Payer Workshops on Clinical Endpoints and P&R for Novel Biologic

Reimbursement

l biologic, ADVI collaboratively designed, meticulously planned and moderate 1.5 days of EU and US payer workshops.

For a novel biologic, ADVI collaboratively designed, meticulously planned and moderate 1.5 days of EU and US payer workshops, gaining responses to and general consensus of a target product profile that includes P&R needs and expectations; label, including primary and secondary clinical endpoint evaluations; and outcomes data requirements.

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Real analysis from people who’ve been there

23 Jan 2024

29 Sep 2022

Reimbursement

Remote Therapeutic Monitoring

ADVI worked with the client and the AMA’s Digital Medicine Payment Advisory Committee to develop new CPT codes for remote therapeutic monitoring.

19 Sep 2022

Reimbursement

Cardiovascular Technologies

Reviewed primary clinical study literature and, based on published Medicare precedents and processes, produced mock National Coverage Determinations on several invasive cardiovascular technologies, applying typical CMS standards and formats.

19 Sep 2022

Reimbursement

Lumbar Spine Stenosis Device

ADVI worked with the client and CMS to reverse a negative draft NCD and obtained a final NCD with CED that required a randomized clinical study.

19 Sep 2022

Reimbursement

Non-Opioid Device Pain Relief Product

Assessed the positioning of a client's non-opioid pain relief device versus competitive products, including drugs and other devices used to treat pain.

19 Sep 2022

Reimbursement

AI Device for Osteoporosis Assessment

ADVI helped a client obtain a new Category I CPT code for the trabecular bone score AI software device.

19 Sep 2022

Reimbursement

Osseochondral Knee Implant

ADVI analyzed the reimbursement environment for a novel osseochondral implant under development to determine whether existing codes and payment would be sufficient for the new device.

19 Sep 2022

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