Regulatory Filings • Nov 7, 2022
Regulatory Filings
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Photocure: CMS improves Medicare reimbursement for Blue Light Cystoscopy with Cysview and expands access in the surveillance setting
Oslo, Norway, November 7, 2022: Photocure ASA., (OSE: PHO), announces that The
United States Centers for Medicare & Medicaid Services (CMS) has released final
payment rates in connection with the recently approved Medicare reimbursement
changes for Blue Light Cystoscopy (BLC[®]) with Cysview[®] in the hospital
outpatient (HOPD) and ambulatory surgical center (ASC) sites of care. The new
complexity adjustments and resulting increase in payment provide an opportunity
to increase BLC usage in outpatient bladder cancer surveillance procedures.
Link to the CMS Rule: https://www.cms.gov/files/document/cy2023-hospital
-outpatient-prospective-payment-system-and-ambulatory-surgical-center-final
-rule.pdf
CMS confirmed that a complexity adjustment will be available for procedures
billed under CPT Code 52000, as well as CPT Code 52204 which were subject to the
adjustment in 2022. The two procedures, if also billed with the A9589 Code for
Cysview[®] and the C9738 Code for the complexity adjustment, will have higher
reimbursement beginning January 1, 2023.
In the HOPD setting, CMS for the first time has made a complexity adjustment for
CPT 52000 (cystoscopy) and will maintain the current adjustment for CPT 52204
(cystoscopy + biopsy). The new Medicare reimbursement changes increase payment
from $587.56 to $1,854.88 for CPT 52000 (cystoscopy) and from $3,140.04 to
$3,205.12 for CPT 52204 (cystoscopy + biopsy) in the HOPD site of care.
Additionally, CMS for the first time has made a complexity adjustment available
for ASC sites of care for both CPT 52000 and CPT 52204. To facilitate this, CMS
has created two new complexity adjustment C codes for BLC to be used in the ASC
place of service (C7554 with CPT 52000 and C7550 with CPT 52204). The changes
will increase payment beginning in January 2023 from $297.97 to $848.03 for CPT
52000 and from $816.76 to $1,496.56 for CPT 52204.
"The effectiveness and benefits of using Blue Light Cystoscopy with Cysview for
improved detection and management of bladder cancer are widely recognized, and
Photocure has long advocated that CMS provide appropriate reimbursement for BLC
treatment" said Dan Schneider, President and Chief Executive Officer of
Photocure ASA. "We are pleased that CMS has expanded the complexity adjustment
for Cysview in the hospital outpatient setting and will implement a complexity
adjustment for the first time in the ASC site of care. The improved
reimbursement is expected to increase patient access to blue light cystoscopy in
the surveillance setting."
Note to editors
Hexvix[®]/Cysview[®] and BLC[®] are registered trademarks of Photocure ASA.
This press release may contain product details and information which are not
valid, or a product that is not accessible, in your country. Please be aware
that Photocure does not take any responsibility for accessing such information,
which may not comply with any legal process, regulation, registration, or usage
in the country of your origin.
About Bladder Cancer
Bladder cancer ranks as the 8[th] most common cancer worldwide - the 5[th] most
common in men - with 1 720 000 prevalent cases (5-year prevalence rate)[1a],
573 000 new cases and more than 200 000 deaths annually in 2020.[1b]
Approx. 75% of all bladder cancer cases occur in men.[1] It has a high
recurrence rate, with up to 61% in year one and up to 78% over five years.[2]
Bladder cancer has the highest lifetime treatment costs per patient of all
cancers.[3]
Bladder cancer is a costly, potentially progressive disease for which patients
have to undergo multiple cystoscopies due to the high risk of recurrence. There
is an urgent need to improve both the diagnosis and the management of bladder
cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer
(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of
invasion in the bladder wall. NMIBC remains in the inner layer of cells lining
the bladder. These cancers are the most common (75%) of all cases and include
the subtypes Ta, carcinoma in situ (CIS), and T1 lesions. In MIBC, the cancer
has grown into deeper layers of the bladder wall. These cancers, including
subtypes T2, T3, and T4, are more likely to spread and are harder to treat.[4]
[1] Globocan. a) 5-year prevalence / b) incidence/mortality by population.
Available at: https://gco.iarc.fr/today, accessed [January 2022].
[2] Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
[3] Sievert KD et al. World J Urol 2009;27:295-300
[4] Bladder Cancer. American Cancer
Society. https://www.cancer.org/cancer/bladder-cancer.html
About Hexvix[®]/Cysview[®] (hexaminolevulinate HCl)
Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the
bladder, making them glow bright pink during Blue Light Cystoscopy (BLC[®]). BLC
with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves
the detection of tumors and leads to more complete resection, fewer residual
tumors, and better management decisions.
Cysview[ ]is the tradename in the U.S. and Canada, Hexvix[ ]is the tradename in
all other markets. Photocure is commercializing Cysview/Hexvix directly in the
U.S. and Europe and has strategic partnerships for the commercialization of
Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer
to https://photocure.com/partners/our-partners for further information on our
commercial partners.
About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, making
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.hexvix.com, www.cysview.com
For further information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email: [email protected]
Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: [email protected]
David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: [email protected]
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: [email protected]
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