Crosstalk Between Implantable Devices

CMS, Medicare Set-Aside Blog, Medicare Set-Asides on December 30, 2014 | Posted by Jennifer Jordan, JD, MSCC

I recently stumbled across an interesting opinion out of the 6th Circuit Court of Appeals upholding a Medicare coverage determination denying the implantation of an infusion pump. The Medicare beneficiary in question suffered from chronic low back pain for over 20 years and was using high doses of multiple pain medications and a spinal cord stimulator originally implanted in the mid-1990s. The beneficiary’s Medicare Advantage Plan, Humana, denied coverage for the surgery and she appealed, exhausted her administrative remedies within Medicare and the denial was upheld by both the district and appellate court. So how is it that CMS can refuse to pay for a pain pump implantation when they so freely throw them into MSAs with reckless abandon???

As it turns out, pursuant to the Medicare National Coverage Determination Manual, implantation of an infusion pump is contraindicated in patients “with other implanted programmable devices since crosstalk between devices may inadvertently change the prescription.” (See Chapter 1, Part 4, 142, 280.14(B)(2)(e).) Despite testimony that many patients maintain two devices all the time (a fact we in WC know all too well) and that the device requested was allegedly designed not to cross-talk, the beneficiary did not actually challenge the Secretary’s interpretation of the regulation. Viewed as a categorical exclusion for patients already possessing an implanted electronic device, the court found that the Secretary did not abuse her discretion in denying coverage for the pump.

Now let’s not get too excited. We know that CMS will never permit us to limit MSAs to one implantable device when submitting them for approval. But what if we aren’t submitting?  In situations where we are funding “recommendations” that may never come to pass anyway, this is a legitimate legal argument supported by regulations and CMS’ own actions in a similar situation. Now if both have already been implanted and are working flawlessly side-by-side, it is probably a lot less likely that excluding the expenses from the MSA will be viewed favorably. But let us not forget that we do limit ambulation assistance to one device, so on the verge of the New Year, we just wanted to leave you a little bit of hope…

MARY K. WOODFILL, Plaintiff-Appellant, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Defendant-Appellee.
14a0162n.06
Case No. 13-3729
UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT
557 Fed. Appx. 473; 2014 U.S. App. LEXIS 3874; 2014 FED App. 0162N (6th Cir.)
February 27, 2014, Filed