A recent court order invalidated language in the Pneumatic Compression Devices LCD. The decision has implications for all suppliers, not just those providing pneumatic compression devices.
The Decision (in summary)
A summary of the facts of the case and the DME MACs’ collective response is important to understand the broader implications.
CMS’s Pneumatic Compression Devices National Coverage Determination (NCD) stipulates continued coverage under two scenarios after a four-week trial. The DME MACs’ Local Coverage Determination (LCD) on the same topic included only one. Federal regulations prohibit LCDs from being more restrictive than their NCD counterparts, so the court invalidated the LCD.
In their July 2023 response, the DME MACs revised the LCD and related Policy Article, making the revisions retroactive to June 22, 2022. Instead of adopting – or adding – language to mirror the NCD, the DME MACs opted to remain silent on the issue by striking all language about continued coverage after the four-week trial. In my opinion, their approach lessens the completeness and helpfulness of the LCD as a standalone resource.
Broader Implications for all DME Suppliers
I believe the MACs are likely to assume a similar posture with other LCDs in the future, choosing to remain silent on issues simply because the NCDs address specific issues. Doing so will require suppliers to reference NCDs and LCDs collectively rather than the traditional norm of leaning on the LCD as a single aggregated resource.
I suspect the MACs chose to take a safer route using a “less is better” mindset. I don’t love it, but I am sympathetic to the predicament. The MACs are in the difficult position of providing clarification. They sometimes provide that clarification by weeding out ambiguous concepts, and in doing so, leave themselves open to the types of challenges illustrated in the pneumatic compression device case. While staying silent is the safer publishing position, it shifts the burden to DME suppliers to coordinate the multiple sources that define coverage criteria.
Enter the LCD Reconsideration Process
On the other hand, there is a formal LCD Reconsideration Process that, as it becomes more necessary, will actually give suppliers greater say in the ongoing development of coverage rules. Put simply, the process relies on suppliers, manufacturers, and advocacy groups to petition for formal reconsiderations of NCDs and LCDs based on supportable clinical research. The process, while bureaucratic in nature, is thoughtful and well organized. I believe it can improve policy evolution by marrying industry input with formal rulemaking, but it puts the burden of initiation on the industry.
LCD reconsiderations will become more common and more necessary in the days ahead. I do not think it is a bad thing, it’s just different than the way things used to work. In making this transition we shouldn’t forget that the old way had its flaws, too.