April is not yet complete, but two items of interest already bear noting. One of these is perhaps the most important patent case to be heard by the Supreme Court in a long time, at least where life sciences are concerned. The other is of broader but no less intense interest to device makers.
Myriad at SCOTUS
Leading off is the April 15 hearing of the Myriad case at the Supreme Court, a hearing during which Justice Elena Kagan remarked that the Patent and Trademark Office is "very patent-happy." Of all the comments signaling a jurist's likely vote, this was the most obvious. However, as reported in the April 16 edition of Medical Device Daily, Justice Anthony Kennedy also mused that a loss of patent protection leading to taxpayer funding of most such research is an "insufficient" reason to overturn the Myriad patent for portions of the BRCA 1 and 2 genes.
If I had to guess (I don't, but I will anyway), I'd guess the final tally is 5-4, with Chief Justice John Roberts breaking the tie. I'm not entirely sure what Roberts will do, but I'd point out how far out on a rhetorical limb he went to vote that the Affordable Care Act is constitutional. His deference to established law – there is nothing in the statute to prohibit gene patents, and the practice has been to grant them – suggests which way he'll go. The outcome will thus be a narrow win for Myriad.
Needless patient deaths and device makers
One of the sessions at this year's annual meeting of the Medical Device Manufacturers Association detailed an effort by industry and others to improve patient safety by encouraging more routine use of patient monitoring equipment. For the moment, we'll set aside the question of whether Leah's Law is appropriate, but I'm of the view that device makers have to be careful about the optics of their efforts to bolster the use of their offerings.
I'm not questioning the sincerity of device makers that give of their time and money in this effort, but there will be skeptics, and it won't take much to trigger a backlash. Beyond that, the session resurrected a report filed in November 2010 by the Office of Inspector General at the Department of Health and Human Services alleging that 180,000 Medicare patients die needlessly in hospitals each year thanks to events that "contributed to their death."
I have no doubt that providers are skeptical of those numbers, and rightly so. Part of the skepticism stems from the likelihood that many of those events did nothing to hasten the patient's demise, or hastened it by mere hours or even minutes. That's not to excuse sloppy care, but I've always been wary of these kinds of government claims, including IOM's 1999 report "To Err is Human." Let's face it, neither of these reports would constitute a first instance of government getting it flatly wrong, let alone the first time our government pushed an argument out of bounds to make a point.
For device makers, one of the hazards here is that providers will return the favor by insisting that devices and equipment in the hospital be fully interoperable, and start making the argument that lack of device interoperability is killing patients, thus sparking a PR war. And frankly, the last thing anyone needs is a turf war between device makers and hospitals, but that's what we'll get if device makers overplay their hand.
[caption id="attachment_2392" align="alignleft" width="150"] The card, available through MyIBD.org, reads: The holder of this card has Crohn's disease or ulcerative colitis. Colitis is painful and requires immediate access to a toilet facility. This patient cannot physically "hold it". Please make your restroom available.[/caption]
Back in January a columnist for The Virginian-Pilot wrote an incredibly insensitive, misinformed, and elitist piece that had my friends with inflammatory bowel disease (IBD) losing their poop. Pun intended.
The column was written in reaction to a defeated bill that would have required businesses in Virginia to allow patients with Crohn’s disease or ulcerative colitis (collectively known as IBD), access to their restrooms. It would have served the columnist well to do a little research on IBD before equating the sufferers of this debilitating disease to a bunch of sticky-fingered thieves.
As I have mentioned in several previous blog posts, I suffered from ulcerative colitis all through college before eventually undergoing major surgery to remove my entire colon during my senior year. I would not wish Crohn’s or colitis on my worst enemy. Heck, I wouldn’t even wish it on that columnist from Virginia.
The issue of being denied restroom access has come up a number of times on a social forum provided on a mobile app called GI Monitor, designed specifically for people who suffer from IBD and related bowel ailments.
Once, about four months ago, one of my GI Monitor friends was shopping at a popular greeting card store when she was hit by the sudden urge that IBD sufferers are all too familiar with. And for the record, people with IBD cannot physically “hold it”.
My friend approached the counter, explained her condition and even showed her medical alert restroom card, a card designed to encourage shopkeepers to make their restroom available to people with IBD. Still, she was denied.
My friend did everything she could to convince them, but because they showed no compassion to her, she lost control of her bowels and had an accident in the middle of the busy store. It was a humiliating experience for her to say the least, but there was some justice in the end—the same employee who had denied her access to the restroom was forced to clean the mess on the carpet.
One of the store’s employees actually said to her, “you don’t look like a baby so there’s no excuse for what you did.” My friend appropriately replied, “Try living with a disease where you have no control of your bowels” and took her business elsewhere. No pun intended that time.
My point is that this condition, which the Virginian columnist inaccurately called a “rare disease”, is actually something that 1.4 million Americans have to live with. And while the columnist suggested that Crohn’s patients should launch a public relations campaign to raise awareness, I would point out to her that they already have. In fact, The Crohn’s and Colitis Foundation of America just won a national award for their “Escape the Stall” campaign. I highly encourage you to click here and watch the clip if you haven’t already seen it on TV.
IBD is so prevalent that I would be very surprised if the same store employee who snubbed my friend does not unknowingly have a close friend or family member affected by the disease. But because it is so painfully embarrassing, too many patients are afraid to come out of the, um, stall.
Does more coverage actually equate to more care? That's the question I was posed with while writing a story about a survey from the Association of American Physicians and Surgeons (AAPS; Tuscon, Arizona) concerning the upcoming Medicaid expansion.
The Patient Protection and Affordable Care Act calls for a nationwide expansion of Medicaid eligibility, set to begin in 2014. As the law was written, nearly all U.S. citizens under 65 with family incomes up to 133% of the federal poverty level (FPL) ($30,675 for a family of four in 2012) will now qualify for Medicaid.
During an interview with Jane Orient, MD, executive director of AAPS - she pointed out something so simplistic, something so thought provoking - but also something that gets overlooked in the discussion of expansion.
"Coverage just means you have an insurance card in your pocket. Care means that you actually get what you need," she said.
The AAPS survey painted an intriguing picture. According the survey of AAPS members, about 47% of respondents think that it is more difficult for a Medicaid patient, compared with an uninsured patient, to get an appointment with a primary-care physician. Only 26% thought that the uninsured had more difficulty. For specialist appointments, 44% thought uninsured patients were better off, and 32% thought Medicaid patients were better off. Only 2% thought that Medicaid patients had "no problem" getting an appointment with a specialist. Of the 166 respondents, 96 were physician specialists, 63 primary physicians, and 7 emergency physicians.
The red tape and frustration of navigating through the system is a huge turn off for doctors according to AAPS and there even seemed to be a preference to treating uninsured patients that could make payment arrangements to the doctors instead of treating those Medicaid patients.
It will be interesting to see how this question of whether more coverage equals more care, since many have touted the expansion to provide more opportunities med-tech and the healthcare sector as a whole. Time will tell.
[caption id="attachment_2372" align="alignleft" width="300"] There's always something going on with these guys, too[/caption]
There’s always something going on in the world of medical devices, including in the policy, regulatory and legal spheres. Following is a trio of quick updates on stories that have emerged since the start of the year.
FDA pre-emption back in play
The question of FDA’s pre-emption of state regulation (via tort law) of medical devices has resurfaced. This involves Medtronic yet again, leading one to wonder if these pivotal pre-emption cases ever involve anyone else.
Stengel v. Medtronic went the company’s way when a three-judge panel in the U.S. Ninth Appeals Court ruled on it last year, but a full panel of judges at that same court reversed the decision at the beginning of this year, as was discussed in the Jan. 22 edition of Medical Device Daily. Richard Samp of the Washington Legal Foundation told me in an interview he thought Medtronic might win should it appeal to the Supreme Court, but to date I can’t find any indication the company has done so.
St. Jude Medical may have a chance to test out pre-emption over the Riata line of electrophysiology leads. Those suits have been filed in California, which is where the Ninth Appeals Court resides. It’s enough to make one wonder how appealing an appeal at Ninth Appeals might really be.
Durata case report
Speaking of St. Jude, three cardiologists in California (where else, right?) have reported a case of a single Durata lead that exhibited inside-out abrasion, the presumed central issue with the Riata leads. The problem with this story is that abrasion is not what caused the lead to fail. The lead failed because of separation between the body of the lead and the coil at the end of the lead.
It’s just one case, but it attracted a lot of attention largely because of the issues associated with the Riata series of leads. St. Jude says it has performance data on more than 300,000 Durata leads, and that the numbers are quite good. A prominent electrophysiologist, Ed Schloss of Christ Hospital in Cincinnati, told me he’s still not convinced about the need for narrower leads, but he also said the amount of slack in the lead in this case might have had something to do with the failure.
Let’s hope for the sake of all involved, especially the patients, that the Durata rides off into med tech history as an example of a device that performed superbly despite what some see as a troubled lineage. Technological advances will eventually make ICD and pacemaker leads obsolete, but we’re not there yet.
CBO to Congress: Our tax policy stinks
At first glance, this might seem like a facepalm story, but the more one slogged through the January 8 report from the Congressional Budget Office regarding U.S. tax policy and industrial flight, the more predictable the conclusion became. And that means policymakers had to have seen this coming from quite some distance, especially since CBO doesn’t just go around studying things for kicks and giggles.
As was discussed in the Jan. 15 edition of Medical Device Daily, CBO had concluded that the Magnificent 535 who make their living in the nation’s capital had, over a period of years, brewed a great recipe for making business want to do business in places where doing business wasn’t so much about the business of taxation. Thus all the talk of tax reform.
Add a 2.3% dollop of medical device tax on top of all that, and it’s a wonder more firms haven’t already booked flights to Anywhere But Here.
Despite the obvious urgency of the larger of these two tax issues, it seems likely that the Senate and the House will play dueling banjos, given the vast distance between the two chambers’ approaches to fiscal policy. I could be wrong, but they’ll probably just happily pick and pluck at breakneck speeds, grinning at one another like two fools until it’s time to shake hands. Then everyone will fold their arms and look away, and we’ll all look on nearly dumbfounded and ask each other, “what the [insert expletive here] just happened?”
It’s Washington. That’s what happened.