[caption id="attachment_2733" align="alignleft" width="300"]He's sure to be looking for a lot more than just two nuggets.[/caption]
Sometimes little nuggets of information don’t mean much, but sometimes they mean a lot. It’s not always clear, though, is it? Following are a couple such nuggets, but I’ll let the reader decide what they’re worth.
In a recent congressional hearing, Sen. Patty Murray, said something that surely gave providers a nasty case of the hives. Murray, who chairs the Senate Budget Committee, said at a July 30 hearing that bundled payments “could help incentivize coordination and efficiency” by “creating fixed payments for all the care a patient is expected to need during a period of time.”
I approached the dais after the hearing for clarification (did she really say the “C” word?), but Murray handed me off to a staffer, who promised to get back to me. He e-mailed me as promised, but he didn’t respond when I explained what I was after. He also didn’t respond the following day when I inquired a second time.
There are a lot of people in this town who think capitation is inevitable under accountable care organizations, but it seems as though it’s a bit impolitic to say as much out in the open. It’s a safe bet we haven’t heard the last of this, though.
Devices driving healthcare inflation?
We’ve all heard about statistical cherry picking, but let’s go ahead and dive into the discussion of how medical device spending is driving Medicare spending … or not.
Kavita Patel, MD, of the Brookings Institute appeared at the July 30 Senate hearing mentioned above, and Patel had some interesting numbers to offer. Among these is a table she drew from Medicare data stating that Medicare spending on pharmaceuticals “across the continuum of care” rose from $2.4 billion in 2001 to $63.7 billion a decade later. That’s up by more than a factor of 25.
Meanwhile, spending on durable medical equipment went from $4.5 billion in 2001 to $7.7 billion in 2011, and non-durable medical equipment rose from $1.6 billion to $3.2 billion, again all within the nebulously named “continuum of care.”
I’m not entirely sure what those durable and non-durable categories cover – do they include defibrillators and drug-eluting stents? – but a lot of the numbers I’ve heard about med tech inflation is that it comes in at about 6% a year most years, and routinely accounts for about 6% of total Medicare spending. According to my wizardly arithmetic calculations, 6% annual inflation comes to an increase of about 80% over a decade.
Assuming that’s the case, how can all the policymakers and policy wonks bleat endlessly about medical device spending and not be equally unhinged over a 25-fold increase for inpatient and outpatient drug spending in just 10 years? That’s like losing your cool over a spilled bucket of water while standing in front of a dam that’s about to collapse.
As the picture above reminds us, you can’t always distinguish between gold and iron pyrite until you do a little digging, but there’ll be a lot more where that came from starting next month when Congress returns to Washington for the fiscal 2014 budget talks.
[caption id="attachment_2722" align="alignleft" width="300"] All is necessarily for the best end, eh?[/caption]
A story of bureaucratic overreach, clinical trial data disclosure, and Washingtonian flights of fancy with a tip ‘o the hat to Voltaire.
In a castle of Silver Springalia, belonging to the Baron of Our-Way-or-the-Highway, lived an industrious youth endowed with the most inventive of manners. The old servants of the Baron preferred that the youth, named Indeed!, be the supplicant of the Baron, needful of the Baron’s approval in all things. The youth was expected to address the Baron as “oh Lord!” and laugh agreeably at all the Baron’s impetuous declarations.
The Preceptor Panglossover, a professor of meta-analytical-governmental-causation, was the instructor of the youth, and Panglossover said: “Indeed! It is demonstrable that things cannot be otherwise than as they are decreed; for all being created by the Baron for an end, all is necessarily for the best end.”
However, Indeed! found himself in a rapturous state with a mere handmaiden of the Baron, Cunecessity de Commerce, whose handkerchief was prized by all. Cunecessity unwittingly dropped her handkerchief once in plain view, whereupon Indeed! duly retrieved the necessary and secret item.
Cunecessity touched his hand and they sensed a connection of utmost urgency, one requiring the most tender guarding of their secrets, without which their relationship would wither and the kingdom would suffer for want of little Cunecessities and Indeeds!
However, the handkerchief was prized by the Baron, too, who demanded that Cunecessity de Commerce let fall the handkerchief in plain view of all, and thus put an end to this vile denial of the greater good. Indeed! proclaimed, “oh Lord!”
Indeed! beseeched the Baron “please, reconsider. What you propose is beyond the charge bestowed upon thee by the King’s Council of 535! Even the holy writs of Fidazia do not countenance this!” the inventive youth cried out.
However, the Baron, who had passed near their goings-on and beheld this pernicious cause and effect, chased the inventive youth from the castle with great kicks on the backside, bellowing, “Indeed! you shall have no secrets with Cunecessity in my kingdom!
Thus driven from a paradise, Indeed! wandered, and was conscripted into a force for the King of the O-U-S-ians, whereupon he was dealt 30 blows with a cudgel for the poor performance of his duties. He escaped from the forces of the O-U-S-ians, only to find himself in a dark alley, face-to-face with Panglossover, who was in a downtrodden state.
“Alas!” said Panglossover to his star pupil. “Indeed! do you no longer know your dear Panglossover?"
Upon recognizing his former tutor, Indeed! cried out, “what misfortune has happened to you?” He inquired further, “what has become of Miss Cunecessity de Commerce?”
“She is dead,” replied Panglossover. Indeed! nearly fainted, but mused after having regained his senses, “ah, best of worlds, where art thou? But of what illness did she die? Was it not for grief, upon seeing the Baron kick me out of his magnificent castle?”
“No,” said Panglossover, “she was ripped open by the O-U-S-ian soldiers, after having been violated by many. They broke the Baron's head for his feeble, half-hearted attempt to defend her,” he answered. At this discourse Indeed! nearly fainted again; but snapped out of it and inquired into the cause and effect, as well as into the sufficient reason that had reduced Panglossover to so miserable a plight and led to the demise of his beloved Cunecessity.
“Alas!” said the other, "it was transparent love; love of sharing, the comfort of the human species at the expense of common sense. Love, tender love,” Panglossover replied.
Panglossover continued: “It was unavoidable, a necessary ingredient in the best of worlds; for if Columbus had not in an island of America caught this disease of innovation, we should have neither chocolate nor cochineal.”
“This distemper is like religious controversy, confined to a particular spot for now,” Panglossover said, shaking his shaggy head. “The O-U-S-ians, the Asiaticans, know nothing of it; but there is a sufficient reason for believing that they will know it in their turn in a few centuries.”
“In the meantime, it has made marvelous progressiveness among us, especially in those great armies composed of honest well-disciplined Silver Springalian hirelings, who decide the destiny of states,” Panglossover said. “For we may safely affirm that when an army of ten thousand Silver Springalians fights another of an equal number, there are about nine thousand of them who are SOL on the other side,” he sadly concluded.
A decade ago it would have been hard to imagine a bioabsorbable tissue-lined stent graft capable of treating blood vessels that have been ripped apart by a bomb, or a spray-on solution that would promote the regrowth of your own skin after a traumatic injury or burn, or even a portable machine that could treat deadly infections like sepsis in much the same way that dialysis machines treat kidney failure. But today these innovations and many more are being developed to treat wounded warriors and will someday be used not just on the battlefield but in civilian hospitals as well.
This week Medical Device Daily will be reporting on the various ways that combat needs have influenced R&D for medical technology in a three-part series. Of course this is not a new phenomenon but something that has occurred throughout history, as far back as World War I and beyond. Probably for as long as battles have existed, war wounds have played a role in advancing medicine on the homefront. But what has changed is the types of injuries that combat medics and surgeons have had to deal with during these two most recent conflicts overseas, primarily because the military now has such advanced, high-tech body armor and armored vehicles, that soldiers are now surviving blasts that otherwise might have killed them. That’s why the majority of injuries these wounded warriors suffer from have been quite traumatic and life-altering, like amputations, paralysis and severe burns.
As a military spouse I’m sensitive to the sacrifice that these wounded warriors have made and I am grateful that organizations like the Armed Forces Institute of Regenerative Medicine (AFIRM) at Fort Detrick, Maryland have been able to fund so many R&D projects to advance combat treatment. My fear is that as the U.S. pulls out of Iraq and Afghanistan the government will also stop funding this type of research.
During an interview with Maj. Louis Alvarez of the AFIRM, he expressed similar concerns. “We want to maintain awareness and visibility of these injuries that will be lifelong and traumatic,” he said. “... We should maintain as much momentum as possible,” on these fronts.
Marvel Comics' popular character Wolverine is known for his ability to heal from nearly any wound. Researchers at Drexel University in Philadelphia have developed an ultrasound technology aimed at giving patients who suffer from chronic wounds, an extra boost in recovering from the injuries.
And while it's not anywhere near the level of Wolverine's powers (he is a fictional character after all), initial studies show promising results for the device. In the study, researchers treated patients suffering from venous ulcers, which account for 80% of all chronic wounds found on lower extremities and affect approximately 500,000 U.S. patients annually, a number that’s expected to increase as obesity rates climb. It’s estimated that treatment for venous ulcers costs the U.S. healthcare system over $1 billion dollars per year.
Researchers applied the device to patients for 15 to 45 minutes, once a week, while they were seeing their physician for a routine appointment. The end results was improved healing compared to the control group that did not receive treatment.
I interviewed some of the researchers involved in this project, and while there are definite plans to try and get this technology into the market place, there is also a sense of urgency.
Joshua Samuels, one of the researchers in the study spoke passionately about the technology and perhaps gave one of the most heartfelt interviews that I have had in my six years here at Medical Device Daily. I think his quote pretty much sums up the pure unbridled mission of med-tech.
“It’s always slow moving getting it from the research lab to the market place,” Samuels said. “What I would really like to see is the device get used by patients as quick as possible. It’s always tough when you do biomedical research knowing that it could take six to seven years to get onto the market place. I know that there are regulations and I know that everything has to go through its due process, but that’s something I would really like to see – to get to patients so that it can help them.”
Here's hoping that happens.
[caption id="attachment_2690" align="alignleft" width="300"]The dangers of too much hot air: Known but routinely ignored[/caption]
If you like controversy, a job at FDA would be right up your alley, but it’s tempting to think some of these controversies are contrived. The question of the influence of user fees on FDA reviews has surfaced (yet again), but even those who would like to do away with the user fees might find this latest rehashing a bit over the top.
An article titled “Risky Drugs: Why the FDA Cannot Be Trusted” at the website for Harvard University is the latest to take up the issue of user fee-induced malfeasance at FDA. The article starts out by stating that another soon-to-be-published article “presents evidence that about 90 percent of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs.” The italics are provided courtesy of author Donald Light, PhD, an ethicist at Harvard. Also among the claims in this article is that prescription drugs “are the fourth leading cause of death.” And it's all because of user fees.
These are quite some allegations, but are they true?
Light does not disclose where he gets his information about the fourth leading cause of death, which is quite convenient. CDC pegs stroke as the fourth-leading cause of death in 2010 (by the way, the term “drugs” does not appear anywhere on the CDC top 10 list).
This reminds us of the 1999 screed by the Institute of Medicine titled in part “To Err is Human.” IOM claimed that somewhere between 44,000 and 98,000 patients lose their lives to medical errors annually. I’ve enunciated the position for some time that if you have that fat a margin for error, you really aren’t sure of anything at all, are you?
That doesn’t account for other methodological issues of substantial heft in the IOM report, but as for Light’s allegation about the fourth-leading cause of death, my response is “are you sure you didn’t make that up?”
As for the efficacy question, Light omits entirely the fact that drugs that hit the market 30-plus years ago were administered to patients under pharmacological treatment for that disease for the first time. The newer drugs are used on many patients who are refractory to those other treatments and hence are likely to be resistant to treatment.
I’d add that if any such analysis includes generics, it stands to reason that improved efficacy is not the idea. Lower cost is.
But I dare Dr. Light to make such arguments to cancer patients. If he really thinks that the therapy for cancers in 1983 are the match for modern pharmacology, he should screw up the nerve and tell that to cancer patients to their faces. I promise he will not. He’d get slugged if he did, and rightly so.
One might extend this kind of conspiracy theory to FDA advisory panels, because these panels approve many of the truly new drugs and are populated by people who have conflicts of interest. However, the only analysis I’m aware of indicates that the outcome of advisory panels would be the same if the purportedly conflicted voting members hadn’t made it to the meeting.
In fact, the report states that the data suggest that advisory committee members and consultants “with financial ties to pharmaceutical companies tend to vote against the financial interest of those companies.”
Light’s lightweight rant is yet another example of academicians going off on things that they either utterly fail to understand – despite the enormous amounts of time spent in their ivory towers “studying this important issue” – or understand all too well and simply want to justify their tenure by making controversial remarks. I’ll add to the pile of pointless controversies by arguing that PhDs who spend their time adding yet more hot air to the debate might be a source of global warming.
Can you prove me wrong?
And when one considers the possibility that the taxpayer is on the hook for a good chunk of Light’s salary, I’d ask “who is really guilty of malfeasance here?”
[caption id="attachment_2646" align="alignleft" width="201"]He wasn't greedy, but those subs ain't cheap![/caption]
A cynic’s guide to the galaxy might suggest everyone in healthcare is in it strictly for the money, but it’s tough to tell. After all, what can you do without the stuff? Even FDA and NIH are constantly clamoring for more. Does anyone ever accuse them of having been corrupted by the almighty dollar?
Maybe a few who gripe about FDA user fees, but that’s about it. Following are a couple of stories about the greenback and how these stories might play out between now and the end of the current fiscal year.
Sequestering the sequester
Two bills have surfaced that would exempt FDA user fees from the effect of the sequester, which could drain $40 million in device user fees this year alone. Some might shrug at $40 million, but it’s not exactly chump change when we’re talking about the budget for the Center for Devices and Radiological Health (CDRH).
The net cost for shielding all FDA user fees from the sequester – not just those for CDRH – would be $83 million. Is that enough money to make appropriators wince as they examine the fiscal 2014 budget?
Tough to say, but this movement is much more politically palatable for everyone in Washington than the device tax repeal effort. So this might just fly, especially if there’s a high-profile recall of an FDA-regulated product between now and Oct. 1.
Doc fix thyself
The sustainable growth rate problem has been around for so long that it reportedly has its own office in the Rayburn House office building, but the time for a permanent Medicare Part B doc fix may be nigh. The House Energy and Commerce Committee passed a bill this week that would drop-kick SGR into oblivion, but there are concerns about the $14 billion a year price tag.
Will the money have to come out of another location within Medicare? Democrats will never go for a higher co-pay for Medicare beneficiaries, but a politically palatable threshold for means testing might not create enough loot to cover the hole.
There are rumblings that the doc fix might have better chances if it attaches itself to a debt ceiling deal or the fiscal 2014 budget wagon, but there are a lot of unhappy partisans involved in both discussions.
In either case, it’s the classic high-risk/high-reward scenario. The cost of H.R. 2810 would disappear into a deal for these other fiscal considerations, but Congress and the White House have been throwing down over the next debt ceiling like a couple of professional wrestlers. They’ve avoided fiscal Armageddon in previous debt ceiling clashes, but you never know when all that rancor might blow the roof clean off and take the ceiling with it.
As for the fiscal 2014 budget, when was the last time Congress passed a full suite of budget bills? At least five years and it’s not like Sen. Patty Murray and Rep. Paul Ryan are reading from the same playbook. There’s always tax reform, but it’s tough to see tax reform elbowing ahead of the debt ceiling or the fiscal 2014 budget in the next 50-something days.
This might be a situation in which doctors will have to push H.R. 2810 as a solo act if they want a lasting doc fix by October 1. Otherwise, they’ll have to hope for passage between then and December 31, by which time another one-year patch might look less obnoxious to everyone in Washington than trying to find room for a permanent SGR overwrite.
A few years back my brother-in-law Sam was starting a new job and was required to get a physical as part of the hiring process. A standard X-ray revealed a spot on his lungs and further testing confirmed it was cancer. The diagnosis came about two years after he’d quit smoking, but he had been a smoker for many years and was somewhere in his early 40s. Thankfully, because it was caught and treated so early, he is still with us today and doing great. But what if he hadn't had that physical?
Earlier this week the U.S. Preventive Services Task Force issued a draft recommendation giving its second highest approval rating for routine CT screening for those at high risk for lung cancer. The grade B recommendation was widely applauded by advocacy groups such as the Lung Cancer Alliance, the American College of Radiology, and the Prevent Cancer Foundation. If approved in final form, the recommendation will trigger Medicare and insurance coverage and bring about a dramatic drop in lung cancer deaths. Experts say as many as 20,000 deaths a year could be prevented by screening.
Naturally my first thought when I heard about the recommendation was my brother-in-law and all the people like him who could be saved by this move.
But the recommendation only applies to current and former smokers age 55 to 80 with a smoking history the equivalent of smoking a pack a day for 30 years or two packs a day for 15 years. My brother-in-law would have been too young to meet that criteria at the time that he was diagnosed. How many other current and former smokers would slip through the cracks? How many of them could be saved by screening if the age range of the recommendation was widened?
I don’t claim to be an expert on lung cancer but it seems the criteria needs to be broadened. At least one advocacy group agrees. Legacy, a group that says it supports the task force recommendations but takes issue with some of the specifics, says the age range is too narrow.
According to the Lung Cancer Alliance, lung cancer takes 160,000 lives a year. Only 15% of people diagnosed with lung cancer will live five years or longer, primarily because the vast majority of lung cancers are diagnosed at a late stage. Sam was one of the lucky few, but he could have easily been one of the unlucky thousands, had it not been for that one physical that prompted additional screening.
Screening saves lives. The task force made an important decision when it issued its draft recommendation, but it would be even better if the minimum age for routine screening was lowered to 40.