Below The Knee | Market Signal

The Rate Held. The Visit Didn’t.

CMS released the CY2027 Physician Fee Schedule and OPPS final rules on November 4. Skin substitutes held at $127.14 per sq cm in both settings. Non-sheet products gained national parity in the office but stay packaged in the hospital. The rest of what matters to wound and limb salvage practices lands on the visit: a deeper-than-proposed conversion factor cut, a 20% reduction when an E/M is billed the same day as a 0-day procedure, and new limits on remote monitoring, with the hardest one pushed to 2029.

Earnings show the market already reallocating. Smith+Nephew’s skin substitute line fell 8.8% while its wound devices grew 10.7%. Coloplast’s biologics fell 12%, and Kerecis earned a 1% margin. Capital went to a drug-pathway collagen therapy and to Net Health’s purchase of Sanara’s clinical AI assets. Organogenesis, still almost entirely a wound care company, is the cleanest test of how the transition year ends.

It reported after the close. Revenue fell 70%, the full-year guide came down, and cash ended the quarter at $26.9 million against a $22.4 million adjusted EBITDA loss. The price reset is done. The balance sheet reset is not.

Physician Payment | Conversion Factor Cut Deeper Than Proposed

The non-qualifying APM conversion factor drops 2.31% to $32.63. The qualifying APM factor drops 1.83% to $32.95. Both are below the July proposal ($32.84 and $33.17). The main driver is the expiration of the one-year 2.5% increase Congress provided for 2026. The rule publishes in the Federal Register on November 9 and takes effect January 1. cms

The BTK read: The cut lands on office practices that already lost most of their CAMP margin this year. Hospital outpatient departments get a 2.3% increase in the same year. The site-of-service gap widens from both ends.

Physician Payment | Same-Day E/M Reduction Finalized, Narrowed

CMS finalized a payment reduction when a separately identifiable office/outpatient E/M visit is billed on the same day as a procedure. The final policy is narrower than proposed. It applies only to 0-day global procedures, not 10- and 90-day, and the lower-paid service is paid at 80%, not 50%. CMS expects dermatology, otolaryngology, and podiatry to see the largest effects. APMA publicly denounced the decision. cms apma

The BTK read: The coalition won on scope and lost on structure. CMS dropped this idea in CY2019. This time it’s in the rule. E/M plus debridement or a CAMP application is the standard wound visit, and both are 0-day globals, so the narrowing that protected surgeons does little for wound care. Once the mechanism exists, extending it to 10- and 90-day globals is a rate change, not a new policy. Still open: how the cut stacks with the multiple-procedure reduction.

Remote Delivery | Vendor-Run Monitoring Gets Two Years

CMS finalized three of its four remote monitoring proposals: RTM limited to established patients, a required initiating visit, and lower valuations. The fourth, paying only when practice-employed staff do the work, is delayed to January 1, 2029. cms aha

The BTK read: Last week we asked whether the vendor ban would be narrowed. It was delayed instead. Smart offloading, remote temperature, and home surveillance companies have two years to move to models the rule allows, and lower payment starts now. Treat 2029 as a fixed date.

Skin Substitutes / CAMP | $127.14 Holds; Non-Sheet Splits by Site of Care

Sheet-form products stay flat at $127.14 per sq cm in both the physician fee schedule and OPPS, with no split by FDA pathway. CMS said it lacks enough CY2026 claims data and will revisit in CY2028 rulemaking, and it rejected industry-proposed rates of $478–$715 per sq cm. In the office, non-sheet products are now nationally priced at the same $127.14 per sq cm of wound surface area treated, and application codes G0681–G0684 move to national RVUs. In hospital outpatient, non-sheet products stay packaged. The rule text makes applications G0681 and G0683 separately paid, but OPPS Addendum B still lists both as packaged with no rate. Claims pay off the addenda, so as published, hospitals get no separate payment for non-sheet application until CMS issues a correction or the January quarterly update fixes it. The inflation rebate exclusion was narrowed as proposed, with no current product affected. cms

The BTK read: A second year at one rate, and a PMA product still earns no premium over a 361 HCT/P. CY2028 is the next window, built on this year’s claims. The new problem is the non-sheet split. The same gel pays $127.14 per sq cm in the office and nothing separate in a hospital wound center, which pushes volume toward office and mobile settings. The lobbying was aimed at the rate. The rate didn’t move.

Hospital Outpatient | 2.3% Update, More Procedures Leave the Inpatient List

The OPPS and ASC rates rise 2.3%, slightly below the proposed 2.4%. CMS finalized site-neutral payment for non-contrast imaging at excepted off-campus departments, 340B-acquired drug payment at ASP minus 28% (proposed: minus 33.4%), and removal of 637 more services from the inpatient-only list, including integumentary procedures. The ASC covered procedures list adds 618 codes. cms asca

The BTK read: The 340B cut is budget neutral, so it lifts non-drug OPPS rates and pushes ASC rates down relative to hospitals. Hospital wound centers get a raise in 2027. Office practices get a cut.

Diagnostics | Fluorescence Imaging Gets a National Code: CPT 97611

CPT 97611 replaces Category III codes 0598T and 0599T with national pricing in both settings. CMS finalized a work RVU of 0.80 and rejected requests for contractor pricing. The equipment input is a generic fluorescence imaging system, not tied to one manufacturer. The national office rate is $109.74 ($108.65 for non-qualifying APM clinicians). In hospital outpatient, 97611 pays $244.85 in APC 5722, a diagnostic test APC. The hospital rate is about 2.2 times the office rate, so the OPPS cap doesn’t bind. 97611 has no global period, so the same-day reduction doesn’t apply. The MAC comment period on the proposed RTFI and NIRS non-coverage LCDs closes November 14. cms

The BTK read: Coded but not covered is now final. CMS has set a national price for a service that the MACs propose not to cover. A payment code establishes what a service is worth. It doesn’t establish that it’s reasonable and necessary. The comment window is where that gets argued. Clinical comments that describe a changed management decision carry the most weight.

Add your voice: → WHA proposed LCD campaigns

Wound Therapy | Ultrasonic 97610 Cut in the Office, Raised in the Hospital

CMS cut the 97610 supply kit input from $320.18 to $125, in a case built on the manufacturer’s own investor deck. The office rate falls to $317.68 from roughly $400, with the rest of the cut phased into 2028. The hospital rate rises to $235.04 and is now always separately paid, including with same-day debridement. cms

The BTK read: A warning for every device-plus-disposable model. CMS priced the procedure off what the disposable costs the manufacturer, not what it charges. Any company that tells investors its consumable costs less than the CMS supply input should expect the same review.

Skin Substitutes / CAMP | Organogenesis: Revenue Down 70%, Cash at $27 Million

Organogenesis reported Q3 revenue of $45.5 million, down 70%. Advanced Wound Care fell 73% to $38.2 million, and surgical fell 19%. Gross margin dropped to 52% from 76%, and the adjusted EBITDA loss was $22.4 million. Cash was $26.9 million, down from $94.3 million at year-end. Full-year guidance is now $179.4–$200.0 million, down 65–68%. globenewswire

The BTK read: Sequential growth was about $2 million. The balance sheet is the story. Cash burn this year was held to $29 million mostly by collecting 2025 receivables, which fell from $217 million to $93 million, and that cushion shrinks every quarter. With $27 million of cash against a $22 million quarterly EBITDA loss, financing is a near-term question: the ATM in place, debt, or a strategic deal. MiMedx had surgical to lean on. Organogenesis’s surgical line fell 19%.

Advanced Wound Management | Smith+Nephew: Devices Up, Bioactives Down, J&J Talks Over

Smith+Nephew cut full-year guidance to about 3% underlying growth on weak US hips and knees. Advanced Wound Management was flat at $454 million. Devices grew 10.7% on PICO and LEAF, and bioactives fell 8.8%, with the skin substitute headwind now at the top of its $20–40 million range. The company confirmed that talks with J&J about its Orthopaedics business have ended. sec

The BTK read: Devices carried the business unit while skin substitutes shrank. S+N says volume and price both fell outside surgical settings. MiMedx reported volume up at wound care centers. The difference is site of service.

Skin Substitutes / CAMP | Coloplast: Kerecis Margin at 1%

Coloplast’s biologics sales fell 12% in Q4 under the outpatient reimbursement change, and Kerecis’ margin before PPA amortization was 1%. Inpatient biologics grew about double digits. Wound & Tissue Repair grew 2% for the year. Guidance assumes biologics return to growth from Q2 FY27. globenewswire

The BTK read: Kerecis was bought as a high-margin US growth platform. A 1% margin after a DKK 3 billion impairment is what the flat rate does to that thesis. Inpatient is untouched by the flat rate but a smaller pool, and the Q2 return to growth is mostly an easy comparison.

NPWT / Advanced Wound Care | Solventum: AWC Up 8.9%, Mostly Acera

Solventum’s Advanced Wound Care sales rose 8.9% to $528 million, but only 1.5% organically. The Acera acquisition added 7.2 points. Total organic sales fell 2.8% on an ERP order reversal, and the company raised EPS guidance. It also received 510(k) clearance for combined use of Restrata and V.A.C. Therapy. solventum

The BTK read: The reported growth was bought with Acera. Restrata sold through the V.A.C. installed base is the integration thesis. With S+N devices up 10.7%, watch NPWT share as the ERP noise clears.

Earnings Roundup

Diagnostics / Workflow | Net Health Buys Tissue Health Plus Clinical AI Assets from Sanara

Net Health acquired clinical decision support, AI/ML imaging technology, clinical data, and value-based care analytics from Tissue Health Plus, a Sanara MedTech subsidiary. The assets go into Net Health’s WoundExpert and Tissue Analytics platforms. net health

The BTK read: Sanara is shedding the value-based care bet before the MiMedx close, which tells you MiMedx is buying the product business. Wound informatics is consolidating into the EHR layer, and point-solution AI vendors now compete with a feature in the system of record.

Pharma / Drug | Nova Anchora Raises $23 Million for Topical Collagen VII in DEB

Nova Anchora raised $23 million to advance a topical collagen VII therapy for dystrophic epidermolysis bullosa. globenewswire

The BTK read: This fits the Q3 Capital Flow pattern: venture money goes to regulated drug pathways with rare-disease economics, not to products priced under the flat rate. DEB is a narrow indication. Any read-through to chronic wounds is years and several trials away.

Diagnostics | Kent Imaging’s PRISM Algorithm Published in Journal of Wound Care

Kent Imaging’s PRISM algorithm, presented at DFCon, is now published in the Journal of Wound Care. It maps SnapshotNIR oxygenation and SnapshotGLO autofluorescence findings to eight treatment scenarios. courier-journal

The BTK read: Mapping imaging results to treatment decisions answers the MACs’ critique better than detection data does. It is a protocol, not outcome data. Expect it in comment letters before November 14.

Briefs

Reported this week: Coloplast and Tactile (Nov 2), Philips (Nov 3), Smith+Nephew, Zimmer Biomet, LeMaitre, and Medline (Nov 4), Teleflex, BD, Enovis, Solventum, and Organogenesis (Nov 5).

Estimates are based on prior-year timing. Confirmed dates come from company releases.

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November 9: CY2027 PFS final rule publishes in the Federal Register

November 14: Comment deadline for the MAC RTFI and NIRS draft LCDs

December 5–6 | San Antonio, TX: DFUpdate 2026 (Diabetic Foot Update), UT Health San Antonio. Hosted by ALPS, with pre-meeting workshops December 4.

December 9–12 | Phoenix, AZ: Desert Foot, Multi-Disciplinary Limb Salvage & Wound Care Conference

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-Scott