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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What the Biopharmaceutical Industry Needs to Know in the Wake of the Supreme Court Decision Upholding the Affordable Care Act

No Worries, We Recorded it Will the PhRMA Deal Stand and What Happens Next? What the Biopharmaceutical Industry Needs to Know in the Wake of the Supreme Court Decision Upholding the Affordable Care Act July 26 This 90-minute archived webinar lets you hear experts cut through the hype to consider the real effects of the decision on the drug, device and biopharmaceutical industries. Among other things, panelists discussed how states may limit the expansion of Medicaid and how that may affect the PhRMA deal with Congress, including the $80 Billion contribution in exchange for additional patients with Part D coverage. At the conclusion of this webinar, you will be able to: • Explain the effects of the Affordable Care Act decision on the medicine companies, especially its affect on Medicare Part D covered recipients and the biopharmaceutical industries • Discuss how the decision may impact the development of biosimilars • Discuss the options and possible political outcomes as health care reform evolves, including likely legislation next year important to the biopharmaceutical and related industries Moderator: • John F. Kamp, JD, PhD, Executive Director Coalition for Healthcare Communication Presenters: • Peter J. Pitts, President, Center for Medicine in the Public Interest • Arnold I. Friede, Former FDA Associate Chief Counsel, Principal, Arnold I. Friede & Associates • Richard Manning, PhD, Partner, Bates White Economic Consulting Please Note: Continuing education credits are not available for archived webinars. Overview | Register The Patient-Centered Outcomes Research Institute’s National Priorities and Research Agenda Biosimilar Guidances: Explanation and Discussion: Part 1 and Part 2 Meeting Global Patient Demand for Access to Medicines Prior to Approval and Launch Two-part Series: Impact of the New European Pharmacovigilance Legislation on International Companies View the Full List of Archived Webinars. Questions on Archived Webinars? Contact: Carolyn Callahan

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

The Unanswered Labor Question at PhRMA, By Cole Werble for Elsevier

If the Supreme Court overturns the health care reform act, PhRMA may have to try to reconstruct the innovator-friendly biosimilar pathway that became law with ACA in 2010. The base for that law was built on a strong set of alliances with labor unions. Is PhRMA keeping those ties strong or losing sight of them in the effort to refocus on the more traditional alliances with patient and disease advocacy groups?

---

The silence in response to a question from the audience at the PhRMA annual meeting in Boston was awkward and almost painful.

The first question to a panel on the “Innovation Ecosystem” came from Fred Mason (president of the Maryland and DC AFL-CIO).

Noting that Maryland Governor Martin O’Malley (D) had been a speaker at the PhRMA annual meeting in 2011 in part because of his state’s creation of a $100 million venture capital fund called InvestMaryland, Mason pointed out that “organized labor supported that addition because we thought it was a good investment and because it creates the jobs in the sector.”

Mason followed up with a question: “How are we going to make sure that those small startup companies that were invested in by the state of Maryland, when they are sold to larger concerns, that there is some return for the state?”

There was an extended period of silence from the four-person panel and the moderator. No answer; and then a call for “next question.”

more... http://www.elsevierbi.com/publications/rpm-report/first-take/2012/03/phrma-unanswered-labor-question

Before the Affordable Care Act young adults had the highest uninsured rate of any age group for health care in the country, from CNN Money

NEW YORK (CNNMoney) -- When you're young, health insurance is hardly a priority. But for Sarah Adkins, 25, it was a lifesaver.

Because of a provision in the Affordable Care Act that enables young adults to remain on their parents' insurance plans until age 26, Adkins received health coverage just as her kidney was shutting down from an untreated kidney stone.

She hadn't been able to find a full-time job with benefits after graduating from college nearly two years earlier. Without health insurance, the freelance graphic designer had avoided treatment for her chronic kidney stones -- even painfully trying to pass a stone herself in a moment of desperation.
After the Affordable Care Act took effect in September 2010, Adkins was able to go on her father's plan and have emergency kidney surgery. "The doctor told me my kidney was shutting down and if I continued to avoid treatment, I could have died. I was only 24," she said.

What health care reform is (and isn't) doing now

 

more ...

http://money.cnn.com/2012/04/16/pf/health-care-young-adults/?source=cnn_bin

Limit certain patents, not patient care, from American Medical News

The AMA and other medical organizations have taken a strong stand on how wrongly permitted patents stand in the way of good health care.

Editorial. Posted April 16, 2012.

A recent opinion of the U.S. Supreme Court starts out citing an earlier judicial example tying together Albert Einstein, Sir Isaac Newton and the essence of what’s off-limits to be patented. Einstein could not have patented E=mc2, nor could Newton have patented the law of gravity, noted the court, because those discoveries were manifestations of nature upon which no one could make an exclusive claim.

Smaller in scale, but no less a manifestation of nature, are workings and responses of the human body. In a unanimous decision, the justices rightly applied the example from that earlier ruling to a patent case that represented a major threat to patient care.

more... http://www.ama-assn.org/amednews/2012/04/16/edsa0416.htm

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

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

Health Insurers Move Ahead, With Or Without Individual Mandate, NPR shots

Moving away from "sick care" to "health care"...


For the health policy world, the Supreme Court's tough questioning of the individual mandate last week was a seismic event.

But in Hartford, Conn., the city sometimes called the epicenter of the insurance industry, David Cordani isn't quaking.

Cordani is the CEO of Cigna, the nation's fourth-largest health insurer. He says the insurance industry started changing itself before the Affordable Care Act became law in 2010. And the changes will continue regardless of what happens at the high court.
"The broader health care debate is way larger than the individual mandate," Cordani said during an interview in his sunny corner office, just a few hours after some of the justices seemed ready to strike down the mandate.
  Cigna, like the broader insurance industry, hasn't taken a position on whether or not the mandate requiring Americans to buy health coverage is constitutional. Cordani points out that it really only deals with expanding care to people in the small-group and individual markets. That's a fraction of the total number of people insured, and it's not a major market for Cigna.
Cordani says the act does a fair enough job at expanding access to care, but it doesn't do as much to improve the quality of care and drive down costs. That's his focus: changing the way we think about insurance, from paying for "sick care" to paying for "health care," driving consumers to stay healthy and giving doctors incentives to keep them that way.

for full article:


listen to the audio:

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

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?

Live Blog: Obama Health Law at the Supreme Court, WSJ

The Supreme Court, starting Monday, is hearing three days of arguments on the constitutionality of President Obama’s health overhaul. A ruling is expected in late June. On Monday, the justices hear arguments on whether to shelve the entire case until 2014, when most of the law takes effect.

The Journal has several reporters at the court, and they will rotate in and out of the courtroom to post updates here. The arguments started shortly after 10 a.m. E.T. and run for 90 minutes.

Check out the details and resources from Wall Street Journal over the next three days...
http://blogs.wsj.com/washwire/2012/03/26/live-blog-obama-health-law-at-the-supreme-court/?mod=wsj_share_twitter