Tuesday, July 5, 2016

Continuous Glucose Monitors: Coverage Possible After an LCD Challenge in 2016?

This blog details an important case where Medicare administrative judges rule that Medicare non coverage of continuous glucose monitors is wrong.   Details after the break.

While Medicare covers glucose monitors for diabetics, and has limited coverage of insulin pumps for diabetics, for some years Medicare has held the position that "continuous glucose monitors" are not reasonable and necessary.   (For advocacy information on this problem, see a 2014 article, here. and a 2015 article, here).  This has always seemed ridiculous to me; we regularly see diabetics who get a lot of use from CGMs, and I would certainly want one if I had insulin-dependent diabetes.  CGMs now pair seamlessly to your smartphones; it's 2016.  See a story at Dexcom, here.  On July 21, 2016, an FDA AdComm will review whether the Dexcom G5 CGM can be labeled as a replacement for conventional meters for managing insulin, here.

CMS non-coverage is based on DME MAC LCDs.   Since they are DME LCDs, they are uniform in all 50 states.   While from time to time individual beneficiaries have one a personal CGM based on a claims appeal in their own case (here), there is now a case where these non-coverage LCDs have been challenged through the LCD Challenge process (42 CFR 426.300ff).[*]

On April 29, 2016, the CMS Departmental Appeals Board issued a ruling (C-15-1021, CR4596), that LCDs and collateral CMS policies that arbitrarily stated (without discussion and evidence) that CGMs were not a statutory benefit were wrong.

The judge's ruling in the LCD Challenge is online here.   Judge Sickendick writes,
"The specific language that denies coverage is found ...in LCA A33614...denies coverage for CGMs and related supplies on a contractor-wide basis without a determination of whether or not CGM is reasonable and necessary, is not [in itself] valid under the reasonableness standard."
Several things here.  First, the statement about non coverage appears in an article, not an LCD, but the judge views the article as equivalent to an LCD for the purposes of LCD appeal.   Second, the article declares noncoverage, but provides no rationale.[*]  Medicare MACs aren't supposed to that they, but they do, listing spreadsheets of non covered codes or simply created an LCD that lists non-covered codes with no further justification.  Not "reasonable."   Third, this could be a major opening for a revision of an important area of Medicare coverage.   Note, though, that the judge isn't ruling CGMs as "necessary," only that the present telegraphic statement of non coverage is not "reasonable."   Fifth, while a lot of LCD Challenges fail (as the judge must defer to a "reasonable" LCD), some can win.  


CGMs are covered for appropriate patients by commercial insurance and there is no statutory or medical reason that are invalid for coverage under Medicare.

The judge's ruling is not trivial.  It doesn't require coverage of CGM, but it requires the MAC concerned to adjucate coverage of CGM without the nonsensical rationale that throws around empty buzzwords like "precautionary."  Also, while it appeals the LCD of one MAC, all four DME MACs are required to have the same LCDs, so presumably this change would require them to remain in lockstep with the same LCDs.

CMS does change policy based on court cases that find something nonsensical.  One good example was in 2014, after a class action lawsuit found a dated and irrational CMS physical therapy policy to be invalid (here).  I see a lot of analogies with this CGM judgement.


Medicare trivia buffs may enjoy the following endnotes.

Debra Parrish was the attorney of record for the case.

Legislation to force CMS coverage of CGM has been proposed, e.g. here.


A detailed case study report of an LCD challenge (regarding DME patient lifts; the DME case), by Gustas & Sheldon, is online here.  This case relied in part on the contractor's weak and arbitrary use of the term "convenience" as an exclusion to coverage whereas the CGM case hinges on the weak and arbitrary use of the term "preventative" as an exclusion to coverage.  All three cases (CGM, Transfer Factor, and the DME case) involved "constructive LCDs."   In both the CGM and DME case, CMS tried to have the case thrown out of the LCD Challenge process because the device under appeal was "not DME" and DME classification is not within the scope of an LCD challenge.  That angle, although it has a patina of procedural plausibility, was not accepted as a reason for termination of the LCD challenges by either the CGM judge or the DME judge.  "I do not accept that NHIC can avoid review [in an LCD challenge] by the simple expedient of characterizing [the equipment] as not DME, particularly because the lifts clearly fall within the broad definition of DME" (quoted in Gustas & Sheldon, p. 434).

Both the CGM and the DME cases contain callbacks to a 1996 agency decision, HCFA Decision 96-1, that has to do with the interpretation of statutory benefit categories in Medicare (here).  For example, diagnostic tests defined in 1965 as "x-rays and other diagnostic tests" (SSA 1861(s)(3)) which today includes everything from PET scans to genomic tests.

In my career at Medicare a decade ago, I was involved in a lengthy LCD Challenge regarding a homeopathic treatment, Transfer Factor (cases online here and here; the same Judge Sickendick who wrote the CGM case was involved at some points).

In 2001, in the case Erringer v Thompson (here), there was a judicial challenge to whether LCDs by local contractors violated federal laws such as the Administrative Procedures Act (see also here).   To shore up the statutory status of LCDs, subsequently Congress enshrined the LCD in statute and created a process for challenging LCDs.  See 42 CFR 426.300ff (here).

For an example of thinly justified non-coverage, see here or here and this text:

Who says they "are considered" precautionary?
What does "precautionary" mean?
Who says that "The DME Benefit" excludes precautionary items?