As discussed previously, a repeal of the device tax faces longish odds. Opponents of the tax have punted to a suspension of the tax as was disclosed by a letter from nearly 20 members of the U.S. Senate, a move purportedly prompted by the short turn-around from the date of the IRS’s final rule to the effective date of the tax.
Despite the disclaimers, it’s important to point out that you clearly don’t believe a repeal has any chance in the short term if you’re arguing for a suspension. So let’s ask ourselves what sort of headwinds the device tax discussion faces in Washington.
Both President Obama and House Speaker John Boehner have their constituencies, which is only part of the reason it’s difficult to close the gap. There are, after all, serious ideological differences. The original battle lines were drawn at allowing the Bush-era tax cuts to lapse for those making more than $250,000 a year (Obama) versus no increases in tax rates (Boehner), and each of them has nudged a bit on that point.
Fiscal conservatives are still demanding more serious cuts to mandatory spending programs (Social Security and Medicare) than the White House has offered, however, and Obama has to reckon with his constituencies if he bends too much on that score. Rumor in Washington has it that Obama is loathe to bend too much this time around because of what is seen among liberals as too large a set of concessions in last year’s budget sequestration negotiations. After that legislation was agreed on, nearly everyone was up for re-election, making a final deal this year highly implausible because of … well, because of the election.
I might also point out that among those with the President’s ear is the doctor lobby, which everyone in Washington probably sees as a proxy for the senior vote, a constituency that’s not going anywhere anytime soon.
In response to the stalled fiscal cliff negotiations, Boehner indicated he would allow a Dec. 20 vote on a bill that would set the bar on income tax rate increases at $1 million, a level that a leading Democrat, Sen. Chuck Schumer, has endorsed. The problem is that this bill may pass the House, but has no chance in the Senate (which by the way has passed no spending bills at all for fiscal 2013).
The disingenuousness on the other side is even more brazen. President Obama used the slaughter of children at Sandy Hook in an attempt to get Republicans to capitulate in a televised set of comments on Dec. 19. It was breathtaking even by the standards in Washington, but Boehner is determined to push the bill onto the floor for a vote, and so it goes.
The problem for the device tax is that the intractability of the positions of the two sides, which has already clobbered any prospect of a repeal, now seems likely to kayo even a suspension.
There’s an old saying in the public relations business that states basically, “may your bad news be buried under even worse news.” Conversely, the prospect of your legislation being buried under something politically heftier is a problem, and is precisely the dilemma faced by opponents of the device tax.
Add to all this the fact that Obama has argued against even a hold-up in the device tax, and it’s tough to avoid the conclusion that the corpus formed to hold off the tax is either dead at the scene or in critical condition. The only thing that’ll save the patient now is a miracle. Those who are agnostic will not hold their breath.
Dec. 21 update: The House bill Boehner had hoped to pass, which would have set the tax bar at $1 million, was pulled due to lack of support. There is an exceedingly high probability at this point that Jan. 1 will arrive with no resolution to the fiscal cliff issues. Stock markets are reacting badly to the news, and U.S. debt instruments are snaring larger returns, which boosts the government's borrowing costs. Will Moody's further downgrade U.S. bonds as a result? The device tax suspension effort is buried, and so in all likelihood is the push for repeal.
[caption id="attachment_2075" align="alignleft" width="199"] Amanda at the finish line of the Rock & Roll Las Vegas Half-Marathon, a Team Challenge event to benefit the Crohn's and Colitis Foundation of America.[/caption]
When I signed up for my first half-marathon, which took place recently on the Las Vegas strip at night, I knew I was in for a tremendous challenge. But I had no idea I would be finishing the 13.1 mile race while battling a small bowel obstruction.
While this setback easily could have sidelined me from the race, it made me all the more determined to see it through. The idea of letting down all the people who supported me for this event with kindness and generosity was more painful, to me, than the obstruction itself.
You see, this was Team Challenge, a fundraising event for the Crohn’s and Colitis Foundation of America (CCFA), a cause I truly believe in not only for myself, but for the millions of other people around the globe who suffer from these diseases, collectively known as inflammatory bowel disease (IBD).
One of the brighter parts of my Team Challenge experience was the opportunity to meet in person someone who has become a personal hero because of everything he does for IBD patients, Dewey Thom. I met Dewey about a year ago through a mobile app called GI Monitor. When I felt a major obstruction building the night before the race, Dewey was the one I called in the middle of the night for advice. Between him, our CCFA team manager and our coach, I was quickly put in touch with a gastroenterologist from the University of California Los Angeles who was volunteering his time and services during the event.
The following is what Dewey shared on GI Monitor a few days after the race: “To fully appreciate Amanda’s accomplishment you should know that she has been largely on an Ensure diet for months, and not able to fully train … She fought off an obstruction Saturday night in the wee hours of the morning, with full onset of symptoms including nausea, bloating, pain etc., probably ‘slept’ for a few hours that morning, then with CCFA doc clearance was able to fully complete 13.1 miles.”
Dewey knew I was determined to finish the Team Challenge half-marathon regardless of training or fundraising shortcomings, because he knows how much it means to me to finally be able to actively fight back against Crohn’s and colitis.
In the past year, bowel obstructions have become a near-constant part of my life. A complication, I believe, from the multiple surgeries I went through ten years ago for ulcerative colitis. To read more about my battle with the disease click here.
“And notwithstanding being short of her fundraising requirement, she made her way to Vegas and crossed the finish line, hurdling those challenges with grace and aplomb,” Dewey said. “And if you have the means or desire to help her to her goal, I include her page here as she’s too modest to. Hell of a job Amanda. I cheer your accomplishment and thank you for your endurance!”
The Centers for Medicare & Medicaid Services has published a draft guidance for the new framework for coverage with evidence development, or CED, a very interesting framework indeed. Following is a list of some fascinating tidbits from the draft guidance.
Interesting item #1: The passage stating that CMS is examining the question of “whether local contractors should have the discretion to apply CED in local coverage” is pretty close to an earthquake.
I’m assuming that most CED trials will have to span more than one Medicare carrier’s jurisdiction, which suggests a patchwork of CED coverage or a need to get multiple carriers on board with a single CED protocol. This might be the worst idea since pet rocks and it’s exceedingly difficult to imagine anyone would want to go this route. Is there a reason not to believe this is CMS’s way of saying: “Come to Baltimore and talk to us about your novel and expensive offerings, not the local carriers”?
Interesting item #2: CMS states that the authority to invoke CED “has existed for more than a decade but has been applied sparingly.” The document states also that CMS “believes that the lessons learned during the initial implementation of CED can inform its more frequent use.”
Interesting item #3: The draft acknowledges that there may be a problem with the fact that coverage of an item or service ends after the CED study ends. CMS suggests sponsors might develop “integrated research strategies during the planning of CED studies” that would allow the use of “practical observational studies to close outstanding evidence gaps and allow coverage” after a randomized, controlled CED trial ends. The fly in the paste here is that this would call for “an interim analysis, based on pre-agreed public criteria … to open or close enrollment in the follow up study.”
So how long will this interim analysis take? That’s how long coverage would be absent.
There’s a lot more to the guidance than is covered here, but a cynic’s guide to the galaxy might state that the agency’s proclaimed interest in using CED more frequently comes with CMS’s unstated but widely suspected effort to draw a tighter noose around Medicare medical device spending. Beyond that, the difference between the old CED and the new CED might be “lots and none at all,” as Bilbo Baggins told the trolls.
FDA-to-CMS trial transition: strictly incidental?
Up to now, the vast majority of Medicare coverage decisions have taken place at the local level, but clearly the ratios are going to change. CMS also seems to argue that its cooperation with FDA is incidental to the CED process. The draft CED guidance states that the agency sees the “alignment of CED with an FDA post-approval study requirement” as nothing more than “an example of a CED application rather than a new CED paradigm.”
I wonder if device makers with first-of-a-kind devices will believe that, given the talk about integrated research strategies, practical observational studies and gaps in coverage after the CED study is over. These “practical observational studies” are yet another clinical study requirement, and device makers are not going to ignore the need to mesh their FDA trial mandates with those of CMS in order to keep the number of studies down to a manageable number. Not if they want to keep investors on board, anyway.
This is anything but a mere “example of a CED application,” and a lot closer to “a new CED paradigm” as best as I can tell. If I’m not mistaken, it’s called “parallel review.”