Oslo, Norway, November 6, 2019 Photocure ASA., (OSE: PHO), The United States Centers for Medicare and Medicaid Services (CMS) has released its Final Rule maintaining the reimbursement code (A Code) for Cysview when used in hospital outpatient and other sites of care and improved the complexity adjustment codes. This will result in additional reimbursement of $92 for certain Blue Light Cystoscopy (BLC™) procedures when used in hospital outpatient departments effective January 1st, 2020.
Link for access to the Rule: https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-24138.pdf
In addition, CMS confirmed that the complexity adjustment will be available for procedures billed under 52204, 52214, and 52224 (52214 being new for 2020), if also billed with the A9589 code for the drug and the C9738 code for the complexity adjustment. The increased reimbursement due to the complexity adjustment will be $1,247 ($1,187 in 2019). This will result in an increase in reimbursement of payment for Blue Light Cystoscopy procedures when used in hospital outpatient department under the complexity adjustment conditions applicable to the three procedures in 2020 from standard white light at $1,771 (for APC 5373) to $3,018 with Cysview (for APC 5374).
“The effectiveness and benefits of using Blue Light Cystoscopy (BLC™) with Cysview for improved detection and management of bladder cancer are widely recognized. We are pleased that CMS has implemented an additional complexity adjustment code for Cysview and improved reimbursement compared to 2019. We, along with many stakeholders in the Bladder Cancer Community, (including the Large Urology Group Practice Association (LUGPA), American Urological Association (AUA), the patient advocacy group Bladder Cancer Advocacy Network (BCAN), and individual Urologists and Patients), will continue to work to further increase access for all patients regardless of the site of care to this leading-edge technology for the management of bladder cancer,” commented Dan Schneider, President and Chief Executive Officer of Photocure ASA.
About Bladder Cancer
Bladder cancer ranks as the ninth most common cancer worldwide with 430 000 new cases and more than 165 000 deaths annually. Approx. 75% of all bladder cancer cases occur in men1. It has a high recurrence rate with an average of 61% in year one and 78% over five years2. Bladder cancer has the highest lifetime treatment costs per patient of all cancers3.
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 BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when 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 treat4.
About Hexvix®/Cysview® (hexaminolevulinate HCl)
Hexvix®/Cysview® is a drug that is selectively taken up by tumor cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLC™ with Hexvix® /Cysview® improves the detection of tumors and leads to more complete resection, fewer residual tumors and better management decisions.
Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all other markets. Photocure is commercializing Cysview® / Hexvix® directly in the US and the Nordic region and has strategic partnerships for the commercialization of Hexvix® / Cysview® in Europe, Canada, Australia and New Zealand. Please refer to https://bit.ly/2wzqSQQ for further information on our commercial partners.
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1. Globocan. Incidence/mortality by population. Available at: http://globocan.iarc.fr/Default.aspx
2. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al. EAU Guidelines on
non-muscle-invasive bladder cancer (Ta, T1 and CIS). Eur Urol. 2016 Guidelines Edition:1-40.
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