On Friday, July 15, after market close, CMS released the proposed hospital outpatient rule for CY2023.
The rule in typescript format is here:
The typeset version will appear July 29. The typescript version weighs in at 866 pages.
Data files and addenda are an important part of the process, and are found here. For example, CMS classifies all CPT Category III codes with a hospital pricing level.
The inevitable press release promising great improvements to U.S. medical care through this rulemaking is here and the more detailed fact sheet that summarizes the rule is here.
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I haven't reviewed in detail but I noted some changes to organ acquisition charges, which can include lab testing for organ matches (regulations at 42 CFR 413.416, 413.420). I noted some updates to regulations about drug costs for non-opioid pain management drugs, 416.174.
CMS has a new regulation for HCPCS codes for IDE studies (419.47).
There is the now-perennial payment classification and reclassification discussion for the Heartflow technology 0503T (typescript page 158ff, or search 0503T). This has to do with payment rationales for machine learning (or AI) which makes it worth tracking. As CMS writes,
We noted that HeartFlow was one of the first procedures utilizing artificial intelligence to be separately payable in the OPPS, and providers were learning how to accurately report their charges to Medicare when billing for artificial intelligence services (85 FR 85943). This especially appeared to be the case for allocating the cost of staff resources between the HeartFlow procedure and the coronary CT imaging services. Therefore, we decided it would be appropriate to use our equitable adjustment authority [etc]
CMS remarks that the adjusted claims value (from hospitals to CMS) for Heartflow comes in at $827, which falls between APCs at $498 and $961. "Since $827 is closer to $961" they classify it at $961.
More broadly than the payment level alone, there is an important later discussion of OPPS Payment for Software as a Service (typescript page 449 ff, final rule, 44502ff) which seems to be evolving some nuances in viewpoint between PFS RVU payments and OPPS APC payments for this important area of medicine. CMS provides several options for new outpatient software policies, and asks for public comment. I discuss more about new CMS ideas about algorithms in a July 29 blog here.
There is a section on payment policy for Category B Investigational Device trials (Fed Reg 44683ff).
