CYGNUS REIMBURSEMENT GUIDE

Transcription

1 CYGNUS REIMBURSEMENT GUIDE

2 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 1x2 cm 2x2 cm 2x3 cm 3x3 cm 3x4 cm 3x6 cm 3x8 cm CAM CAM CAM CAM CAM CAM CAM 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 payer policies change frequently, it is highly recommended that providers consult their payers, coding specialists and/or legal counsel regarding coverage, coding, and payment issues. CYGNUS (DUAL LAYER) Size 1x1 cm CAP x2 cm CAP x3 cm CAP x4 cm CAP x6 cm CAP x8 cm CAP mm disc CAP mm disc CAP CYGNUS SOLO (THIN) Size 1x1 cm CAS x2 cm CAS x3 cm CAS x3 cm CAS x4 cm CAS x6 cm CAS x8 cm CAS x7 cm CAS x10 cm CAS x12 cm CAS021200

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 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. 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. 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 $ 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. 3

4 Inpatient Reimbursement Common ICD-9-CM Procedure s The following ICD-9-CM code may be appropriate for the use of the CYGNUS amnion patch in the Inpatient setting. Description Dermal Regenerative Graft The following ICD-9-CM code may be appropriate for the use of the CYGNUS amnion patch in the Inpatient setting. 0HR0XK3 0HR0XK4 0HR1XK3 0HR1XK4 0HR4XK3 0HR4XK4 0HR5XK3 0HR5XK4 0HR6XK3 0HR6XK4 0HR7XK3 0HR7XK4 0HR8XK3 0HR8XK4 0HRAXK3 0HRAXK4 0HRBXK3 Description 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

5 0HRBXK4 0HRCXK3 0HRCXK4 0HRDXK3 0HRDXK4 0HREXK3 0HREXK4 0HRFXK3 0HRFXK4 0HRGXK3 0HRGXK4 0HRHXK3 0HRHXK4 0HRJXK3 0HRJXK4 0HRKXK3 0HRKXK4 0HRLXK3 0HRLXK4 0HRMXK3 0HRMXK4 0HRNXK3 0HRNXK4 Description 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 Common ICD-9-CM Diagnosis s The following ICD-9-CM diagnosis codes may be appropriate for the use of the CYGNUS amnion patch. Burns X-948.9X Scar Contracture Description Burns of varying body regions Burns classified according to extent of body surface Description Keloid Scar Scar Conditions and Fibrosis of Skin Late Effect of Burns 5

6 Common ICD-10-CM Diagnosis s The following ICD-10-CM diagnosis codes may be appropriate for the use of the CYGNUS amnion patch. Burns 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 Description 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 Source: CMS General Equivalence Mappings Potential MS-DRG Assignments Associated with ICD-9-CM or ICD-10-PCS s MS-DRG Description Relative Weight (RW) Medicare Average Payment Rate 927 Extensive Burns or Full Thickness Burns with Mechanical Ventilation for 96+ Hours with Skin Graft $91, Full Thickness Burn with Skin Graft or Inhalation Injury with CC/MCC* $31, Full Thickness Burn with Skin Graft or Inhalation Injury without CC/MCC* $13, Skin Graft and/or Debridement Except for Skin Ulcer or Cellulitis with MCC* $24, Skin Graft and/or Debridement Except for Skin Ulcer or Cellulitis with CC* $11, Skin Graft and/or Debridement Except for Skin Ulcer or Cellulitis without CC/MCC* $7,720 *CC/MCC: Complication or Comorbidity (CC), Major Complication or Comorbidity (MCC)

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 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 ( ) or complex repair ( ). 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 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 ( , 97602) and debridement codes ( ) for this service. For necrotizing soft tissue infections in specific anatomic locations, see Select the appropriate code from based upon location and size of the resultant defect. Use or 15004, as appropriate, for excisions and incisional releases resulting in wounds up to and including 100 sq cm of surface area. Use or 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 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 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 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. 7

8 Surgical Preparation s* for Skin Replacement Surgery May Be Applicable to Burns, Traumatic Wounds, or Necrotizing Infection CPT Description (Based on Size of Wound) APC Status Indicator Outpatient Hospital Outpatient Payment Status Indicator ASC ASC Payment 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 327 T $430 A2 $ 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) N/A N N 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 327 T $430 A2 $ 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) N/A N N1 *s are typically used for the initial excision of a wound bed for a graft. Use debridement codes , or 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 Topical Placement of Skin Substitute CPT Intended Use Wound Surface Area Less than 100 Sq CM APC Status Indicator Outpatient Hospital Outpatient Payment Status Indicator ASC ASC Payment First 25 Sq Cm 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 327 T $430 A2 $ Each Additional 25 Sq Cm Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) N/A N N First 25 Sq Cm 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 327 T $430 A2 $ Each Additional 25 Sq Cm Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) N/A N N1

9 Topical Placement of Skin Substitute CPT Intended Use Wound Surface Area Equal or Greater Than 100 Sq Cm APC Status Indicator Outpatient Hospital Outpatient Payment Status Indicator ASC ASC Payment First 100 Sq Cm 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 329 T $2,301 G2 $1, Each Additional 100 Sq Cm 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) N/A N N First 100 Sq Cm 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 328 T $1,407 G2 $ Each Additional 100 Sq Cm 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 N1 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 ASC Status Indicator T = N = Significant Procedure, Multiple Reduction Applies Items and Services Packaged into APC Rates A2 = Surgical procedure on ASC list in 2007; payment based on OPPS relative payment rate. N1 = Packaged service/item; no separate payment made G2 = Non office-based surgical procedure added in CY 2008 or later; payment based on OPPS relative payment weight HCPCS Summary for CYGNUS* Product HCPCS Description Payment CYGNUS Q4100 Skin Substitute, NOS Carrier Priced *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. 9

10 Potential MS-DRG Assignments Associated with ICD-9-CM or ICD-10-PCS s CPT Description (Based on Size of Wound) RVU Physician Payment Facility Physician Payment Non-Facility 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 3.65 $235 $ 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) 0.80 $47 $ 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 4.58 $281 $ 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) 1.60 $94 $128 *s are typically used for the initial excision of a wound bed for a graft. Use debridement codes , or 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 CPT Intended Use Wound Surface Area Less than 100 Sq CM RVU Physician Payment Facility Physician Payment Non-Facility First 25 Sq Cm 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 1.50 $88 $ Each Additional 25 Sq Cm Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) 0.33 $18 $ First 25 Sq Cm 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 1.83 $99 $ Each Additional 25 Sq Cm Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) 0.50 $26 $35

11 CPT Intended Use Wound Surface Area Less than 100 Sq CM RVU Physician Payment Facility Physician Payment Non-Facility First 100 Sq Cm 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 3.50 $210 $ Each Additional 100 Sq Cm 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) 0.80 $47 $ First 100 Sq Cm 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 4.00 $234 $ Each Additional 100 Sq Cm 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) 1.00 $59 $87 11

12 CPT 2015 provided additional coding guideline for and 15272: Use in conjunction with For total wound surface area greater than or equal to 100 sq cm, see 15273, Do not report 15271, in conjunction with 15273, CPT 2015 provided additional coding guideline for and 15276: Use in conjunction with For total wound surface area greater than or equal to 100 sq cm, see 15277, Do not report 15275, in conjunction with 15277, CPT 2015 provided additional coding guideline for and 15274: Use in conjunction with For total wound surface area up to 100 sq cm, see 15271, CPT 2015 provided additional coding guideline for and 15278: Use in conjunction with For total wound surface area up to 100 sq cm, see 15275, Additional Descriptions for CPT s Associated with Skin Substitutes from the CPT Changes 2012: An Insider s View, American Medical Association, pages Description of Procedures 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 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 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 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.

13 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 and 99292) may be separately reimbursed in some situations. 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. 13

14 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 annotation in 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 and 99292) unrelated to the surgery where a seriously injured or burned patient is critically ill and requires extensive monitoring by a physician. List of Global Periods by CPT CPT Global Period CPT Global Period ZZZ ZZZ ZZZ ZZZ ZZZ 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.

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 amnion patch is an immune-privileged tissue containing the natural regenerative factors responsible for creating a wound healing environment conducive to tissue regeneration. 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. 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. 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 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 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. 15

16 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 Rawhide Dr. #410, Round Rock, TX (office) (fax) sales@parametricsmedical.com Document: DM-001-L-01