Information on reimbursement is provided as a courtesy. The information provided is “AS IS” and without any other warranty or guarantee, expressed or implied, as to completeness or accuracy, or otherwise. Physicians and providers are responsible for accurate documentation of patient conditions and for reporting procedures and products in accordance with particular payer requirements.

CYGNUS™

REIMBURSEMENT GUIDE

This document is for educational purposes only. While CYGNUS can be used across a variety of different therapeutic areas, this reimbursement guides pertains to its use in reconstructive surgery.

Please Note: This document pertains to reimbursement information related to the hospital inpatient, outpatient department (HOPD), ambulatory surgery center (ASC), and the physician office. This guide does not apply to the use of CYGNUS in oral surgery, ophthalmology, and spine/neurosurgery.

This document is for educational purposes only. Coding, coverage and reimbursement decisions are subject to change without notice. Providers should always check with the appropriate payer before submitting claims. Vivex Biomedical, Inc., has used reasonable efforts to provide accurate information, but this information should not be construed as providing clinical advice, dictating reimbursement policy,or as a substitution for the judgement of a healthcare provider. It is always the healthcare provider’s responsibility to determine the appropriate codes, charges for services, and use of modifiers for services rendered. Providers are responsible for verifying coverage with payers, including the applicability of any non-coverage policies that may exist. Vivex Biomedical, Inc., assumes no responsibility for the timeliness, accuracy, or completeness of the information contained within this document. Since reimbursement laws, regulations, and payerpolicies change frequently, it is highly recommended that providers consult their payers, coding specialists and/or legal counsel regarding coverage, coding, and payment issues.

The CYGNUS™ amnion patch is an immune-privileged tissue containing the natural

regenerative factors responsible for creating a wound healing environment conducive

to tissue regeneration.

Applied surgically as an anatomical barrier keeping potentially adherent surfaces apart, CYGNUS offers mechanical protection while providing a regenerative tissue matrix with specific anti-inflammatory, anti-scarring and

anti-microbial properties.

CYGNUS is available in multiple sizes and configurations:

CYGNUS™ MAX (THICK)

Size Code

1x2 cm CAM010200

2x2 cm CAM020200

2x3 cm CAM020300

3x3 cm CAM030300

3x4 cm CAM030400

3x6 cm CAM030600

3x8 cm CAM030800

CYGNUS™ (DUAL LAYER)

Size Code

1x1 cm CAP010100

2x2 cm CAP020200

2x3 cm CAP020300

4x4 cm CAP040400

4x6 cm CAP040600

4x8 cm CAP040800

10mm disc CAP100000

16mm disc CAP160000

CYGNUS™ SOLO (THIN)

Size Code

1x1 cm CAS010100

2x2 cm CAS020200

2x3 cm CAS020300

3x3 cm CAS030300

4x4 cm CAS040400

4x6 cm CAS040600

4x8 cm CAS040800

7x7 cm CAS070700

10x10 cm CAS101000

2x12 cm CAS021200

15

Frequently Asked Questions

What is CYGNUS?

CYGNUS is an amniotic tissue matrix with innate regenerative capability to support healing without adhesion or scar formation. Applied surgically as an anatomical barrier keeping potentially adherent surfaces apart, CYGNUS offers mechanical protection while providing a regenerative tissue matrix with specific anti-inflammatory, anti-scarring and antimicrobial properties. CYGNUS amnionpatch is an immune-privileged tissue containing the natural regenerative factors responsible for creating a wound healing environment conducive to tissue regeneration.

What are the indications for CYGNUS?

Amniotic tissue has been used for over 100 years with excellent clinical success. CYGNUS is available in multiple sizes and configurations, offering options for key indications such as reconstructive surgery, spine and neurosurgery, foot and ankle, wound care, ophthalmology, and oral surgery.

Does CYGNUS have a Q or a C-code?

Presently, CYGNUS does not have a Q or a C-code.

Is a Q-code necessary for the inpatient setting?

No, Q-codes are HCPCS (Healthcare Common Procedure Coding System) codes that are frequently used to report supplies and services that are not assigned Level II CPT code. In some instances, private payers and/or Medicare may provide additional reimbursement for some HCPCS codes. Facilities may use them to track device costs on the facility charge master or super bill. Q-codes are HCPCS codes used in the hospital outpatient setting; not in the hospital inpatient setting.

If a facility requires a Q-code for the charge master or super bill, what is the most appropriate code for CYGNUS?

Should a facility require a Q-code for inpatient tracking purposes, Q-4100 (Skin substitute, not otherwise specified) is the most appropriate code

Is a Q-code necessary for the outpatient setting?

Yes, the code is necessary for the outpatient setting. CYGNUS should be reported with code Q4100. Reimbursement for CYGNUS will be packaged into the reimbursement for the facility. Until CYGNUS receives a unique HCPCS code, it will be classified as a low-cost skin substitute. Facilities should still indicate the cost of CYGNUS (even if higher than $32 per sq. cm) as categorization of Q-codes for skin substitutes is based on historical cost.

Services Not Included in the Global Surgical Package

Reference: Medicare Claims Processing Manual, Chapter 12, section 40.1

Payers do not include the services listed below in the payment amount for a procedure with the appropriate indicator in Field 16 of the MFSDB (Medicare Fee Schedule Data Base). These services may be paid for separately.

• The initial consultation or evaluation to diagnose the problem and determine the need for surgery. Important: this policy only applies to major surgical procedures. The initial evaluation is generally included in the global surgical payment for minor procedures.

• Services provided by other physicians except where the surgeon and other physician agree on the transfer of care from one physician to another. This agreement is typically a letter or an annotationin the discharge summary, or hospital medical record.

• Visits unrelated to the diagnosis for which the surgery was performed, unless the visits are due to complications from the surgery.

• Treatment for an underlying condition, or an additional course of treatment, which is not part of the normal recovery from the surgery.

• Diagnostic tests and procedures, including diagnostic radiological procedures.

• Distinct surgical procedures during the post-operative period which are not re-operations or treatment for complications. This includes procedures done in two or more parts for which the decision to stage the procedure is made prospectively or at the time of the first procedure.

• Treatment for post-operative complications which require a return to the operating room (OR). For the purposes of this payment rule, an OR is defined as a place of service specifically equipped and staffed for the sole purpose of performing procedures. This includes cardiac catheterization labs, laser suite/lab, and an endoscopy suite. It does not include the patient’s room, a minor procedure treatment room, recovery room, or an intensive care unit (unless the patient’s condition is so critical there is no time for transport to the OR).

• Should a less extensive procedure fail, and a more extensive surgery is required, the second surgery may be reimbursed separately.

• Immunosuppressive therapy for organ transplants.

• Critical care services (CPT 99291 and 99292) unrelated to the surgery where a seriously injured or burned patient is critically ill and requires extensive monitoring by a physician.

CPT Code Global Period

15002 000

+15003 ZZZ

15004 000

+15005 ZZZ

15271 000

+15272 ZZZ

List of Global Periods by CPT Code

CPT Code Global Period

15273 000

+15274 ZZZ

15275 000

+15276 ZZZ

15277 000

+15278 ZZZ

ZZZ: The code is related to another service and is always included in the global period of the other service.

000: Endoscopic or minor procedure with related pre-operative and post-operative relative values on the day of the procedure are included in the fee schedule payment amount; E/M services on the day of the procedure are generally not separately reimbursed.

3

Insurance Overview

Medicare

Inpatient: Medicare inpatient benefits are covered under Medicare Part A. Medicare reimburses hospitals for services provided to patients via the Inpatient Prospective Payment System, using MS-DRG’s (Medical Severity Diagnosis Related Groups). There are no separate payments for individual products in the inpatient setting. The cost of products and supplies usedto treat patients are factored into a lump sum payment the facility. Patients are assigned to MS-DRGs based on the care provided during the inpatient hospital stay (such as burn debridement), and the severity of their condition. In the Inpatient Reimbursement section of this Guide, examples of MS-DRGs are provided for reference only. The payment rates are based on from the Federal Register, published in August 2014, and will be valid through September 2015. Hospital Finance Departments should be able to provide specific payment information, by MS-DRG. Facilities should always check to ensure the patient inpatient stay is considered medically necessary.

Outpatient: Medicare reimburses hospital outpatient surgeries via the Ambulatory Payment Classification (APC) methodology, which is also known as the Outpatient Prospective Payment System (OPPS). APC payment rates that may be associated with the CYGNUS Amnion Patch are highlighted below. Medicare no longer provides separate reimbursement for drugs and biologics as these products are now packaged with the APC payment for the procedure. Medicare coverage policies will determine whether or not there is payment for the APC associated with the procedure.

Ambulatory Surgical Centers (ASC): ASCs are reimbursed using the ASC payment methodology which is similar to the APC system. Medicare no longer provides separate payment for drugs and biologics in the ASC setting (similar to the hospital outpatient setting). CPT codes that are approved for use in the ASC setting are provided by Medicare program on an annual basis.

Physician: The physician is reimbursed based on the RBRVS (Resource Based Relative ValueSystem). Each CPT® code physicians use to report services is assigned a Relative Value Unit (RVU). To determine the payment rate for the code, the number of RVUs associated with a CPT code is multiplied by the conversion factor. The temporary conversion factor for 2015 is $35.8013. Examples of physician payments are included in the Physician Payment section of this guide. If the physician performs an approved procedure in his/her office, payment will be increased via the amount allowed for a “non-facility” based physician. This designation allows higher payment for the billed CPT codes to account for the supplies, drugs, or products used in the office-based procedure.

Coverage/Eligibility: Healthcare providers should always confirm coverage with local Medicare carriers using the CMS website. The following link below will provide guidance for confirming coverage.

http://www.cms.hhs.gov/CoverageGenInfo/01_overview.asp?

Medicaid

Medicaid coverage and reimbursement varies from state to state for Inpatient services. Please verify state Medicaid coverage and reimbursement policies before treatment.

Other Carriers

Other payers such as HMO’s and PPO’s (commercial insurance) will usually pay based on negotiated contract rates (similar to an MS-DRG), a percent of billed charges, or per diem payments. Hospitals may sometimes negotiate a separate payment for implanted devices or biologics, however this is not typically common.

The following ICD-9-CM code may be appropriate for the use of the CYGNUS amnion patch in the Inpatient setting.

Code Description

0HR0XK3

0HR0XK4

0HR1XK3

0HR1XK4

0HR4XK3

0HR4XK4

0HR5XK3

0HR5XK4

0HR6XK3

0HR6XK4

0HR7XK3

0HR7XK4

0HR8XK3

0HR8XK4

0HRAXK3

0HRAXK4

0HRBXK3

Replacement of Scalp Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Scalp Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Face Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Face Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Neck Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Neck Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Chest Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Chest Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Back Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Back Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Abdomen Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Abdomen Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Buttock Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Buttock Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Genitalia Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Genitalia Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Right Upper Arm Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Common ICD-9-CM Procedure Codes

The following ICD-9-CM code may be appropriate for the use of the CYGNUS amnion patch in the Inpatient setting.

86.67 Dermal Regenerative Graft

Code Description

Inpatient Reimbursement

13

Services Included in the Global Surgical Package

Reference: Medicare Claims Processing Manual, Chapter 12, section 40.1

• Preoperative visits are not separately reimbursable services when performed within the assigned global period by the same physician or other qualified health professional of the same specialty and federal tax identification number.

• For a procedure with a global period of 0-10 days, the decision to perform the procedure is included in the payment for the surgical procedure and should not be reported separately as an evaluation and management (E/M) service.

• For a procedure with a global period of 90 days, if an E/M service is performed one day before or on the same date of service as a major surgical procedure, it is included in the global payment for the procedure and is not separately reimbursable unless the decision to perform surgery was made during the visit. If the decision to perform surgery was made during the E/M visit, the E/M would be separately reimbursable with modifier -57 appended to the code.

• Postoperative visits, including follow-up E/M visits that occur within the designated global period that are related to the patient recovery following surgery.

• Complications following surgery, including all additional medical and/or surgical services required of the physician or other qualified health care professional (not resulting in a return trip to the operating room) that occur within the designated global period.

• Post-surgical pain management by the physician or other qualified health care professional.

• Supplies (except for select procedures).

• Miscellaneous Services; items such as dressing changes; local incisional care; removal of operative pack; removal of cutaneous sutures and staples, lines, wires, tubes, drains, casts, and splints; insertion, irrigation and removal of urinary catheters, routine peripheral intravenous lines, nasogastric and rectal tubes; and changes and removal of tracheostomy tubes.

The Global Payment Period

The Medicare approved amount for the above procedures includes payment for the following services related to the

surgery when furnished by the physician who performed the surgery. The services included in the global surgical package

may be furnished in any setting (e.g. hospital inpatient, physician office). Visits to a patient in the Intensive Care Unit (ICU) are also included if made by the surgeon. Critical care

services (CPT 99291 and 99292) may be separately reimbursed in some situations.

CPT 2015 provided additional coding guideline for 15271 and 15272:

• Use 15272 in conjunction with 15271• For total wound surface area greater than or equal to 100 sq cm, see 15273, 15274• Do not report 15271, 15272 in conjunction with 15273, 15724

CPT 2015 provided additional coding guideline for 15275 and 15276:

• Use 15276 in conjunction with 15275• For total wound surface area greater than or equal to 100 sq cm, see 15277, 15278• Do not report 15275, 15276 in conjunction with 15277, 15278

CPT 2015 provided additional coding guideline for 15273 and 15274:

• Use 15274 in conjunction with 15273• For total wound surface area up to 100 sq cm, see 15271, 15272

CPT 2015 provided additional coding guideline for 15277 and 15278:

• Use 15278 in conjunction with 15277• For total wound surface area up to 100 sq cm, see 15275, 15276

Additional Descriptions for CPT Codes Associated with Skin Substitutes from the CPT Changes 2012:

An Insider’s View, American Medical Association, pages 27-29.

Description of Procedures 15271 and 15275: “Simple cleansing of the wound bed is performed and hemostasis is achieved. The wound is measured and the appropriate sized skin substitute graft is prepared and applied to the prepared wound surface, including wound margins, and secured in place.”

Description of Procedures 15272 and 15276: “Additional simple cleansing of the wound and hemostasis is performed. Additional skin substitute graft material is prepared and applied to the prepared wound surface, including wound margins, and secured in place.”

Description of Procedures 12573 and 15277: “Under general anesthesia, hemostasis of the graft site with epinephrine soaked laparotomy pads and/or topical thrombin is accomplished. Skin substitute graft totaling 100 sq cm is prepared and applied to the prepared wound surface, including the wound margins, and secured in place.”

Description of Procedures 15274 and 15278: “Additional hemostasis of the graft site with epinephrine soaked laparotomy pads and/or topical thrombin is accomplished. Additional skin substitute graft totaling 100 sq cm is applied to the leg and secured in place.”

5

Common ICD-9-CM Diagnosis Codes

The following ICD-9-CM diagnosis codes may be appropriate for the use of the CYGNUS amnion patch.

941-946

948.0X-948.9X

Scar Contracture

701.4

709.2

906.5-906.9

Burns of varying body regions

Burns classified according to extent of body surface

Keloid Scar

Scar Conditions and Fibrosis of Skin

Late Effect of Burns

Burns Description

Description

Code Description

0HRBXK4

0HRCXK3

0HRCXK4

0HRDXK3

0HRDXK4

0HREXK3

0HREXK4

0HRFXK3

0HRFXK4

0HRGXK3

0HRGXK4

0HRHXK3

0HRHXK4

0HRJXK3

0HRJXK4

0HRKXK3

0HRKXK4

0HRLXK3

0HRLXK4

0HRMXK3

0HRMXK4

0HRNXK3

0HRNXK4

Replacement of Right Upper Arm Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Left Upper Arm Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Left Upper Arm Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Right Lower Arm Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Right Lower Arm Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Left Lower Arm Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Left Lower Arm Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Right Hand Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Right Hand Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Left Hand Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Left Hand Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Right Upper Leg Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Right Upper Leg Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Left Upper Leg Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Left Upper Leg Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Right Lower Leg Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Right Lower Leg Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Left Lower Leg Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Left Lower Leg Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Right Foot Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Right Foot Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Left Foot Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Left Foot Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Source: CMS General Equivalence Mappings

Potential MS-DRG Assignments Associated with ICD-9-CM or ICD-10-PCS Codes

DescriptionMS-DRGMedicare AveragePayment Rate

Relative Weight (RW)

Source: CMS General Equivalence Mappings

*CC/MCC: Complication or Comorbidity (CC), Major Complication or Comorbidity (MCC)

Common ICD-10-CM Diagnosis Codes

The following ICD-10-CM diagnosis codes may be appropriate for the use of the CYGNUS amnion patch.

T20.00XA-T20.39XA

T20.40XA-T79.XA

L91.0

L90.5

T20.00XS

T20.40XS

T21.00XS

T21.40XS

T22.00XS

T22.40XS

T23.009S

T23.079S

T23.409S

T23.479S

T28.40XS

T28.90XS

Skin Graft and/or Debridement Except for Skin Ulcer or Cellulitis without CC/MCC*

Burns of varying degree and body regions

Corrosion of varying degree and body regions

Hypertrophic scar

Scar Conditions and Fibrosis of Skin

Burn of unspecified degree of head, face, and neck, unspecified site, sequela

Corrosion of unspecified degree of head, face, and neck, unspecified site, sequela

Corrosion of unspecified degree of trunk, unspecified site, sequela

Corrosion of unspecified degree of trunk, unspecified site, sequela

Burn of unspecified degree of shoulder and upper limb, except wrist and hand, unspecified site, sequela

Corrosion of unspecified degree of shoulder and upper limb, except wrist and hand, unspecified site, sequela

Burn of unspecified degree of unspecified hand, unspecified site, sequela

Burn of unspecified degree of unspecified wrist, sequela

Corrosion of unspecified degree of unspecified hand, unspecified site, sequela

Corrosion of unspecified degree of unspecified wrist, sequela

Burn of unspecified internal organ, sequela

Corrosions of unspecified internal organs, sequela

Burns Description

Extensive Burns or Full Thickness Burns with Mechanical Ventilation for 96+ Hours with Skin Graft

Full Thickness Burn with Skin Graft or Inhalation Injury with CC/MCC*

Full Thickness Burn with Skin Graft or Inhalation Injury without CC/MCC*

Skin Graft and/or Debridement Except for Skin Ulcer or Cellulitis with MCC*

Skin Graft and/or Debridement Except for Skin Ulcer or Cellulitis with CC*

927

928

929

576

577

578

15.5499

5.3820

2.3344

4.1423

1.9812

1.3162

$91,208

$31,568

$13,692

$24,297

$11,621

$7,720

11

Wound Surface Area Less than 100 Sq CM RVU

Physician Payment Facility

Physician Payment Non-Facility

15273

Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children

+15274

Each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure)

15277

Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children

+15278

3.50

0.80

4.00

1.00

$210

$47

$234

$59

$304

$73

$331

$87

Each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body are of infants and children, or thereof (List separately in addition to code for primary procedure)

CPT Code

First 100Sq Cm

Each Additional 100 Sq Cm

First 100 Sq Cm

Each Additional 100 Sq Cm

Intended Use

*Codes 15002-15005 are typically used for the initial excision of a wound bed for a graft. Use debridement codes 11042-11047, or 97597-97602 for removal of non-viable tissue/debris in a chronic wound when the wound is left to heal by secondary intention when appropriate. Please check NCCI (National Correct Coding Initiative) edits to verify the appropriate reporting ofdebridement codes in conjunction with application of skin substitute codes 15271-15278.

Wound Surface Area Less than 100 Sq CM RVU

Physician Payment Facility

Physician Payment Non-Facility

15271

Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area

+15272

Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)

15275

Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area

+15276

1.50

0.33

1.83

0.50

$88

$18

$99

$26

$144

$28

$152

$35

Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)

CPTCode

First 25 Sq Cm

Each Additional 25 Sq Cm

First 25 Sq Cm

Each Additional 25 Sq Cm

Intended Use

Potential MS-DRG Assignments Associated with ICD-9-CM or ICD-10-PCS Codes

Description (Based on Size of Wound)CPT CodePhysician Payment Non-Facility

Physician Payment FacilityRVU

Surgical preparation or creation of recipient site by excision of open wounds, burn eschar or scar (including subcutaneous tissues), or incisional release of scar contracture, trunk, arms, legs; first 100 square cm or 1% of body area infants and children

Each additional 100 sq cm, or part thereof, or additional 1% of body area of infants and children (List separately in addition to code for primary procedure)

Surgical preparation or creation of recipient site by excision of open wounds, burn eschar or scar (including subcutaneous tissues), or incisional release of scar contracture, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits; first 100 sq cm or 1% of body area of infants and children

Each additional 100 sq cm, or part thereof, or each additional 1% of body area of infants and children (List separately in addition to code for primary procedure)

15002

+15003

15004

+15005

$235

$47

$281

$94

3.65

0.80

4.58

1.60

$354

$78

$410

$128

7

Surgical Preparations for Skin Replacement Surgery-Outpatient Setting

CPT ®2015, Skin Replacement Surgery and Skin Substitutes Section, Current Procedural Terminology (CPT) copyright 2014 American Medical Association (AMA). All rights reserved. CPT is a registered trademark of the AMA

Skin Replacement Surgery

Skin replacement surgery consists of surgical preparation and topical placement of an autograft (including tissue cultured autograft) or substitute graft (ie, homograft, allograft, xenograft). The graft is anchored using the provider’s choice of fixation. When services are performed in the office, routine dressing supplies are not reported separately.

The following definition should be applied to those codes that reference “100 sq cm or 1% of body area of infants and children” when determining the involvement of body size: The measurement of 100 sq cm is applicable to adults and children age 10 or older; percentages of body surface area apply to infants and children younger than 10 years of age. The measurements apply to the size of the recipient site.

Procedures involving wrist and/or ankle are reported with codes that include arm or leg in the descriptor.

Surgical Preparation

Surgical preparation codes 15002-15005 for skin replacement surgery describe the initial services related to preparing a clean and viable wound surface for placement of an autograft, flap, skin substitute graft or for negative pressure wound therapy. In some cases, closure may be possible using adjacent tissue transfer (14000-14061) or complex repair (13100-13153). In all cases, appreciable nonviable tissue is removed to treat a burn, traumatic wound or a necrotizing infection. The clean wound bed may also be created by incisional release of a scar contracture resulting in a surface defect from separation of tissues. The intent is to heal the wound by primary intention, or by the use of negative pressure wound therapy. Patient conditions may require the closure or application of graft, flap, or skin substitute to be delayed, but in all cases the intent is to include these treatments or negative pressure therapy to heal the wound. Do not report 15002-15005 for removal of nonviable tissue/debris in a chronic wound (eg, venous or diabetic) when the wound is left to heal by secondary intention. See active wound management codes (97597-97598, 97602) and debridement codes (11042-11047) for this service. For necrotizing soft tissue infections in specific anatomic locations, see 11004-11008.

Select the appropriate code from 15002-15005 based upon location and size of the resultant defect. Use 15002 or 15004, as appropriate, for excisions and incisional releases resulting in wounds up to and including 100 sq cm of surface area. Use 15003 or 15005 for each additional 100 sq cm or part thereof. Report complex repairs, adjacent tissue transfer, flaps and grafts separately. Report the application of the skin substitute codes 15271-15278 separately.

Application of Skin Substitute Grafts

Skin substitute grafts include non-autologous human skin (dermal or epidermal, cellular and acellular) grafts (eg, homograft, allograft), non-human skin substitute grafts (ie, xenograft) and biological products that form a sheet scaffolding for skin growth. These codes are not to be reported for application of non-graft wound dressings (eg, gel, ointment, foam, liquid) or injected skin substitutes. Removal of current graft and/or simple cleansing of the wound is included, when performed. Do not report 97602. Debridement is considered a separate procedure only when gross contamination requires prolonged cleansing, when appreciable amounts of devitalized or contaminated tissues are removed, or when debridement is carried out separately without immediate primary closure.

Select the appropriate code from 15271-15278 based upon location and size of the defect. For multiple wounds, sum the surface area of all wounds from all anatomic sites that are grouped together into the same code descriptor.

Surgical Preparation Codes* for Skin Replacement SurgeryMay Be Applicable to Burns, Traumatic Wounds, or Necrotizing Infection

Description (Based on Size of Wound) APC

ASC Payment

Hospital Outpatient Payment

Status Indicator ASC

Status Indicator Outpatient

15002

Surgical preparation or creation of recipient site by excision of open wounds, burn eschar or scar (including subcutaneous tissues), or incisional release of scar contracture, trunk, arms, legs; first 100 square cm or 1% of body area infants and children

+15003

Each additional 100 sq cm, or part thereof, or additional 1% of body area of infants and children (List separately in addition to code for primary procedure)

15004

Surgical preparation or creation of recipient site by excision of open wounds, burn eschar or scar (including subcutaneous tissues), or incisional release of scar contracture, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits; first 100 sq cm or 1% of body area of infants and children

+15005

327

N/A

327

N/A

T

N

T

N

$430

$0

$430

$0

A2

N1

A2

N1

$236

$0

$236

$0

Each additional 100 sq cm, or part thereof, or each additional 1% of body area of infants and children (List separately in addition to code for primary procedure)

CPT Code

*Codes 15002-15005 are typically used for the initial excision of a wound bed for a graft. Use debridement codes 11042-11047, or 97597-97602 for removal of non-viable tissue/debris in a chronic wound when the wound is left to heal by secondary intention when appropriate. Please check NCCI (National Correct Coding Initiative) edits to verify the appropriate reporting of debridement codes in conjunction with application of skin substitute codes 15271-15278.

Topical Placement of Skin Substitute

Wound Surface Area Less than 100 Sq CM APC

ASC Payment

Hospital Outpatient Payment

Status Indicator ASC

Status Indicator Outpatient

15271

Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area

+15272

Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)

15275

Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area

+15276

327

N/A

327

N/A

T

N

T

N

$430

$0

$430

$0

A2

N1

A2

N1

$236

$0

$236

$0

Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)

CPT Code

First 25 Sq Cm

Each Additional 25 Sq Cm

First 25 Sq Cm

Each Additional 25 Sq Cm

Intended Use

9

ASC Payment

Topical Placement of Skin Substitute

Wound Surface Area Equal or Greater Than 100 Sq Cm APC

Hospital Outpatient Payment

Status Indicator ASC

Status Indicator Outpatient

15273

Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children

+15274

Each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure)

15277

Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children

329

N/A

328

T

N

T

$2,301

$0

$1,407

G2

N1

G2

$1,261

$0

$711

CPT Code

Each Additional 100 Sq Cm

First 100Sq Cm

+15278

Each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body are of infants and children, or thereof (List separately in addition to code for primary procedure)

N/A N $0 N1 $0Each Additional 100 Sq Cm

Intended Use

First 100Sq Cm

ASC Status Indicator

A2 = Surgical procedure on ASC list in 2007; payment based on OPPS relative payment rate.N1 = Packaged service/item; no separate payment madeG2 = Non office-based surgical procedure added in CY 2008 or later; payment based on OPPS relative payment weight.

Please note: The wound surface area applies to the size of the recipient site and not the size of the product used. The wrists are considered part of the arm, and ankles are considered part of the leg.

Outpatient Status Indicator

T = Significant Procedure, Multiple Reduction AppliesN = Items and Services Packaged into APC Rates

*CYGNUS does not yet have a unique HCPCS code. The use of Q4100 is appropriate and the price should be based on similar products which may include products classified as “high cost” skin substitutes. Q-codes are priced annually based on historical cost data. CYGNUS may be reclassified as a high cost skin substitute once it receives its own HCPCS codes. For now, the cost of CYGNUS will be packaged into the APC or ASC payment based on its classification as a low-cost skin substitute. Facilities should include proper documentation to support the use of CYGNUS as a skin substitute with the claim submission.

2015 HCPCS Summary for CYGNUS*

CYGNUS Skin Substitute, NOS Carrier PricedQ4100

Product HCPCS Code Description Payment

Surgical Preparation Codes* for Skin Replacement SurgeryMay Be Applicable to Burns, Traumatic Wounds, or Necrotizing Infection

Description (Based on Size of Wound) APC

ASC Payment

Hospital Outpatient Payment

Status Indicator ASC

Status Indicator Outpatient

15002

Surgical preparation or creation of recipient site by excision of open wounds, burn eschar or scar (including subcutaneous tissues), or incisional release of scar contracture, trunk, arms, legs; first 100 square cm or 1% of body area infants and children

+15003

Each additional 100 sq cm, or part thereof, or additional 1% of body area of infants and children (List separately in addition to code for primary procedure)

15004

Surgical preparation or creation of recipient site by excision of open wounds, burn eschar or scar (including subcutaneous tissues), or incisional release of scar contracture, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits; first 100 sq cm or 1% of body area of infants and children

+15005

327

N/A

327

N/A

T

N

T

N

$430

$0

$430

$0

A2

N1

A2

N1

$236

$0

$236

$0

Each additional 100 sq cm, or part thereof, or each additional 1% of body area of infants and children (List separately in addition to code for primary procedure)

CPT Code

*Codes 15002-15005 are typically used for the initial excision of a wound bed for a graft. Use debridement codes 11042-11047, or 97597-97602 for removal of non-viable tissue/debris in a chronic wound when the wound is left to heal by secondary intention when appropriate. Please check NCCI (National Correct Coding Initiative) edits to verify the appropriate reporting of debridement codes in conjunction with application of skin substitute codes 15271-15278.

Topical Placement of Skin Substitute

Wound Surface Area Less than 100 Sq CM APC

ASC Payment

Hospital Outpatient Payment

Status Indicator ASC

Status Indicator Outpatient

15271

Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area

+15272

Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)

15275

Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area

+15276

327

N/A

327

N/A

T

N

T

N

$430

$0

$430

$0

A2

N1

A2

N1

$236

$0

$236

$0

Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)

CPT Code

First 25 Sq Cm

Each Additional 25 Sq Cm

First 25 Sq Cm

Each Additional 25 Sq Cm

Intended Use

9

ASC Payment

Topical Placement of Skin Substitute

Wound Surface Area Equal or Greater Than 100 Sq Cm APC

Hospital Outpatient Payment

Status Indicator ASC

Status Indicator Outpatient

15273

Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children

+15274

Each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure)

15277

Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children

329

N/A

328

T

N

T

$2,301

$0

$1,407

G2

N1

G2

$1,261

$0

$711

CPT Code

Each Additional 100 Sq Cm

First 100Sq Cm

+15278

Each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body are of infants and children, or thereof (List separately in addition to code for primary procedure)

N/A N $0 N1 $0Each Additional 100 Sq Cm

Intended Use

First 100Sq Cm

ASC Status Indicator

A2 = Surgical procedure on ASC list in 2007; payment based on OPPS relative payment rate.N1 = Packaged service/item; no separate payment madeG2 = Non office-based surgical procedure added in CY 2008 or later; payment based on OPPS relative payment weight.

Please note: The wound surface area applies to the size of the recipient site and not the size of the product used. The wrists are considered part of the arm, and ankles are considered part of the leg.

Outpatient Status Indicator

T = Significant Procedure, Multiple Reduction AppliesN = Items and Services Packaged into APC Rates

*CYGNUS does not yet have a unique HCPCS code. The use of Q4100 is appropriate and the price should be based on similar products which may include products classified as “high cost” skin substitutes. Q-codes are priced annually based on historical cost data. CYGNUS may be reclassified as a high cost skin substitute once it receives its own HCPCS codes. For now, the cost of CYGNUS will be packaged into the APC or ASC payment based on its classification as a low-cost skin substitute. Facilities should include proper documentation to support the use of CYGNUS as a skin substitute with the claim submission.

2015 HCPCS Summary for CYGNUS*

CYGNUS Skin Substitute, NOS Carrier PricedQ4100

Product HCPCS Code Description Payment

*Codes 15002-15005 are typically used for the initial excision of a wound bed for a graft. Use debridement codes 11042-11047, or 97597-97602 for removal of non-viable tissue/debris in a chronic wound when the wound is left to heal by secondary intention when appropriate. Please check NCCI (National Correct Coding Initiative) edits to verify the appropriate reporting of debridement codes in conjunction with application of skin substitute codes 15271-15278.

Wound Surface Area Less than 100 Sq CM RVU

Physician Payment Facility

Physician Payment Non-Facility

15271

Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area

+15272

Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)

15275

Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area

+15276

1.50

0.33

1.83

0.50

$88

$18

$99

$26

$144

$28

$152

$35

Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)

CPT Code

First 25 Sq Cm

Each Additional 25 Sq Cm

First 25 Sq Cm

Each Additional 25 Sq Cm

Intended Use

Potential MS-DRG Assignments Associated with ICD-9-CM or ICD-10-PCS Codes

Description (Based on Size of Wound)CPT CodePhysician Payment Non-Facility

Physician Payment FacilityRVU

Surgical preparation or creation of recipient site by excision of open wounds, burn eschar or scar (including subcutaneous tissues), or incisional release of scar contracture, trunk, arms, legs; first 100 square cm or 1% of body area infants and children

Each additional 100 sq cm, or part thereof, or additional 1% of body area of infants and children (List separately in addition to code for primary procedure)

Surgical preparation or creation of recipient site by excision of open wounds, burn eschar or scar (including subcutaneous tissues), or incisional release of scar contracture, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits; first 100 sq cm or 1% of body area of infants and children

Each additional 100 sq cm, or part thereof, or each additional 1% of body area of infants and children (List separately in addition to code for primary procedure)

15002

+15003

15004

+15005

$235

$47

$281

$94

3.65

0.80

4.58

1.60

$354

$78

$410

$128

7

Surgical Preparations for Skin Replacement Surgery-Outpatient Setting

CPT ®2015, Skin Replacement Surgery and Skin Substitutes Section, Current Procedural Terminology (CPT) copyright 2014 American Medical Association (AMA). All rights reserved. CPT is a registered trademark of the AMA

Skin Replacement Surgery

Skin replacement surgery consists of surgical preparation and topical placement of an autograft (including tissue cultured autograft) or substitute graft (ie, homograft, allograft, xenograft). The graft is anchored using the provider’s choice of fixation. When services are performed in the office, routine dressing supplies are not reported separately.

The following definition should be applied to those codes that reference “100 sq cm or 1% of body area of infants and children” when determining the involvement of body size: The measurement of 100 sq cm is applicable to adults and children age 10 or older; percentages of body surface area apply to infants and children younger than 10 years of age. The measurements apply to the size of the recipient site.

Procedures involving wrist and/or ankle are reported with codes that include arm or leg in the descriptor.

Surgical Preparation

Surgical preparation codes 15002-15005 for skin replacement surgery describe the initial services related to preparing a clean and viable wound surface for placement of an autograft, flap, skin substitute graft or for negative pressure wound therapy. In some cases, closure may be possible using adjacent tissue transfer (14000-14061) or complex repair (13100-13153). In all cases, appreciable nonviable tissue is removed to treat a burn, traumatic wound or a necrotizing infection. The clean wound bed may also be created by incisional release of a scar contracture resulting in a surface defect from separation of tissues. The intent is to heal the wound by primary intention, or by the use of negative pressure wound therapy. Patient conditions may require the closure or application of graft, flap, or skin substitute to be delayed, but in all cases the intent is to include these treatments or negative pressure therapy to heal the wound. Do not report 15002-15005 for removal of nonviable tissue/debris in a chronic wound (eg, venous or diabetic) when the wound is left to heal by secondary intention. See active wound management codes (97597-97598, 97602) and debridement codes (11042-11047) for this service. For necrotizing soft tissue infections in specific anatomic locations, see 11004-11008.

Select the appropriate code from 15002-15005 based upon location and size of the resultant defect. Use 15002 or 15004, as appropriate, for excisions and incisional releases resulting in wounds up to and including 100 sq cm of surface area. Use 15003 or 15005 for each additional 100 sq cm or part thereof. Report complex repairs, adjacent tissue transfer, flaps and grafts separately. Report the application of the skin substitute codes 15271-15278 separately.

Application of Skin Substitute Grafts

Skin substitute grafts include non-autologous human skin (dermal or epidermal, cellular and acellular) grafts (eg, homograft, allograft), non-human skin substitute grafts (ie, xenograft) and biological products that form a sheet scaffolding for skin growth. These codes are not to be reported for application of non-graft wound dressings (eg, gel, ointment, foam, liquid) or injected skin substitutes. Removal of current graft and/or simple cleansing of the wound is included, when performed. Do not report 97602. Debridement is considered a separate procedure only when gross contamination requires prolonged cleansing, when appreciable amounts of devitalized or contaminated tissues are removed, or when debridement is carried out separately without immediate primary closure.

Select the appropriate code from 15271-15278 based upon location and size of the defect. For multiple wounds, sum the surface area of all wounds from all anatomic sites that are grouped together into the same code descriptor.

Potential MS-DRG Assignments Associated with ICD-9-CM or ICD-10-PCS Codes

DescriptionMS-DRGMedicare AveragePayment Rate

Relative Weight (RW)

Source: CMS General Equivalence Mappings

*CC/MCC: Complication or Comorbidity (CC), Major Complication or Comorbidity (MCC)

Common ICD-10-CM Diagnosis Codes

The following ICD-10-CM diagnosis codes may be appropriate for the use of the CYGNUS amnion patch.

T20.00XA-T20.39XA

T20.40XA-T79.XA

L91.0

L90.5

T20.00XS

T20.40XS

T21.00XS

T21.40XS

T22.00XS

T22.40XS

T23.009S

T23.079S

T23.409S

T23.479S

T28.40XS

T28.90XS

Skin Graft and/or Debridement Except for Skin Ulcer or Cellulitis without CC/MCC*

Burns of varying degree and body regions

Corrosion of varying degree and body regions

Hypertrophic scar

Scar Conditions and Fibrosis of Skin

Burn of unspecified degree of head, face, and neck, unspecified site, sequela

Corrosion of unspecified degree of head, face, and neck, unspecified site, sequela

Corrosion of unspecified degree of trunk, unspecified site, sequela

Corrosion of unspecified degree of trunk, unspecified site, sequela

Burn of unspecified degree of shoulder and upper limb, except wrist and hand, unspecified site, sequela

Corrosion of unspecified degree of shoulder and upper limb, except wrist and hand, unspecified site, sequela

Burn of unspecified degree of unspecified hand, unspecified site, sequela

Burn of unspecified degree of unspecified wrist, sequela

Corrosion of unspecified degree of unspecified hand, unspecified site, sequela

Corrosion of unspecified degree of unspecified wrist, sequela

Burn of unspecified internal organ, sequela

Corrosions of unspecified internal organs, sequela

Burns Description

Extensive Burns or Full Thickness Burns with Mechanical Ventilation for 96+ Hours with Skin Graft

Full Thickness Burn with Skin Graft or Inhalation Injury with CC/MCC*

Full Thickness Burn with Skin Graft or Inhalation Injury without CC/MCC*

Skin Graft and/or Debridement Except for Skin Ulcer or Cellulitis with MCC*

Skin Graft and/or Debridement Except for Skin Ulcer or Cellulitis with CC*

927

928

929

576

577

578

15.5499

5.3820

2.3344

4.1423

1.9812

1.3162

$91,208

$31,568

$13,692

$24,297

$11,621

$7,720

11

Wound Surface Area Less than 100 Sq CM RVU

Physician Payment Facility

Physician Payment Non-Facility

15273

Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children

+15274

Each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure)

15277

Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children

+15278

3.50

0.80

4.00

1.00

$210

$47

$234

$59

$304

$73

$331

$87

Each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body are of infants and children, or thereof (List separately in addition to code for primary procedure)

CPT Code

First 100Sq Cm

Each Additional 100 Sq Cm

First 100 Sq Cm

Each Additional 100 Sq Cm

Intended Use

CPT 2015 provided additional coding guideline for 15271 and 15272:

• Use 15272 in conjunction with 15271• For total wound surface area greater than or equal to 100 sq cm, see 15273, 15274• Do not report 15271, 15272 in conjunction with 15273, 15724

CPT 2015 provided additional coding guideline for 15275 and 15276:

• Use 15276 in conjunction with 15275• For total wound surface area greater than or equal to 100 sq cm, see 15277, 15278• Do not report 15275, 15276 in conjunction with 15277, 15278

CPT 2015 provided additional coding guideline for 15273 and 15274:

• Use 15274 in conjunction with 15273• For total wound surface area up to 100 sq cm, see 15271, 15272

CPT 2015 provided additional coding guideline for 15277 and 15278:

• Use 15278 in conjunction with 15277• For total wound surface area up to 100 sq cm, see 15275, 15276

Additional Descriptions for CPT Codes Associated with Skin Substitutes from the CPT Changes 2012:

An Insider’s View, American Medical Association, pages 27-29.

Description of Procedures 15271 and 15275: “Simple cleansing of the wound bed is performed and hemostasis is achieved. The wound is measured and the appropriate sized skin substitute graft is prepared and applied to the prepared wound surface, including wound margins, and secured in place.”

Description of Procedures 15272 and 15276: “Additional simple cleansing of the wound and hemostasis is performed. Additional skin substitute graft material is prepared and applied to the prepared wound surface, including wound margins, and secured in place.”

Description of Procedures 12573 and 15277: “Under general anesthesia, hemostasis of the graft site with epinephrine soaked laparotomy pads and/or topical thrombin is accomplished. Skin substitute graft totaling 100 sq cm is prepared and applied to the prepared wound surface, including the wound margins, and secured in place.”

Description of Procedures 15274 and 15278: “Additional hemostasis of the graft site with epinephrine soaked laparotomy pads and/or topical thrombin is accomplished. Additional skin substitute graft totaling 100 sq cm is applied to the leg and secured in place.”

5

Common ICD-9-CM Diagnosis Codes

The following ICD-9-CM diagnosis codes may be appropriate for the use of the CYGNUS amnion patch.

941-946

948.0X-948.9X

Scar Contracture

701.4

709.2

906.5-906.9

Burns of varying body regions

Burns classified according to extent of body surface

Keloid Scar

Scar Conditions and Fibrosis of Skin

Late Effect of Burns

Burns Description

Description

Code Description

0HRBXK4

0HRCXK3

0HRCXK4

0HRDXK3

0HRDXK4

0HREXK3

0HREXK4

0HRFXK3

0HRFXK4

0HRGXK3

0HRGXK4

0HRHXK3

0HRHXK4

0HRJXK3

0HRJXK4

0HRKXK3

0HRKXK4

0HRLXK3

0HRLXK4

0HRMXK3

0HRMXK4

0HRNXK3

0HRNXK4

Replacement of Right Upper Arm Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Left Upper Arm Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Left Upper Arm Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Right Lower Arm Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Right Lower Arm Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Left Lower Arm Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Left Lower Arm Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Right Hand Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Right Hand Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Left Hand Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Left Hand Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Right Upper Leg Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Right Upper Leg Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Left Upper Leg Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Left Upper Leg Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Right Lower Leg Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Right Lower Leg Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Left Lower Leg Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Left Lower Leg Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Right Foot Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Right Foot Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Left Foot Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Left Foot Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Source: CMS General Equivalence Mappings

The following ICD-9-CM code may be appropriate for the use of the CYGNUS amnion patch in the Inpatient setting.

Code Description

0HR0XK3

0HR0XK4

0HR1XK3

0HR1XK4

0HR4XK3

0HR4XK4

0HR5XK3

0HR5XK4

0HR6XK3

0HR6XK4

0HR7XK3

0HR7XK4

0HR8XK3

0HR8XK4

0HRAXK3

0HRAXK4

0HRBXK3

Replacement of Scalp Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Scalp Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Face Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Face Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Neck Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Neck Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Chest Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Chest Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Back Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Back Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Abdomen Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Abdomen Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Buttock Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Buttock Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Genitalia Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Replacement of Genitalia Skin with Nonautologous Tissue Substitute, Partial Thickness, External Approach

Replacement of Right Upper Arm Skin with Nonautologous Tissue Substitute, Full Thickness, External Approach

Common ICD-9-CM Procedure Codes

The following ICD-9-CM code may be appropriate for the use of the CYGNUS amnion patch in the Inpatient setting.

86.67 Dermal Regenerative Graft

Code Description

Inpatient Reimbursement

13

Services Included in the Global Surgical Package

Reference: Medicare Claims Processing Manual, Chapter 12, section 40.1

• Preoperative visits are not separately reimbursable services when performed within the assigned global period by the same physician or other qualified health professional of the same specialty and federal tax identification number.

• For a procedure with a global period of 0-10 days, the decision to perform the procedure is included in the payment for the surgical procedure and should not be reported separately as an evaluation and management (E/M) service.

• For a procedure with a global period of 90 days, if an E/M service is performed one day before or on the same date of service as a major surgical procedure, it is included in the global payment for the procedure and is not separately reimbursable unless the decision to perform surgery was made during the visit. If the decision to perform surgery was made during the E/M visit, the E/M would be separately reimbursable with modifier -57 appended to the code.

• Postoperative visits, including follow-up E/M visits that occur within the designated global period that are related to the patient recovery following surgery.

• Complications following surgery, including all additional medical and/or surgical services required of the physician or other qualified health care professional (not resulting in a return trip to the operating room) that occur within the designated global period.

• Post-surgical pain management by the physician or other qualified health care professional.

• Supplies (except for select procedures).

• Miscellaneous Services; items such as dressing changes; local incisional care; removal of operative pack; removal of cutaneous sutures and staples, lines, wires, tubes, drains, casts, and splints; insertion, irrigation and removal of urinary catheters, routine peripheral intravenous lines, nasogastric and rectal tubes; and changes and removal of tracheostomy tubes.

The Global Payment Period

The Medicare approved amount for the above procedures includes payment for the following services related to the

surgery when furnished by the physician who performed the surgery. The services included in the global surgical package

may be furnished in any setting (e.g. hospital inpatient, physician office). Visits to a patient in the Intensive Care Unit (ICU) are also included if made by the surgeon. Critical care

services (CPT 99291 and 99292) may be separately reimbursed in some situations.

Services Not Included in the Global Surgical Package

Reference: Medicare Claims Processing Manual, Chapter 12, section 40.1

Payers do not include the services listed below in the payment amount for a procedure with the appropriate indicator in Field 16 of the MFSDB (Medicare Fee Schedule Data Base). These services may be paid for separately.

• The initial consultation or evaluation to diagnose the problem and determine the need for surgery. Important: this policy only applies to major surgical procedures. The initial evaluation is generally included in the global surgical payment for minor procedures.

• Services provided by other physicians except where the surgeon and other physician agree on the transfer of care from one physician to another. This agreement is typically a letter or an annotationin the discharge summary, or hospital medical record.

• Visits unrelated to the diagnosis for which the surgery was performed, unless the visits are due to complications from the surgery.

• Treatment for an underlying condition, or an additional course of treatment, which is not part of the normal recovery from the surgery.

• Diagnostic tests and procedures, including diagnostic radiological procedures.

• Distinct surgical procedures during the post-operative period which are not re-operations or treatment for complications. This includes procedures done in two or more parts for which the decision to stage the procedure is made prospectively or at the time of the first procedure.

• Treatment for post-operative complications which require a return to the operating room (OR). For the purposes of this payment rule, an OR is defined as a place of service specifically equipped and staffed for the sole purpose of performing procedures. This includes cardiac catheterization labs, laser suite/lab, and an endoscopy suite. It does not include the patient’s room, a minor procedure treatment room, recovery room, or an intensive care unit (unless the patient’s condition is so critical there is no time for transport to the OR).

• Should a less extensive procedure fail, and a more extensive surgery is required, the second surgery may be reimbursed separately.

• Immunosuppressive therapy for organ transplants.

• Critical care services (CPT 99291 and 99292) unrelated to the surgery where a seriously injured or burned patient is critically ill and requires extensive monitoring by a physician.

CPT Code Global Period

15002 000

+15003 ZZZ

15004 000

+15005 ZZZ

15271 000

+15272 ZZZ

List of Global Periods by CPT Code

CPT Code Global Period

15273 000

+15274 ZZZ

15275 000

+15276 ZZZ

15277 000

+15278 ZZZ

ZZZ: The code is related to another service and is always included in the global period of the other service.

000: Endoscopic or minor procedure with related pre-operative and post-operative relative values on the day of the procedure are included in the fee schedule payment amount; E/M services on the day of the procedure are generally not separately reimbursed.

3

Insurance Overview

Medicare

Inpatient: Medicare inpatient benefits are covered under Medicare Part A. Medicare reimburses hospitals for services provided to patients via the Inpatient Prospective Payment System, using MS-DRG’s (Medical Severity Diagnosis Related Groups). There are no separate payments for individual products in the inpatient setting. The cost of products and supplies usedto treat patients are factored into a lump sum payment the facility. Patients are assigned to MS-DRGs based on the care provided during the inpatient hospital stay (such as burn debridement), and the severity of their condition. In the Inpatient Reimbursement section of this Guide, examples of MS-DRGs are provided for reference only. The payment rates are based on from the Federal Register, published in August 2014, and will be valid through September 2015. Hospital Finance Departments should be able to provide specific payment information, by MS-DRG. Facilities should always check to ensure the patient inpatient stay is considered medically necessary.

Outpatient: Medicare reimburses hospital outpatient surgeries via the Ambulatory Payment Classification (APC) methodology, which is also known as the Outpatient Prospective Payment System (OPPS). APC payment rates that may be associated with the CYGNUS Amnion Patch are highlighted below. Medicare no longer provides separate reimbursement for drugs and biologics as these products are now packaged with the APC payment for the procedure. Medicare coverage policies will determine whether or not there is payment for the APC associated with the procedure.

Ambulatory Surgical Centers (ASC): ASCs are reimbursed using the ASC payment methodology which is similar to the APC system. Medicare no longer provides separate payment for drugs and biologics in the ASC setting (similar to the hospital outpatient setting). CPT codes that are approved for use in the ASC setting are provided by Medicare program on an annual basis.

Physician: The physician is reimbursed based on the RBRVS (Resource Based Relative ValueSystem). Each CPT® code physicians use to report services is assigned a Relative Value Unit (RVU). To determine the payment rate for the code, the number of RVUs associated with a CPT code is multiplied by the conversion factor. The temporary conversion factor for 2015 is $35.8013. Examples of physician payments are included in the Physician Payment section of this guide. If the physician performs an approved procedure in his/her office, payment will be increased via the amount allowed for a “non-facility” based physician. This designation allows higher payment for the billed CPT codes to account for the supplies, drugs, or products used in the office-based procedure.

Coverage/Eligibility: Healthcare providers should always confirm coverage with local Medicare carriers using the CMS website. The following link below will provide guidance for confirming coverage.

http://www.cms.hhs.gov/CoverageGenInfo/01_overview.asp?

Medicaid

Medicaid coverage and reimbursement varies from state to state for Inpatient services. Please verify state Medicaid coverage and reimbursement policies before treatment.

Other Carriers

Other payers such as HMO’s and PPO’s (commercial insurance) will usually pay based on negotiated contract rates (similar to an MS-DRG), a percent of billed charges, or per diem payments. Hospitals may sometimes negotiate a separate payment for implanted devices or biologics, however this is not typically common.

This document is for educational purposes only. While CYGNUS can be used across a variety of different therapeutic areas, this reimbursement guides pertains to its use in reconstructive surgery.

Please Note: This document pertains to reimbursement information related to the hospital inpatient, outpatient department (HOPD), ambulatory surgery center (ASC), and the physician office. This guide does not apply to the use of CYGNUS in oral surgery, ophthalmology, and spine/neurosurgery.

This document is for educational purposes only. Coding, coverage and reimbursement decisions are subject to change without notice. Providers should always check with the appropriate payer before submitting claims. Vivex Biomedical, Inc., has used reasonable efforts to provide accurate information, but this information should not be construed as providing clinical advice, dictating reimbursement policy,or as a substitution for the judgement of a healthcare provider. It is always the healthcare provider’s responsibility to determine the appropriate codes, charges for services, and use of modifiers for services rendered. Providers are responsible for verifying coverage with payers, including the applicability of any non-coverage policies that may exist. Vivex Biomedical, Inc., assumes no responsibility for the timeliness, accuracy, or completeness of the information contained within this document. Since reimbursement laws, regulations, and payerpolicies change frequently, it is highly recommended that providers consult their payers, coding specialists and/or legal counsel regarding coverage, coding, and payment issues.

The CYGNUS™ amnion patch is an immune-privileged tissue containing the natural

regenerative factors responsible for creating a wound healing environment conducive

to tissue regeneration.

Applied surgically as an anatomical barrier keeping potentially adherent surfaces apart, CYGNUS offers mechanical protection while providing a regenerative tissue matrix with specific anti-inflammatory, anti-scarring and

anti-microbial properties.

CYGNUS is available in multiple sizes and configurations:

CYGNUS™ MAX (THICK)

Size Code

1x2 cm CAM010200

2x2 cm CAM020200

2x3 cm CAM020300

3x3 cm CAM030300

3x4 cm CAM030400

3x6 cm CAM030600

3x8 cm CAM030800

CYGNUS™ (DUAL LAYER)

Size Code

1x1 cm CAP010100

2x2 cm CAP020200

2x3 cm CAP020300

4x4 cm CAP040400

4x6 cm CAP040600

4x8 cm CAP040800

10mm disc CAP100000

16mm disc CAP160000

CYGNUS™ SOLO (THIN)

Size Code

1x1 cm CAS010100

2x2 cm CAS020200

2x3 cm CAS020300

3x3 cm CAS030300

4x4 cm CAS040400

4x6 cm CAS040600

4x8 cm CAS040800

7x7 cm CAS070700

10x10 cm CAS101000

2x12 cm CAS021200

15

Frequently Asked Questions

What is CYGNUS?

CYGNUS is an amniotic tissue matrix with innate regenerative capability to support healing without adhesion or scar formation. Applied surgically as an anatomical barrier keeping potentially adherent surfaces apart, CYGNUS offers mechanical protection while providing a regenerative tissue matrix with specific anti-inflammatory, anti-scarring and antimicrobial properties. CYGNUS amnionpatch is an immune-privileged tissue containing the natural regenerative factors responsible for creating a wound healing environment conducive to tissue regeneration.

What are the indications for CYGNUS?

Amniotic tissue has been used for over 100 years with excellent clinical success. CYGNUS is available in multiple sizes and configurations, offering options for key indications such as reconstructive surgery, spine and neurosurgery, foot and ankle, wound care, ophthalmology, and oral surgery.

Does CYGNUS have a Q or a C-code?

Presently, CYGNUS does not have a Q or a C-code.

Is a Q-code necessary for the inpatient setting?

No, Q-codes are HCPCS (Healthcare Common Procedure Coding System) codes that are frequently used to report supplies and services that are not assigned Level II CPT code. In some instances, private payers and/or Medicare may provide additional reimbursement for some HCPCS codes. Facilities may use them to track device costs on the facility charge master or super bill. Q-codes are HCPCS codes used in the hospital outpatient setting; not in the hospital inpatient setting.

If a facility requires a Q-code for the charge master or super bill, what is the most appropriate code for CYGNUS?

Should a facility require a Q-code for inpatient tracking purposes, Q-4100 (Skin substitute, not otherwise specified) is the most appropriate code

Is a Q-code necessary for the outpatient setting?

Yes, the code is necessary for the outpatient setting. CYGNUS should be reported with code Q4100. Reimbursement for CYGNUS will be packaged into the reimbursement for the facility. Until CYGNUS receives a unique HCPCS code, it will be classified as a low-cost skin substitute. Facilities should still indicate the cost of CYGNUS (even if higher than $32 per sq. cm) as categorization of Q-codes for skin substitutes is based on historical cost.

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Information on reimbursement is provided as a courtesy. The information provided is “AS IS” and without any other warranty or guarantee, expressed or implied, as to completeness or accuracy, or otherwise. Physicians and providers are responsible for accurate documentation of patient conditions and for reporting procedures and products in accordance with particular payer requirements.

CYGNUS™

REIMBURSEMENT GUIDEDocument: DM-001-L-01