# #427: Medical Device Reimbursement - Pitfalls to Avoid

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-10-06
- Length: 41m
- Episode: 427
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-06-427-medical-device-reimbursement-pitfalls-to-avoid
- Listen: https://podcast.greenlight.guru/episode/a-guide-to-medical-device-reimbursement

## Summary

Haley King, co-founder and CEO of Paxos Health, explains the critical distinction between FDA approval and securing reimbursement, detailing the three pillars of coding, coverage, and payment. She highlights the challenge of navigating CPT codes, specifically the gap between temporary Category 3 codes and the gold-standard Category 1, and notes that securing Medicare coverage can take an average of 5.7 years for innovative devices. King discusses how AI tools are being used to streamline manual patient access tasks, such as prior authorizations and appeals, while emphasizing the necessity of keeping human experts in the loop for high-stakes decisions. The conversation covers the importance of designing clinical trials with payer requirements in mind to avoid costly delays and ensure commercial success.

## Chapters

- [0:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-06-427-medical-device-reimbursement-pitfalls-to-avoid#t=31) Introduction: Haley King and Paxos Health
- [2:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-06-427-medical-device-reimbursement-pitfalls-to-avoid#t=168) The Reimbursement Journey: Coding, Coverage, and Payment
- [4:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-06-427-medical-device-reimbursement-pitfalls-to-avoid#t=269) Navigating CPT Codes: Category 3 vs. Category 1
- [9:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-06-427-medical-device-reimbursement-pitfalls-to-avoid#t=594) Challenges in Securing Payer Coverage and Timelines
- [15:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-06-427-medical-device-reimbursement-pitfalls-to-avoid#t=929) Integrating Reimbursement Strategy into Clinical Trials
- [20:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-06-427-medical-device-reimbursement-pitfalls-to-avoid#t=1219) Using AI to Streamline Patient Access and Appeals
- [24:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-06-427-medical-device-reimbursement-pitfalls-to-avoid#t=1478) AI Accuracy, Human-in-the-Loop, and HIPAA Compliance
- [30:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-06-427-medical-device-reimbursement-pitfalls-to-avoid#t=1820) Voice AI and Future Use Cases in Medical Device Development

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies

## Mentioned

- Paxos Health (company)
- Medtronic (company)
- Cooler Heads Care (company)
- CMS (other)
- United Healthcare (company)
- Aetna (company)
- Epic (other)
- Athena (other)
- ChatGPT (other)
- FDA (other)
- AMA (other)

## Related episodes from other shows

- [S2 E2: Demystifying Medical Device and System Development with Alan Cohen](https://hardwarepodcasts.com/podcast/the-builder-circle/2023-12-12-s2-e2-demystifying-medical-device-and-system-development-with-alan-cohen) (The Builder Circle)
- [027 - "Become a Historian of the Problem" with Duane Mancini](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini) (Let's Combinate)
- [S6E19 Stuart Grant | MedTech Innovation](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-05-09-s6e19-stuart-grant-medtech-innovation) (Being an Engineer)
- [176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski](https://hardwarepodcasts.com/podcast/lets-combinate/2025-02-19-176-the-fastest-way-to-ruin-drug-device-development-and-how-to-avoid-it-with-eri) (Let's Combinate)
- [104: Medical Device Certification vs Wellness Device](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device) (Product Startup)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-06-427-medical-device-reimbursement-pitfalls-to-avoid. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.