Meet to Focus on Rare Diseases & Orphan Product Research, Development, and Access

Meet to Focus on Rare Diseases & Orphan Product Research, Development, and Access Mobile App Now AvailableClick to download today. US Conference on Rare Diseases & Orphan Products: The New Era in Health Care October 7-9 | North Bethesda, MD Co-sponsored with National Organization for Rare Disorders Overview: At this annual conference, all stakeholders in the rare disease/orphan product community - patients, patient organizations, researchers, drug and device companies, investors, thought leaders and government – meet to focus on rare diseases and orphan product research, development, and access. Search the Online Program. Keynote Speaker: Bill Corr Deputy Secretary U.S. Department of Health and Human Services Luncheon Speaker: FDA Initiatives on Orphan Products Monday, October 7 | 11:45AM-1:00PM Janet Woodcock, MD Director, Center for Drug Evaluation and Research (CDER) FDA Plenary Sessions: • The Affordable Care Act and the Rare Diseases Community • Plenary Session 2: - NINDS NeuroNext Program - NORD Initiative on Natural History Studies • Health Care System of the Future • Research Frontiers in Rare Diseases: The Next Opportunities • The Next 30 Years Session Topics: • Patients and Industry: Partnership and Collaboration in Research Funding and FDA Review • The Investment Environment for Orphan Drugs/Devices • FDA's Orphan Grants Program • FDASIA Provision Highlights • Collaboration from Bench to Bedside: How Industry and Patients Can Partner in Rare Diseases • Hearing the Voice of the Patient • The International Perspective on Orphan Drug/Devices • Assuring Patient Access to Treatments • Paying for Orphan Therapies • Repurposing: FDA and NIH Perspectives • Managing Orphan Drug Recalls and Shortages • NIH Clinical Center-CDER Clinical Trials and Regulatory Training Collaborative • Plus More Just Added: New Tutorial | October 6: Overview of The Regulatory Frameworks and Opportunities for Orphan Medicinal Products (OMPs) The tutorial will describe regulatory frameworks from FDA and EMA and incentives for development of Orphan Medicinal Products (OMPs). It will cover details regarding incentives for developments of OMPs, opportunities and challenges. Additionally, this tutorial will give an overview of the different options to gather control data in rare/ultra rare disease settings. Case studies for requests for ODDs and marketing authorizations for OMPs will be presented and discussed. Overview | Agenda | Register Now Move Toward Better Communication and Collaboration Among Patients, Payers, and Product Developers A Model of Patient, Payer, and Product Developer Collaboration to Support Innovating for ValueOctober 30-31 | Washington, DC DIA and the Brookings Institution are collaborating to strengthen communication between health care stakeholder communities. This conference will focus on highlighting the perspectives and outcomes most relevant to patient communities, reimbursement requirements and innovative payment models of most interest for payer groups, and how both can help inform product developers as they drive toward novel value-based innovation. Register by October 9 to Save $100! Keynote Speaker: James Heywood Co-Founder, Chairman PatientsLikeMe Session Topics: • Aligning Perspectives on Value and Outcomes • Identifying Stakeholder Needs and Challenges to Strategic Communication • Exploring Opportunities for Efficient Engagement Throughout Discovery, Clinical Development, Regulatory Review, and Product Use • Case Studies and Current Initiatives • Next Steps: Charting a Course Forward • And More Overview | Register Online

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PCORI To Launch Comparative-Effectiveness Research Network.

Taken from 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.

The Washington Post (4/24, Kliff) "Wonkblog" reports a "new nonprofit is putting millions" of Federal healthcare reform money "towards an effort to turn routine doctor visits into a treasure trove of data on what medical treatments work best." The Patient Centered Research Outcomes Institute, which the Affordable Care Act created to "support comparative effectiveness research," announced Tuesday that it "would move forward on that mission" by spending "$68 million to fund a network of health-care systems that cover as many as 12 million patients."

        CQ (4/24, Adams, Subscription Publication) adds that the Food and Drug Administration's Center for Drug Evaluation and Research Director Janet Woodcock, MD, "noted that the FDA has been involved for decades in trying to support comparative effectiveness research and find out more about the products that the agency approves for use in the United States." According to Dr. Woodcock, "What the FDA needs and what the medical community needs is actionable information."

        According to Government Health IT (4/24, Sullivan), the "hybrid model will include patients, health systems, payers, physicians and researchers as active participants in the research. To that end, PCORI detailed two cooperative funding agreement opportunities to support the creation of Clinical Data Research Networks (CRDN) and Patient-Powered Research Networks (PPRNs)." For the CRDNs, PCORI "will award $56 million to as many as 8 existing or new networks, while the PPRNs funding total is $12 million, available to 18 networks," according to the statement the institute released yesterday.

        Modern Healthcare (4/24, Robeznieks, Subscription Publication) notes that PCORI Executive Director Dr. Joe Selby announced the funding during a roundtable discussion in the District of Columbia. "Putting patients' interests first in such an endeavor can make a difference and 'smooth the friction' between stakeholders," Selby "said of the project's patient-first focus." American Medical Association President-Elect Dr. Ardis Hoven, who was one of the roundtable participants, "called the effort 'an exciting opportunity,' and noted its potential for advancing the use of information gleaned from clinical registries into medicine." Organizations interested in participating in the network "must file a letter of intent by June 19 and must complete an application by Sept. 27."

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Obama Administration Finalizes Medicaid Expansion Regulations.

The Hill (3/29, Goad) "Regwatch" blog reported HHS finalized new regulations Friday that said "the federal government will reimburse states for 100 percent of the costs for some newly eligible Medicaid patients" for three years, and "after that, the federal contribution would be gradually phased down to 90 percent in 2020, and would remain there permanently." The rule was released after HHS Secretary Sebelius said this week that the new law "could cause healthcare costs to increase for some Americans. It was the first time a top administration official publicly made such a statement."

        The Washington Times (3/29, Howell) "Inside Politics" blog reported, "The Department of Health and Human Services announced it has proposed a final rule that describes a 'simple and accurate method' for states to claim the matching rate for enrollees deemed 'newly eligible' under the Affordable Care Act, which expands the program in 2014 to those making up to 133 percent of the federal poverty level."

        Modern Healthcare (3/30, Block, Subscription Publication) added that "although HHS on Friday released a final rule regarding the expanded 100% federal funding of the cost of new Medicaid beneficiaries, the department is still accepting comments on the methodology states can use to determine whether a new beneficiary qualifies for the enhanced funding."

        HHS To Allow Private Medicaid Expansion Option With Waiver. The Gannett News Service (3/29, Barton) reported that the Obama Administration "said Friday it would allow states to experiment with alternative approaches to the Medicaid expansion called for by the 2010 healthcare reform law." CMS provided "guidelines under which alternative or 'demonstration programs' could be established as a way of 'providing flexibility in pursuit of our shared goals,'" CMS Deputy Administrator Cindy Mann said. Several states are looking for something "other than a expansion of traditional Medicaid, something seen as politically tricky for those in conservative states."

        The Hill (3/29, Baker) "Healthwatch" blog reported that HHS said Friday that "states that want to privatize the healthcare law's Medicaid expansion will need a waiver from the federal government." HHS also "released a questions-and-answers document Friday explaining more about its approach to private expansions." The Hill points out that the privatization option "has gained traction since Arkansas Gov. Mike Beebe (D) first proposed it last month."

        The Washington Post (3/29, Kliff) "Wonkblog" reported that states that wanted "the so-called Arkansas option" to buy private insurance with Medicaid expansion money "have a few more answers." CMS "on Friday issued a Q&A to address some of the questions posed by states. It's not comprehensive - it includes three questions that span two pages - but it has a few new details that might help states make up their minds." Among the answers are that "a partial expansion isn't on the table," while "a waiver might be in order, though." Moreover, CMS said "benefits need to be comparable."

        Bloomberg News (3/29, Wayne) reported that CMS made "a departure" from the ACA and said Friday that "an unspecified number of states" will be able to use Medicaid money to allow low-income residents "to buy health insurance from private plans such as UnitedHealth Group Inc. or Humana Inc." CMS said it would allow the practice "as long as it doesn't cost the government more than the traditional Medicaid program." Arkansas and Ohio both have asked for permission to try private plans.

        Modern Healthcare (4/1, Blesch, Subscription Publication) notes that HHS will only grant a "limited number" of waivers.

        The National Journal (3/29, Sanger-Katz, Subscription Publication) reported that the Obama Administration on Friday "dampened...enthusiasm" in states that want to use private health plans to cover the poor, "laying out strict rules for the program that will interest only a few states." While "the details will reassure many Medicaid advocates," the "rules also could discourage some on-the-fence states from pursuing a Medicaid expansion at all, leaving more Americans without health insurance after the health law's biggest provisions kick in next year." The National Journal said Friday's announcement of rules "sets a high bar for the states to clear."

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.

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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.

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

CVS, Wal-Mart Clinics' Retail Growth Examined.

Bloomberg News (2/13, Dudley) noted that in 2007, Lee Scott, Wal-Mart's CEO at the time, "trumpeted plans to open as many as 2,000 in-house medical clinics by mid-2012," calling the initiative "a great opportunity." But presently, Wal-Mart has "fewer than 130 clinics and is closing locations faster than it's opening them" whereas, CVS Caremark Corp., which "already has about 630 MinuteClinics, is opening about three a week, and aims to have 1,500 within four years." However, analysts say Scott's "great opportunity" still exists: As essential provisions of the Affordable Care Act start kicking in over the "next year, some 30 million newly insured Americans will be looking for care amid a doctor shortage"; and Wal-Mart's clinics are "usually staffed by nurse practitioners or physician assistants."

        The Minneapolis-St. Paul (MN) Business Journal (2/13, Reilly, Subscription Publication) in its "MSPBJ Morning Roundup" also covers the comparison between CVS and Wal-Mart clinics, citing the Bloomberg News article.
 

from DIA Daily

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...

IRS Finalizes ACA's Medical Device Tax Rule.

Reuters (12/6, Temple-West) reports that the Internal Revenue Service on Wednesday released a final rule (pdf) on medical-device taxes, under which manufacturers will have to pay a 2.3 percent tax on their gross sales, starting in January, unless industry groups succeed with their calls, urging Congress to repeal it. The tax is projected to generate $29 billion to help fund the Affordable Care Act through 2022. Reuters quotes IRS spokesperson Sabrina Siddiqui as saying, "The excise tax is on the medical device manufacturers and importers (who) will now have access to 30 million new customers due to the healthcare law."

        CQ (12/6, Adams, Subscription Publication) notes that although the "58-page final rule" explains "which types of manufacturers will face the excise tax and filing requirements," the bulk of the document is "devoted to responding to comments from manufacturers and others about which products are subject to the tax and under what conditions." Unless Congress acts to change it, the rule mandates that medical-device manufacturers must "start sending in semimonthly tax payments starting Jan. 29." CQ adds that the release of the rule sparked renewed outcries from industry groups. For example, Advanced Medical Technology Association CEO Stephen Ubl issued a statement saying, "While Washington talks about a fiscal cliff, this tax could push us off an innovation cliff, costing as many as 43,000 jobs and hurting the ability of medical technology companies to find tomorrow's treatments and cures." The rule "should be repealed," Ubl added.

        Modern Healthcare (12/6, Lee, Subscription Publication) adds that the Medical Imaging and Technology Alliance "urged lawmakers to pass legislation that would delay implementation of the excise tax." Its Executive Director Gail Rodriguez issued a statement saying, "MITA strongly urges Congress to enact legislation immediately to delay implementation of the medical device tax." She stressed that, "ultimately, Congress should repeal this job-killing tax."

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.

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 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

Affortable Care Act - Health Reform Benefits from WhiteHouse.gov

http://www.whitehouse.gov/blog/2012/06/28/supreme-court-upholds-president-obamas-health-care-reform?utm_source=email168&utm_medium=graphic&utm_campaign=healthcare#health-care-checklist

Physician Payments Sunshine Act is part of the Patient Protection and Affordable Care Act - from Philly Pharma's David Sell

The Physician Payments Sunshine Act is part of the Patient Protection and Affordable Care Act, all of which hangs in the balance Thursday morning when the U.S. Supreme Court will likely rule on the constitutionality of all or parts of the package.

One legal possibility is that the court could decide to defer a decision until the law is fully implemented in 2014, but the betting line has the nine justices making history, one way or another. And, yes, there is a betting line.

The Sunshine Act requires pharmaceutical and medical device companies to report payments made to doctors and teaching hospitals. It is designed to give patients and others more information and shed light on potential conflicts of interest. The question is whether a doctor paid by a company is more inclined to prescribe that company's drug over a competitor's drug or no drug because of his or her financial relationship with the first company, regardless of the effect on the patient.

The Sunshine Act was the topic of a panel discussion Wednesday afternoon at the Drug Information Association's 48th annual meeting at the Philadelphia Convention Center. The meeting concludes Thursday morning.

Read more: http://www.philly.com/philly/blogs/phillypharma/160627445.html#ixzz1zBXhqbbg
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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

Sunshine Act one of the topics at the Drug Information Association meeting

Casting more light on doctors' financial ties may be delayed

A rule in the federal Affordable Care Act could shine light on the financial relationships that doctors share with drug companies and medical device makers. People from across the biopharmaceutical industry are converging on Philadelphia this month for a Drug Information Association meeting -- and plans for the Physician Payments Sunshine Act provision are on the agenda.

The law was designed to create a website to disclose any payment of $10 or more that drug and device makers give to doctors or research hospitals.

Psychiatrist Daniel Carlat says patients would benefit from a national database to look up doctors.
"They really want their doctors to practice medicine based on the evidence rather than based on a marketing visit from a drug rep or a pharmaceutical company," he said.

Carlat leads a group at the Pew Charitable Trusts working to reduce conflicts of interest that hurt health care. He said information from within the pharmaceutical industry shows that treatment decisions can be influenced.

"When pharmaceutical companies have doctors sit in on lectures with either pharmaceutical reps or other doctors, they keep track of how those interactions affect prescribing," Carlat said.

http://www.newsworks.org/index.php/local/item/39331

Should the States set up ObamaCare Exchanges? point-counter point by John Goodman & Linda Gorman

From The Health Care Blog

Under the Patient Protection and Affordable Care Act (PPACA), state governments are expected to set up health insurance exchanges through which individuals will buy their own health insurance, in many cases with substantial subsidies. Should the states comply?

In the following point-counterpoint discussion, Linda Gorman and I give opposing answers to this important question. Leave your thoughts in the comments.

John Goodman: Yes
If the states abdicate their responsibilities under PPACA, the federal government will step in and act in lieu of the state. Under this scenario, states will relinquish all power to make a bad law better. Letting the federal government implement reform almost guarantees bad outcomes.

Linda Gorman: No
Exchanges are required to perform a variety of duties beyond distributing ObamaCare subsidies, and these duties are likely to add significantly to estimated costs. Some of them will damage a state’s business climate by creating new opportunities for crony capitalism. Some require that currently fashionable, but poorly tested, models be forced on health care providers. Some require that state exchanges have expertise equal to private insurers. Others force states to increase the cost of health insurance for people who currently have coverage.

John Goodman continued:
The states should engage in preemptive reform over the next two years. This means enacting responsible, rational reforms — the kind of reforms that they should have enacted all along, in the absence of federal legislation. Where possible, states should try to make their reforms compatible with the new federal law — but only if compatibility does not sacrifice the major goals of the state’s reform.

There are four arguments in favor of preemptive action at the state level:

If The Health Care Overhaul Goes Down, Could Medicare Follow?, from Julie Rovner of NPR

A growing number of health experts are warning of potential collateral damage if the Supreme Court strikes down the entire 2010 Affordable Care Act: potential chaos in the Medicare program.

"The Affordable Care Act has become part and parcel of the Medicare system, encouraging providers to deliver better, more integrated, better coordinated care, at lower cost," says Judy Feder, a public policy professor at Georgetown University and former Clinton administration health official. "To all of a sudden eliminate that would be highly disruptive."

Sara Rosenbaum, a professor of health law and policy at George Washington University, puts it a bit more bluntly: "We could find ourselves at kind of a grand stopping point for the entire health care system."

And it's not just Democrats warning of potential problems. Gail Wilensky, who ran Medicare and Medicaid under President George H.W. Bush, says she doesn't think it's likely that the court will strike down the entire health law. But if it does, she says, "it seems like it takes everything with it, including those aspects that are only very peripherally related to the expansion of coverage."
So why are experts so worried?

One reason is that the law changed the payment rates for just about every type of health care professional who treats Medicare patients. Every time Medicare sets a payment rate, it needs to cite a legal authority. And for the past two years, says Rosenbaum, that legal authority has been the Affordable Care Act.

So if the law is found unconstitutional, she says, every one of those changes "doesn't exist anymore because the law doesn't exist."

And the result? "You have agencies sitting on two years of policies that are up in smoke," she says. "Hospitals might not get paid. Nursing homes might not get paid. Doctors might not get paid. Changes in coverage that have begun to take effect for the elderly, closing the doughnut hole might not happen. We don't know."

more...

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

Louisiana Senate committee defied the Jindal administration in "attempt to be prepared" for affordable health care

Health proposal advances in Senate

BY MARK BALLARD

Capitol news bureau

April 26, 2012

A Louisiana Senate committee defied the Jindal administration and advanced legislation Wednesday to organize an exchange to help facilitate the purchase and sale of health-care insurance under the new federal law.

The Senate Insurance Committee voted to 6-2 to send Senate Bill 744 to the Senate floor for debate.
The panel “just voted to make a very risky move,” said Bruce Greenstein, secretary of the state Department of Health and Hospitals, after the vote.

Louisiana is one of a handful of states that has refused to set up a health insurance exchange.
The federal Patient Protection and Affordable Care Act requires states to either join a federal exchange, a website where people without health insurance could go to find and compare policies, or set up one on its own.

Greenstein said the Jindal administration opposed the legislation because the exchange would set up a new government bureaucracy that ultimately would be funded with state taxpayer dollars or increased premiums.

“This is an attempt to be prepared,” countered state Sen. Karen Peterson, D-New Orleans. “This instrument gives people in Louisiana the opportunity to access affordable health care.”

for more... http://theadvocate.com/news/2668033-123/health-proposal-advances-in-senate

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/

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

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

Obamacare’s Effect on Drug Spending

Published by Angie Drakulich on April 6, 2012 08:10 am under Trends

This blog post was written by Ben Comer.

Provisions in the Affordable Care Act (ACA) drove out-of-pocket costs down, while increasing drug spending among 19 to 25-year-olds in 2011, according to research published on Wednesday. The decline observed in overall out-of-pocket spending last year was the “first on record,” and was “largely related to the introduction of the ‘donut-hole’ subsidy for Medicare Part D beneficiaries,” a highly-touted element of the ACA, according to the IMS Institute for Healthcare Informatics. While copays for commercial providers and Medicaid were flat (average commercial plan copays increased by $1.14, to $26.10 in 2011), seniors covered by Medicare Part D got the largest break, with average copays decreasing by $2.66 – from $25.97 in 2010, to $23.31 in 2011 – according to the report.

The dip in copay costs for seniors didn’t translate into an increase in volume for chronic or acute medications, however; in fact, patients 65-years and older reduced their drug usage by 3.1%. Prescription use among the same group declined in 2010 as well, by 2.7%, but the last two years represent an inflection from prior years, when “seniors’ usage of medicines grew on average at 4%,” the report found. College-aged patients (19-24 years old), on the other hand, were the only age group to increase their drug usage, by a modest 2%. That increase “coincides with the first full year of implementation of the provision of the ACA allowing under-26-year-olds to stay on their parents’ health insurance,” according to the report.

Michael Kleinrock, director of research development at the institute, said on a call with reporters that patients over 65 years old are foregoing the medications they use the most. Drug usage for hypertension, the most common disease among this population, decreased more than any other class of drugs. “This correlates strongly with the economy…seniors are on a fixed income, and costs [of living] are rising,” said Kleinrock on the call. Kleinrock called the development a “tipping point,” adding that seniors are resetting their expectations around how often, and under what circumstances, they will visit a doctor.

Per capita figures adjusted for currency changes showed a 0.5% growth in total drug spending in 2011 – to $320 billion. Other fun facts from the report include:

more...
http://blog.pharmtech.com/2012/04/06/obamacares-effect-on-drug-spending/

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