Earlier this week, CMS released a wide-ranging set of policy modifications to DME policy, ranging from HCPCS code procedures to benefit category determination rules to some specific policymaking, such as for Continuous Glucose Monitors (CGMs).
- See the CMS fact sheet here.
- See the CMS Press Release here.
- "Today, under the leadership of President Trump [etc]."
- See the Proposed Rule Homepage here.
- See the "inspection copy" or typed rule here [211 pages]. [Fed Reg Publication Nov 4]
- The official Fed Reg publication will be November 4 at the homepage cited.
CMS policy for CGM has been tortured, with non-coverage for a number of years under the vaguest of rationales, court cases, and interim policy changes on the CMS or the DME MAC websites. The new rule classes CGM as DME.
I've covered CGM weirdness in a number of skeptical blogs since 2016, several being here, here, and here. Parrish Law Offices has won a number of CGM cases for clients (here and here). The rule cites several CGM legal cases (e.g. "Finigan v Burwell 2016").
Elevated Volume of DME/HCPCS Rulemaking
In most years, a few pages of DME policy changes are tucked inside the annual summer ESRD rule. This year, DME gets a standalone rule. In addition, the rule contains histories of many of the obscure policy rules of DME, a history of CGM coverage that discusses DME payment concepts for glucose devices back to the early 1980s.
I've borrowed the phrase "Policy Worth Watching," from Indiana's Lance Geiger (here), who runs a YouTube channel of colorful ten-minute history vignettes several times a week (see "The History Guy" channel here), and his tag line "History that Deserves to be Remembered."
In last year's rulemaking, CMS proposed making a public advisory panel that would advise it on gapfill pricing for DME based on costs. I was alarmed this could occur and could be later applied to genomics also. For example, the panel might have little insight into costs and investments and return on risk capital; they were instructed to look at the end-product and estimate its costs. Here. CMS deferred action on the "pricing panel."