercehealthit.com/story/health-it-impact-supreme-court-decision-depends-extent-ruling/2012-04-02?utm_medium=nl&utm_source=internal#ixzz1qugKrIcw
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FDA Extends Deadline for Reporting Samples Under ACA

FDA Extends Deadline for Reporting Samples Under ACA

By Alan M. Kirschenbaum –
Two days ago, during argument before the Supreme Court on the Affordable Care Act ("ACA"), Justice Breyer referred to “loads” of miscellaneous provisions of the Act outside the core insurance provisions.  One of these is section 6004, which requires manufacturers and authorized distributors of record to submit information on drug samples to FDA annually beginning April 1, 2012 (this Sunday).  Today, FDA issued a brief draft guidance announcing that FDA will exercise its enforcement discretion to extend the deadline for reporting until at least October 1, 2012.  The guidance states that FDA will provide notice before revising this policy, indicating the possibly of a further extension.  By then, we will know whether this and “loads” of other ACA provisions will survive the Supreme Court’s decision, expected in June.  If and when required, the sample information will be submitted electronically through FDA’s Electronic Submissions Gateway.

http://www.typepad.com/services/trackback/6a00d8341d150c53ef0167647090a2970b

Small business owners mixed over health care law

from CBS News Money Watch

By Alain Sherter

Protesters in favor of health care reform demonstrate outside of the Supreme Court in Washington, D.C., March 26, 2012, as a hearing on President Obama's health care legislation began. (AP Photo/Jacquelyn Martin)

(MoneyWatch) The Supreme Court on Wednesday wrapped up three days of arguments over President Obama's landmark health care law, and Vintage Vinyl co-owner Lew Prince is scared -- that the legal challenge will work. If the Patient Protection and Affordable Care Act is overturned, "I'll be back in the crappy system I was in two years ago," says Prince, co-owner of the small St. Louis music store. "We'd go back to fighting for every inch of coverage every year."

Such fears highlight the division of opinion among small business owners about the health care overhaul. One of the main litigants against the law is the National Federation of Independent Business (NFIB), a Washington trade association that contends the new law will raise its members' costs, burden them with regulations, and kill jobs. Other small business groups argue the opposite, claiming that the law is already lowering costs, expanding firms' insurance options, and easing the process of arranging coverage.

What's impact on N.J. if health care law overturned?

http://www.app.com/article/20120328/NJNEWS/303280072/What-s-impact-on-N-J-if-health-care-law-overturned-

Written by
Bonnie Delaney, Asbury Park Press, Staff Writer
 

Love it or hate it, the Affordable Care Act has already helped New Jersey’s senior citizens save an estimated $95 million by closing the Medicare prescription plan doughnut hole. As of last June, 2.5 million young adults nationwide have gained coverage through a provision that requires employers and health insurers to allow them to stay on their parents’ plans until they turn 26.

But those popular components of the act — as well as many others like guaranteed coverage for people with pre-existing conditions — could be lost if the U.S. Supreme Court strikes down the 2010 law passed by Congress and challenged by 26 states as unconstitutional, said Joel C. Cantor, director of the Rutgers Center for State Health Policy and a professor of public policy at Rutgers...

BEHIND THE NEWS

An August 2011 report by the Rutgers Center for State Health Policy, headed by Joel C. Cantor, said the following estimates of changes in coverage could be expected with implementation of the Affordable Care Act:

• The number of uninsured in New Jersey will decline from 14.5 percent of the non-elderly population to 8.6 percent, increasing the number of covered people by about 444,000.
• The non-group health insurance market will gain the most covered individuals, increasing from 2.8 percent of the non-elderly to 7.6 percent, an increase of about 362,000 people. Of those enrolled in non-group coverage after reform, more than half would be eligible for federal tax credit subsidies.
• Medicaid/NJ FamilyCare also will expand substantially under reform, increasing from covering 13.6 percent to 16.7 percent of the non-elderly in the state, an expansion of about 234,000 individuals. More than half of this projected increase will be non-parent adults (132,000), although it is projected that the number of enrolled children will also increase.
• The percentage of people with employer-sponsored coverage will decline slightly.

Scott Brown and Elizabeth Warren spar over medical device excise tax in federal health care law

From MassLive.com

As the United States Supreme Court wraps up three days of arguments over the Constitutionality of the health care mandate in the Patient Protection and Affordable Care Act, a medical device excise tax included in the sweeping legislation is being debated in the U.S. Senate race on Massachusetts.

Republican U.S. Sen. Scott Brown's campaign criticized its chief Democratic rival Elizabeth Warren for her support of the health care law on Wednesday, charging that the 2.3 percent medical device tax included in it would hurt the more than 400 medical technology companies in the Bay State.

If the Supreme Court strikes down the health care mandate in the coming weeks, it could kill the overall legislation, including the medical device tax. But if the legislation stands, Brown says the tax will result in jobs being lost in Massachusetts. 

For full article: http://www.masslive.com/politics/index.ssf/2012/03/scott_brown_and_elizabeth_warr_2.html 

Health system reform: Abstract debate inside Supreme Court as protest signs dominate outside - amednews.com

See link for complete article:

Health system reform: Abstract debate inside Supreme Court as protest signs dominate outside - amednews.com

Washington --Away from the emotional atmosphere outside the U.S. Supreme Court, justices in their three days of oral arguments on the national health system reform law focused on the constitutional and legal issues. Philosophical discussions among the justices about markets, mandates and tax code were more common than talk of patients, preexisting conditions and access to medical care.

The heart of the justices’ review was the law’s individual mandate, the provision requiring nearly all Americans to obtain insurance by 2014 or pay a penalty. That was the primary line of attack by states and employers that want to see the statute overturned, and justices in their questioning appeared evenly split along ideological lines on whether the federal government can compel the purchase of a commercial product.

 

The four questions before the court

When U.S. Supreme Court justices rule on the health system reform law, probably in June, they will make decisions on four distinct questions.

• Does the Anti-Injunction Act prevent justices from ruling on the law’s individual mandate until after 2014?
• Did Congress have the authority under the Commerce Clause to require individuals to obtain health coverage or pay a penalty?
• If the individual mandate is struck down, must any or all of the law’s other provisions be struck down, too?
• Does the law’s requirement that states pay a portion of a Medicaid expansion or give up all federal Medicaid funding represent unconstitutional coercion?