Services — major code sets, all technologies
The work that decides whether you get paid
Fourteen engagements. Eight cover the major U.S. code sets and supplemental-payment pathways — CPT, HCPCS Level II, ICD-10-CM, and ICD-10-PCS — plus the payment classifications those codes feed: new DRG assignments under IPPS and new technology APC applications under OPPS, with independent code application reviews and general reimbursement consulting rounding out the filing practice. Six standing services sit around the filings — advisory services, investment perspective engagements, reimbursement strategy, landscape assessments, strategic assessment analysis, and the mock CMS review panel — for drugs, biologics, medical devices, diagnostics, and combination products. Each is scoped as a fixed-fee statement of work: you know the deliverable, the timeline, and the price before we start. Not sure which one is yours? That's exactly what the code readiness assessment answers first.
01CPT Code Applications
CPT · PLA · Diagnostics
Category I, II, and III applications to the AMA CPT Editorial Panel — plus PLA codes and the coverage pathway work diagnostics actually live or die on. For devices, diagnostics, and physician-administered technologies alike.
- Category I vs. Category III strategy and timing against FDA authorization; the Editorial Panel meets three times a year, on application deadlines set months ahead
- Full application drafting: clinical vignettes, literature, and utilization rationale
- RUC / valuation preparation so the code lands with a payable value
- PLA codes for proprietary diagnostics — quarterly application and effectuation cycle, and the PLA-vs.-Category I decision: proprietary and fast, or established and broadly payable
- CLFS payment strategy — whether CMS crosswalks your test to an existing rate or gapfills it through the MACs, and what each route does to your first years of payment
- Coverage pathway work, in scope: LCD landscape analysis, MolDx technical-assessment support, and payer sequencing — the code gets you listed; coverage gets you paid
Best when: your technology needs a procedure or service code that payers will actually recognize — not a workaround.
02HCPCS Level II & J-Code Applications
HCPCS · MEARIS · CMS-10224
The application CMS actually reads — built the way the HCPCS Workgroup evaluates it, precedent by precedent. Drugs and biologics file on quarterly cycles; devices, supplies, and DME file on biannual cycles.
- Full MEARIS CMS-10224 answers (Questions A–N) with evidence binder
- J-codes, A/E/K/Q and other Level II families; descriptor & billing-unit design with JW/JZ waste math
- Existing-code analysis — why a miscellaneous code or a packaged supply code won’t do
- Therapeutic / functional distinction case with systematic literature review, including unfavorable articles
- Every draft scored in a Workgroup simulation before it files — how the simulation works
Best when: you’re 12–24 months from launch and the trial or evidence plan can still capture what the application will need.
03ICD-10-CM & ICD-10-PCS Code Applications
ICD-10 · C&M Committee
Diagnosis and inpatient-procedure codes through the ICD-10 Coordination & Maintenance Committee (CMS + CDC/NCHS). Without the right ICD-10 code, the claim has nothing to hang on.
- ICD-10-CM new diagnosis codes and Tabular / Index revisions
- ICD-10-PCS new technology Section X and procedure codes for inpatient cases
- Committee proposal drafting, presentation support, and comment-cycle strategy
- Alignment of ICD-10 with CPT/HCPCS so inpatient and outpatient stories agree
Best when: your product treats a condition or is used in a procedure that the current code set describes poorly — or not at all.
04New Technology Add-On & Pass-Through Applications
NTAP · OPPS · §419.64
The supplemental-payment pathways that make new technology viable while the data catch up — inpatient NTAP under IPPS and transitional pass-through under OPPS.
- IPPS New Technology Add-on Payment (NTAP): eligibility, cost-threshold modeling, and application
- Alternative NTAP pathway support for Breakthrough Devices and qualified technologies
- OPPS transitional pass-through (§419.64 cost tests) and §419.2(b)(16) supply-packaging defense
- APC-by-APC dollar hurdles and post-pass-through / post-NTAP cliff planning
- Site-of-care strategy across physician office, ASC, HOPD, and inpatient
Best when: the base payment doesn’t cover your technology yet and you need the bridge — modeled before you promise anyone a number.
05Medicare PDAC Applications & Coding Verification
PDAC · DMEPOS
Applications to the Medicare Pricing, Data Analysis and Coding (PDAC) contractor — the coding verification and DMEPOS determinations that decide how DME, prosthetics, orthotics, and supplies get billed.
- PDAC Coding Verification Review applications for DMEPOS products
- Correct Coding Initiative and product-classification strategy
- Level II code verification letters and re-review / reconsideration support
- Billing and documentation guidance aligned to the PDAC determination
Best when: your device or supply needs a defensible HCPCS assignment that DME MACs will honor on the first claim.
06Pricing, Payment Analysis & Fractional Leadership
Strategy · ASP · Launch
WAC is a one-way door and payment policy moves quarterly. We run the analysis before pricing locks — and provide fractional leadership when you need it.
- WAC / ASP trajectory modeling, ASP+6% office economics, and IRA inflation-rebate exposure
- Commercial & Medicaid payment cross-checks by setting; UB-04 / claim-form readiness
- Launch readiness: interim miscellaneous-code playbook before the permanent code lands
- Payer policy monitoring, denial triage, sales-team guardrails, and quarterly steering reviews
- Pricing checked in models built for the decision at hand — §419.64 cost tests, Question N consistency — against filings experience going back to 2001
Best when: approval is in sight and reimbursement is about to become daily weather — not an episodic project.
07New DRG & New Technology APC Applications
DRG · APC · IPPS / OPPS
Codes get you recognized; DRGs and APCs decide what the case actually pays. We build the classification requests that place a new technology in the right payment group — inpatient MS-DRGs under IPPS and new technology APCs under OPPS.
- New DRG applications and MS-DRG assignment requests — severity logic, CC/MCC structure, and the case-cost data CMS's annual rulemaking runs on
- ICD-10-PCS code-to-DRG mapping analysis, so the procedure code and the payment group tell the same story
- New technology APC applications under OPPS, including device and service category placement
- Case-cost and charge modeling that shows whether the group actually pays for the technology
- Post-assignment monitoring — recalibration, weight changes, and packaging exposure as the rules turn over each year
Best when: the code exists but the payment group doesn't fit — the case pays as if your technology weren't in the room.
08Code Application Reviews & Reimbursement Consulting
Review · Second Opinion
Already have a draft — written in-house or by another firm? An independent review before you file is the cheapest insurance in this business. And for everything that isn't a filing, general consulting puts the firm's reimbursement judgment on call.
- Independent review of CPT, HCPCS, ICD-10, DRG, APC, NTAP, and pass-through applications before filing
- Findings ranked by severity — what a panel, workgroup, or committee will challenge, and how to fix it while there's still time
- Second opinions on code-path, descriptor, and payment-pathway decisions already made
- General reimbursement consulting: coding, coverage, and payment questions answered as they arise
- Reimbursement expertise for internal teams and diligence — the risk read on someone else's coding and payment claims
Best when: the application is drafted but unfiled, or you need senior reimbursement expertise without a full application engagement.
09Advisory Services
Advisory · Ongoing Counsel
Senior reimbursement counsel on call — the questions that don't wait for a filing cycle, answered by senior practitioners who have filed, appealed, and collected on them.
- Ongoing senior counsel on coding, coverage, and payment questions as they arise
- A standing second read on payer policy changes, denial patterns, and coding guidance
- Direct access to senior advisors — no junior hand-offs, no call-center layers
- Scoped to the hours you'll actually use, with regular steering reviews
Best when: reimbursement questions land weekly and you want one senior answer, not a research project each time.
10Investment Perspective Engagements
Diligence · Investor Perspective
Reimbursement is where medtech and life-science valuations quietly succeed or fail. We give investors and acquirers the operator's read — before the term sheet, not after the write-down.
- Reimbursement diligence on medtech and life-science assets: code status, coverage posture, and payment reality
- The pathway read — what a code, NTAP, pass-through, or DRG assignment would actually require, and how long it takes
- Revenue-model stress test: whether the forecast's coding and payment assumptions survive contact with CMS policy
- Findings in writing, ranked by severity — the risks priced in, and the ones that aren't
Best when: you're evaluating an acquisition, an investment, or a portfolio company whose value depends on getting paid.
11Reimbursement Strategy
Strategy · Portfolio & Launch
The plan above the filings: which codes, in which order, in which settings — set at portfolio and launch level, before individual applications are scoped.
- Portfolio-level coding, coverage, and payment strategy across products and indications
- Launch sequencing: code path, evidence plan, and pricing decisions ordered against the filing calendars
- Site-of-care and channel strategy — office, ASC, HOPD, and inpatient economics compared before you commit
- Board- and investor-ready reimbursement narratives grounded in the actual pathways
Best when: the decisions interact — multiple products, multiple settings, one launch window — and somebody has to hold the whole map.
12Landscape Assessments
Landscape · Coding · Coverage · Payment
Before you commit to a pathway, see the whole field. A landscape assessment maps how a product or category is actually coded, covered, and paid today — the competitors, the precedents, and the gaps your strategy has to be built on.
- Coding landscape: the codes in use across the category, who holds them, and where existing descriptors leave your product unserved
- Coverage landscape: LCDs, payer medical policies, and MolDx postures across Medicare and commercial payers — who pays, under what conditions, and who doesn't
- Payment landscape: rates by site of care (office, ASC, HOPD, inpatient), packaging exposure, and the supplemental pathways already in play
- Precedent landscape: granted and denied applications in and around your category — what reviewers accepted, what they rejected, and why
- Findings delivered as a written assessment: the map, the gaps, and the openings, ranked by what they mean for your filing and launch decisions
Best when: you're entering a category, sizing a market, or choosing a direction — and need the reimbursement terrain mapped before money is committed.
13Strategic Assessment & Analysis
Analysis · Options · Decisions
A landscape tells you where things stand; a strategic assessment tells you what to do about it. We take the evidence — your product, the landscape, the filing calendars — and turn it into a decision: options scored, trade-offs priced, and a recommendation you can defend in the room.
- Pathway options analysis: each viable code and payment route scored on probability, timing, payment outcome, and evidence cost
- Scenario and sensitivity modeling — what the plan looks like if the code is granted, packaged, delayed a cycle, or denied
- Sequencing and timing analysis against the filing calendars, FDA authorization, and launch window
- Risk-weighted recommendation in writing — the move we would make, the alternatives considered, and the conditions that would change the call
- Board- and investor-ready presentation of the analysis for teams that have to carry the decision upward
Best when: the options are real, the stakes are material, and the decision has to be made on analysis — not on whoever argues loudest.
14Mock CMS Review Panel
Panel Review · Verdict · Feedback
Your application is finished — but is it ready? Before CMS sees it, a panel of former CMS reviewers drawn from the firm's expert bench reviews your completed application the way CMS will: independently, against the same criteria, and with the verdict and feedback delivered while there is still time to act on them.
- Panel of former CMS reviewers and senior specialists from the firm's network — each reviewer works independently, so you get separate reads, not one negotiated opinion
- A clear readiness verdict from each reviewer on the application as it stands: file it, fix it first, or rethink it
- Field-by-field findings across the whole application — descriptor, distinction evidence, existing-code analysis, billing units, and pricing — what holds, what doesn't, and why
- Prioritized remediation: every finding ranked by how much it moves the outcome, so the remaining window before your deadline goes to the fixes that matter
- Findings delivered as a written panel memorandum, with a walkthrough session for your team
Best when: the application is complete and the filing deadline is close — you want CMS's likely answer before CMS gives it.