HEA LTH ECONOM I C S A ND R EIM B U RS E M E NT

VA SCUL AR

ABSORB GT1™ BIORESORBABLE VASCULAR SCAFFOLD (BVS) HOSPITAL AND PHYSICIAN REIMBURSEMENT 2016 The Absorb GT1™ bioresorbable vascular scaffold system (BVS) is the first fully resorbable stent for the treatment of coronary artery disease (CAD). The BVS is a drug-eluting scaffold that performs similar to a metallic drug-eluting stent (DES) in terms of safety and efficacy, but resorbs without leaving behind a permanent implant 1. Reimbursement for percutaneous coronary interventions (PCI) with BVS is similar to reimbursement for PCI with DES.

Inpatient Prospective Payment System (IPPS) for FY 2016 Abbott Vascular provides you with this summary of the Medicare Hospital Inpatient Prospective Payment System for PCI procedures utilizing DES for FY 2016. The information in this document is effective October 1, 2015 to September 30, 2016. MS-DRG

Description

FY 2016 National Average Payment2

246

Percutaneous cardiovascular procedure with drug-eluting stent with major complication or comorbidity or 4+ vessels/stents

$19,191

247

Percutaneous cardiovascular procedure with drug-eluting stent without major complication or comorbidity

$12,584

*MS-DRG = Medicare Severity-Diagnosis Related Group.

ICD-10-PCS Code Guide for PCI Procedures With Drug-Eluting Intraluminal Devices ICD-10-PCS Procedure Codes3 0 2 7

Medical and Surgical Heart and Great Vessels Dilation – Expanding an orifice or the lumen of a tubular body part

Body Part Character 4 0 1 2 3

Coronary Artery, One Site Coronary Artery, Two Sites Coronary Artery, Three Sites Coronary Artery, Four or More Sites

Approach Character 5 3 Percutaneous

Device Character 6 4 Intraluminal Device, Drug-Eluting

Qualifier Character 7 6 Bifurcation Z No Qualifier

*ICD-10-PCS = International Classification of Diseases, Tenth Revision, Procedure Codes.

Ellis, S.G., Kereiakes, D.J., Metzger, D.C. et al., ABSORB III Investigators. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. N. Engl. J. Med. 2015;373:1905-1915. 2 FY 2016 Inpatient Prospective Payment System Final Rule CMS-1632-F, and corrections released October 2, 2015. 3 ICD-10 Procedure Coding System (ICD-10-PCS) 2016 Tables and Index, downloaded from http://www.cms.gov/Medicare/Coding/ICD10/2016-ICD-10-PCS-and-GEMs.html on June 15, 2016. 1

INDICATIONS

The Absorb GT1 Bioresorbable Vascular Scaffold (BVS) is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

See Important Safety Information referenced within. ©2016 Abbott. All rights reserved. AP2942664-US Rev. A

AV1633-036 HEORAbsorbReimb2016_C5b.indd 1

7/19/16 11:10 AM

ABBOTT VASCULAR

Health Economics and Reimbursement

Outpatient Prospective Payment System (OPPS) for CY 2016 Abbott Vascular provides you with this summary of the Medicare Hospital Outpatient Prospective Payment System for PCI procedures utilizing DES for CY 2016. The information in this document is effective January 1, 2016 to December 31, 2016. Please find a list of CPT codes on page 4. OPPS Status Indicator

C-APC

Description

CY 2016 National Average Payment4

C9600

Percutaneous transcatheter placement of drugeluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch

J1

5192

Level II Endovascular Procedures

$9,542

C9601

Percutaneous transcatheter placement of drugeluting intracoronary stent(s), with coronary angioplasty when performed; each additional branch of a major coronary artery (list separately in addition to code for primary procedure)

N

N/A

N/A

N/A

C9602

Percutaneous transluminal coronary atherectomy, with drug-eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch

J1

5193

Level III Endovascular Procedures

$14,612

C9603

Percutaneous transluminal coronary atherectomy, with drug-eluting intracoronary stent, with coronary angioplasty when performed; each additional branch of a major coronary artery (list separately in addition to code for primary procedure)

N

N/A

N/A

N/A

C9604

Percutaneous transluminal revascularization of or through coronary artery bypass graft (internal mammary, free arterial, venous), any combination of drug-eluting intracoronary stent, atherectomy and angioplasty, including distal protection when performed; single vessel

J1

5192

Level II Endovascular Procedures

$9,542

HCPCS

Description

* HCPCS = Healthcare Common Procedure Coding System; * C-APC = Comprehensive Ambulatory Payment Classifications; * OPPS Status Indicator J1 = Hospital Part B services paid through a comprehensive APC; * OPPS Status Indicator N = Items and services packaged into APC rates.

4

CY 2016 Outpatient Prospective Payment System Final Rule; 42 CFR Parts 405, 410, 412, 413, 416, and 419 [CMS-1633-FC]. Accessed June 8, 2016.

See Important Safety Information referenced within. ©2016 Abbott. All rights reserved. AP2942664-US Rev. A

2 AV1633-036 HEORAbsorbReimb2016_C5b.indd 2

7/19/16 11:10 AM

ABBOTT VASCULAR

Health Economics and Reimbursement

HCPCS

Description

OPPS Status Indicator

C-APC

Description

CY 2016 National Average Payment4

C9605

Percutaneous transluminal revascularization of or through coronary artery bypass graft (internal mammary, free arterial, venous), any combination of drug-eluting intracoronary stent, atherectomy and angioplasty, including distal protection when performed; each additional branch subtended by the bypass graft (list separately in addition to code for primary procedure)

N

N/A

N/A

N/A

C9606

Percutaneous transluminal revascularization of acute total/subtotal occlusion during acute myocardial infarction, coronary artery or coronary artery bypass graft, any combination of drug-eluting intracoronary stent, atherectomy and angioplasty, including aspiration thrombectomy when performed, single vessel

J1

5193

Level III Endovascular Procedures

$14,612

C9607

Percutaneous transluminal revascularization of chronic total occlusion, coronary artery, coronary artery branch, or coronary artery bypass graft, any combination of drugeluting intracoronary stent, atherectomy and angioplasty; single vessel

J1

5193

Level III Endovascular Procedures

$14,612

C9608

Percutaneous transluminal revascularization of chronic total occlusion, coronary artery, coronary artery branch, or coronary artery bypass graft, any combination of drugeluting intracoronary stent, atherectomy and angioplasty; each additional coronary artery, coronary artery branch, or bypass graft (list separately in addition to code for primary procedure)

N

N/A

N/A

N/A

* HCPCS = Healthcare Common Procedure Coding System; * C-APC = Comprehensive Ambulatory Payment Classifications; * OPPS Status Indicator J1 = Hospital Part B services paid through a comprehensive APC; * OPPS Status Indicator N = Items and services packaged into APC rates.

C-Code

Medicare Description of the C-Code

C1874

Stent, Coated/Covered, With Delivery System

* C-Code = Device codes used for billing in the outpatient setting.

4

CY 2016 Outpatient Prospective Payment System Final Rule; 42 CFR Parts 405, 410, 412, 413, 416, and 419 [CMS-1633-FC]. Accessed June 8, 2016.

See Important Safety Information referenced within. ©2016 Abbott. All rights reserved. AP2942664-US Rev. A

3 AV1633-036 HEORAbsorbReimb2016_C5b.indd 3

7/19/16 11:10 AM

ABBOTT VASCULAR

Health Economics and Reimbursement

Physician Fee Schedule (PFS) for CY 2016 Abbott Vascular provides you with this summary of the Medicare Physician Fee Schedule for PCI procedures utilizing DES in the inpatient and outpatient hospital settings for CY 2016. The information in this document is effective January 1, 2016 to December 31, 2016.

CPT

Description

2016 Total Facility RVUs

CY 2016 National Average Payment5

92928

Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch

17.62

$631

+92929

Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed; each additional branch of a major coronary artery (list separately in addition to code for primary procedure)

N/A

$0

92933

Percutaneous transluminal coronary atherectomy, with intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch

19.71

$706

+92934

Percutaneous transluminal coronary atherectomy, with intracoronary stent, with coronary angioplasty when performed; each additional branch of a major coronary artery (list separately in addition to code for primary procedure)

N/A

$0

92937

Percutaneous transluminal revascularization of or through coronary artery bypass graft (internal mammary, free arterial, venous), any combination of intracoronary stent, atherectomy and angioplasty, including distal protection when performed; single vessel

17.61

$631

+92938

Percutaneous transluminal revascularization of or through coronary artery bypass graft (internal mammary, free arterial, venous), any combination of intracoronary stent, atherectomy and angioplasty, including distal protection when performed; each additional branch subtended by the bypass graft (list separately in addition to code for primary procedure)

N/A

$0

92941

Percutaneous transluminal revascularization of acute total/subtotal occlusion during acute myocardial infarction, coronary artery or coronary artery bypass graft, any combination of intracoronary stent, atherectomy and angioplasty, including aspiration thrombectomy when performed, single vessel

19.75

$708

92943

Percutaneous transluminal revascularization of chronic total occlusion, coronary artery, coronary artery branch, or coronary artery bypass graft, any combination of intracoronary stent, atherectomy and angioplasty; single vessel

19.74

$707

+92944

Percutaneous transluminal revascularization of chronic total occlusion, coronary artery, coronary artery branch, or coronary artery bypass graft, any combination of intracoronary stent, atherectomy and angioplasty; each additional coronary artery, coronary artery branch, or bypass graft (list separately in addition to code for primary procedure)

N/A

$0

* CPT = Current Procedural Terminology; * RVUs = Relative Value Units; + Indicates an add-on procedure to the primary procedure. 5

 Y 2016 Physician Fee Schedule, Final Rule; Centers for Medicare & Medicaid Services 42 CFR Parts 405, 410, 411, 414, 425, and 495 [CMS-1631-FC]. C Accessed June 10, 2016.

See Important Safety Information referenced within. ©2016 Abbott. All rights reserved. AP2942664-US Rev. A

4 AV1633-036 HEORAbsorbReimb2016_C5b.indd 4

7/19/16 11:10 AM

ABBOTT VASCULAR

Health Economics and Reimbursement

Please visit the Abbott Vascular Reimbursement website at:



www.abbottvascular.com/us/reimbursement.html

Please direct all questions regarding the content of this Reimbursement Update to:



Abbott Vascular Reimbursement Hotline



800.354.9997 [email protected]

DISCLAIMER The information provided in this document was obtained from third-party sources and is subject to change without notice as a result of changes in reimbursement laws, regulations, rules, policies and payment amounts. All content is informational only, general in nature, and does not cover all situations or all payers’ rules and policies. It is the responsibility of the hospital or physician to determine appropriate coding for a particular patient and/or procedure. Any claim should be coded appropriately and supported with adequate documentation in the medical record. A determination of medical necessity is a prerequisite that Abbott Vascular assumes will have been made prior to assigning codes or requesting payments. Any codes provided are examples of codes that specify some procedures or which are otherwise supported by prevailing coding practices. They are not necessarily correct coding for any specific procedure using Abbott Vascular’s products. Hospitals and physicians should consult with appropriate payers, including Medicare Administrative Contractors, for specific information on proper coding, billing and payment levels for healthcare procedures. Abbott Vascular makes no express or implied warranty or guarantee that (i) the list of codes and narratives in this document is complete or errorfree, (ii) the use of this information will prevent difference of opinions or disputes with payers, (iii) these codes will be covered [or (iv) the provider will receive the reimbursement amounts set forth herein]. Reimbursement policies can vary considerably from one region to another and may change over time. The FDA-approved/cleared labeling for all products may not be consistent with all uses described herein. This document is in no way intended to promote the off-label use of medical devices. The content is not intended to instruct hospitals and/ or physicians on how to use medical devices or bill for healthcare procedures.

A B B O T T P R O D U C T I N F O R M AT I O N Any questions or comments about products, codes or Medicare policies that may be applicable to Abbott Vascular products should be directed to the Abbott Vascular Reimbursement Hotline (1-800-354-9997). This document does not address Abbott products or specific codes or policies expressly applicable to Abbott products. Product information including FDA-approved or cleared indications for Abbott Vascular products is only provided in accordance with Abbott Vascular policies, and FDA regulations and requirements. CPT® Copyright 2015 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. See Important Safety Information referenced within. ©2016 Abbott. All rights reserved. AP2942664-US Rev. A

5 AV1633-036 HEORAbsorbReimb2016_C5b.indd 5

7/19/16 11:10 AM

ABBOTT VASCULAR

Health Economics and Reimbursement

Absorb GT1TM Bioresorbable Vascular Scaffold System INDICATIONS The Absorb GT1 Bioresorbable Vascular Scaffold (BVS) is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

CONTRAINDICATIONS The Absorb GT1 BVS System is contraindicated for use in: • Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or the post-procedural antiplatelet regimen. • Patients with hypersensitivity or contraindication to everolimus or structurally-related compounds, or known hypersensitivity to scaffold components (poly(L-lactide), poly(D,L-lactide), platinum) or with contrast sensitivity.

WARNINGS • For single use only. Do not resterilize or reuse. Note the product “Use by” date on the package. • Careful assessment of the target lesion reference vessel diameter and selection of the appropriate scaffold diameter relative to the target lesion reference vessel diameter are required to minimize potential damage to the scaffold during postdilatation and to ensure adequate scaffold apposition and an appropriate post-implantation minimum lumen diameter. • In small vessels (visually assessed reference vessel diameter ≤ 2.75 mm), on-line QCA or intravascular imaging with intravascular ultrasound or optical coherence tomography is strongly recommended to accurately measure and confirm appropriate vessel sizing (reference vessel diameter ≥ 2.5 mm). (See Section 8.1.6 – Implantation of Absorb in Small Coronary Arteries (Post Hoc Analysis)). • If quantitative imaging determines a vessel size < 2.5 mm, do not implant the Absorb GT1 BVS. Implantation of the device in vessels < 2.5 mm may lead to an increased risk of adverse events such as myocardial infarction and scaffold thrombosis. • Adequate lesion preparation prior to scaffold implantation is required to ensure safe delivery of the scaffold across the target lesion. It is not recommended to treat patients having a lesion that prevents complete inflation of an angioplasty balloon. It is strongly recommended to achieve a residual

stenosis between 20% and 40% after pre-dilatation to enable successful delivery and full expansion of the scaffold. • Ensure the scaffold is not post-dilated beyond the allowable expansion limits (see Absorb GT1 IFU Section 12.7 - Clinician Use Information, Further Expansion of the Deployed Scaffold). • Antiplatelet therapy should be administered post-procedure (see Absorb GT1 IFU Section 9.1 - Patient Selection and Treatment, Individualization of Treatment). • This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy. • Judicious selection of patients is necessary, since the use of this device carries the associated risk of scaffold thrombosis, vascular complications, and / or bleeding events.

PRECAUTIONS • Implantation of the scaffold should be performed only by physicians who have received appropriate training. • Do not exceed the Rated Burst Pressure (RBP) as indicated on the product label. • Post-dilatation is strongly recommended for optimal scaffold apposition. When performed, post-dilatation should be at high pressure (> 16 atm) with a noncompliant balloon. • Care must be taken to properly size the scaffold to ensure that the scaffold is in full contact with the arterial wall upon deflation of the balloon. All efforts should be made to ensure that the scaffold is not under dilated. Refer to Absorb GT1 IFU Section 12.7 - Clinical Use Information, Further Expansion of the Deployed Scaffold. • Balloon dilatation of any cells of a deployed Absorb GT1 BVS may cause scaffold damage. Avoid scaffolding across any side branches ≥ 2.0 mm in diameter. Placement of a scaffold has the potential to compromise side branch patency. • It is not recommended to treat patients having a lesion with excessive tortuosity proximal to or within the lesion. • Non-clinical testing has demonstrated the Absorb GT1 BVS is MR Conditional. A patient with this device can be safely scanned in all MR environments 3T or less. • The safety and effectiveness of the Absorb GT1 BVS have not been established for subject populations with the following characteristics: • Coronary artery reference vessel diameters < 2.5 mm or > 3.75 mm • Lesion lengths > 24 mm • Lesions located in arterial or saphenous vein grafts

• Lesions located in unprotected left main artery • Ostial lesions • Lesions located at a bifurcation • Previously stented lesions • Moderate to severe calcification • Chronic total occlusion or poor flow (< TIMI 1) distal to the identified lesions • Threevessel disease • Unresolved thrombus at the lesion site or anywhere in the vessel to be treated • Excessive tortuosity proximal to or within the lesion • Recent acute myocardial infarction (AMI)

POTENTIAL ADVERSE EVENTS Adverse events that may be associated with PCI, treatment procedures and the use of a coronary scaffold in native coronary arteries include the following, but are not limited to: • Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, device materials (platinum, or polymer [poly(L-lactide) (PLLA), polymer poly(D,L-lactide) (PDLLA)]), and drug reactions to everolimus, anticoagulation, or antiplatelet drugs, Vascular access complications which may require transfusion or vessel repair, including: Catheter site reactions, Bleeding (ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage), Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, Embolism (air, tissue, plaque, thrombotic material or device), Peripheral nerve injury, Peripheral ischemia, Coronary artery complications which may require additional intervention, including: Total occlusion or abrupt closure, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, Tissue prolapse / plaque shift, Embolism (air, tissue, plaque, thrombotic material or device), Coronary or scaffold thrombosis (acute, subacute, late, very late), Stenosis or restenosis, Pericardial complications which may require additional intervention, including: Cardiac tamponade, Pericardial effusion, Pericarditis, Cardiac arrhythmias (including conduction disorders, atrial and ventricular arrhythmias), Cardiac ischemic conditions (including myocardial ischemia, myocardial infarction [including acute], coronary artery spasm and unstable or stable angina pectoris), Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA), System organ failures: Cardio-respiratory arrest, Cardiac failure, Cardiopulmonary failure (including pulmonary edema), Renal insufficiency / failure, Shock, Blood cell disorders (including Heparin Induced Thrombocytopenia [HIT]), Hypotension / hypertension, Infection, Nausea and vomiting, Palpitations, dizziness, and syncope, Chest pain, Fever, Pain, Death.

Abbott Vascular

3200 Lakeside Dr., Santa Clara, CA 95054 USA, Tel: 1.800.227.9902 Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available) or at www.abbottvascular.com/ifu for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs. Photos taken by and on file at Abbott Vascular. Absorb and Absorb GT1 are trademarks of the Abbott Group of Companies. www.AbbottVascular.com ©2016 Abbott. All rights reserved. AP2942664-US Rev. A

6 AV1633-036 HEORAbsorbReimb2016_C5b.indd 6

7/19/16 11:10 AM