What you’ll get out of this episode

Host Carrie Nixon talks about Biotech and Life Science opportunities with innovation attorney Tommy Miller, who works with these types of companies every day and often serves as an expert speaker and commentator for the industry. 

In this episode, you’ll discover opportunities for Life Science and Biotech innovators in:

• Biologics, including reimbursement, accelerated FDA approval pathways, what sector of the industry can speed growth for everyone, and the push for developing mRNA and gene editing therapeutics for difficult or rare disease states;
• Software as a Medical Device (SaMD) and how the new “remote therapeutic monitoring” CPT codes revealed last week in the proposed 2022 MFPS will increase reimbursement options for mood and pain management—as well as the FDA’s investment in the Digital Center for Excellence to improve the regulation of SaMD;
• Decentralized trials and home digital health tools and how these trends are expanding recruiting options and returning more realistic data because people are accessing and using these products at home.

And much more! If you’re in the Life Science or Biotech industry, you are a provider who uses these products and tools in your practice, or you are an innovator, then then is a conversion you won’t want to miss.

Quotables

“We need to be sure that CMS is clearly signalling reimbursement opportunities for innovations, because we know things that don’t get paid don’t get done” Ep5 of @DecodingHealth1 w/ @NixonGwiltLaw https://sliceofhealthcare.com/category/decoding-healthcare-innovation/

“The opp is for companies w/ advanced and clean mfg tech to really start pushing for funding and advancement. The more we have, the more these pharma companies can rely on it and the more comfy the FDA is going to get.” Ep5 @DecodingHealth1 @NixonGwiltLaw https://sliceofhealthcare.com/category/decoding-healthcare-innovation/

“It’s a little bit chicken & egg: CMS says ‘we need to see demonstrated results before we reimburse’ & innovators say ‘we need need to make sure there’s going to be a rev stream or it’s not worth our while’” Ep5 of @DecodingHealth1 w @NixonGwiltLaw https://sliceofhealthcare.com/category/decoding-healthcare-innovation/

Recommended Resources

• Follow Life Science and Biotech Innovation Attorney Tommy Miller on LinkedIn and read more about Tommy here
• From the Nixon Gwilt blog: Read more about the 2022 Proposed MFPS rule and the new remote therapeutic monitoring (RTM) CPT codes and reimbursement options for SaMD and digital health innovators

Find out how to share your input with the FDA Digital Center for Excellence to effect change in into how SaMD products are regulated

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