A group of industry and association stakeholders met with CMS in May 2017 to discuss long-postponed and much-needed changes to the 14 Day Rule. Below, I use the document's pagination (large numbers on the pages). This PPT and meeting didn't sway CMS alone; there were many other touchpoints and stakeholders involved over a couple years. But since this deck was associated with a success, it's probably worth study.
- The title is "The Impact of the Date of Service 14 Day Rule." So the "point" is "The Impact" and the "topic" is the 14DR.
- The stakeholders were Biodesix, Boehringer-Ingelheim, Guardant Health, LUNGevity, Myriad Genetics, Veracyte.
- Slide 2 is a detailed OVERVIEW with three sections, about ten bullet points, and a concluding signal to the "recommendation" or ask.
- So if you walk out after slide 2, you know everything the meeting was about.
- Slide 3 is a detailed "history of the problem" from 2001-2017.
- Slide 4 actually explains the whole 14DR, with a lot of text, but in a friendly "[Question]?" format.
- Note they chose to place "the history of the problem" ahead of "what the 14DR is." In part, they could be confident the people they were talking to knew what 14DR was. On the other hand, and we don't know, if this was a meeting with The Administrator, rather than mid level policy staffers, you couldn't assume that content knowledge.
- Slide 5 is clinical: "Impact on Lung Cancer Outcomes." ("Delay in treatment can result in worse outcomes, ^tiny journal footnote.")
- "Impact" here echoes the title of the whole deck.
- Slide 6 is similar, but colorectal cancer.
- Slide 7 is a fancy flow chart infographic of the whole landscape presented visually and organized L to R by time.
- Is the message "here's how the Swiss watch works" or "This damn thing you've created is more complex than a Swiss watch! It hurts my eyes!"
- "Consequences of These Billing Policies." Three bold categories, visual, "Inconsistent billing," "Beneficiary Access Problems," "Reduced Efficacy of Treatment" due to 14DR delay.
- From "Impact" to "Consequences."
- Slide is titled, "Real World Examples" but consists of a bullet description of the 7 stakeholders. Possibly this slide was a "backdrop" for a planned discussed segment with a script for each stakeholder.
- Make the problem real. Tell a story.
- "Evaluating the DOS Rule Effects." This is actually a short description of a CMS demo (requested by Congress) in 2012-2014, reported in 2016, that had no conclusions.
- Years go by and you CMS do nothing. At the least, do the following, next slide:
- ASK. Recommend that CMS Solicit Comments on DOS in Proposed Regulation." Flagged for CMS what points to request comment on. Stakeholders, in this deck, did not tell CMS what an "edit" or "redline" should be.
- "Additional Outreach." Coalition has a broad swatch of Hill meetings and has previously met with CMS at different level, and with groups like OMB. Notably, the group had already also formally asked in 2016 that CMS take public comment on 2017, the same ask that is already on record and being repeated in this deck.
- "The Landscape of Precision Diagnostics." Unclear why this occurs here, but it states that typical precision medicine tests are by a "lab that is unaffiliated with a hospital and specialized in one type of molecular testing." It states that "some" ADLTs are performed by a "single laboratory" but I think all ADLTs must be sole source.
- Landing slide; Simple "Thank you" (not an ask or other message.)
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