0IMT Photocure Asa

OSLO, Norway, Nov. 7, 2022 /PRNewswire/ -- 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."

Hexvix^®/Cysview^® and BLC^® are registered trademarks of Photocure ASA.

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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 atwww.photocure.com , www.hexvix.com , www.cysview.com 

For further information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email: ds@photocure.com

Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com

David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: david.moskowitz@photocure.com

Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no

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SOURCE Photocure