2016 MEDICARE PHYSICIAN & FACILITY REIMBURSEMENT INFORMATION*
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1 2016 MEDICARE & FACILITY REIMBURSEMENT INFORMATION* CODING FOR CLARIX PRODUCTS UTILIZED AS SURGICAL COVERINGS, WRAPS OR BARRIERS CLARIX CORD 1K, CLARIX 100 and CLARIX FLO are cryopreserved human umbilical cord and/or amniotic membrane products. The biological integrity of the umbilical cord and amniotic membrane is maintained through a proprietary and patented cryopreservation process, called CRYOTEK. These products are registered with the Food and Drug Administration (FDA) as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) under Section 361 of the Public Health Service (PHS) Act. CORD 1K 100 CLARIX CORD 1K CLARIX 100 Cryopreserved umbilical cord and amniotic membrane matrix Cryopreserved amniotic membrane matrix Catalog # CR , CR , CR , CR , CR Catalog # CR , CR , CR HCPCS HCPCS CODES C1762 Connective tissue, human (includes fascia lata) C1765 Adhesion Barrier C9399 Unclassified drugs or biologics Per payer contract and/or policy guidelines. 1 L8699 Prosthetic implant, not otherwise specified Q4100 Skin Substitute, not otherwise specified 1 Please refer to Q&A document on page 9. ICD-10-CM diagnosis codes - bill to the highest level of specificity. REVENUE CODES 278 Other implants REI-CLX-REV C Page 1 of 9
2 2016 MEDICARE & FACILITY REIMBURSEMENT INFORMATION* IMPLANTATION Bill with surgical repair CPT codes first (Biologic implantation for sites other than breast or trunk) Unlisted, skin, mucous membrane and subcutaneous tissue (List separately in addition to code for primary procedure) n/a Local Carrier Priced Excluded from payment in ASC $ Add-on (Biologic implantation in breast or trunk) Implantation of biologic implant (e.g., acellular dermal matrix) for soft tissue reinforcement (i.e., breast, trunk) (List separately in addition to code for primary procedure) n/a $ Packaged Service/Item Bundled into Primary - No separate Payment Along with billing the primary surgical CPT code/s, CPT has been identified for use by the American Medical Association s CPT Editorial Board for Implantation of biologic implants for soft tissue reinforcement in tissues other than breast or trunk. Since is an unspecified procedural code with no payment rate assigned and is subject to approval of payers, it is appropriate to include the verbiage is comparable to in Field 19 of the HCFA 1500 professional claim form to assist the payer with understanding what service has been performed by identifying a procedure that is fairly equivalent. Add-on CPT is utilized for Implantation of biologic implant (e.g., acellular dermal matrix) for soft tissue reinforcement in breast or trunk. SELECT MUSCULOSKELETAL SYSTEM Listing not all-inclusive SHOULDER Repair ruptured musculotendinous cuff (e.g. rotator cuff) open; acute Repair of ruptured musculotendinous cuff (e.g. rotator cuff) open; chronic Reconstruction of complete shoulder (rotator) cuffavulsion, chronic (incudes acromioplasty) Arthroscopy, shoulder, distal claviculectomy (Mumford procedure); with rotator cuff procedure $ $ $2, $4, $ $ $2, $4, $ $ $2, $4, $1, $1, $2, $4, REI-CLX-REV C Page 2 of 9
3 2016 MEDICARE & FACILITY REIMBURSEMENT INFORMATION* UPPER EXTREMITY Muscle or tendon transfer, any type, upper arm or elbow, single $ $ $1, $2, Tenotomy, elbow, lateral, or medial (e.g. epicondylitis, tennis elbow, golfer s elbow); percutaneous $ $ $ $1, Excision, lesion of tendon sheath, forearm $ $ $ $1, Radical excision of bursa, synovia of wrist, or forearm tendon sheaths e.g. tenosynobitis, fungus, Tbc, or other granulomas, rheumatoid arthritis; flexors $ $ $ $1, Tenotomy, open flexor or extensor tendon, forearm and/or wrist, single, each tendon $ $ $ $1, Synovectomy, tendon sheath, radical (tenosynovectomy), flexor tendon, palm and/or finger, each tendon $ $ $ $1, Excision of lesion sheath or joint capsule (e.g. cyst, mucous cyst, or ganglion), hand or finger $ $ $ $1, Excision of tendon, flexor or extensor, each tendon $ $ $ $1, Repair or advancement, flexor tendon, not in zone 2 digital flexor sheath (e.g. no man s land); primary or secondary without free $ $ $1, $2, graft, each tendon Secondary with free graft (includes obtaining graft), each tendon $ $ $1, $2, Repair or advancement, flexor tendon, in zone 2 digital flexor tendon sheath (e.g. no man s land); primary, without free graft, $ $ $1, $2, each tendon Secondary, without free graft, each tendon $ $ $1, $2, Secondary, with free graft (includes obtaining graft, each tendon) $ $ $1, $2, Tenolysis, flexor; palm or finger, each tendon $ $ $1, $1, Tenolysis, extensor tendon, hand or tendon, finger, including forearm, each tendon $ $ $1, $1, Reconstruction of tendon pulley, each tendon; with local tissues (separate procedure) $ $ $1, $2, With tendon or facial graft (includes obtaining graft) (separate procedure) $ $ $1, $2, Open treatment of metacarpal fracture, single, includes internal fixation, when performed, each bone $ $ $1, $2, Open treatment of articular fracture, involving metacarpophalangeal or interphalangeal joint, includes internal fixation, when performed, each $ $ $1, $2, Endoscopy, wrist, surgical, with release of transverse carpal ligament $ $ $ $1, Neuroplasty and/or transposition; ulnar nerve at elbow $ $ $ $1, Neuroplasty and/or transposition; ulnar nerve at wrist $ $ $ $1, Neuroplasty and/or transposition; median nerve at carpal tunnel $ $ $ $1, REI-CLX-REV C Page 3 of 9
4 2016 MEDICARE & FACILITY REIMBURSEMENT INFORMATION* LOWER EXTREMITY Autologous chondrocyte implantation, knee $1, $1, Excluded from payment in ASC $4, Osteochondral allograft, knee, open $1, $1, $3, $7, Osteochondral autograft(s), knee, open (e.g. mosiacplasty (includes harvesting of autograft[s]). $1, $1, $2, $4, Repair, primary, open or percutaneous, ruptured Achilles tendon $ $ $1, $2, Repair, primary, open or percutaneous, ruptured Achilles tendon; with graft (includes obtaining graft) $ $ $2, $4, Repair, secondary, achilles tendon, with or without graft $ $ $2, $4, Repair flexor tendon, leg, primary, without graft $ $ $1, $2, Repair flexor tendon, leg, secondary with or without graft, each tendon $ $ $1, $2, Repair, extensor tendon leg; secondary, with or without graft, each tendon $ $ $2, $4, Repair dislocating peroneal tendons; without fibular osteotomy $ $ $1, $2, Repair dislocating peroneal tendons; with fibular osteotomy $ $ $1, $2, Tenolysis, flexor or extensor tendon, leg and/or ankle; multiple tendons (through separate incision(s) $ $ $1, $2, Tenolysis, flexor or extensor tendon, leg and/or ankle; multiple tendons (through separate incision(s) $ $ $1, $2, Lengthening or shortening of tendon, leg or ankle; single tendon (separate procedure) $ $ $1, $2, Lengthening or shortening of tendon, leg or ankle; multiple tendons (through sane incision), each $ $ $1, $2, Transfer or transplant of single tendon (with muscle redirection or rerouting); superficial (e.g., anterior tibial extensors into midfoot) $ $ $1, $2, Transfer or transplant of single tendon (with muscle redirection or rerouting); deep (e.g., anterior tibial or posterior through interosseous space, flexor or digitorum longus, flexor halluxes longus, or peroneal tendon to midfoot or hindfoot) $ $ $1, $2, Arthroplasty, ankle $ $ $2, $4, Arthroplasty, ankle; with implant (total ankle) $ $ Excluded from payment in ASC Not paid under OPPS Arthroplasty ankle; revision, total ankle $1, $1, Excluded from payment in ASC Not paid under OPPS Release, tarsal tunnel (posterior tibial nerve decompression) $ $ $ $1, Reconstruction (advancement), posterior tibial tendon with excision of accessory tarsal navicular bone (e.g., Kidner type procedure) $ $ $1, $2, Hallux rigidus correction with cheilectomy, debridement and capsular release of the first metatarsophalangeal $ $ $1, $2, continued on the next page REI-CLX-REV C Page 4 of 9
5 2016 MEDICARE & FACILITY REIMBURSEMENT INFORMATION* LOWER EXTREMITY continued Hallux valgus correction with metatarsal osteotomy (e.g., Mitchell, Chevron, or concentric type procedure $ $ $1, $2, Hallux valgus correction by double osteotomy $ $ $1, $2, Osteotomy, with or without lengthening, shortening or angular correction, metatarsal; first metatarsal $ $ $1, $2, Osteotomy, with or without lengthening, shortening or angular correction, metatarsal; other than first metatarsal, each $ $ $1, $2, Arthrodesis, great toe; metatarsophalangeal joint $ $ $2, $4, Arthrodesis, great toe; interphalangeal joint $ $ $1, $2, Arthroscopy, knee, surgical; osteochondral autograft(s) (e.g., mosiacplasty) includes harvesting of the autograft[s]) $1, $1, $2, $4, Arthroscopy, knee, surgical; osteochondral allograft $1, $1, Excluded from payment in ASC $7, UNLISTED Unlisted procedure, shoulder $ Unlisted procedure, humerus or elbow $ Unlisted procedure, hands or fingers $ Unlisted procedure, pelvis or hip joint Local Carrier Local Carrier Excluded from $ Unlisted procedure, femur or knee Priced Priced Payment in ASC $ Unlisted procedure, leg or ankle $ Unlisted procedure, foot or toes $ Unlisted procedure, pelvis or hip joint $ Unlisted procedure, musculoskeletal system, general $1, Unlisted procedure, abdomen, musculoskeletal system $1, INPATIENT MS-DRGS RATE* 502 Soft tissue procedure w/o CC/MCC $6, Major shoulder or elbow joint procedure w/o CC/MCC $8, Other musculoskeletal system and connective tissue OR proced w/o CC/MCC $9, Fracture, sprain, strain & dislocation except femur, hip, pelvis & thigh w/o MCC $4, Unlisted procedure, leg or ankle $7, Other O.R. procedure for injuries w/o CC/MCC $9, REI-CLX-REV C Page 5 of 9
6 2016 MEDICARE & FACILITY REIMBURSEMENT INFORMATION* ULTRASOUND Ultrasound, extremity, nonvascular, real time with image documentation, limited; anatomic specific Ultrasound, extremity, nonvascular, real time with image documentation; complete $36.52 $ $36.52 $ Packaged Service/ Item $92.07 $ RADIOLOGY Radiologic examination, foot; 2 views $26.14 $26.14 $ Radiologic examination, foot; complete, minimum 3 views $29.00 $29.00 Packaged Service/ Item $ Radiologic examination, calcaneus, minimum 2 views $27.21 $27.21 $60.80 *Notes/References: The payment allowables specified in this document are Centers for Medicare & Medicaid Services (CMS) national unadjusted averages. Actual payment rates will vary based on geographical adjustments to payment allowables and are updated quarterly. Medicare bundles products into facility procedural payment. Commercial payment rates will vary per contract and coverage policy. HOPPS and ASC Addenda Updates/2016 OPPS/ASC Final Rule - Notices-Items/CMS-1633-FC.html Acute Hospital Inpatient/2016 IPPS Final Rule- AcuteInpatientPPS/FY2016-IPPS-Final-Rule-Home-Page-Items/FY2016-IPPS-Final-Rule-Tables.html HCPCS Medicare code file - CPT code 2016 Medicare physician payment rates - REI-CLX-REV C Page 6 of 9
7 2016 MEDICARE & FACILITY REIMBURSEMENT INFORMATION* FLO CLARIX FLO Q4155 Cryopreserved umbilical cord and amniotic membrane product in particulate form for the replacement or supplementation of damaged or inadequate integumental tissue Catalog # CR-FL- 25MG, CR-FL- 50MG, CR-FL- 100MG HCPCS ICD-10-CM diagnosis codes - bill to the highest level of specificity. HCPCS CODES Q4155 NEOX FLO or CLARIX FLO, per mg Bill with total milligrams utilized. INJECTION Injection(s); single tendon sheath, or ligament, aponeurosis (eg, plantar fascia ) $59.79 $42.97 $ Injection; single tendon origin/insertion $61.23 $43.68 $ Arthrocentesis, aspiration and/or injection, small joint or bursa (e.g. fingers, toes); without ultrasound guidance With ultrasound guidance, with permanent recording and reporting Arthrocentesis, aspiration and/or injection, intermediate joint or bursa (temporomandibular, acromioclavicular, wrist, elbow, or ankle, olecranon bursa; without ultrasound guidance With ultrasound guidance, with permanent recording and reporting Arthrocentesis, aspiration and/or injection, major joint or bursa (e.g. shoulder, hip, knee, subacromial bursa); without ultrasound guidance With ultrasound guidance, with permanent recording and reporting Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular $48.34 $36.52 $73.40 $47.26 $50.84 $38.31 $81.28 $54.06 $61.23 $47.26 $93.09 $63.37 $25.42 $25.42 $42.31 Local Carrier Priced REI-CLX-REV C Page 7 of 9
8 2016 MEDICARE & FACILITY REIMBURSEMENT INFORMATION* REVENUE CODES 272 Sterile supply 278 Other Implants 279 Other supplies/devices RADIOLOGY Fluoroscopic guidance for needle placement (e.g. biopsy, aspiration, injection, localization device) $93.81 $ Computed tomography guidance for needle placement (e.g. biopsy, aspiration, injection, localization device), radiological supervision and interpretation $ $ Packaged Service/Item Packaged Service/Item Magnetic resonance guidance for needle placement (e.g. for biopsy, needle aspiration, injection, or placement of localization device) radiological supervision and interpretation $ $ *Notes/References: The payment allowables specified in this document are Centers for Medicare & Medicaid Services (CMS) national unadjusted averages. Actual payment rates will vary based on geographical adjustments to payment allowables and are updated quarterly. Medicare bundles product into facility procedural payment. Commercial payment rates will vary per contract and coverage policy. Check with your payer for coverage determination for in-office use. Bill with total milligrams utilized. HOPPS and ASC Addenda Updates/2016 OPPS/ASC Final Rule HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1633-FC.html Acute Hospital Inpatient/2016 IPPS Final Rule- AcuteInpatientPPS/FY2016-IPPS-Final-Rule-Home-Page-Items/FY2016-IPPS-Final-Rule-Tables.html HCPCS Medicare code file - CPT code 2016 Medicare physician payment rates - REI-CLX-REV C Page 8 of 9
9 2016 MEDICARE & FACILITY REIMBURSEMENT INFORMATION* Questions and Answers - CLARIX Regenerative Matrix QUESTIONS What are the CLARIX products? What are the indications for Amniox Medical s CLARIX products? What is the regulatory status of the CLARIX products? Do the CLARIX products have National Drug Numbers (NDCs)? Are there specific HCPCS codes to be utilized with the CLARIX products? Is pre-authorization necessary? ANSWERS The CLARIX products are cryopreserved and/or lyophilized human umbilical cord and amniotic membrane products. The CLARIX products are utilized for tectonic support as a surgical covering, wrap or barrier as well as to replace or supplement damaged or inadequate integumental tissue. The CLARIX products are regulated by the FDA as Human Cells, and Cellular Tissue Products (HCT/Ps) under Section 361 of the Public Health Service (PHS) Act. NDC numbers are not applicable to the CLARIX products. The CLARIX products have been assigned Universal Product Codes (UPCs) like other HCT/Ps. The CLARIX CORD 1K and CLARIX 100 matrices do not have specific HCPCS codes (e.g. C codes) assigned to them. The CLARIX FLO particulate has been assigned HCPCS code Q4155 by Medicare. Pre-authorization allows payers to determine whether the service is medically necessary and is eligible for coverage prior to the procedure. Pre-authorization does not always guarantee payment. While Medicare does not pre-authorize procedures, most private payers do. Pre-authorization helps to clarify eligibility, benefits and payment rates. Will the physician get paid to implant the CLARIX products? Will the facility get reimbursed separately for the cost of the product? What if the claim is denied? There are several CPT codes that a provider can utilize for implantation/injection of the CLARIX products. If a generic CPT code is utilized, medical information may be requested. Payment will be dependent on medical necessity and coverage policy. Please check with your payer for specific coding guidelines and policy. Payment will vary from payer to payer. Medicare bundles the cost of implantable and particulate products in the hospital inpatient, outpatient and ambulatory surgical center settings. Reimbursement by private payers varies based on contracts and policy between the facility and payer. If the claim is denied, review the reason for the denial. Most payers have appeal processes in place. If the procedure was pre-authorized, information must be provided. Amniox Medical can assist if needed. REI-CLX-REV C Page 9 of 9
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