Hi
@Wilba32in answer to your question, yes ASCs thoughout the US would be able to conduct transendocardial injections to administer cell delivery, provided the individual centers are properly resourced & an appropriate application is made.
IMO there would need to be a specific application made for a biologic such as Rexlemestrocel-l and its delivery by an ASC to be reimbursed on a passthrough basis, however the delivery procedure itself or the fact that it would be carried out in an ASC by ASC personnel shouldn't be an issue for Medicare to come to grips with.
Regarding 2023 payments to ASCs for complete delivery procedures, here's an extract (p. 176) from the
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency etc Final Rule that was published in the US Federal Register on 31 July 2023 (see link:
https://public-inspection.federalregister.gov/2023-14768.pdf).
The extract indicates, IMO, that the Federal Government in the US is willing to reimburse catheter-based surgical intramyocardial injections carried out in ASCs i.e. they are OK with risk of complications and mortality (whether the injection is transcoronary venous or transendocardial (as was the case in DREAM-HF where Dr Perin & his colleagues preferred to use the NOGA system linked with EEm or electromechanical mapping)). I believe Dr Perin et al used a Helix catheter in that trial as well:
NB 1: APC is an acronym for Ambulatory Payment Classification. Here the Federal Government is making clear the payment entitlement of ASCs delivering autologous cells in ambulatory surgical centers via a particular method of catheter-based intramycardial injection pursuant to two trials (run under the C9782 code). In this case the manner of injection was considered a New Technology, meaning it hadn't yet been assigned or was unable to be assigned to an existing clinical APC, as I understand it. However, there was no problem with the ASC actually carrying out the procedure.
NB 2: OPPS is an acronym for Outpatient Prospective Payments System. It's the way that Medicare in the US works out how much an ASC (or hospital or health centre) will get paid for what's considered outpatient care for anyone with Medicare in the US.
Hope this assists.
Cheers
(20min delay)