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Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027 FDA posts a Class I recall of Medtronic's Bravo CF delivery device after 184 serious injuries FDA approves Abbott's Aveir VR Mini, 14 percent shorter than the current Aveir VR Mayo Clinic and Thermo Fisher launch Precure to build a million-specimen molecular dataset FDA opens a reliance portal so foreign regulators can lean on its device decisions Medtronic offers a 7 percent discount to push 80.1% of MiniMed onto its own shareholders Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027 FDA posts a Class I recall of Medtronic's Bravo CF delivery device after 184 serious injuries FDA approves Abbott's Aveir VR Mini, 14 percent shorter than the current Aveir VR Mayo Clinic and Thermo Fisher launch Precure to build a million-specimen molecular dataset FDA opens a reliance portal so foreign regulators can lean on its device decisions Medtronic offers a 7 percent discount to push 80.1% of MiniMed onto its own shareholders

Reimbursement

CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027

MedDevice Startups Staff · 2 days ago · 2 min read · Via CMS press release

CMS is expanding its ACCESS model to cover heart failure, COPD, substance use disorders and tobacco cessation, and widening the existing bone, joint and mobility track. The model already covered high blood pressure, diabetes, chronic musculoskeletal pain and depression. It launches in spring 2027 with 160 participating organizations, across a ten-year run.

ACCESS ties payment to measured improvement in patient health rather than to individual billed services. CMS says participating organizations may deliver care through virtual visits, remote monitoring, connected devices and wearables. The agency plans to add organizations as the program runs.

This is the reimbursement question a remote monitoring or software-as-a-device company keeps running into: a route inside original Medicare where a device that moves an outcome gets paid for moving it. The buyer is still the participating organization, not CMS, so the addressable list at launch is 160 contracts long.

Questions & Answers

What conditions did CMS add to the ACCESS model in September 2026?

CMS added heart failure, COPD, substance use disorders and tobacco cessation, and widened the existing bone, joint and mobility track. The model already covered high blood pressure, diabetes, chronic musculoskeletal pain and depression.

When does the CMS ACCESS model start and how long does it run?

The ACCESS model launches in spring 2027 with 160 participating organizations and runs for ten years. CMS says it will add organizations over the course of the program.

How does the CMS ACCESS model pay for remote monitoring and connected devices?

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