Announcement no. 06/2025 | 19 August 2025
13
Other matters
Proposed update to DMEPOS
Competitive Bidding Program
announced by CMS
On 30 June 2025, the Centers for
Medicare and Medicaid Services (CMS)
announced a proposed rule
1
, which,
among other, included an update on the
Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS)
Competitive Bidding Program (CBP).
The authorities propose that medical
equipment such as ostomy,
tracheostomy, and urological supplies
(which covers catheters and catheter
supplies), should be included in the list of
items that CMS may subject to the
DMEPOS CBP. This means that the
categories are considered to be eligible
for CBP, but it does not necessarily
mean that they will be subject to CBP.
Potential implementation of a CBP for
our categories is expected to have an
impact on the entire supply chain. Given
the complexity of the matter and the US
market, we are unable to provide an
estimation of potential financial impact
at this point in time.
As a next step, Coloplast will work
together with industry associations and
provide comments to the document.
The deadline for providing comments is
set for 29 August 2025 and we expect
an update to be published in late 2025.
While there is no timeline laid out in the
document, we expect any potential
changes to take effect at the earliest in
2027 based on internal assessment.
The US chronic care business (covering
Ostomy, Continence and Voice and
Respiratory Care) accounted for around
12% of group sales in FY 2023/24.
Proposed change to payment for skin
substitutes announced by CMS
On 14 July 2025, the CMS announced a
substantially changed Physician Fee
Schedule
2
, where the Average Selling
Price (ASP) pricing model for the out-
patient setting (covering physician office
and hospital-based wound centres) is
replaced by a fixed payment of $125/
cm2 for all products for the
implementation year 2026. The
proposal for the 2026 calendar year
Physician Fee Schedule rule is now in
the 60-day comment window, ending
12 September 2025, and should be
finalized in October, with the policy
changes taking effect on 1 January
2026.
In addition, the policy proposes that
over time, three payment tiers are
introduced, based on the FDA pathway
for the products (PMA, 510k and
section 361 HCT/Ps approval).
Coloplast welcomes the effort by the
authorities to increase quality care for
Medicare recipients with payment and
coverage policy changes. The previously
announced Local Coverage
Determination policy, relating to which
products are covered, is also set to be
implemented on 1 January 2026.
Kerecis currently has two product
brands, MariGen® and Shield®, affected
by CMS payment and coverage policies,
with a current average price for the out-
patient setting of $110/cm2. Around
20% of Kerecis total revenue comes
from the out-patient segment and is
covered by Medicare.
US tariffs
Coloplast is closely monitoring the
implementation of tariffs on goods
imported into the US. Products used in
the management of chronic conditions
continue to be exempt from tariffs and
as such, the financial impact on
Coloplast from US tariffs is expected to
be immaterial.
Capital Markets Day
Coloplast will host a Capital Markets
Day on 2 September 2025 in Denmark,
at the Clarion Hotel (Copenhagen
Airport). More details are available on
Coloplast’s website: Coloplast Investors
information
Changes to the Executive Leadership
Team
3
The Coloplast Board of Directors are
making changes to the Executive
Leadership Team (ELT) to support the
successful execution of the new
Coloplast Group strategy.
With immediate effect, a new Chronic
Care Commercial business unit is being
established. It includes the existing
Chronic Care sales regions, relevant
commercial functions and the Voice &
Respiratory Care business. A stand-
alone Chronic Care R&D function is also
being established, and its leader will be
part of the ELT and report to the CEO.
Caroline Vagner Rosenstand, previously
Executive Vice President (EVP) of Voice
and Respiratory Care, will step into the
role of EVP of Chronic Care
Commercial. Rasmus Just will re-join
Coloplast from Novo Nordisk, into the
role of EVP of Chronic Care R&D.
A new Acute Care business unit is being
introduced, which includes
Interventional Urology (IU), Advanced
Wound Dressings (AWD) and Kerecis.
Effective immediately, AWD and Kerecis
are being merged into a new Wound &
Tissue Repair organisation within Acute
Care. Wound & Tissue Repair will be led
by EVP, Fertram Sigurjonsson. Fertram
will report to the CEO and be part of the
ELT. There are no changes to the IU
business.
The new ELT consists of:
• Lars Rasmussen, interim CEO
• Anders Lonning-Skovgaard, EVP, &
CFO
• Allan Rasmussen, EVP Global
Operations
• Dorthe Rønnau, EVP People &
Culture
• Caroline Vagner Rosenstand, EVP
Chronic Care Commercial
• Rasmus Just, EVP Chronic Care
R&D (start date 1 November)
• Fertram Sigurjonsson, EVP Wound
& Tissue Repair
• Tommy Johns, EVP Interventional
Urology