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BioWorld - Sunday, March 7, 2021
Home » Blogs » BioWorld MedTech Perspectives » The non-clinical hazards of low-dose CT

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The non-clinical hazards of low-dose CT

June 9, 2014
By Mark McCarty
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CMS's dilemma: Hear about it now, or hear about it later.
CMS's dilemma: Hear about it now, or hear about it later.

The behind-the-scenes story of Medicare coverage of low-dose CT (LDCT) screening for lung cancer is not the kind that makes page A1 in the major daily newspapers, but maybe it should. Physicians and device makers have lobbied extensively on the issue, as is their right, but I wonder if getting Congress to weigh in on this issue is really a smart move.

To start at the beginning, more or less, the Centers for Medicare & Medicaid Services recently opened a coverage analysis for LDCT, and the agency gave itself 12 months to sort through things. That might seem like a long time given that CMS needed only nine months to get through the hepatitis C screening analysis, but there’s no reason CMS should need the exact same amount of time to conduct two very different analyses.

Still, that didn’t stop physicians and industry from lobbying Capitol Hill on the issue. They were quite effective, prompting more than 40 Senators and nearly 140 members of the House to ink letters to CMS essentially urging CMS to drop the 12-month plan and hurry up and cover the USPSTF recommendations for high-risk beneficiaries.

I get that there is a public health issue at work here, but that can be said of just about anything CMS covers or declines to cover. So there’s nothing new about that. If you want to talk about public health, why not ask how many Americans are six feet under because CMS has been behind the times on coverage of implantable defibrillators?

I’d remind the reader that heart disease still kills more Americans over the age of 40 than what, the three deadliest cancers combined? So if you want to talk about public health, let’s talk about heart disease, shall we? Or Alzheimer’s? This is yet another indication that the cancer lobby has absolutely no sense of proportion, and indeed seems to have an entitlement air about it.

The dilemma CMS faces now is that if it speeds up the review, it sends a signal that it will succumb to congressional micromanagement if the cancer (or some other) lobby can create enough noise on Capitol Hill. That’s really a horrible message to send, so CMS really cannot – or at the very least really should not – deviate from the timeline it laid out earlier this year. Another problem with speeding things up is this: Which tasks at CMS will now take a back seat to this review?

Wait, you mean it might require that CMS take longer to review another life-saving technology? Doctors, device makers and public health advocates might say “sure,” and argue it’s a zero-sum game or better, so what’s the harm?

There’s a lot of harm when CMS has to blindly overrule an advisory conclusion that maybe the task force recommendation has holes in it, that’s what.

And just watch and see what happens if LDCT is overused for this indication as a consequence of the wished-for rush job. Do you genuinely believe docs and device makers will stand up and say mea culpa should such a situation emerge? Do you think anyone on Capitol Hill will take the hit?

If you do, you are the most hopelessly naïve person on Earth.

Again, I get that there are lives at stake, but I also think that subverting a process that has worked reasonably well up to now for a single outcome is amazingly short-sighted. Argue all you want that this is a one-time thing, but we all know that this will not be the last time someone lobbies Congress to mess with CMS on a coverage analysis if the agency caves.

This is a terrible idea, but the cancer lobby has never, ever, wanted for hubris. Let’s hope this fails and everyone involved learns a lesson in the process, but it might not be smart to hold one’s breath.

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