Short answer
A path to paid use covers the steps between an account's yes and the payment: price and terms, code, authorization, order and delivery, claim and appeal. Each step has an owner, an evidence file and a review date. The 2026 record at Inspire shows what happens when one step, the billing code, changes under a product that physicians already use.
Series · Commercial Planning · Part 3 of 5
Inspire: the code behind 10,000 cases
In its May 4 first quarter release, Inspire said the CPT code used for about 10,000 Inspire V cases in 2025 had stopped being available for Medicare cases. Physicians, centers and the company had to work through coding alternatives during the quarter. [1] Revenue grew 1.6% to $204.6 million, with the release citing the adverse effects of reimbursement disruption and the WISeR program. Inspire lowered its 2026 revenue outlook to $825 million to $875 million, a decline of 4% to 10% from 2025. [1]
In the second quarter, revenue fell 7.6% to $200.6 million, and Inspire attributed the U.S. decline primarily to the evolving coding and reimbursement environment. It raised its revenue range to $835 million to $875 million. [2]
On October 1, Inspire announced that the AMA CPT Editorial Panel approved new Category I codes covering single-lead implantation with an implantable pulse generator, effective January 1, 2028. Inspire expects CMS to publish proposed valuations in July 2027 and final valuations in November 2027. [3]
The lesson for a launch team is about timing. The product, the clinical evidence and the physician demand were in place. The payment path ran through a code, and the code determined what could be billed for Medicare cases. The new codes are expected about two years after the disruption began, so a plan needs a stated interim path for that period.
WISeR: authorization reviewed against a checklist
CMS began the WISeR model on January 1, 2026 in six states: New Jersey, Ohio, Oklahoma, Texas, Arizona and Washington. Participants use technology plus clinical review for prior authorization of selected services, including implantation of electrical nerve stimulators. CMS states that the model leaves Medicare coverage and payment policy unchanged. [4]
CMS publishes the reason statements a reviewer can cite. For hypoglossal nerve stimulation they refer to six documentation items: minimum age, body mass index, polysomnography results within 24 months of the first consultation, CPAP failure or intolerance, drug-induced sleep endoscopy findings and the presence of a contraindication. [5] Inspire named WISeR among the effects on its first quarter. [1]
A launch team can read this list as an authorization packet. Each reason statement maps to a document, a person who collects it and a date it must exist before submission. The reviewer's checklist then becomes the site's checklist.
Prices and terms follow the payment path
Price and contract language belong in the same review as code and authorization. A price set against one payment amount needs a review date for the day that amount changes. A contract with a site or distributor needs a stated plan for a code change, a documentation requirement or a delayed shipment. These checkpoints are proposed in this article as a working method, and the table below turns them into gates.
An order and delivery exception: Stryker and Boston Scientific
Orders also depend on product reaching the site. Stryker identified a cybersecurity incident on March 11, 2026 and reported on April 9 that it had a material impact on first quarter results, that it was fully operational across its manufacturing network and that its ordering and distribution systems had been restored. [6] Organic net sales grew 2.4% in the first quarter and 9.0% in the second. [7][8] Those are company-wide totals. They report aggregate growth and leave account-level ordering unreported.
Boston Scientific identified its incident on August 25, 2026. On September 8 it said a network outage had affected its ability to manufacture and to process and ship orders, that it expected to recover some portion of the impacted revenue as it reduced backlogs and that the full impacts were still unknown. [9] On September 9 it reported manufacturing, order fulfillment and shipping fully restored, with some customers possibly seeing temporary delays on orders from before and during the disruption. [10] As of October 13, the company has said it will update its outlook on its October 28 call. [9]
For a launch plan, the shared point is the date set: when systems were restored, when the backlog reached normal levels and when each affected account returned to its earlier pattern. A team can record the three dates for any disruption, even when public figures report only the first.
Practical asset: the paid-use pathway, authorization packet and exception log
Use the pathway table to describe the route for your first account. Leave a gate blank until you learn the answer. A blank gate shows what to find out.
| Gate | Question to answer | Evidence | Owner | Next decision |
|---|---|---|---|---|
| Price and terms | Which payment amount, code and terms does the price assume, and when is it reviewed? | Price file, payment source, review date | Commercial lead | Set a review date and a fallback price |
| Payer or budget | Who pays, and from which budget? | Named payer or budget owner, confirmed in writing | Commercial lead | Confirm the path before the first account |
| Contract or purchase | Which agreement or approval step comes before the first order? | Draft contract, committee date, plan for code or policy change | Account owner | Approve or revise terms |
| Code and coverage | Which code, policy or formulary position applies today, and what replaces it if it changes? | Code listing, policy text, interim billing path | Reimbursement lead | Seek a policy or choose a workaround |
| Authorization | What must exist in the file before submission? | Authorization packet, approval rate and time by payer | Market access lead | Fix the most common gap |
| Order and delivery | What happens to a confirmed order when a system, plant or carrier is down? | Order-to-ship time, backlog by account, fallback plan | Operations lead | Name the fallback and the customer message |
| Claim and payment | When does payment arrive, and for how much? | Paid claims, days to payment, amount versus list | Finance lead | Adjust pricing or terms |
| Appeal | What happens after a denial? | Appeal outcomes by reason | Reimbursement lead | Continue, escalate or stop |
Then build the authorization packet from the payer's own list of reasons. The first row shows the pattern with the CMS hypoglossal nerve stimulation items:
| Reviewer item | Document that answers it | Who collects it | Needed by |
|---|---|---|---|
| Polysomnography within 24 months of first consultation | Sleep study report with date | Sleep clinic coordinator | Before consultation closes |
Then keep the exception log. One row per denial or delay:
| Date | Account or payer | Gate | Category | What happened | Owner | Next action | Decision date |
|---|---|---|---|---|---|---|---|
Categories to start with: payer administration, clinical evidence, coverage, account or budget timing, order and supply, and activation. For a disruption, add three columns: systems restored, backlog at normal level, account back to its earlier order pattern.
In the weekly review, ask three questions. Which gate has the oldest open exception? Which exceptions are restored but still waiting to recover? Which owner needs help? Part 5 returns to this review.
Which gate in your own path to paid use still lacks an owner?
Sources and evidence scope
Public filings, company releases and CMS documents checked October 13, 2026. Company statements are reported as company statements, and dates for future codes and valuations are company expectations. The gates, categories, owners, packet and measures are a proposed operating framework.
- Inspire Medical Systems, "Announces First Quarter 2026 Financial Results and Updates 2026 Guidance," May 4, 2026.
- Inspire Medical Systems, "Announces Second Quarter 2026 Financial Results, Raised 2026 Guidance and Strategic Growth Plan," August 3, 2026.
- Inspire Medical Systems, "Announces Approval of New Hypoglossal Nerve Stimulation CPT Codes by the AMA Editorial Panel," October 1, 2026.
- CMS, "WISeR (Wasteful and Inappropriate Service Reduction) Model."
- CMS, "eMDR WISeR Reason Codes and Statements," Table 12, hypoglossal nerve stimulation.
- Stryker Corporation, Form 8-K/A, April 9, 2026.
- Stryker, "Stryker reports first quarter 2026 operating results," April 30, 2026.
- Stryker, "Stryker reports second quarter 2026 operating results," July 30, 2026.
- Boston Scientific Corporation, Form 8-K, September 8, 2026, Item 1.05.
- Boston Scientific, archived cybersecurity incident update, September 9, 2026.
What comes next
Part 4, Make the Second Use Repeatable: account ownership, procedure ramp, training and field enablement, with an account activation scorecard. Part 5, Run the Commercial Plan Every Week: cross-functional cadence and leading indicators, with a weekly commercial review template.
Catch up on Part 1 and Part 2.
Frequently asked questions
- What is a path to paid use?
- The ordered steps from an account's decision to buy or use a product to the payment for it, including price, contract, code, authorization, order, delivery, claim and appeal.
- How does a team build an authorization packet?
- Each reason statement a reviewer can cite becomes a row in the packet, with a document, a collector and a date. The CMS hypoglossal nerve stimulation statements show six such rows.
- What should a plan say about a code change?
- A code change can leave the product available and the payment path unclear. A plan names the interim billing path, the owner and the review date before the change arrives.
- What is the difference between restored and recovered?
- Restored means the systems or plants work again. Recovered means the delayed orders shipped and the affected accounts returned to their earlier pattern. Company filings report the first and, in aggregate, the sales totals.
- Who owns an exception that crosses teams?
- Name one person accountable for the whole path. Reimbursement, finance, operations and account owners handle the gates they know best.