5 for Five: Device coverage from the pages of MDD

May 31, 2013 – 7:35 AM | By Mark McCarty | No comments yet

Another interesting quintet, no?

The merry month of May is just about kaput, so let’s ask ourselves how entertaining the past five months of May have been. Entertaining, that is, if you’re a med tech geek or wonk, and it’s a cinch you’re one or both of those if you’re reading this.

The May 5, 2008, edition of Medical Device Daily included a story by MDD’s Omar Ford describing the decision by the Centers for Medicare & Medicaid Services to cover the use of artificial hearts. The decision was a landmark for patients, but one of the interesting things about the story was that CMS was at the time headed by one of those “acting administrators,” Kerry Weems. Thankfully we now have a real administrator, Marilyn Tavenner, on the job, the first to be able to say that in a number of years.

SynCardia (Tucson, Arizona) has manufactured a lot of temporary total artificial hearts since that time, including one that went into the chest of Justin Ryder, a 35-year old former professional athlete. Ryder was on the Syncardia artificial for nearly three months earlier this year while waiting for a suitable transplant.

Abiomed (Danvers, Massachusetts) has also maintained a space in the artificial heart space with the Abiocor, an ingenious fully implantable system. It’s remarkable to think that more than 30 years have passed since Barney Clark had a Jarvik 7 implanted in his chest in 1982. It really is amazing to think how much has changed in this technological area in those three short decades.

As was the case for the previous year, 2009 presented a lot of interesting content. One of the most interesting was a hearing in the Senate Finance Committee dealing with healthcare reform. The May 6, 2009, edition of MDD includes a description of how some protesters attempted to disrupt the hearing with calls for a single-payer system.

Committee chairman Max Baucus (D-Montana) called for a little civility, but his previous comments had made clear he would not push for single-payer healthcare. The calls for deploying healthcare reform “in a fiscally responsible way” echoed throughout the hearing, but that promise is looking increasingly tenuous as the ramifications of the Affordable Care Act continue to make themselves felt.

Anyone who thinks “interoperability” is a dirty word is obviously not a healthcare IT consultant, and the May 7, 2010, edition of Medical Device Daily showed once again that government can dole out money toward the search for the Holy Grail even when the knights have no idea where to look.

The federal government had announced that week it would supply providers with $200 million in healthcare IT grants despite the absence of an interoperability standard, a predicament that hasn’t been relieved by billions of dollars in HIT grants and untold effort by a wide range of interested parties. Healthcare IT interoperability would be fodder for any comic working the clubs in DC if not for the justifiable outrage over Uncle Sam’s borderline criminal abuse of taxpayer dollars.

If you like the word “innovation,” you’ll love what Eidosmed (Chicago) did with its compliance systems. According to FDA’s March 16, 2011, warning letter to the firm, Eidosmed was in the habit of maintaining design history documentation in company e-mails.

I didn’t come out and say this in the May 4, 2011, edition of MDD, but let’s face it: While this is not a good way to impress FDA, it cannot be argued the idea lacked originality.

CMS announced last year it would cover the use of transcatheter aortic valve replacements (TAVR) via the coverage with evidence development (CED) framework. It was an interesting bit of coverage in the May 2, 2012, edition of MDD, not just because the write-up had its share of acronym soup.

CMS dropped the notion of requiring that the CED trial be designed to demonstrate superiority of TAVR thanks to the objections of clinicians from just about everywhere outside of Antarctica. The decision was also interesting in that it purportedly involved the use of parallel review, a much-touted mechanism seemingly destined to never account for more than a handful of device applications per year, if any.

However, team medicine also got a big boost in this coverage decision, a rubric for clinical decision-making sure to get a lot more use than parallel review in the years to come.


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