Photocure 2014 Reimbursement Guide. Billing for Blue Light Cystoscopy with Cysview (hexaminolevulinate hydrochloride) Medicare Program

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1 Photocure 2014 Reimbursement Guide Billing for Blue Light Cystoscopy with Cysview (hexaminolevulinate hydrochloride) Medicare Program

2 Cysview (hexaminolevulinate hydrochloride) is a photodynamic optical imaging drug. Indicated for use in the cystoscopic detection of non-muscle invasive papillary bladder cancer For use with patients suspected or known to have lesion(s) on the basis of a prior cystoscopy Cysview is used with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system to perform cystoscopy with the blue light setting (Mode 2) as an adjunct to the white light setting (Mode 1). The procedure is known as Blue Light Cystoscopy with Cysview. Cysview (hexaminolevulinate hydrochloride) for intravesical solution summary of prescribing information INDICATIONS AND USAGE: Cysview is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. Cysview is used with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system to perform cystoscopy with the blue light setting (Mode 2) as an adjunct to the white light setting (Mode 1). Cysview is not for repetitive use and is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. CONTRAINDICATIONS: Cysview is contraindicated in patients with porphyria, gross hematuria, BCG immunotherapy or intravesical chemotherapy within 90 days prior, or with known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. WARNINGS AND PRECAUTIONS: Anaphylaxis: Anaphylaxis, including anaphylactoid shock, has been reported following administration of Cysview. ADVERSE REACTIONS: Clinical Study experience: The most common adverse reactions were bladder spasm, dysuria, hematuria, and bladder pain. Postmarketing experience: Anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis and abnormal urinalysis have been reported. USE IN SPECIFIC POPULATIONS: Pregnancy: Cysview should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether hexaminolevulinate is excreted in human milk. Because many drugs are excreted in human milk, exercise caution when Cysview is administered to nursing mothers. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: No clinically important differences in safety or efficacy have been observed between older and younger patients. Prior to Cysview administration, please read the full Prescribing information.

3 Photocure has developed the following Medicare reimbursement overview for Cysview (hexaminolevulinate hydrochloride) for its customers who perform Blue Light Cystoscopy in a hospital outpatient department/ambulatory surgical center. The information contained in this guide is provided to help you understand the reimbursement process, and is not intended to suggest any manner in which you can increase or maximize reimbursement from any payer. The information in this guide does not pertain to commercial payers or state Medicaid programs, and only applies to Medicare. We recommend that you consult with your private payer organizations and state Medicaid programs with regard to their reimbursement policies. The information in this guide is for informational purposes only, and represents no promise, commitment, statement or guarantee by Photocure concerning proper billing or coding practices or levels of reimbursement, payment or charges. All Current Procedural Terminology (CPT ), Healthcare Common Procedural Coding System (HCPCS), Ambulatory Payment Classifications (APCs) or National Drug Classification (NDC) codes are provided for your information only and Photocure does not represent that these codes are or will be appropriate or that reimbursement will be made if using them or any other codes. CPT codes and descriptions only are copyright by the American Medical Association. CPT, APC and other codes do not include fee schedules, relative values or related listings. The Centers for Medicare & Medicaid Services (CMS) updates coding and coverage information frequently, and it is the responsibility of each health service provider to confirm the appropriate billing required by the local Medicare contractor. CPT copyright 2012 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

4 2014 Medicare Reimbursement Hospital Outpatient Departments and Ambulatory Surgical Centers Reimbursement information is gathered from third-party sources and is subject to change. This information is provided for illustrative purposes only. Photocure recommends that you consult with payers for specific coverage and billing requirements. 1 Cysview and the KARL STORZ D-Light C PDD rigid cystoscope are typically used in a hospital outpatient department (HOPD) or ambulatory surgical center (ASC). The HOPD or ASC is responsible for billing for the Cysview product in addition to the facility charges that are based on services provided by the Physician. Note that if products/services billed by the HOPD or ASC do not match the services billed by the Physician, Medicare will likely reject the claim. In the 2014 Hospital Outpatient Prospective Payment System (OPPS) Final Rule, CMS determined that Cysview is subject to packaged payment (i.e., payment for Cysview is part of the APC procedure payment). Because the APC procedure payment is intended to incorporate the cost of the use of Cysview, it is essential to report HCPCS code C9275 (Injection, Hexaminolevulinate Hydrochloride, 100mg, per study dose) on a separate claim line for each case in which Cysview is utilized. Although the HOPD or ASC will not be separately paid for this claim line, CMS uses these claims data to calculate APC procedure payments for future years. If C9275 is not reported each time Cysview is used, then future reimbursement calculations will not include these costs and payment amounts for the associated APCs will decrease. To submit claims in accordance with this guidance: o STEP 1: Report the appropriate CPT code for the procedure listed below for each case in which Cysview with the KARL STORZ D-Light C PDD is used. o STEP 2: Report HCPCS code C9275 for Cysview. Physicians performing blue light cystoscopy with Cysview may report the most appropriate CPT code for the service performed. 1 Blue light cystoscopy with Cysview may be covered by private payers and Medicaid programs when medically necessary. Coverage guidelines and payment levels vary by payer and specific plan. Providers should contact each specific plan to determine coverage and payment. CPT copyright 2012 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

5 STEP 1 SELECTED 2014 CPT CODES FOR BLADDER CYSTOSCOPY CPT / HCPCS Code Description RELEVANT APC CODE Cystourethroscopy (separate procedure) Cystourethroscopy, with biopsy(s) Ambulatory Payment Classification (APC) 160 (2014 Medicare payment for APC 160 is $539.01) (2014 Medicare payment for is $2,007.32) of trigone, bladder neck, prostatic fossa, urethra, or periurethral glands or treatment of MINOR (less than 0.5 cm) lesion(s) with or without biopsy and/or resection of SMALL bladder tumor(s) (0.5 to 2.0 cm) and/or resection of MEDIUM bladder tumor(s) (2.0 to 5.0 cm) and/or resection of LARGE bladder tumor(s) STEP 2 HCPCS Code C9275 Description Injection, Hexaminolevulinate Hydrochloride, 100mg, per study dose Hospital Outpatient Setting C9275 is designated status N (packaged), so payment is part of the APC procedure payment and the HOPD or ASC will not be paid for this claim line. However, it is essential to report C9275 for each case in which Cysview is utilized, because CMS uses these claims data to calculate APC procedure payments for future years. APC procedure payments are based on an average of all codes and related costs included in each service. 3 2 Hospital Outpatient Departments are typically reimbursed at the relevant APC Payment rate. Ambulatory Surgical Centers are reimbursed at a percentage of the OPPS APC rate. 3 Private insurers plans and Medicaid payment rates may vary. For these payers, you may be instructed to use C9275 (Injection, Hexaminolevulinate Hydrochloride, 100mg, per study dose) or an unlisted code such as J3490. Blue light cystoscopy with Cysview may be covered by private payers and Medicaid programs when medically necessary. Coverage guidelines and payment levels vary by payer and specific plan. Providers should contact each specific plan to determine coverage and payment and appropriate reporting methods. CPT copyright 2012 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

6 Sample UB Form 1/26/14 1/26/14 Code for primary procedure performed C9275 Code for Cysview should be listed on a separate claim line, although this line will not generate separate payment. Establishing charges is the responsibility of the provider. Any dollar figures mentioned in this document are examples only, and are not intended to suggest actual amounts that should be charged.

7 Sample CMS-1500 Form A JOHN DOE SAME 1234 MAIN ST ANYWHERE MA NONE NONE Code for primary procedure performed $ Establishing charges is the responsibility of the provider. Any dollar figures mentioned in this document are examples only, and are not intended to suggest actual amounts that should be charged P ST. HOSPITAL ST MA PLEASE PRINT OR TYPE ST. HOSPITAL ST MA APPROVED OMB FORM 1500 (02-12)

8 Photocure is pleased to offer toll-free customer support and documentation for coding and reimbursement related to Cysview. For additional questions, please contact Photocure s reimbursement helpline at CYSVIEW ( ) Disclaimers The materials referenced and provided are based upon coding experience and research of current general coding practices. The existence of codes does not guarantee coverage or payment for any procedure by any payer. The final decision for coding of any procedure must be made by the provider of care after considering the medical necessity of the services and supplies provided as well as the regulations and local, state, or federal laws that may apply. The coding and payment data is furnished for general informational purposes only and should not be relied upon for purposes of determining payer coverage and coding for a specific case or claim for payment. Providers should refer to authoritative coding sources, such as the Common Procedural Terminology CPT codes and Healthcare Common Procedure Coding System (HCPCS) codes. CPT copyright 2012 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors and/ or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. For reference only. Information does not guarantee coverage or payment. The information provided in this guide is for informational purposes only. Payment will vary by geographic locality. It is always the provider s responsibility to determine coding and claims information for the services that were provided. Cysview Web Site For more information regarding Cysview please visit our web site at: Photocure Inc. All rights reserved. Cysview is a registered trademark of Photocure ASA. January 2014 CYSC

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