Pelvic Floor. Reimbursement & Coding Guide

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Pelvic Floor Reimbursement & Coding Guide

Pelvic Floor Reimbursement and Coding Guide ACell Pelvic Floor Matrix products are biologically-derived devices comprised of porcine Urinary Bladder Matrix (UBM), a patented, proprietary technology of ACell, Inc. The Pelvic Floor Matrix maintains an intact epithelial basement membrane, and facilitates the body s ability to form site-appropriate tissue at the site of the pelvic floor defect. The product will resorb over time, leaving behind remodeled tissue to continue supporting the patient s pelvic anatomy. Reimbursement and eligibility for coverage for the use of these products and associated procedures varies by and payers, coverage policies, prior authorizations, contract terms, billing edits, and site of service influence reimbursement. It is recommended that providers verify coverage and billing policies. The following information is shared for educational purposes only to help answer common coding and reimbursement questions. While ACell believes this information to be correct, information is subject to change without notice. For assistance with reimbursement questions, contact the Reimbursement Support Center at reimbursement@acell.com or call 800-826-2926 x7. PLEASE NOTE: The payments specified in this document reflect national unadjusted published payments from the Centers for & Medicaid Services (CMS). Actual payment rates will vary based on geographical adjustments. As such, all codes provided herein are for illustrative purposes and shall not be construed as a warranty, statement, promise or guarantee that these codes are accurate or that the product will be covered in all instances, and if covered, that reimbursement in the amounts specified will be received. The decision of how to complete a reimbursement claim form, including codes and amounts to bill, is exclusively the responsibility of the QHPs and other providers. Coding requirements are subject to change at any time; please check with your local payer regularly for updates. Rx ONLY - Refer to IFU with each device for indications, contraindications, and precautions. US Toll-Free 800-826-2926 ACell, Inc. All Rights Reserved. CPT Copyright 2017 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. 1

Indications for Use Refer to Product Label for Full Instructions for Use ACell Pelvic Floor Matrix (6-Layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological or gynecological surgery. Reinforcement of soft tissue within urological and gynecological surgery includes, but is not limited to, the following procedures: pubourethral support, urethral and vaginal prolapse repair, reconstruction of pelvic floor, and bladder support. By providing pubourethral support, ACell Pelvic Floor Matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency. 2

Pelvic Organ Prolapse: CPT Codes and s Physician and Outpatient Facility Anterior Wall (Cystocele) Repair APC Hospital Outpatient ASC CPT CODE Descriptor Physician: In-Facility Status Indicator (S1) 57284 57285 57267 57423 Paravaginal defect repair (including repair of cystocele, if performed); open abdominal approach note: insertion of mesh is not separately reported Paravaginal defect repair (including repair of cystocele, if performed); vaginal approach note: insertion of mesh may be separately reported +57267 Insertion of mesh or other prosthesis for repair of pelvic floor defect, each site (anterior, posterior compartment), vaginal approach. (List separately in addition to code for primary procedure) Paravaginal defect repair (including repair of cystocele, if performed); laparoscopic approach note: insertion of mesh is not separately reported $833.03 J1 $5,415.00 $4,111.52 N/A $686.87 J1 $5,416.00 $6,286.92 N/A $262.44 N N/A Packaged Packaged $930.59 J1 $5,362.00 $7,594.89 N/A 3

Posterior Wall (Rectocele) Repair APC Hospital Outpatient ASC CPT CODE Descriptor Physician: In-Facility Status Indicator (S1) 45560 Repair of rectocele (separate procedure) note: insertion of mesh may be separately reported +57267 $712.79 J1 $5,313.00 $2,315.47 $1,139.22 subject to multiple procedure discounting +57267 Insertion of mesh or other prosthesis for repair of pelvic floor defect, each site (anterior, posterior compartment), vaginal approach. (List separately in addition to code for primary procedure) $262.44 N N/A Packaged Packaged 57250 Repair rectum and vagina note: insertion of mesh may be separately reported +57267 $606.23 J1 $5,415.00 $4,111.52 $1,839.48 subject to multiple procedure discounting Combined Anatomy and Physiology Procedures that Include Perineorrhaphy APC Hospital Outpatient ASC CPT CODE Descriptor Physician: In-Facility Status Indicator (S1) 57260 Repair of vagina note: insertion of mesh may be separately reported +57267 $776.87 J1 $5,415.00 $4,111.52 $1,839.48 subject to multiple discounting +57267 Insertion of mesh or other prosthesis for repair of pelvic floor defect, each site (anterior, posterior compartment), vaginal approach. (List separately in addition to code for primary procedure) $262.44 N N/A Packaged Packaged 57265 Combined anteroposterior colporrhaphy; with enterocele repair note: insertion of mesh may be separately reported +57267 $872.63 J1 $5,415.00 $4,111.52 $1,839.48 subject to multiple discounting 4

Enterocele Repair APC Hospital Outpatient ASC CPT CODE Descriptor Physician: In-Facility Status Indicator (S1) 57268 Repair of enterocele, vaginal approach note: insertion of mesh is not separately reported $493.55 J1 $5,414.00 $2,272.61 $1,122.14 subject to multiple procedure discounting 57270 57283 Repair of enterocele, abdominal approach note: insertion of mesh is not separately reported Colpopexy, vaginal, intra-peritoneal approach note: insertion of mesh is not separately reported $821.51 C N/A N/A N/A $700.55 J1 $5,416.00 $6,286.92 N/A Vaginal Vault Prolapse Repair APC Hospital Outpatient ASC CPT CODE Descriptor Physician: In-Facility Status Indicator (S1) 57280 Colpopexy, abdominal approach $974.13 C N/A N/A N/A 57282 Colpopexy, vaginal; extra-peritoneal approach $510.83 J1 $5,416.00 $6,286.92 N/A 57425 Laparoscopy, surgical, colpopexy $989.99 J1 $5,362.00 $7,594.89 N/A C: Not paid under outpatient; inpatient procedure only J1: Paid Items under and services OPPS. Hospital are packaged Part B into services APC rate paid through a Comprehensive APC; all covered Part B services on the claim are packaged with the primary "J1" service for the claim, except services with OPPS SI=F,G, H, L and U; ambulance services; diagnostic and screening mammography; all preventive services; and certain Part B inpatient services N: Items and services are packaged into payment for other services 5

HCPCS "C" Codes: Product, Hospital Outpatient "C" codes are only reported by hospitals. When devices are used in combination with associated procedures provided in the outpatient setting, hospitals report these codes for patient procedures. While the following codes are not paid separately from the procedure, reporting these codes and assignment of charges identify device-related costs. This is important for future rate-setting by. Private payers policies vary if they require the use of these "C" codes. HCPCS Code Definition C1781 Mesh (implantable) C1763 Connective tissue, non-human (includes synthetic) A mesh implant or synthetic patch composed of absorbable or non-absorbable material that is used to repair hernias, support weakened or attenuated tissue, cover tissue defects, etc Connective tissue, non-human (includes synthetic) - These tissues include a natural, acellular collagen matrix typically obtained from porcine or bovine small intestinal submucosa, or pericardium. This bio-material is intended to repair or support damaged or inadequate soft tissue. They are used to treat urinary incontinence resulting from hypermobility or Intrinsic Sphincter Deficiency (ISD), pelvic floor repair, or for implantation to reinforce soft tissues where weakness exists in the urological or musculoskeletal anatomy. Indicator N1: Packaged service/item; no separate payment made Hospital Inpatient Codes and s: uses a prospective payment system to reimburse hospitals for inpatient services based on Severity Diagnosis Related Groups (MS-DRGs). Services are classified into clinically cohesive groups that exhibit similar use of hospital resources. Hospitals receive a single payment for all services provided during an inpatient admission based on the MS-DRG assigned, regardless of the actual length of stay or costs of services. Only one MS-DRG may be assigned per patient stay. The MS-DRG assignment to the categories of Complications or Comorbidities (CCs) and/or Major Complications or Comorbidities (MCCs) is influenced by the medical record documentation describing the clinical circumstances. Diagnoses and procedures are reported with ICD-10 codes. The following tables are examples of potential ICD-10 procedure codes that are available for hospitals when reporting inpatient pelvic procedures. 6

Anterior Wall (Cystocele), Enterocele, and Vaginal Vault Prolapse Repair ICD-10-PCS Codes 0JQ - Medical and Surgical - Subcutaneous Tissue and Fascia - Repair Section: Body System: Operation: 0 - Medical and Surgical J - Subcutaneous Tissue and Fascia Q - Repair: Restoring, to the extent possible, a body part to its normal anatomic structure and function Body Part Approach Device Qualifier 0 - Subcutaneous Tissue and Fascia, Scalp 1 - Subcutaneous Tissue and Fascia, Face 4 - Subcutaneous Tissue and Fascia, Anterior Neck 5 - Subcutaneous Tissue and Fascia, Posterior Neck 6 - Subcutaneous Tissue and Fascia, Chest 7 - Subcutaneous Tissue and Fascia, Back 8 - Subcutaneous Tissue and Fascia, Abdomen 9 - Subcutaneous Tissue and Fascia, Buttock B - Subcutaneous Tissue and Fascia, Perineum C - Subcutaneous Tissue and Fascia, Pelvic Region D - Subcutaneous Tissue and Fascia, Right Upper Arm F - Subcutaneous Tissue and Fascia, Left Upper Arm X - Open 3 - Percutaneous Z - No Device Z - No Qualifier G - Subcutaneous Tissue and Fascia, Right Lower Arm H - Subcutaneous Tissue and Fascia, Left Lower Arm J - Subcutaneous Tissue and Fascia, Right Hand K - Subcutaneous Tissue and Fascia, Left Hand L - Subcutaneous Tissue and Fascia, Right Upper Leg M - Subcutaneous Tissue and Fascia, Left Upper Leg N - Subcutaneous Tissue and Fascia, Right Lower Leg P - Subcutaneous Tissue and Fascia, Left Lower Leg Q - Subcutaneous Tissue and Fascia, Right Foot R - Subcutaneous Tissue and Fascia, Left Foot 7

Anterior Wall (Cystocele), Enterocele, and Vaginal Vault Prolapse Repair ICD-10-PCS Codes (continued) 0JR - Medical and Surgical - Subcutaneous Tissue and Fascia - Replacement Section: Body System: Operation: 0 - Medical and Surgical J - Subcutaneous Tissue and Fascia R - Replacement: Putting in or on biological or synthetic material that physically takes the place and/or function of all or a portion of a body part Body Part Approach Device Qualifier 0 - Subcutaneous Tissue and Fascia, Scalp 1 - Subcutaneous Tissue and Fascia, Face 4 - Subcutaneous Tissue and Fascia, Anterior Neck 5 - Subcutaneous Tissue and Fascia, Posterior Neck 6 - Subcutaneous Tissue and Fascia, Chest 7 - Subcutaneous Tissue and Fascia, Back 8 - Subcutaneous Tissue and Fascia, Abdomen 9 - Subcutaneous Tissue and Fascia, Buttock B - Subcutaneous Tissue and Fascia, Perineum C - Subcutaneous Tissue and Fascia, Pelvic Region D - Subcutaneous Tissue and Fascia, Right Upper Arm F - Subcutaneous Tissue and Fascia, Left Upper Arm G - Subcutaneous Tissue and Fascia, Right Lower Arm X - Open 3 - Percutaneous 7 - Autologous Tissue Substitute J - Synthetic Substitute K - Nonautologous Tissue Substitute Z - No Qualifier H - Subcutaneous Tissue and Fascia, Left Lower Arm J - Subcutaneous Tissue and Fascia, Right Hand K - Subcutaneous Tissue and Fascia, Left Hand L - Subcutaneous Tissue and Fascia, Right Upper Leg M - Subcutaneous Tissue and Fascia, Left Upper Leg N - Subcutaneous Tissue and Fascia, Right Lower Leg P - Subcutaneous Tissue and Fascia, Left Lower Leg Q - Subcutaneous Tissue and Fascia, Right Foot R - Subcutaneous Tissue and Fascia, Left Foot 8

Anterior Wall (Cystocele), Enterocele, and Vaginal Vault Prolapse Repair ICD-10-PCS Codes 0JU - Medical and Surgical - Subcutaneous Tissue and Fascia - Supplement Section: Body System: Operation: 0 - Medical and Surgical J - Subcutaneous Tissue and Fascia U - Supplement: Putting in or on biological or synthetic material that physically reinforces and/or augments the function of a portion of a body part Body Part Approach Device Qualifier 0 - Subcutaneous Tissue and Fascia, Scalp 1 - Subcutaneous Tissue and Fascia, Face 4 - Subcutaneous Tissue and Fascia, Anterior Neck 5 - Subcutaneous Tissue and Fascia, Posterior Neck 6 - Subcutaneous Tissue and Fascia, Chest 7 - Subcutaneous Tissue and Fascia, Back 8 - Subcutaneous Tissue and Fascia, Abdomen 9 - Subcutaneous Tissue and Fascia, Buttock B - Subcutaneous Tissue and Fascia, Perineum C - Subcutaneous Tissue and Fascia, Pelvic Region D - Subcutaneous Tissue and Fascia, Right Upper Arm F - Subcutaneous Tissue and Fascia, Left Upper Arm G - Subcutaneous Tissue and Fascia, Right Lower Arm X - Open 3 - Percutaneous 7 - Autologous Tissue Substitute J - Synthetic Substitute K - Nonautologous Tissue Substitute Z - No Qualifier H - Subcutaneous Tissue and Fascia, Left Lower Arm J - Subcutaneous Tissue and Fascia, Right Hand K - Subcutaneous Tissue and Fascia, Left Hand L - Subcutaneous Tissue and Fascia, Right Upper Leg M - Subcutaneous Tissue and Fascia, Left Upper Leg N - Subcutaneous Tissue and Fascia, Right Lower Leg P - Subcutaneous Tissue and Fascia, Left Lower Leg Q - Subcutaneous Tissue and Fascia, Right Foot R - Subcutaneous Tissue and Fascia, Left Foot 9

Anterior Wall (Cystocele), Enterocele, and Vaginal Vault Prolapse Repair ICD-10-PCS Codes (continued) 0UQ - Medical and Surgical - Female Reproductive System - Repair Section: Body System: Operation: 0 - Medical and Surgical U - Female Reproductive System Q - Repair: Restoring, to the extent possible, a body part to its normal anatomic structure and function Body Part Approach Device Qualifier 0 - Ovary, Right 1 - Ovary, Left 2 - Ovaries, Bilateral 4 - Uterine Supporting Structure 0 - Open 3 - Percutaneous 4 - Percutaneous Endoscopic Z - No Device Z - No Qualifier Body Part Approach Device Qualifier 5 - Fallopian Tube, Right 0 - Open 6 - Fallopian Tube, Left 7 - Fallopian Tubes, Bilateral 9 - Uterus C - Cervix F - Cul-de-sac 3 - Percutaneous 4 - Percutaneous Endoscopic 7 - Via Natural or Artificial Opening 8 - Via Natural or Artificial Opening Endoscopic Z - No Device Z - No Qualifier Body Part Approach Device Qualifier G - Vagina K - Hymen 0 - Open 3 - Percutaneous 4 - Percutaneous Endoscopic 7 - Via Natural or Artificial Opening 8 - Via Natural or Artificial Opening Endoscopic X - External Z - No Device Z - No Qualifier Body Part Approach Device Qualifier J - Clitoris L - Vestibular Gland M - Vulva 0 - Open X - External Z - No Device Z - No Qualifier 10

MS-DRGs - Hospital Inpatients Pelvic Floor Matrix product payment is included in the DRG payment; may be identified on the hospital claim using the HCPCS and/or revenue code; captured as a surgical supply for hospital cost accounting. MS-DRG MS-DRG Title FY 662 Minor bladder procedures w/mcc $18,354 663 Minor bladder procedures w/cc $10,731 664 Minor bladder procedures w/o cc/mcc $7,754 748 Female reproductive system reconstructive procedures $7,637 Note: Comorbidities and Complications/Major Comorbidities and Complications (cc/mcc) Product payment: Is included in the DRG payment. May be identified on the hospital claim using a revenue code but it is not itemized for payment. Is captured as a surgical supply for hospital cost accounting. Sources CPT Professional. (2017). American Medical Association. CPT Assistant through 2017 CPT Changes through 2017 - Correct Coding Policy Manual, Physician Version 23.3 Effective October 1, 2017 Hospital Outpatient Prospective System (CMS-1678-FC) Addendum B Ambulatory Surgery Center Prospective System (CMS-1678-FC) Addendum AA CMS-1676-F Revisions to Policies under the Physician Fee Schedule and Other Revisions to Part B for CY /Downloads FY Hospital Inpatient Prospective Systems for Acute Care Hospitals...(CMS 1677-CN), Effective October 1, 2017 Physician Fee Schedule RVU File 11

The ACell Reimbursement Support Center Monday - Friday: 9:00 am - 5:00 pm, Eastern 800-826-2926, x 7 reimbursement@acell.com ACell s Reimbursement Support Center is dedicated to providing answers to all of your reimbursement questions. It also serves as a resource for obtaining accurate billing information and reimbursement support for ACell's surgical products. 12

ACell, Inc. 6640 Eli Whitney Drive Columbia, MD 21046 www.acell.com 800-826-2926 MK-0106.6 03/