Every year, CMS publishes rulemaking about Durable Medical Equipment policies, often fairly inconsequential and often annexed to some passing major rule, like the annual ESRD rule.
In 2020, CMS made a more elaborate proposal (as well as as rolling up some DME topics in interim final rulemakings related to COVID last year). See 85 FR 70358, November 4, 2020, 57pp. CMS publishes new ways of making fee schedule adjustments outside of competitive bidding areas; CMS provides adjustments for rural areas; CMS provides rules for benefit category determinations for DME (and prosthetics etc, DMEPOS). Determining a benefit category sets whether something is payable at all, but the specific benefit category choosing will invoke different payments rules specific to that benefit.
As a side note, this benefit category thinking built into HCPCS decisions isn't brand new; many products for years and years have gotten a turn-down with the comment, "We do not believe there is a benefit category." And other items are assigned a code and a pricing method (such as an E-code and pricing as rental DME) meaning a benefit category choice was implicit.
Find The Stuff
Find the home page for the final rule here. Find the pre-publication or typescript inspection copy of the rule, 167 pp, here. On December 28, Fed Reg will release the final paginated and typeset version.
HCPCS "Theory and Goals" Simply Dropped from Final Rule; Bookmark the Proposed Rule
CMS is dropping some proposals such as regulations that HCPCS codes would follow CMS determining a service has a Medicare "claims processing need." CMS already utilizes this type of consideration (E.g. we read something was rejected because "we did not identify a claims processing need") but CMS won't be memorializing this and other concepts in permanent and formal regulations at this time.
To understand some of the nuances of CMS's thinking about HCPCS coding, one should definitely continue to bookmark the many pages written in November 2020 about "claims processing need" and coding theory and goals (e.g. 85 FR 70385), since all those pages were deleted from the final rule. But savvy HCPCS applicants will keep all those statements of policy and frameworks in mind.
Submit a Standalone Benefit Category Analysis; Timetable Matches HCPCS Requests
CMS will allow parties to submit benefit category requests without requesting a HCPCS code. These requests will be dovetailed with the existing twice-a-year HCPCS review and public comment process. (E.g. imagine a day with agenda items 1-10 = DME, agenda items 11-15 = Prosthetics, and then agenda items 16-18 are benefit category requests only).
If parties request a less formal benefit category decision off-cycle from HCPCS meetings, CMS seems to say it will in the future channel such requests into the biannual process rather than giving one-off replies.
I'm not sure how this new process fits with or replaces an existing, but very very rare process, called a National Benefit Category Determination (e.g.
here, for IBOT
here.) These resembled NCDs, for 40-page public analyses being publishes, as opposed to implicit or informal benefit category decisions made during coding, or stated in a sentence or two during the issuance of a new HCPCS code.
Lots About CGM - Continuous Glucose Meters
There are many pages covering precise and hotly debated nuances about the details of CGM policy, which I leave as an exercise to the reader.