Wednesday, July 10, 2024

CMS Releases Outpatient Proposed Rule CY2025 - Big Day for Radiopharmaceuticals

 As usual for early July, CMS releases the proposed hospital outpatient rule on July 10, 2024.

See the fact sheet here.   The press release is here.

The typescript inspection copy is here.  It weighs in at 984 pages.

The typeset version will appear July 22 in Federal Register.

Early coverage at Fierce Healthcare here. At Advisory Board.

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There are new quality and conditions of participation rules for obstetric services, including E.R.

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Scanning for words like "molecular" and "laboratory" I did not see anything noteworthy.

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CMS proposed to revised its longstanding bundling of radiopharmaceuticals, whatever cost, into single average charges for the PET or other nuclear scan.  See the radiology website "aunt minnie."  See also an AI discussion of the proposal at sidebar.

  • Diagnostic radiopharmaceuticals with a per-day cost more than $630 would be paid for separately under CMS’ newly-proposed rule, rather than being bundled with nuclear medicine tests.
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  • “This update should address challenges for patients in accessing these prescribed nuclear medicine tests with higher-cost radiopharmaceuticals,” CMS wrote in its press release describing the rule.
  • Similar changes have been proposed a few times by legislation, but hasn't passed [FIND Act].

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At PDF pages 189ff, Section (g), there is a rather comical dance around range of prices that could be assigned to AI-assisted imaging services (From $3 to $900) related to APC 1511 and codes 0623ff.   

CMS writes,  it is unlikely that a service with a current payment rate of $950.50 would have a geometric mean of $4.20, an arithmetic mean of $6.60, and a median of $3.52.  These findings lead to uncertainty about the appropriate payment rate for the service described by CPT code 0625T...

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See a Hill letter to CMS on June 20 on this topic:

https://www.acr.org/-/media/ACR/Files/Advocacy/AIA/Letter-to-CMS-on-OPPS---Diagnostic-Radiopharmaceuticals---FINAL.pdf

See the SNM page on "FIND" act

Facilitating Innovative Nuclear Diagnostics

https://snmmi.org/Web/Advocacy-and-Initiatives/FIND-Act/Default.aspx 

Scott Gottlieb criticized the over-bundling back to early 2000s


click to enlarge