Updated: Jul 8, 2021
MCDA and Washington Analysis produced the recent technical analysis and review regarding likely rate outcomes for Inspire Medical. See here for MCDA’s technical analysis and here for Washington Analysis’s summary note. As is a feature of our collective style, this analysis asked the question: Do optimistic assertions from the company and true believers fit within the bounds of what the policy math will allow, based on strict statutory and regulatory translations of the known framework into payment rates? Do those assertions work within reality as it now stands, and how best can we model the contingencies given what we know from all available sources?
Ultimately, nobody can know the eventual outcomes of a CMS payment decision before it happens except for CMS. Not Inspire, not MCDA, nor any other commenter or stakeholder. CMS’s initial specification for Inspire will be proposed over the next few weeks in the PFS 2022 proposed rule (most likely 7/16, second-most likely 7/23), commented on over the following 60 days by any public stakeholder, and finalized in November.
When the 2022 proposed rule is released, the company and commenters will, for the first time (with Inspire being allowed to release details without violating their NDAs with the AMA), have things to say that are informed by actual data and dynamics of the rate-setting process. The AMA’s RUC will also release their meeting minutes and recommendations shortly after the proposed rule is published, providing information and allowing further fact-checking and clarification, as well as analyses of AMA and CMS thinking. Nothing is certain until the comments are processed by CMS and its final rule is released.
Until then, our analysis, based on a detailed best-available-information research and interview process, builds up from assumptions about what would, mathematically, arise from the data and assumptions CMS ultimately applies the same methodology when the PFS rate-setting methodology applies. To repeat: nobody – particularly us and the company in question – knows what CMS will do. Until then, we recommend stakeholders wanting to bet for or against the company ask two simple and logical questions:
How much higher is the intensity of service for 645X1 than 64568?
How much longer does the intra-service procedure take (the main procedure as we would usually think of it – within the operating room) for 645X1 relative to 82568?
Ultimately, the validity of our conclusions rests on the answers to these questions. If you have different assumptions, they will translate into different outcomes. We would certainly invite you to ask both us or Inspire about those questions.
For queries on this post, please email james.muller@MCDAintel.com.