At the risk of becoming mired in the past, we are inclined to glance backward now and then to see where we’ve been and ask what the past says about where we’re going. So let’s examine July 30, 1965, the date President Lyndon Johnson signed Medicare into law.
As may or may not be widely known, the initial forecast of the cost of Medicare was way off. In 1967, so the story goes, the House Ways and Means Committee guessed that Medicare would aggregately cost roughly $12 billion a year by 1990, a figure that ran fairly close to $110 billion by 1990.
In the intervening years, Congress and others involved in the Medicare policy discussion have perspired heavily over the future of Medicare and Social Security, and the annual Trustee’s report is a great way to find out who listens in on the conversation because they’re the ones who are always wringing their hands.
Rick Foster, the chief actuary at the Centers for Medicare & Medicaid Services predicted in May of last year at an event at the American Enterprise Institute that the Part A trust fund would be gone by 2024, but more recent estimates say 2017 or 2019, depending on whom you ask. Granted the fund is somewhat sensitive to economic conditions, but does anyone really expect a rising economy to balloon it back up to a 2024 expiry?
Lest we become tongue-tied trying to say “Part A trust fund” three times quickly, let’s not forget Part B, the terrain stalked by physicians. Cuts to Medicare spending on Part B imaging have been the norm since the Deficit Reduction Act of 2005, but the consensus now seems to be that this turnip has been bled dry. Squeeze all you want from DME bidding and fraud, but the Part B doc fix (a.k.a., the SGR mess) is still tabulated at $300 billion or better over a decade. You want to find offsets you say? In this fiscal environment?
One possible fix nobody really wants to think about is the use of the word “cost” in the statute that gave rise to Medicare. As many know, the government lost badly in the lawsuit of Hays v. Leavitt, and Hays v. Sebelius didn’t go much better if I’m not mistaken. Would the Independent Payment Advisory Board recommend that Congress allow the Centers for Medicare & Medicaid Services to use cost as a factor in coverage decisions? It’s hard to say, but we do know one thing: That rail has more juice to it than most third rails available to Congress, so only IPAB could get away with even saying such a thing.
So what will become of Medicare in the decades to come if current estimates of its cost are similarly delusional to those bandied about in the early years of the program? I can only guess, but I do know this: If we don’t fix it soon, Generation X will fix it when it finally achieves a majority in Congress. If Medicare is still draining the economy when that day arrives, the fix is nearly certain to be swift and brutal.
The July 20 hearing at the Court of Appeals for the Federal Circuit addressing the Myriad case did not last a terribly long time, but there were a few object lessons to take away. We last visited this situation shortly after the Supreme Court decision in Prometheus v Mayo, when I opined that there might not be much reason to hit the panic button, and I have to say I didn’t hear much on July 20 to change my mind.
But who can say for certain? After all, who’d have guessed at the 9-0 outcome at the Supreme Court (a.k.a., SCOTUS) for Prometheus? At any rate, here are the three take-aways courtesy of yours truly.
1. The same three judges = the same three views
I didn’t see much reason to think any of the three justices had changed their minds. Judge Alan Lourie did not make much noise over the machine-or-transformation test in the second go-round, but he didn’t evince much sympathy for the claims of the Department of Justice and the American Civil Liberties Union, both of which argued strenuously that the prime principal should be whether a patent pre-empts other uses of the DNA in question.
Judge Kimberly Moore wasn’t particularly inclined to give DoJ and ACLU much room on the pre-emption argument either, describing such discussions as “a waste of time.” However, Judge William Bryson also didn’t seem inclined to change his views, and hence can be counted on to vote against the Myriad patent.
2. PTO can indeed frustrate the Supreme Court’s intent
As we’d discussed previously, the U.S. Patent and Trademark Office is not exactly powerless to frustrate what might appear to the Supreme Court’s intent in Prometheus.
Take for example the March 21 rule published by PTO in response to the Prometheus decision. The guidance states that claims “that recite a law of nature or natural correlation, with additional steps that involve well-understood, routine, conventional activity” are not eligible for patents, but patents that recite a law of nature coupled with “several unconventional steps … that confine the claims to a particular, useful application of the principal” are eligible for patent protection.
Now it’s true that I’m not a patent attorney and this could be read several different ways. But I do write quite a bit and know something about the English language, and I have to tell you … this could be read several different ways. One thing it says is that the patent in Prometheus is too simplistic, but it’s not just me who believes this passage is not all that prescriptive otherwise. An individual with some expertise in this area spoke to me off the record at CAFC and said PTO has a lot of leeway in interpreting the Prometheus decision.
One little point of interest in this context is that Bryson asked the DoJ attorney whether PTO was on board with the government’s argument. DoJ’s Melissa Patterson struggled mightily to avoid admitting that PTO disagrees, but it was strikingly obvious that PTO director David Kappos thinks DoJ is nuts on this score.
3. CAFC is in no way hamstrung by Prometheus
This obviously is similar to the discussion of PTO, but let’s face it, if CAFC doubles down on its first decision in Myriad, it’d be more of an in-your-face response to the Supreme Court than anything PTO is liable to engage in. Still, what can the Supreme Court do? Send over a nasty letter? The Supreme Court, like all courts, can’t do anything unless someone files a case in its jurisdiction.
Furthermore, there is one huge problem in the arguments leveled by ACLU and DoJ. I won’t argue that a patent should be allowed to tie up an entire area of scientific inquiry, but if you’re going to grant patents on genes – or patents for anything for that matter – there has to be at least some pre-emption of activity. Otherwise a patent is worthless.
Beyond that, I’d point out that biotech exclusivity lasts only a dozen years. Whatever the scope of pre-emption, it won’t last very long at all regardless of what happens next at CAFC, which is another reason for Moore and Lourie to hold their ground.
An experienced patent attorney might argue that if my prediction turns out to be correct but for the wrong reasons, I might as well have got it wrong, period. Whatever the case, I don’t see Lourie and Moore as having shed their previous positions on this, and Myriad will show that the outcome in Prometheus is far less earth-shaking than some might have believed.
P.S.: To the guy who showed up at CAFC in sneakers, jeans and a polo shirt: Seriously? Sneakers, jeans and a polo shirt? Did you just get out of high school?
An acquaintance of mine who, like me, has inflammatory bowel disease, received a call recently from her local hospital informing her they had lost her MRI images. They found them, but she is concerned they will have to retake them anyway because at this point her images are no longer current enough for the doctor to make an informed treatment decision.
This is a prime example of why all hospitals should use electronic health records (EHRs). At a time when health IT (HIT) companies are cropping up faster than Starbucks coffee shops, and the federal government is handing out incentive funds to those hospitals who use electronic records, there is truly no excuse for not having an EHR system in place.
Asking patients to retake an MRI simply because they can’t keep their records together is not only inconvenient for the patient but extremely inefficient for the hospital. Assuming this sort of thing happens regularly, these are dollars the hospital is flushing away that could be invested in an EHR system.
Sure, there are initial costs involved with installing a reliable EHR system, but many of these costs are reimbursable under the American Recovery and Reinvestment Act and most HIT companies are eager to guide clients through the meaningful use requirements. It makes the company look good and it recovers critical funds for the hospitals to put to other uses, like saving lives.
Just as one example, we recently reported in Medical Device Daily that a financially-strapped 319-bed county hospital in California went live on Medsphere Systems’ OpenVista open source EHR. That hospital is expected, according to Medsphere, to receive “substantially more” in federal reimbursement than the five-year costs to acquire the system. It makes sense not only from a patient care standpoint but from a financial perspective also.
Medsphere President/CEO Irv Lichtenwald called the move a compelling example of responsible decision-making, and I agree. “Especially in these troubled economic times, public hospitals can still improve care without making financial matters worse for local government,” Lichtenwald said.
And of course Medsphere is not alone in the HIT market, the firm has plenty of competitors, all more than happy to help private and public hospitals alike experience similar financial gains by implementing these invaluable electronic records systems.
Well, God forbid people in my line of work should run out of things to be outraged about, but the saga of the FDA whistleblowers has boiled over again.
As readers of MDD Perspectives know, one of the members of FDA’s staff involved in all this blowing of whistles had a bad reputation before he arrived at FDA. Robert Smith, MD, made a name for himself suing hospitals for alleged overbilling of Medicare, and more recently crying to Congress and the White House that he wasn’t getting his way with his demand for PMAs for software and hardware used in medical imaging procedures.
The problem with Smith is that he doesn’t understand mammography, or so said Etta Pisano, PhD, of the University of North Carolina, who told me two years ago that she had talked to Smith about mammography. Pisano ought to know. She engineered the DMIST study that clarified that full-field digital mammography was sufficiently well understood that it could be governed with special controls rather than requiring a PMA for new units.
Just to remind you, Smith’s lawsuit against Yale New Haven Hospital over alleged fraudulent billing was dumped not just for lack of standing, but also because he couldn’t prove anything. The reason he couldn’t prove anything was that he didn’t know anything. The reason he didn’t know anything … well, I’ll let you fill in that blank.
FDA’s concerns about leaks: disclosure of confidential information
One of the concerns FDA had about Smith et al was that this business of sending device applications to Capitol Hill might result in disclosure of confidential commercial information. That’s exactly what happened as reported in the New York Times, which states that the documents were posted online “by mistake” by the company that was conducting the surveillance for FDA.
Sure, by mistake. If you believe that, you’re probably one of those people who still leaves a mug of hot chocolate on the hearth when you go to bed on Dec. 24 despite that there is nobody under the age of 25 in your home.
But here’s how the Grey Lady handled the story. FDA had “an enemies list of sorts,” but do the authors of the NYT piece ever cite an instance in which these oh-so dangerous medical devices actually hurt someone?
No, of course not, because it never happened, so it doesn’t fit in with their narrative, which goes something like this: If it’s government against industry, industry’s the bad guy. If it’s the individual (read; rabble-rouser) against government, government’s the bad guy.
Not to be outdone, Charles Ornstein and his fellow scribblers at the Association of Health Care Journalists describe the monitoring of communications between FDA and the press as “Orwellian.” Leave it to people in my line of work to raise the specter of “Orwellian” government. Please. If you think the U.S. government is Orwellian, just try and get access to government officials anyplace in Europe.
Don’t get me wrong, I have problems with the way things are run at FDA’s device branch. Just ask CDRH director Jeff Shuren. Shuren knows me by sight if not by name, and I guarantee you he remembers when Sen. Richard Burr reminded him during a Senate hearing about my article quoting Shuren as saying the slow-downs in 510(k) review times were “all on industry.”
But this time Shuren got it right. Smith and his band of troublemakers needed to be brought into line or dismissed. And please, is it not high time to take the whistles away from the children so we can all move on to things that actually matter?
Crohn’s and Ulcerative Colitis, known collectively as inflammatory bowel disease (IBD), do not discriminate between age, race, gender, economic status, or geographic borders. It is truly an equal-opportunity disease!
I was 18, a freshman in college, when I was diagnosed with ulcerative colitis (UC) and was told I was “too young” to be that sick. IBD was an old-person's disease, my gastroenterologist said.
He was wrong, of course. Because my symptoms were not taken seriously from the beginning, I continued to get worse over the course of the next three years of college. Looking back, I don’t know how I managed to stay on track academically and make it to my senior year, but to me, giving up was not an option. So I kept my textbooks in the bathroom, where we IBD patients spend most of our time anyway, and studied while my disease slowly took over my entire large intestine.
Finally, during my senior year, I sought a second opinion from a GI who took one look at my colon and sent me to a colorectal surgeon. In December that year, while on winter break from school, I went in for an ileoanal pouch surgery, commonly known as J-pouch surgery because it involves removing the diseased colon and folding the small intestine back onto itself until it resembles a J, creating an internal reservoir that allows the patient to poop normally.
Because I was so determined to graduate that May, my surgeon planned to do the procedure in one step instead of the more common two-steps. Unfortunately, I awoke from surgery with a temporary ileostomy bag because my colon was so inflamed that my surgeon had no choice but to create a stoma until I healed enough to undergo the rest of the procedure.
So I returned to college for my final semester wearing an ostomy bag. I went in for the second step of the procedure over spring break. One complication led to another and I ended up in the operating room several more times within 40 days. Finally, I went home with another ileostomy bag.
I was 80-some pounds and could barely walk. Too weak to even shower by myself, I sat on a stool in the bathtub while my grandmother bathed me. I was 21, she was 70.
I had missed the entire second half of my final semester, but still managed to walk across the graduation stage that May. I had to use a wheelchair to get to the stage and arranged to have it waiting for me on the other side, but I was hell-bent on walking across.
A year later, I returned to the operating room where my surgeon was able to successfully complete the rest of my J-pouch surgery. I still struggle with IBD-related issues and my fear is that someday I’ll end up with a permanent ileostomy bag. But overall, life without a colon has been considerably better than life with a diseased colon. And to think – I was “too young” to be that sick.
If/when I do have to go through another surgery, I won’t be alone. I have found an amazing source of support through a mobile app, GI Monitor, lovingly dubbed Buttbook by those who use it. Click here to read more about this fantastic app.
My BB friends range in age from 13 to 60-something and in geography from California to Australia. Like I said, IBD does not discriminate. The individuals I have met through GI Monitor are all truly incredible people who struggle with daily bouts of pain, diarrhea, and other symptoms, and still manage to go to school and work most days. But there is one BB friend who has become my personal IBD hero: Dewey Thom.
Like me, Dewey has a J-pouch and, like me, he was originally told he was “too young” to have IBD. What I admire most about Dewey is the fact that he has selflessly dedicated so much of his time to raising awareness about this terrible disease and to offering moral support to fellow IBD patients. Dewey rarely complains about his own pain and struggles with the disease, but instead focuses on educating and supporting the rest of us.
Currently, Dewey is participating (not for the first time) in the Crohn’s and Colitis Foundation of America’s Team Challenge marathon to raise money for IBD research. Click here to visit the Team Challenge homepage for more information. Or, to help Dewey reach his fundraising goal for the event, and to read more about his personal journey with IBD, click here.