Posts Tagged ‘health care’

asellers
Amanda
Sellers

PDUFA: Rounding Third, Headed Home

Friday, June 29th, 2012

President Obama got in a little hot water earlier this week when he brought up the Boston Red Sox trade of Kevin Youkilis to the Chicago White Sox while hosting a Boston fundraiser. It wasn’t that great of a decision to bring up this unpleasantness with angry Red Sox fans, but now he has a chance to redeem himself and help an important piece of legislation slide across home plate, figuratively speaking.

Earlier this week, the Senate passed the updated PDUFA legislation that was developed and passed the House earlier in the year. Now that the bill has passed the Senate, it’s on to the POTUS (I want to see how many D.C. acronyms I can get in here). As a refresher, PDUFA is one of the many Washington acronyms that almost no one else outside of the health care world knows – it stands for Prescription Drug User Fee Act. If you need the PDUFA Cliff Notes check out my last blog post and check out FiercePharma and Washington Post for more coverage on what it all means when in practice. 

So, what does PDUFA really mean? It means that the FDA will have more resources to process drug applications, including the new additions of generic drugs and biosimilars (more affordable versions of biologic drugs) to the mix. This is great news for not only the FDA, but for the companies pushing innovation in medicines and new treatment options. But, most importantly, patients will reap the greatest benefit from this legislation. This is one piece of legislation that touches everyone in the U.S. who currently takes a prescription medicine or will take one in the future — which should be just about everyone. Quicker, more efficient review times without a heavy financial burden on the system is positive progress enough, but providing patients with a wider range of better treatment options is the best outcome anyone could hope for.

President Obama, since you’re on a roll with health care legislation, please give this legislation your stamp of approval too. Lots of folks are counting on this for another five years of PDUFA!

Posted in Biotechnology, FDA, Health Care Industry, Health Policy
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LukeDickinson
Luke
Dickinson

Supreme Court Upholds the Affordable Care Act

Thursday, June 28th, 2012

President Obama signs the Affordable Care Act into law in 2010

Amid great anticipation, fanfare – and even a belly dancer – the Supreme Court of the United States (SCOTUS) announced a 5-4 ruling to UPHOLD the constitutionality of the Affordable Care Act (ACA) – the health care reform legislation passed by President Obama in March 2010.

Question of Constitutionality

The ruling hinged on the question of constitutionality of the law; particularly the clause that would require Americans to purchase health insurance. The Court ruled that while it is unconstitutional for the government to command citizens to purchase insurance, as a part of its power to regulate commerce between states, five Justices agreed that Congress DOES have the authority to levy a tax on those who do not purchase insurance. As cited in Footnote #11, on page 44 of the 193 page ruling, this is laid out as:

“Those subject to the individual mandate may lawfully forgo health insurance and pay higher taxes, or buy health insurance and pay lower taxes. The only thing they may not lawfully do is not buy health insurance and not pay the resulting tax.”

In a move that came as a surprise to many, Chief Justice Roberts sided with the liberal element of the Court in voting to uphold the mandate as a tax. In his lengthy ruling, Roberts noted that “The Affordable Care Act is constitutional in part and unconstitutional in part,” while adding that the decision “makes going without insurance just another thing the Government taxes, like buying gasoline or earning income.” As experts have pointed out, the ACA’s primary provision is now more of an invitation to purchase insurance – as opposed to a requirement – with an, arguably light tax penalty for those who chose to go without.

States Access to Medicaid

While the ruling that the individual mandate is constitutional made moot many of the other constitutionality questions surrounding the law, the Court did rule on the Medicaid provision that required states to comply with new requirements or risk losing funding. In a complicated decision, that favors the supporters of states rights, the Court ruled that the provision is constitutional if states would only lose access to NEW funds if they chose not to comply with new requirements, rather than lose access to all Medicaid funding.

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Posted in doctors, Health Care Reform, Health Policy, SCOTUS, SCOTUS Beat
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Ricki McCarroll
Ricki
McCarroll

Social Media & Health Care, Battle of the Ages

Monday, April 30th, 2012

Last week a colleague sent over a comic (at left) illustrating a generation even past mine. Technology has changed everything – the way we communicate, receive information and push out information about ourselves and what is plaguing us at the current moment, with an ever apparent #Really hashtag.

As we are all becoming aware of, there is not a place to hide when it comes to social media. Even if your organization isn’t using social media, people are having conversations about you…without you. The health care industry is no exception, even though there continues to be a patient privacy issue within platforms like Facebook and Twitter.

In a recent study released by PricewaterhouseCoopers surveying 1,060 U.S. adults, 42 percent of consumers have used social media to access reviews of treatments or physicians while 25 percent have posted about their health experience.

When broken down by age, 54 percent of people between the ages of 18-24 and 41 percent of people between the ages of 25-34 post about their health care experiences on a social media channel, while only 14 percent of people aged 35-44 use social media to communicate about their health care experiences.

In MedCity News, it is pointed out that although consumers are trending toward social media for health care answers, the health care industry is lagging behind in their reach. This is true, as “two out of three health providers and insures allow individuals to post on their Facebook walls, but fewer than one in three allow the same in the pharmaceutical world.” (more…)

Posted in doctors, E-Patient, Facebook, FDA, Health 2.0, Health Care Industry, New Media, Public Health, Social Media, Technology
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LukeDickinson
Luke
Dickinson

Decision 2012 – Presidential Candidates on Health Care

Tuesday, December 20th, 2011

Across early primary states Republican Presidential candidates are fighting tooth and nail to appeal to voters in the hope of becoming the next President of the United States of America.

While prime-time pundits may revel in polling data, “zany” tactics or the latest campaign trail gaffe, serious voters remain concerned with the issues. The economy has become the hot topic for the cycle, but with Democrat-led health care reforms still riling many Republicans, voters are paying close attention to the candidates’ stance on health care.

The overarching message from each and every candidate is dire need to “repeal Obamacare.” Republicans argue that “Obamacare,” the Affordable Care Act passed by President Obama in March of 2010, does little to improve health care quality while simultaneously restricting individual freedoms through requirements to purchase health insurance. If elected, each major Republican candidate would repeal “Obamacare.” But where will each candidate go from there?

(more…)

Posted in Health Care Industry, Health Care Reform, Health Policy, Public Affairs, SCOTUS, SCOTUS Beat
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LukeDickinson
Luke
Dickinson

SCOTUS Beat: Review of Health Care Reform Heats Up

Friday, October 28th, 2011

The highly anticipated Supreme Court review of landmark health care reform legislation has taken a step closer to reality. The nine Supreme Court Justices announced on Oct. 26 that they will review five of six pending petitions on Nov. 10, one of their closed-door conference days.

In this session, the Justices will decide whether or not to hear any or all of the petitions that challenge the massive Patient Protection and Affordable Care Act (ACA), spearheaded by the Obama administration. While it is not guaranteed that the petitions will come before the court, legal experts anticipate that the Justices will take on this controversial topic, notably as lower federal appeals courts have previously made divergent rulings on the constitutionality of the new law.

So just what are these petitions? Four of the five to be reviewed on Nov. 10 are challenges to the ACA, with the fifth presented by the federal government to defend the constitutionality of key elements of the act. A sixth petition, which is not yet ready to be presented to the Justices, examines the rights of states, specifically Virginia, to challenge the federal government in court.

The most contentious element that the Court may decide is whether Congress exceeded its authority by mandating that virtually all Americans purchase health insurance by 2014. Also up for possible review is whether new Medicaid requirements place too great a strain on the states. Further, if the Justices rule that the individual mandate is indeed unconstitutional, they must determine whether this invalidates the entire ACA or whether parts of it can remain enacted.

The decision of the Court on whether or not to hear these cases could come very quickly, either the day of the conference or the following Monday, Nov. 14. If the Court does, as anticipated, decide to hear the cases, it is more than likely they will be heard in the current term, with possible oral arguments coming in March 2012, with a decision as early as June 2012.

Lawyers, law makers, health care providers and individual citizens will be waiting with baited breath for the decision of the Supreme Court Justices. There is a great deal at stake for all parties on the potential decision of the Court, from the rights of patients and providers to statewide Medicare and Medicaid budgets, and potentially even the outcome of the 2012 Presidential election. Rest assured, the Full Spectrum Blog will be tracking the court every step of the way to keep our readers up-to-date.

Posted in Health Care Industry, Health Care Reform, Health Policy, Public Affairs, SCOTUS, SCOTUS Beat
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LukeDickinson
Luke
Dickinson

SCOTUS Beat: Inside the Chamber – The Supreme Court Comes to Order

Monday, October 17th, 2011

October 3 marked an important day in the justice system, and I’m not talking about the decision for Amanda Knox. It rang in the opening of the October 2011 session of the Supreme Court of the United States (SCOTUS), our nation’s highest and most influential court. While there is never a SCOTUS session that goes by without controversy and cases that impact all Americans, the focus of the latest term is clearly centered on the beast that is Health Care Reform. A host of challenges to President Obama’s health care legislation will be heard this term, along with some other eye opening issues, including a challenge by broadcasters over the reach of the FCC, questions of immigration and police surveillance limits.

Inside the Hallowed Chamber

Along with Spectrum colleagues, I had the pleasure of attending opening day arguments from inside the Supreme Court. Once I got over the grandeur of the building, I had an eye opening experience witnessing the court in session. The last time I was in a courtroom was to be sworn in as an American citizen, so it was particularly poignant to see one of our nation’s three pillars of government in action.

As the counsel approached the bench for oral arguments, I could sense that even for the most experienced attorney this moment must feel like the World Series, Super Bowl and World Cup Final rolled into one. To look at the nine Justices, the most educated and respected in all the land, they gave the air of, at times, being annoyed that someone would dare challenge their Court’s past judgment, while at others nonplused by the whole situation, lolling in their high-backed leather chairs.

With each probing question, however, it was abundantly clear that they are each thoroughly engaged – even Justice Thomas who has not spoken in oral arguments for more than five years – and knowledgeable on every intricate aspect of not only the case at hand, but the annals of historical prescient, Constitutional implications and the impact their ruling will have on all Americans.

Influencing Our Nation

Every ruling hangs on a knife edge that could reposition our nation’s laws, mold interpretations to the Constitution and impact the day-to-day lives of every American. Health care reform, and indeed the 2012 Presidential race, could hinge on the rulings of key cases in the term, including the first case to be heard, Douglas v. Independent Living Center of Southern California. With rulings generally announced following the end of the term, it will be some time before the decisions are known. Every American should be watching the court closely, be that through the media – including this blog – or if the opportunity arises, from the gallery inside 1 First Street.

Posted in Community Involvement, Health Care Industry, Health Care Reform, Public Affairs, SCOTUS, SCOTUS Beat
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