Photocure 2017 Reimbursement GuideBilling for Blue Light Cystoscopy with Cysview® (hexaminolevulinate hydrochloride) Medicare Program

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 informationINDICATIONS 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.

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.

2017 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 2015 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.

STEP 1

SELECTED 2017 CPT® CODES FOR BLADDER CYSTOSCOPY

CPT®/HCPCS Code

DescriptionAmbulatory Payment Code (APC) CODE2

2017 Medicare Payment

52000 Cystourethroscopy (separate procedure)

New Ambulatory Payment Classification (APC) 5372

$167.96 - Medical Office

$297.08 - ASC

$594.44 - Hospital OPD

52204 Cystourethroscopy, with biopsy(s) APC 5373$792.79 - ASC

$1644.66 - Hospital OPD

52214Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) of trigone, bladder neck, prostatic fossa,

APC 5373$792.79 - ASC

$1644.66 - Hospital OPD

52224Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) or treatment of MINOR

APC 5373$792.79 - ASC

$1644.66 - Hospital OPD

52234

Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) and/or resection of SMALL bladder tumor(s) (0.5 to 2.0 cm)

APC 5374$1,181.53 - ASC

$2,542.56 - Hospital OPD

52235Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) and/or resection of MEDIUM bladder tumor(s)

APC 5374$1,181.53 - ASC

$2,542.56 - Hospital OPD

52240 Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) and/ APC 5375

$1,741.26- ASC

$3,484.01 - Hospital OPD

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.

STEP 2

HCPCS Code Description Hospital Outpatient Setting

C9275Injection, Hexaminolevulinate Hydrochloride, 100mg, per study dose

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

Code for primary procedure performed

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.

Sample UB Form

APPROVED OMB-0938-1197 FORM 1500 (02-12) PLEASE PRINT OR TYPE

X

ABC123456

ABC Insurance Company

01JOHN DOE

55512345

X01

MA

X

1900

1234 MAIN ST

SAME

ANYWHERE

123456789A

NONE

X

X

555-1212

188 1

25 1525 1501 22 5223501 $XXXX XX

$XXXX XX

1 1111111111

2222222MA 1234 1 ST

ST. HOSPITAL

2222222MA 1234 1 ST

2222222 P1111

ST. HOSPITAL

X

XXX X X XXXXXX

$

11 11111111111111111111522333555 1

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.

Sample CMS-1500 Form

DisclaimersThe 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.

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 1-855-CYSVIEW (1-855-297-8439)

Cysview® Web SiteFor more information regarding Cysview please visit our web site at: http://www.cysview.com

© 2017 Photocure Inc. All rights reserved. Cysview is a registered trademark of Photocure ASA. January 2017 CYSC20173191