In past cases, ALJs have ruled that there can be "constructive LCDs" - for example, if a contractor says in an Article that Service XYZ is not reasonable and necessary and is non-covered, that may not be formally called an LCD by its MAC author, but it is a de facto LCD, and can be appealed through the BIPA 522 channel.
A 2017 Medicare review board case reversed an ALJ who had broadly construed his ability to call something a constructive LCD based on a reasonable and necessary decision. In the case, a DME MAC had ruled that continuous glucose monitors were "not a benefit category" because they were "precautionary" to check for low glucose levels. The ALJ ruled this was equivalent to saying they were not reasonable and necessary and found the CGM should be covered. CMS escalated the case to a panel of review judges, who ruled that the decision of the MAC was a "benefit category decision" and therefore not accessible by the LCD review process, which is only for "reasonable and necessary" decisions.
- I describe in more detail here and provide links.
- DME benefit category decisions can have close overlap with reasonable and necessary decisions because categorizing something as DME invokes some steps that involve its medical use and purpose.
The potential adverse affect is for devious MACs to couch decisions in articles rather than in LCDs and switch to terms like "experimental and investigational" or as "precautionary" or as "benefit category decisions" with an eye to avoiding the textual keywords that would allow review by ALJs under the LCD review channel. I never understood the reasoning around "precautionary" - all glucose tests are precautionary for an abnormal glucose finding, INR tests in warfarin patients are "precautionary" for an abnormal INR finding. An MRI in a unilateral headache patient could be styled as "precautionary" for discovering if he has a brain tumor, and so on.
The particular decision about CGMs is of historic interest now as later CMS decisions allow coverage of some CGMs.