I am living with a pain in the rear. Casey Abrams, a musician and American Idol alumnus, would say I am living with a “chip on my shoulder,” but I prefer to be as literal as possible. So yes, I live with a pain in the rear – along with about 1.4 million other Americans who have been diagnosed with ulcerative colitis (UC) and Crohn’s disease – collectively known as inflammatory bowel disease (IBD).
In advance of releasing his debut album today (June 26), Abrams created an original song, “Chip on Your Shoulder” and music video inspired by his personal experience with IBD and the people he met through the national disease awareness campaign IBD Icons. You can view Abram’s music video by joining the fan club at www.IBDIcons.com. For every fan who joins, a donation will be made to the Crohn’s & Colitis Foundation of America (CCFA), IBD Icons partner and the only national non-profit organization dedicated to finding cures for IBD.
This is the second year in a row that Abrams is teaming up with Janssen Biotech (Horsham, Pennsylvania) in partnership with CCFA to raise awareness and celebrate the achievements of those living beyond IBD through IBD Icons. Abrams, who was diagnosed with UC three years ago, said he feels a heightened sense of responsibility to speak up about his disease. Despite his struggle with UC, he finished sixth on Season 10 of American Idol and signed a record deal with Concord Music Group.
“Music has always helped me get through difficult times, especially when I was first diagnosed with UC," Abrams said. "After meeting hundreds of people through IBD Icons, I was amazed by their drive and determination to not give in to this disease. I hope this song unites all of the IBD Icons fans in an effort to raise awareness and encourages others to get control of their disease so they can pursue their dreams."
For every fan who registers to view Abrams’ music video, Janssen said it will donate $1, up to $10,000, to CCFA in support of IBD research and education. In addition to Abrams’ music video, updates from the 2011 IBD Icons finalists and winners on their latest endeavors to raise awareness and inspire others are also featured on the site. The finalists were chosen by Abrams and a panel of CCFA judges from the hundreds of inspirational stories submitted by people pursuing their dreams despite the challenge of IBD. Two winners were announced in December after nearly 150,000 votes were cast.
It’s easy to understand how someone with IBD, or any chronic disease really, could relate to the lyrics of Abrams’ song. “Life can be a little bit colder, when you’re living with a chip on your shoulder.” I suppose “chip on your shoulder” rhymes better with “colder” and makes for a more pleasant lyric than “when you’re living with a pain in the rear.” I would have suggested “life can be a little unclear, when you’re living with a pain the rear,” but perhaps I should leave the song writing to the experts.
Next week I will share my personal IBD story as well as introduce you to an IBD friend of mine who has been doing great things to support other IBD patients and to raise money and awareness for CCFA.
The biggest judicial showdown in quite a while is finally over, and here are a couple of things to consider while we’re playing numerology games in an effort to interpret the scribblings of nine citizens in black robes we all now refer to as SCOTUS.
I for one can understand why the Supreme Court was unimpressed with the attempt to argue the validity of the Affordable Care Act on the basis of the Commerce Clause. In this decision the Court basically said the government cannot force citizens to participate in commerce, a position that comports with precedent. By the way, that fencing-off of the Commerce Clause suggests the broccoli debate is over … for now anyway.
The point I’d make about the Commerce Clause is that it was originally added to the Constitution as a means of tamping down on trade wars between the states. This may sound naïve, but to the best of my knowledge there’s nothing particularly “interstate” about sickness and healthcare, especially since health insurance is regulated primarily by the states. So this layperson’s sensibilities would argue that the Commerce Clause argument was a flatly disingenuous one, even if one supported the ACA as a whole.
Nov. 6 + 51 = repeal?
It appears that the majority decision left open – inadvertently or otherwise – the use of budget reconciliation to delete the ACA from the books. As we all now know, Chief Justice John Roberts and his four colleagues ditched the Commerce Clause argument in favor of a taxation argument, essentially stating that Congress has the authority to use its powers to tax to force citizens to enroll in a health plan or face a fine.
Another thing we all know is budget reconciliation is a tool used in both houses of Congress to pass legislation that affects the budget, something which taxes clearly do. The real point of interest here is that the Senate, like the House, needs only a simple majority – 51 votes, not 60 – to pass an ACA repeal bill based on budget reconciliation rules. Ergo, all the repeal effort requires is the very tiniest of majorities, a far more attainable goal than six of ten.
I’d love to take credit for having thought of this reconciliation idea first, but I can’t. My wife and I were having dinner when it came to me, which was apparently quite some time after the folks on Capitol Hill came up with it, as this report and others make clear.
One point I will add to those reports is that 23 Democrats (and independents who caucus with them) are either retiring or running for re-election in November, while the same can be said of only 10 Republicans. Given that the GOP currently holds 47 seats, a repeal bill could easily fly in the Senate next year using budget reconciliation.
Et tu device tax?
Precisely how this all affects device makers is tough to flesh out, because while the device tax is still the law of the land, it could be repealed by year’s end, or it could be offset by other tax issues that have to be dealt with by then.
Among the tax issues Congress has to take up before Jan. 1 are the tax cuts passed during the George W. Bush administration and sustained by the Obama administration, the bonus depreciation, and the research and experimentation credit. The 2.3% device tax could sidestep industry opposition if Congress and the White House find an offsetting measure somewhere in this panoply of expiring taxes.
Of course, if you can use budget reconciliation to delete the ACA, you could use it to dump the device tax, too, no?
It is hardly a curse for someone in my line of work to live in interesting times, but making sense of all the moving parts is tricky. Still, even someone like me can count to 51, a number that could reverse what nine black robes wouldn’t.
The highest court in the land is poised to make a ruling that will undoubtedly change the face of healthcare forever. As the Supreme Court is set to bury or uphold President Obama's presidential campaign healthcare plan, there should be one question that people should be asking no matter what the outcome is.
If the Supreme Court doesn't strike down the individual mandate portion of the plan, the component that would push families to either pay for coverage (generally with help from the tax subsidies) or pay a fine, then the question remains how are we going to be able to pay for this and will it have any positive impact. How can the plan be implemented and garner the strong results needed to turn around our broken system?
If the Supreme Court strikes down this part of the plan, then we're back to the drawing board, because this component is the heart of President Obama's healthcare plan and without it the plan can't survive (or so the pundits say). It's already a universal fact that America cannot continue down the same path with the current broken healthcare system. Estimates show that one out of every six dollars is spent on healthcare, and the results achieved with all this money are subpar. Chronic illnesses and premiums are both on the rise - while one would say that the former caused the latter, I would argue in some cases that it's actually the reverse.
While today's announcement from the Supreme Court will definitely give us an answer, unfortunately, that answer is just going to lead to more questions.
The story of the transcatheter aortic valve implant is well underway thanks to the fact that the Sapien valve, made by Edwards Lifesciences, is on the market, but there is more to this story. Following are three aspects of the TAVR story that bear watching.
One: Coverage does not equal adequate reimbursement
David Cohen, MD, of St. Luke's Mid-America Heart Institute took up this issue at CRT 2012. Cohen offered a number of details, but his talk boiled down to the fact that the bottom line for TAVR is written in red ink for many hospitals.
Cohen said the Medicare diagnostic-related group (DRG) system uses multipliers that adjust for several factors, explaining that for some hospitals, the arithmetic “covers the valve and not much more.” Cohen acknowledged, however, that this problem “is not unique to transcatheter valves.”
Still, the Centers for Medicare & Medicaid Services is not about to simply loose the Sapien on the cardiology landscape, so while the overall DRG system may be “quite arbitrary,” according to Cohen, it probably will not change anytime soon, at least not where TAVR devices are concerned. And it may be that CMS is okay with the fact that pricing squeezes some hospitals out of the TAVR game.
On the other hand, we all know what competition does for prices, which could open things up for some hospitals. What happens to the price of the Sapien once Medtronic gets the CoreValve to market?
Two: Off-label device use is an endangered species
I should be more specific and say off-label use is an endangered species for high unit cost technologies such as TAVR, but the beauty of the coverage memo for TAVR is that the patient has to be screened by more than one physician for appropriateness. CMS cleverly got itself off the hook for trying to suppress off-label use with the willing help of the medical societies.
This team medicine approach to patient evaluation may migrate to other technologies, though, such as artificial feet. David Armstrong, MD, of the University of Arizona Medical Center, told me earlier this year that he and other orthopedists of various stripes are growing amenable to the team medicine paradigm in conspicuous numbers.
Armstrong spoke in the context of a report about total Medicare spending on artificial feet, but part of the story there was unit cost as well. So as new technologies clamber past FDA, we can count on CMS using such screening approaches to ensure that devices that are expensive both in terms of per-item cost and aggregate expenditures will be more commonly subject to team medicine screening.
Three: Will TAVR ever completely supplant SAVR?
FDA has approved the Sapien for patients who would never survive surgical aortic valve replacement (SAVR), and thanks to another panel vote, will likely approve the device for patients at high risk of morbidity and mortality in a surgical replacement.
So what’s to stop TAVR from fully displacing SAVR? For one thing, calcification of the aortic valve root, which can be pretty readily dealt with if the chest cavity is opened up. It appears, however, that nobody has come up with a catheter-based approach.
Granted one would have to have used embolic protection devices when removing calcium build-up via catheter, but that’s the lower hurdle. If you really want to eliminate SAVR (and by implication sternotomy), you have to deal with the stroke issue seen in TAVR and fix paravalvular leak. Can’t do the second item without getting rid of the calcium build-up.
There are more chapters to the TAVR story than are enumerated here, but these are three of the more conspicuous stories. We’ll see how they evolve over time.
Some things in life are obvious, such as what Vice President Joe Biden is thinking. Other things? Not so much. Here are three things I don’t understand about the medical device tax.
One: Why make it a tax on revenues?
One suspects industry would be less exercised if the 2.3% tax had been applied to profits rather than revenues. Yes, device makers will play accounting games, and Max Baucus, chairman of the Senate Finance Committee, was most likely looking at things from 40,000 feet, so perhaps the difference was lost on him.
Still, someone must have told Baucus that device and diagnostic R&D would be badly affected. I think the complaint about device flight is a bit overblown – after all, a good source of export revenues is hard for policymakers everywhere to resist – but there’s no doubt that this tax gives device makers one more reason to get out of the U.S.A.
Two: What it will take to get a repeal through the Senate?
The Senate Finance Committee, which I’m pretty sure is the committee of jurisdiction, has 13 Democrats and 11 Republicans. To get through committee, a medical device tax repeal bill needs two Democrats. As far as I can tell, John Kerry will not back any such bill, and there are no other Democrats on the committee who appear to be from states that are med-tech intensive.
Assuming that’s the case, a repeal bill would have to hitch a ride on another piece of legislation on the Senate floor, meaning 60 votes are needed. There are only 47 Republicans, and that leaves at least 13 Democrats. You can count on Minnesota’s Amy Klobuchar and Al Franken, but Kerry would probably not change his mind. California’s Dianne Feinstein might respond, but Barbara Boxer? No way.
Frankly, I’m hard pressed to scroll through the list of Senate Democrats and find another 10 votes, even if you add Maryland’s Cardin and Mikulski to the tally. So if you can’t get a repeal bill in play via committee, and can’t get 60 votes on the Senate floor …
Three: What in the world is Steve Ubl talking about?
Steve Ubl, President/CEO of AdvaMed, has been trotting around a device tax disclaimer recently. In a June 7 conference call after the House vote on H.R. 436 (by Rep. Erik Paulsen), he did it again, claiming “we never bought into the tax,” asserting further, “we never supported the tax in any form or fashion.”
The problem is found in a letter dated May 11, 2009, signed by Ubl and several others making the collective promise that they were “committed to doing our part to make reform a reality.”
The letter does not mention a device tax, but I guarantee you Ubl didn’t think it meant AdvaMed was on the hook for hot dogs and baked beans at the next Capitol Hill cookout. Furthermore, I can’t see St. Jude bailing out of AdvaMed just because of the hefty dues, so it has to be the device tax, which this source and several others claim is precisely what happened.
How many times has Ubl or someone else at AdvaMed denied having “bought into” the tax? Thrice? I don’t know whether anyone at AdvaMed has been crucified over this thing, but I’m pretty sure I heard cock-a-doodle-doo after Ubl’s June 7 denial.
Will I understand all these things by this time next year? Probably, but not just yet.
OK, social media mavens – this one’s for you.
This coming from someone who, whenever I see or hear a reference to a Tweet, automatically rack up the chorus to Bobby Day’s golden oldie “Rockin’ Robin” (yes, and the Jackson 5, but Bobby Day’s was the original, in 1958):
“Rockin' robin (tweet tweet tweet)Rockin' robin (tweet tweet tweet)Oh rockin' robin well you really gonna rock tonight”
But I digress . . . This is about the use of social media to discuss health issues. According to a recent PricewaterhouseCoopers (PwC) report, more than 40% of all U.S. adults do just that, flocking to all manner of social media platforms using devices of every shape and form.
Full disclosure: I am not among them. I don’t write on anyone’s Facebook wall, except for those occasions when I piggyback on my wife’s account to make a comment (emphasizing right up front that that particular post is FROM JIM). I also don’t do Twitter, and I unlinked from LinkedIn not long after having signed up in a moment of weakness upon receipt of an invite from a former colleague (nothing personal, Marcus).
But despite these obvious signs of personal backwardness, I was not at all surprised to read the results of the PwC survey that the giant global consulting firm conducted among 1,060 U.S. consumers and 124 healthcare executives. I mean, just look around the next time you’re in a public place – a Starbucks for sure, any outdoor café, pretty much any parking lot outside a “big box” store, even a ballgame, for God’s sake – and you’ll see a disproportionate number of your fellow citizens with his or her face buried in a tiny little screen of a phone, tablet or some other device whose name I almost certainly don’t know.
And at any given time, at least some of them are doing something connected with healthcare. They’re trying to learn more about some given medical condition or treatment, checking on physician or hospital reviews, interacting with others as to the care they have received.
PwC puts the number of those who have used social media to access health-related consumer reviews -- of physicians or treatments – at 42%, while “nearly 30% have supported a health cause, 25% have posted about their health experience, and 20% have joined a health forum or community.”
Not surprisingly, age clearly is the most influential factor in engaging and sharing through social media, with PwC saying that more than 80% of the survey respondents ages 18 to 24 indicating they would be likely to share health information through social media and only 45% of those ages 45 to 64 indicating the same. (Cue the smirks by those who found my aforementioned disclaimer a clear indication of backwardness.)
PwC’s report says that social media information clearly is influencing decisions to seek care, with 45% of respondents saying information found via social media would affect their decisions to seek a second opinion and 40% saying that information found that way would affect the way they coped with a chronic condition or their approach to diet and exercise.
As just one example, the Atlanta Journal-Constitution reported that after Facebook added a link allowing users to connect to online organ donor registries, an astounding 100,000 did so within the first 24 hours. The AJC added that in the first week, 804 people signed onto the Georgia site compared to 18 in the same period of the previous year.
None of this is especially surprising, as we clearly are in an era of the informed healthcare consumer. More so than at any time in history, we can easily access information that in the pre-Internet age would either have taken hours upon hours of laborious research through paper-based materials or simply not have been available at all to ordinary citizens.
And yes, I am part of this informed society. I do regularly pursue information on illnesses, treatments and docs -- just not via what we’re dubbing social media. I do it the old-fashioned way, via laptop (sarcasm very much intended).
There’s a huge element of irony to all this information-seeking, however. This revolution, if one would call it that, comes at a time when healthcare organizations of all sorts – from physician practices to hospitals to the companies bringing medical technologies to the marketplace – are pretty much laggards when it comes to the use of social media.
As PricewaterhouseCoopers noted in its report, “Social media activity by industry organizations is dwarfed by consumer activity.” Although eight in 10 companies evaluated in the study reported having some presence on various social media sites, “the volume of activity for companies is in the hundreds versus the thousands of posts, comments and overall activity observed in community sites in a week’s snapshot analysis.”
In fact, said PwC, “community sites had 24 times more social media activity on average than any of the health industry companies over that one-week timeframe.” Its conclusion: “Healthcare businesses [have] started to listen, but aren’t translating social media conversations into practice.”
The report indicates that one in every two healthcare businesses “worry about how to integrate social media data into their businesses and how to connect social media efforts to a return on investment.”
The latter seems a telling point. Without a clear ROI, use of social media may be little more than exercises in collecting “likes” and “followers.”
But organizations that figure out how to make metrics gathered through social media become part of a more active and engaged role in helping manage the health of individuals clearly will be on to something.
One telling quote in the PwC report came from Ed Bennett, who oversees social media efforts at the University of Maryland Medical Center in Baltimore: “If you want to connect with people and be part of their community, you need to go where the community is. You need to be connecting before you actually are needed.”
Makes sense, even to me.
(Jim Stommen, retired executive editor of Medical Device Daily, is a freelance writer focusing on healthcare issues.)
With all the acrimony between Democrats and Republicans in Congress these days, it was truly edifying to see lawmakers on both sides of the aisle agreeing on a piece of legislation - and in the healthcare sector no less - the FDA user fee reauthorization act.
Last week, the U.S. House of Representatives reaffirmed passage of the FDA user fee reauthorization act in a 387-5 roll call vote taken after an earlier voice vote.
The House affirmation followed close on the heels of the earlier congenial vote on the act by the Senate, a nearly unanimous 96-1 approval.
The groundwork for this quick approval came about back in February when industry stakeholders and FDA representatives came to terms on a tentative version of the agreement. At that time the parties agreed in principal to the new five-year user fee agreement for medical devices, and the $595 million agreed to was more than double the amount collected under the prior user fee agreement, which netted the agency less than $290 million. As a sweetener for all the extra money from industry, FDA agreed to measure device reviews by total elapsed time rather than just the number of days an application is on the agency's clock, a much more rigid standard.
Don’t expect the two chambers to partake in a spontaneous rendition of the spiritual song Kumbaya just because they accomplished the passage of some legislation though. As a matter of fact, shortly after this effort, the partisan rancor erupted again; this time over the House’s planned passage of a repeal of the 2.3% device tax.
Republicans on the U.S. House of Representatives' Ways & Means Committee voted to repeal the excise tax included in the Affordable Care Act on May 31. The full House is expected to take up the bill June 7 or 8. The tax is expected to raise $29 billion starting in 2013 to help pay for insurance for the uninsured.
And while the device tax repeal bill is expected to pass the full House, it faces certain defeat in the Senate, where parallel legislation introduced by Republican Senators Orrin Hatch and Scott Brown lacks bipartisan authors.
Well so much for peace, love and understanding.