Reimbursement Pathway Viability Options
$5,000
Which reimbursement pathways are viable for your product?
An assessment of reimbursement pathway options across DME, CPT, hospital, and diagnostics.
For DME and connected-device companies
Faster and fixed-priced
reimbursement strategy.
McCarthy Market Access is an AI-native consulting firm combining reimbursement expertise with operating experience to help you strengthen your business model.
Mount Katahdin from Patten, Maine
Does this sound familiar?
World-class science and no way to get paid.
We won the code and Medicare still pays nothing.
CMS put us in someone else's code, at someone else's price.
CMS says our device is not a Medicare benefit.
Medicare priced us at a fraction of what we charge.
Explore your reimbursement pathway viability before you file.
Illustrative forms. The outcomes are drawn from published CMS HCPCS Level II decisions.
Schedule of fees · Effective September 2026
What do you need to decide?
Start with reimbursement pathway viability, focus on DME benefit category and coding, or build a full strategy. Pricing analysis follows the strategy work as an add-on.
DME Benefit Category and Code Analysis
$10,000
Where does your product fit within DME?
An analysis of the DME benefit category and code options for your product.
Full Strategy
$30,000+
Approximately 1 month
What will it take to build your reimbursement strategy?
Benefit category and code analysis, an evidence-building plan, a handoff brief, and expert review.
Optional add-on
Pricing Strategy and Analysis
$15,000–$20,000 additional
Comparable technologies, gap-fill analysis, and existing risk.
Requires Full Strategy first; not available as a standalone engagement.
Advisory and Fractional Support
$5,000–$15,000 / month
3-month minimum, then month to month
Who stays with us through the application and after?
Ongoing support: a weekly call, written answers within 2 business days and a first look at relevant CMS publications within 3 business days.
For investors and lenders
Reimbursement Diligence
$15,000
10 business days
Will this company's reimbursement plan hold up?
A review of a device company's coding and coverage assumptions and its pricing exposure, with the questions to put to management.
We do not bill hourly. Scope, delivery date, and the final fee are agreed before work begins.
Photographs, left to right: Owls Head; Jordan Pond and the Bubbles, Acadia National Park; Below the summit of Katahdin, Baxter State Park; Mount Katahdin, Baxter State Park; Hendricks Head Light, Southport.
Research publication
The 2026 DME Market Access Report is in preparation.
The record
A proprietary record of how CMS decides, and the knowledge of people who have been through it.
Published decisions show what CMS did. The firm combines that record with firsthand knowledge of what it took.
What CMS has published
831coding decisions, read and structured
330questions CMS asked applicants in public meetings
16cycles, 2017 through 2026-B1, and growing with each one
1 in 4applications ended with a new code
How those 831 decisions came out
- 223New code granted
- 197Existing code assigned
- 209Denied
- 93Deferred
- 109Pricing, revisions and other
What the published record does not tell you
What CMS asks in the room.
We have answered CMS's questions at a public meeting and watched a preliminary decision change.
What makes a software-driven device DME.
We have argued the five DME conditions for a device CMS first compared to a metronome.
What counts as pricing evidence.
We have seen multiple methods used to set a payment amount, including MSRP set aside in favor of VA pricing verified on the Federal Supply Schedule.
What order to do it in.
Code, benefit category and payment are three separate decisions. We know which work has to be finished before each one.
HCPCS Level II · DMEPOS fee schedule
E3200
Gait modulation system, rhythmic auditory stimulation, including restricted therapy software, all components and accessories, prescription only
Case study · MedRhythms · InTandem
This is why we are proven.
In 2024 CMS wrote a new line into the Medicare fee schedule for InTandem, a device it had no category for: a new code, a DME benefit category and a payment amount.
It took a team. Owen McCarthy, who leads this firm, co-founded MedRhythms and was part of that team from the first application to the payment decision. It is the work we now do for other companies.
The outcome reflects the work of the whole MedRhythms team and its contributors. CMS 2024-B1 and 2024-B2 final records. A code and a payment determination do not guarantee coverage or payment for every claim.
People
Operators who get to the so-what faster.
Owen McCarthy
Managing Director. Reviews and signs every recommendation.
Operator and policy: helped create InTandem's new Medicare code and chaired the Digital Therapeutics Alliance board.
Owen McCarthy
Managing Director. Reviews and signs every recommendation.
Operator and policy: helped create InTandem's new Medicare code and chaired the Digital Therapeutics Alliance board.
Owen co-founded MedRhythms and served as its President for a decade. He is a strategic operator rather than a single-issue adviser: his reimbursement advice accounts for the whole business, from the evidence plan and commercial model to financing and partnerships. He was part of the team that created a new Medicare code for InTandem, HCPCS E3200, and won its DME benefit category and payment amount. He brings a policy view as well as an operating one: he chaired the board of the Digital Therapeutics Alliance (2021–2022) after co-chairing its reimbursement working group, and has served on the board of the American Telemedicine Association. He leads the firm's work with device companies and signs each recommendation.
Read about Owen
Jennifer Lavanture
Strategic Advisor
Former DRG market access consultant; SVP of Corporate Development and Strategy at MedRhythms.
Jennifer Lavanture
Strategic Advisor
Former DRG market access consultant; SVP of Corporate Development and Strategy at MedRhythms.
Jennifer began her career as a consultant at DRG (PharmaStrat), advising companies on market access, pricing and reimbursement. She then moved to the operating side: Associate Director of Business Development at Rhodes Pharmaceuticals, running portfolio selection and co-development, licensing and distribution deals, and since 2019 corporate development and strategy at MedRhythms, where she is SVP and was part of the team that took InTandem to its own HCPCS code, DME benefit category and payment amount. She co-authored a book chapter on reimbursement for digital therapeutics with Owen and holds a B.S. in Business Economics, magna cum laude, from Lehigh University.
More strategic advisors coming soon
Let’s talk strategy
Book a strategy call.
A complimentary 20-minute strategy call to discuss your product, reimbursement questions, and the next steps for your business.
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