2016 Cordis® Cardiac & Vascular Procedures Reimbursement Guide

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Table of Contents

Description Page

Hospital Inpatient Issues 2 Hospital Inpatient Coding 4 Hospital Inpatient Reimbursement 9

Hospital Outpatient Issues 13 Hospital Outpatient Reimbursement 15

Ambulatory Surgery Center and Independent Diagnostic Testing Facility Issues 20

Physician Reimbursement Issues 24

Bundling – NCCI and OCE Issues 25

CPT® Coding Updates in Recent Years 26

Modifiers 31

Disclaimer – The information contained in this guide has been compiled by a third-party organization from published sources and is provided for use as a reference for healthcare provider. The information is to the best of our knowledge true and accurate at the time of publication and may be subject to change without notice as a result of changing laws, regulations, local policies and rules. Healthcare providers are ultimately responsible for determining appropriate practices for services provided, procedures performed, and reimbursement sought including, but not limited to, medical necessity determination and documentation requirements, coding, coverage policy, billing, and payment for individual patients. Providers should consult each payor organization with regard to local reimbursement policies and requirements for billing. The information contained in this document is provided for information purposes only and represents no statement, promise or guarantee by Cordis Corporation concerning levels of reimbursement, payment, or charge. Similarly, all codes are provided for information purposes only and represent no statement, promise or guarantee by Cordis Corporation that these codes will be appropriate for any procedure using Cordis® products or that reimbursement will be made. It is important to research coverage and payment for procedures on a payer-specific basis as coverage policies and guidelines vary by payer.

The information in this guide is broad-based and references many different procedures and types of devices. Such a broad discussion is not intended to suggest or imply that Cordis® offers products for every use or procedure discussed and the FDA-approved labeling for all products may not be consistent with the information in this guide. As always, please refer to the package insert for a complete description of indications and contraindications for any medical device type mentioned in these materials prior to use.

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HOSPITAL INPATIENT ISSUES

Introduction to the 2016 Hospital Inpatient Prospective Payment System (IPPS) Final Rule

On July 31, 2015, the Centers for Medicare & Medicaid Services (CMS) issued the final rule for acute inpatient hospital services, detailing changes to Medicare payment rates and policies for fiscal year 2016. The final rule appeared in the August 17th Federal Register and will be effective for discharges on or after October 1, 2015.1

Medicare previously adopted the Medicare Severity Diagnosis Related Group (MS-DRG) system to better account for patient severity of illness, expanding the number of payment groups from 538 to 745; there are now 758 MS-DRGs. The intent of the MS-DRG system is to more accurately stratify groups of Medicare patients with varying levels of severity than the prior DRG system by better aligning payments with the anticipated costs of care, and are assigned based upon the presence or absence of specific diagnosis codes indicating complications or comorbidities (CCs) and/or major complications or comorbidities (MCCs). ‘Complications’ include all conditions that develop after inpatient admission which affect treatment and/or length of stay; ‘cormorbidities’ are conditions which pre-exist at the time of admission. While most commercial insurers are also following MS-DRGs, some may utilize other reimbursement methods.2

The Final Rule includes policies that continue an increasing shift of Medicare payments from volume to value. Among other key changes in the IPPS for FY 2016 are the following:2

1) FY 2016 Inpatient Hospital Update: The final rule updates IPPS payment rates by 1.7% for hospitals that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program AND are meaningful users of EHR, which reflects a market basket increase of 2.4% reduced by several adjustment factors.

2) Quality Measure Reporting for 2016 Updates: Under the Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU), in effect since 2004, hospitals that choose not to participate or fail to meet criteria for successful reporting in a given year received the annual payment update (APU) reduced by 2.0%. The 2016 final rule adds 7 new measures: 4 for the FY 2018 payment determination, and 3 for the FY 2019 payment determination.

3) Hospital Readmissions Reduction Program: The Affordable Care Act established this program, under which payments to certain hospitals will be reduced to account for excess readmissions. Two new measures bring the total to five: acute myocardial infarction (AMI) or heart attack, heart failure, pneumonia, hip/knee arthroplasty, and chronic obstructive pulmonary disease.

4) Other Payment Policy Updates: The Final Rule also addresses operational details regarding:

• The Hospital Value-Based Purchasing (VBP) Program; • Admissions and Medical Review Criteria for Inpatient Services; • Clarifications to the “Two Midnight Rule” and Part B Rebilling for Inpatient Services in Hospitals later determined to be outpatient stays; • Medicare Disproportionate Share Hospitals (DSH) payments; and • Direct Graduate Medical Education (DGME).

Expiring provisions include: the Medicare-Dependent Hospital (MDH) Program, and Affordable Care Act changes to the Low-Volume Hospital Payment Adjustment.

1 October 1, 2015 through September 30, 2016. 2 Centers for Medicare and Medicaid Services Fact Sheet: FY 2016 Final Inpatient and Long-term Care Hospital Policy and Payment Changes (CMS-1632-F); July 31, 2015; http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-Sheets. 3

5) Quality Reporting Programs: The Affordable Care Act called for CMS to create new quality reporting programs for two types of hospitals that are exempt from payment under the IPPS. The Hospital IQR Program grew out of the Hospital Quality Initiative developed by CMS in consultation with hospital groups. By statute, annual payment updates for hospitals that do not participate successfully in the Hospital IQR program are reduced by 2.0 percentage points. Beginning with fiscal year 2015, hospitals that do not participate will lose one-quarter of the percentage increase in their payment updates. Since the implementation of this financial penalty, hospital participation has increased to well over 99 percent.

For the FY 2016 payment determination and subsequent years, CMS will remove six chart abstracted measures and one structural measure, while suspending one chart-abstracted measure and adopting five new claims-based measures: (1) 30-day risk-standardized COPD Readmission; (2) 30-day risk standardized COPD mortality; (3) 30-day risk standardized stroke readmission; (4) 30-day risk standardized stroke mortality; and (5) AMI payment per episode of care.

CMS also finalized a proposal to reduce the number of records used for Hospital Acquired Infection (HAI) validation from 48 records per year to 36 records per year beginning with the FY 2015 payment determination, and to provide hospitals with the option to transmit secure electronic versions of medical information to meet validation requirements.

6) Hospital Acquired Conditions Reduction Program: The FY 2014 hospital payment rule finalized the general framework for the Hospital-Acquired Condition (HAC) Reduction Program. Section 3008 of the Affordable Care Act requires CMS to establish a program for IPPS hospitals to improve patient safety, by imposing financial penalties on hospitals that perform poorly with regard to hospital-acquired conditions. HACs are conditions that patients did not have when they were admitted to the hospital, but which developed during the hospital stay.

Under the HAC Reduction Program, hospitals that rank in the lowest-performing quartile of hospital-acquired conditions will be paid 99 percent of what otherwise would have been paid under IPPS, beginning in FY 2015. The rule finalizes the quality measures and the scoring methodology to determine this quartile, as well as the process hospitals use to review and correct their data. In the first year of the program, FY 2015, CMS used measures that are part of the IQR program. The HAC measures consist of two domains of measure sets.

• Domain 1 includes the Agency for Health Care Research and Quality (AHRQ) composite PSI #90. This measure includes the following indicators: Pressure ulcer rate (PSI 3); Iatrogenic pneumothorax rate (PSI 6); Central venous catheter-related blood stream infection rate (PSI 7); Postoperative hip fracture rate (PSI 8); Postoperative pulmonary embolism (PE) or deep vein thrombosis rate (DVT) (PSI 12); Postoperative sepsis rate (PSI 13); Wound dehiscence rate (PSI 14); and Accidental puncture and laceration rate (PSI 15).

• Domain 2 measures consist of two healthcare-associated infection measures developed by the Centers for Disease Control and Prevention’s (CDC) National Health Safety Network: Central Line-Associated Blood Stream Infection and Catheter-Associated Urinary Tract Infection.

Hospitals will be given a score for each measure within the two domains. A domain score will be calculated—with Domain 1 weighted at 35 percent and Domain 2 weighted at 65 percent—to determine a total score under the program. Risk factors such as the patient’s age, gender, and comorbidities will be considered in the calculation of the measure rates so that hospitals serving a large proportion of sicker patients will not be penalized unfairly. Hospitals will be able to review and correct their information.

In the 2016 Final Rule, CMS is finalizing: (1) the dates of the time period used to calculate hospital performance, (2) an expanded population for two measures that are already included in the program, (3) an adjustment to the relative contribution of each domain to the Total HAC Score, (4) an adjustment to the relative contribution of each measure within Domain 2, and (5) an extraordinary circumstance exception policy.

7) Never Events: CMS has also implemented a policy to not pay for medical care that harms patients or leads to complications that could have been prevented involving three identified “Never Events”. For dates of service on or after January 15, 2009, hospitals should submit the non-covered Type of Bill (TOB 110), clearly indicating in Remarks one of the applicable 2-digit surgical error codes:

MX: Wrong Surgery on Patient MY: Surgery on Wrong Body Part MZ: Surgery on Wrong Patient

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Hospital Inpatient Coding

Beginning this fiscal year, the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM and ICD-10-PCS codes have been implemented to identify diagnoses and procedures in the hospital inpatient setting with dates of service, or dates of discharge for inpatients, that occur on or after October 1, 2015. ICD-10-CM overall format is very much the same as ICD-9-CM. Primarily, changes in ICD-10-CM are in its organization and structure, code composition, and level of detail.3

ICD-9-CM Structure ICD-10-CM Structure Diagnosis codes are 3 – 5 characters in Diagnosis codes are 3 – 7 characters in length: length: • Character 1 is alpha (not case sensitive), including every letter • Character 1 is numeric for most codes except U. – (Exception: Supplementary • Character 2 is numeric Classification codes begin with E or V). • Characters 3 – 7 may be alpha (not case sensitive) or numeric. • Characters 2 - 5 are numeric. Letters I and O are found in the first character position, but not in subsequent characters, to avoid possible confusion with 0 or 1. Categories have a hierarchical structure, Every code has a full title (no references to previous characters). with partial definition at 3-digit category, Exception: 7th characters may be noted at the top of a 3-character completed by 4th and 5th digit descriptors. category. In 2015 had ~13,500 diagnosis codes Currently has ~69,000 diagnosis codes

A number of codes are significantly expanded, providing • Complications -- Codes for postoperative a much greater degree of specificity / granularity. complications are expanded, and a distinction is made between intraoperative complications and • Although ICD-10-CM codes may require 6 or 7 post-procedural disorders. characters, not all codes do – there are valid 3- character codes without further subclassification. • Creation of More Combination Codes: a single code used to classify: two or more interrelated • Inclusion of certain clinical concepts that do not diagnoses, a diagnosis with an associated sign, exist in ICD-9-CM. symptom, or manifestation(s); or a diagnosis with • Laterality -- Many categories have more specific an associated complication -- to capture the identifications of anatomic site, including laterality relationship, as well as to reduce the number of (right, left, bilateral). codes needed to fully describe the condition. • The RIGHT side or LEFT side is not always • Multiple codes should NOT be used when the indicated by the same character. classification provides a combination code that • In those cases where a bilateral code is clearly identifies all of the elements provided, the diagnoses must be identical to documented in the diagnosis. report; otherwise, code each side separately. • Documentation may require a clear indication • Not all codes which identify laterality have a of a relationship between diagnoses in order to subclassification for bilateral; if not, right and assign a combination code. left are each reported separately. • The word “and” in a code descriptor • For codes with laterality, an unspecified side should be interpreted to mean either “and” code is provided should the side not be or “or”, and does not require both be identified in the medical record. The present. unspecified side is usually either a • However, the word “with” should be character 0 or 9. interpreted to mean “associated with” or “due to” when it appears in a code title. • Seventh Character Extension – Certain ICD-10- CM categories have applicable seven characters. • New definitions of certain terms. The applicable seventh character is required for all • Two Types of Excludes Notes: codes within the category, or as the notes in the • Excludes 1 – Indicates that the code excluded th Tabular List instruct. For example, a 7 Character should never be used with the code where the is required for Episode of Care for injuries and note is located (mutually exclusive / do not some other conditions. report both codes). • The seventh character must always be the • Excludes 2 – Indicates that the condition seventh character in the data field. excluded is not part of the condition th • If a code that requires a 7 character is not six represented by the code, but a patient may characters in length, a placeholder X must be have both conditions at the same time, in used to fill in the empty characters. which case both codes may be assigned • Dummy Placeholders – The placeholder together. character “X” is also used in certain codes as a dummy character to allow for future expansion. • Category restructuring and code reorganization, and certain diseases are reclassified to different chapters or sections to reflect current medical knowledge or other classification logic.

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Hospitals must report the principal diagnosis using an appropriate ICD-10-CM code, as well as any secondary diagnoses – some of which may be considered CCs or MCCs for MS-DRG assignment.3 The principal diagnosis is defined in the Uniform Hospital Discharge Data Set (UHDDS) as “that condition established after study to be chiefly responsible for occasioning the admission of the patient to the hospital for care.” The circumstances of inpatient admission always govern the selection of principal diagnosis.”4 Diagnosis codes should be reported to the highest level of specificity available – a code is invalid if it has not been coded to the full number of digits required for that code.

A minimum of one diagnosis code is required on all claims, and it is possible to report up to eighteen. Medicare may require additional clinical information specific to each patient to determine coverage and payment for the reported procedure. Table 1 includes ICD-10-CM diagnosis codes commonly used to report peripheral vascular and cerebrovascular conditions:

Table 1: Common ICD-10-CM Diagnosis Codes – Peripheral Vascular Conditions Diagnosis Code5 Description I26.0 – I26.99 Pulmonary embolism I27.82 Chronic pulmonary embolism I63.00 – I63.09 Cerebral infarction due to thrombosis of precerebral artery I63.10 – I63.19 Cerebral infarction due to embolism of precerebral artery I63.20 – I63.29 Cerebral infarction due to unspecified occlusion or stenosis of precerebral arteries I65.01 – I65.9 Occlusion and stenosis of precerebral arteries, not resulting in cerebral infarction I70.0 Atherosclerosis of aorta I70.1 Atherosclerosis of renal artery I70.201 – I70.299 Atherosclerosis of native arteries of the extremities I70.301 – I70.799 Atherosclerosis of bypass graft(s) of the extremities I70.92 Chronic total occlusion of artery of the extremities I70.8 Atherosclerosis of other arteries I70.90 – I70.91 Other and unspecified atherosclerosis I73.9 Peripheral vascular disease, unspecified I74.2 – I74.5 Arterial embolism and thrombosis of the extremities I74.8 – I74.9 Arterial embolism and thrombosis of other specified arteries I75.011 – I75.89 Atheroembolism I77.1 Stricture of artery I77.3 Arterial fibromuscular dysplasia (renal, carotid arteries) I82.0 – I82.891 Acute / chronic venous embolism and thrombosis of vessels of various specified sites

Table 2 includes ICD-10-CM diagnosis codes commonly used to report cardiac conditions:

Table 2: Common ICD-10-CM Diagnosis Codes – Cardiac Conditions Diagnosis Code Description I20.0 – I20.9 Angina pectoris I21.01 – I22.9 Acute myocardial infarction I24.0 – I24.9 Other acute ischemic heart diseases I25.10 – I25.119 Coronary atherosclerosis Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart I25.700 – I25.799 with angina pectoris I25.82 Chronic total occlusion of coronary artery I25.83 Coronary atherosclerosis due to lipid rich plaque I25.84 Coronary atherosclerosis due to calcified coronary lesion I25.810 – I25.812, Other forms of chronic ischemic heart disease I25.89 I25.9 Chronic ischemic heart disease, unspecified

3 CMS Fact Sheet: ICD-10-CM Classification Enhancements, https://www.cms.gov/Medicare/Coding/ICD10/downloads/icd- 10quickrefer.pdf 4 The UHDDS definitions are used by acute care short-term hospitals to report inpatient data elements in a standardized manner. These data elements and their definitions can be found in the July 31, 1985, Federal Register (Vol. 50, No, 147), pp. 31038-40. 5 International Classification of Diseases, Tenth Revision, Clinical Modification, National Center for Health Statistics, July 2015, http://www.cdc.gov/nchs/icd/icd10cm.htm. 6

For inpatient admissions involving procedures, hospitals must also report ICD-10-PCS procedure code(s) for the surgical and other procedures, up to six procedures on a claim. Medicare recognizes certain ICD-10-PCS procedure codes used in the inpatient setting to report percutaneous angiography, angioplasty, stenting, and other procedures.

ICD-10-PCS, including the ICD-10-PCS Official Guidelines for Coding and Reporting, replaced ICD-9-CM procedure codes for dates of discharge for inpatients that occur on or after October 1, 2015. ICD-10-PCS is not related to ICD- 10-CM, but was developed specifically to meet healthcare needs for a procedure code system.6

ICD-9-CM Structure ICD-10-PCS Structure Procedure codes are 3 – 4 Procedures codes are all 7 characters in length: characters in length: • Codes constructed from flexible code components (values) using tables, • All characters are numeric. where each character is assigned separately, according to clinical • Followed the ICD structure documentation – there are very few options for “unspecified”. designed for diagnosis • Each code represents a distinct procedure. coding, with codes • Each character may be either alpha or numeric (alpha characters are not available as a fixed/finite case sensitive; letters O and I are not used to avoid confusion with numbers set in list form. 0 and 1). • In 2015 had ~4,000 • There are Official Guidelines – none were provided for ICD-9-CM procedures. procedure codes. • Currently has ~71,000 procedure codes.

ICD-10-PCS is designed to permit assignment of a unique code to each substantially different procedure, with the flexible open structure easily allowing the incorporation of future new procedures. There are 16 sections with tables to determine code selection. The largest section, Medical and Surgical, is divided into chapters by anatomic structure. Each character in the seven-character code represents a specific aspect of the procedure, the meaning of which may differ from one section to another. For example:

Medical and Surgical Codes (Section 0):

1 2 3 4 5 6 7 Section Body System Root Operation Body Part Approach Device Qualifier

Imaging Codes (Section B):

1 2 3 4 5 6 7 Section Body System Type Body Part Contrast Qualifier Qualifier

A code is derived by choosing a specific value for each of the seven characters. Because the definition of each character is a function of its physical position in the code, the same value (number or letter) placed in a different position in the code means something different. An ICD-10-PCS code is best understood as the result of a process rather than as an isolated, fixed quantity. The process consists of assigning values from among the valid choices, according to the rules governing the construction of codes.

• ICD-10-PCS framework is based on a multi-axial • Bypass procedures: Bypass procedures are code structure, where each character is an axis of coded by identifying the body part bypassed “from” classification that specifies information about the and the body part bypassed “to.” The fourth procedure performed. The valid values for an axis character body part specifies the body part of classification can be added to or revised as bypassed from, and the qualifier specifies the needed. This makes it possible to be complete, body part bypassed to (Example: Bypass from expandable, and have a high degree of flexibility. femoral artery to popliteal, femoral artery is the body part and popliteal artery is the qualifier). • Diagnosis information is not part of the procedure Exception: For coronary bypass procedures, this code descriptor. is reversed. • All terminology is standardized, and most terms are • Devices: A device is coded only if a device defined within the reference tables. remains after the procedure is completed. If no • There are no eponyms (procedures identified by a device remains, the device value No Device is person’s name, rather than clinical description), coded. Materials such as sutures, ligatures, common names, or acronyms used, although some radiological markers and temporary post-operative are found in the Index for cross-reference. wound drains are considered integral to the performance of a procedure and are not coded as • ICD-10-PCS codes often include references to devices. laterality and other specific sites

6 CMS Fact Sheet: ICD-10-CM/PCS, The Next Generation of Coding, https://www.cms.gov/Medicare/Coding/ICD10/downloads/ICD-10Overview.pdf and 2016 ICD-10-PCS Reference Manual, https://www.cms.gov/Medicare/Coding/ICD10/2016-ICD-10-PCS-and-GEMs.html 7

• If multiple procedures, as defined by distinct objectives, are performed, then multiple codes should be assigned; combination codes are very rare in ICD-10-PCS. During the same operative episode, multiple procedures are coded if: • The same root operation is performed • The intended root operation is attempted using one on different body parts (as a “body part” approach, but is converted to a different approach. is defined in the tables). • The operative approach and closure or other services • The same root operation is repeated at which are integral to a procedure, including different body sites that are included in anastomosis of a tubular body part, are not reported the same body part value, but are separately. anatomically distinct. • When a procedure is initiated, but not fully completed, • Multiple root operations with distinct code the procedure to the root operation which has objectives are performed on the same or been performed; if no root operation is completed, different body part. report as Inspection.

The following two tables list some of the most commonly used code categories for cardiovascular diagnostic and therapeutic procedures. Given the large number of individual procedure codes available for procedures in ICD-10- PCS, please refer to your coding reference book or coding software to look up the associated Body Part, Approach, Contrast, Device and/or Qualifier that best align to the procedure performed as identified below.

Table 3: Common ICD-10-PCS Procedure Code Categories – Diagnostic Procedures7 Procedure Description Category Angiography / Imaging B21– – – – Imaging of heart, fluoroscopy (indicate site, contrast, qualifiers) B31– – – – Imaging of upper arteries, fluoroscopy (indicate site, contrast, qualifiers) B41– – – – Imaging of lower arteries, fluoroscopy (indicate site, contrast, qualifiers) B41– – – – Imaging of veins, fluoroscopy (indicate site, contrast, qualifiers) Imaging, heart, computed tomography (indicate site, contrast, qualifiers; includes 6th character for B22– – – – intravascular optical coherence) Imaging, upper arteries, computed tomography (indicate site, contrast, qualifiers; includes 6th character B32– – – – for intravascular optical coherence) Imaging, lower arteries, computed tomography (indicate site, contrast, qualifiers; includes 6th character for B42– – – – intravascular optical coherence) Measurement and Monitoring 4A023N6 Measurement, cardiac, percutaneous, sampling and pressure, right heart (cardiac catheterization) 4A023N7 Measurement, cardiac, percutaneous, sampling and pressure, left heart (cardiac catheterization) Measurement, cardiac, percutaneous, sampling and pressure, bilateral heart (cardiac 4A023N8 catheterization) 4A033B– Measurement, arterial, percutaneous, pressure (select 7th character for type of vessel) Measurement, arterial, percutaneous, (select 6th character flow (5) or pulse (J)), (select 7th character 4A033– – for type of vessel) Measurement, venous, percutaneous (select 6th character flow (5), pressure (B), or pulse (J)), 4A043– – th (select 7 character for type of vessel)

7 ICD-10 Procedure Coding System (ICD-10-PCS), Centers for Medicare and Medicaid Services, May 2015, https://www.cms.gov/Medicare/Coding/ICD10/2016-ICD-10-PCS-and-GEMs.html. 8

Table 4: Common ICD-10-PCS Procedure Code Categories -- Cardiovascular Interventional Procedures and IVUS Procedure Description Category Percutaneous Angioplasty Percutaneous dilation of coronary arteries (select 4th character for vessel, 7th character qualifier 027–3Z– bifurcation (6) or none (Z)) 037–3ZZ Percutaneous dilation of upper arteries (select 4th character for vessel) Percutaneous dilation of lower arteries (select 4th character for vessel, 7th character qualifier drug- 047–3ZZ coated balloon (1) or none(7)) 057–3ZZ Percutaneous dilation of upper veins (select 4th character for vessel) 067–3ZZ Percutaneous dilation of lower veins (select 4th character for vessel) Percutaneous Atherectomy or Thrombectomy 02C–3ZZ Percutaneous extirpation of coronary arteries (select 4th character for vessel) 03C–3ZZ Percutaneous extirpation of upper arteries (select 4th character for vessel) 04C–3ZZ Percutaneous extirpation of lower arteries (select 4th character for vessel) 05C–3ZZ Percutaneous extirpation of veins (select 4th character for vessel) Percutaneous Stent Placement (Includes Angioplasty) Percutaneous dilation of coronary arteries (select 4th character for vessel) with placement of stent 027–3–Z (select 6th character drug-eluting (4) or other (D) intraluminal device) Percutaneous dilation of upper arteries (select 4th character for vessel) with placement of stent 037–3–Z (select 6th character drug-eluting (4) or other (D) intraluminal device) Percutaneous dilation of lower arteries (select 4th character for vessel) with placement of stent (select 047–3–Z th 6 character drug-eluting (4) or other (D) intraluminal device) Percutaneous dilation of veins (select 4th character for vessel) with placement of stent (select 6th 057–3–Z character drug-eluting (4) or other (D) intraluminal device) Intravascular Ultrasound B24–ZZ3 Intravascular imaging of coronary vessels (select 4th character for body part(s) imaged) Intravascular imaging of upper arteries (cerebrovascular, upper extremities, intrathoracic) (select 4th B34–ZZ3 character for body part(s) imaged) Intravascular imaging of lower arteries (lower extremities, intra-abdominal) (select 4th character for B44–ZZ3 body part(s) imaged) B54–ZZ3 Intravascular imaging of veins (select 4th character for body part(s) imaged) Injections / Infusions 3E0731– Percutaneous intracoronary artery thrombolytic infusion (select 7th character for type of thrombolytic) Injection or infusion of thrombolytic agent (select 4th character for administration route (central or 3E0–31– peripheral vein or artery), and 7th character for type of thrombolytic) Injection of anticoagulant / platelet inhibitor (select 4th character for administration route (central or 3E0–3PZ peripheral vein or artery) Other Supportive Therapies 5A02–2C Super-saturated oxygen therapy (select 4th character for intermittent (1) or continuous (2)) 06H03DZ Percutaneous insertion of intraluminal device into inferior vena cava (vena cava filter) Insertion of extracorporeal assistance (select 4th character for (1) intermittent or (2) continuous, and 5A02–1– th 7 character for device (eg, balloon pump (0), impeller pump(D))) Insertion of percutaneous external heart assist device (select 7th character qualifier biventricular (S) 02HA3R– or none (Z)) 02PYXDZ Non-operative removal of heart assist system

In ICD-9-CM, adjunct vascular system procedure codes were additionally reported, which indicated multi-vessel and multi-stent procedures. These codes applied to both coronary and peripheral vessels, to provide additional information on the number of vessels upon which a procedure was performed and/or the number of stents inserted. In a case involving a combination of coronary and non-coronary vessels, the grand total number of vessels/stents treated during the admission was reported.

Under ICD-10-PCS, the 4th character body part for coronary interventions indicates number of sites within the coronary arteries, so a single code may capture all services provided. However, if different methodologies are used in different sites (eg, angioplasty only, angioplasty with stenting, or atherectomy), or if multiple root operations with different objectives are performed on the same body part, code each separately. When the same root operation is performed on multiple body parts (eg, peripheral vessels), each site is reported separately, thus capturing multiple vessel and/or multiple stent procedures.

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Revenue Codes

Revenue codes allow hospitals to categorize services provided by revenue center. Medicare utilizes revenue codes for cost reporting. For Medicare, revenue codes must be included for each service on a CMS 1450 (UB-04) claim form.

Hospital Inpatient Reimbursement

Medicare beneficiaries who are admitted into hospital inpatient settings typically have coverage through Medicare Part A. Medicare reimburses inpatient hospital services under the Inpatient Prospective Payment System (IPPS), which bases payment on diagnosis-related groups (DRGs), now MS-DRGs. The MS-DRG payment system groups similar diagnoses into a single payment level, and reimburses the hospital according to the extent of resources typically required to treat patients with similar diagnoses undergoing similar treatments.

All services and supplies provided during the inpatient admission are bundled into a single MS-DRG reimbursement rate, regardless of the length of the inpatient stay, the intensity of treatments, or the number of procedures performed for the specific individual. Hospitals will receive one global MS-DRG payment rate per patient admission, and the MS-DRG assignment is primarily determined by the patient’s principle diagnosis and/or principal procedure performed.

Complications and Comorbidities (CCs) and Major Complications and Comorbidities (MCCs)

Beginning October 1, 2007, Medicare revised the entire DRG system to better reflect the severity levels of inpatient treatments. Hospitals performing procedures for Medicare patients now receive payment under the new MS-DRG assignments and MS-DRGs are now distinguished between encounters with or without CCs or MCCs.

MCCs better recognize hospital resource use based on secondary diagnoses. These conditions generally correspond to longer and more complicated inpatient stays due to a need for services such as intensive monitoring, expensive and technically complex procedures, and/or extensive nursing care. Secondary conditions documented in a patient’s medical record may impact the reimbursement a hospital receives.

While there are typically only two levels of MS-DRG for coronary procedures, with or without MCC, some endovascular MS-DRGs include reference to CCs. Under the MS-DRG system, a CC or MCC must represent a secondary diagnosis in combination with the principal diagnosis.

Beginning with FY 2013, documenting and reporting the diagnosis of chronic total occlusion (CTO) of artery of the extremities (ICD-10-CM code I70.92) can significantly affect reimbursement to the hospital for peripheral interventions, as this is now recognized as a “CC”.

The following two tables provide diagnosis codes that may be cormorbidities in cardiovascular patients, which have been identified as CCs or MCCs and may therefore affect MS-DRG assignment.

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Table 5: Partial List of ICD-10-CM Codes – Complications and Cormorbidities (CCs)8 Diagnosis Code9 Description E44.0, E44.1 Mild or moderate protein-calorie malnutrition E46 Unspecified protein-calorie malnutrition E87.0 – E87.3 Hypernatremia, hyponatremia, acidosis, alkalosis I12.0 Hypertensive chronic kidney disease, stage V or end stage renal disease I13.11 Hypertensive heart and chronic kidney disease, without heart failure, with stage V or end stage renal disease I13.0, I13.2 Hypertensive heart and chronic kidney disease, out heart failure, any stage renal disease I20.0, I20.1 Unstable angina, angina pectoris with documented spasm I24.1, I24.8, I24.9 Other acute and subacute forms of ischemic heart disease I27.0 Primary pulmonary hypertension I27.82 Chronic pulmonary embolism I42.0 – I42.9 Cardiomyopathy I47.0 – I47.2 Tachycardias (supraventricular, ventricular, AVNRT) I48.1 Persistent atrial fibrillation I48.1, I48.3, I48.4, Atrial flutter I48.92 I50.1 Left ventricular failure I50.20, I50.22, I50.30, Unspecified or chronic systolic, diastolic, or combined systolic and diastolic heart failure I50.32, I50.40, I50.42 G45.0, G45.1 Basilar artery syndrome, vertebral artery syndrome, carotid artery syndrome, or vertebrobasilar artery syndrome G45.8, G45.9 Other specified or unspecified transient cerebral ischemias, subclavian steal syndrome I67.89 Acute, but ill-defined, cerebrovascular disease I67.81, I67.82, I67.89 Other generalized ischemic cerebrovascular disease I70.261 – I70.269 Atherosclerosis of native arteries of the extremities with gangrene I70.92 Chronic total occlusion of artery of the extremities I74.09 – I74.9 Arterial embolism and thrombosis of aorta, artery of upper or lower extremity, iliac artery, other specified artery, or unspecified artery I75.011 – I75.89 Atheroembolism I77.2 Rupture of artery I82.210 – I82.C29 Acute / chronic venous embolism and thrombosis of vessels of specified sites J45.21, J45.22, J45.31, Mild intermittent, mild persistent, moderate persistent, severe persistent, or unspecified J45.32, J45.41, J45.42, asthma with status asthmaticus or (acute) exacerbation J45.51, J45.52, J45.901, J45.902 J96.10 – J96.12 Chronic respiratory failure N17.8, N17.9 Other or unspecified acute kidney failure N18.4, N18.5 Chronic kidney disease, Stage IV or V N39.0 Urinary tract infection, site not specified L02.01 – L03.91 Cellulitis, abscess, and acute lymphangitis of various specified sites L97.101 – L97.929 Non-pressure chronic ulcer of lower limb R17 Jaundice, unspecified, not of newborn T82.01XA – T82.599A Mechanical complication of vascular device, implant, and graft T82.6XXA – T82.7XXA Infection and inflammatory reaction due to other vascular device, implant, and graft T82.817A – T82.9XXA Other complications due to other vascular device, implant, and graft I97.710 – I97.89 Cardiac, cerebrovascular, or peripheral vascular complications, not elsewhere classified Z68.1, Z68.41 - Z68.45 Body Mass Index less than 19, or 40 and over, adult

8 Centers for Medicare and Medicaid Services, FY16 Final Notice Data, Table 6J - CC List; http://www.cms.gov/AcuteInpatientPPS/ (under Acute Inpatient – Files for Download) 9 Ibid; International Classification of Diseases, Tenth Revision, Clinical Modification, National Center for Health Statistics, July 2015, http://www.cdc.gov/nchs/icd/icd10cm.htm. 11

Table 6: Partial List of ICD-10-CM Codes – Major Complications and Cormorbidities (MCCs)10 Diagnosis Code11 Description E08.00 – E08.11, E08.641, E09.00 – Secondary diabetes mellitus with ketoacidosis, hyperosmolality or other coma E09.11, E09.641 E10.10, E10.11, E10.641, E11.00, E11.01, E11.641, Diabetes mellitus with ketoacidosis, hyperosmolality or other coma E13.00 – E13.11, E13.641 I21.01 – I22.9 Acute myocardial infarction I25.42 Dissection of coronary artery I26.01 – I26.99 Pulmonary embolism and infarction I49.01, I49.02 Ventricular fibrillation, ventricular flutter I46.2 – I46.9 Cardiac arrest I50.21, I50.23 Acute or acute on chronic systolic heart failure I50.31, I50.33 Acute or acute on chronic diastolic heart failure I50.41, I50.43 Acute or acute on chronic combined systolic and diastolic heart failure Cerebral infarction due to thrombosis, embolus, or occlusion / stenosis of precerebral or I63.00 – I63.9 cerebral artery I71.00 – I71.03 Dissection of aorta, unspecified site, thoracic, abdominal, or thoracoabdominal I77.71 – I77.79 Dissection of artery: carotid, iliac, renal, vertebral, or other artery I82.220, I82.221 Acute or chronic embolism and thrombosis of inferior vena cava J95.821, J95.822 Acute or acute and chronic post-procedure acute respiratory failure N18.6 End stage renal disease O90.3 Peripartum cardiomyopathy L89.—3, L89.--4 Pressure ulcer, stage III or stage IV (*principal diagnosis can be its own MCC) 785.51 – 785.59 Cardiogenic, septic, or other shock without mention of trauma S25.00XA – S25.499A, S35.00XA – S35.59XA, S45.001A – S45.099A, Traumatic injuries to specified blood vessels S75.001A – S75.199A, S85.001A – S85.599A A41.9, R65.10 – Sepsis, severe sepsis, systemic inflammatory response syndrome due to noninfectious R65.21 process with acute organ dysfunction T81.11XA Postoperative shock, cardiogenic

Five diagnoses which are closely associated with patient mortality are assigned different CC subclasses, depending upon whether the patient is discharged alive or deceased. These diagnoses are:

I49.01 -- Ventricular fibrillation I46.2 – I46.9 -- Cardiac arrest R57.0 -- Cardiogenic shock R57.1 – R57.9 -- Other shock without mention of trauma R09.2 -- Respiratory arrest

These diagnoses are assigned an MCC subclass for patients who are discharged alive, and a non-CC subclass for patients who expire.

Table 9 below lists common MS-DRGs which may be assigned when conducting endovascular procedures, including peripheral angioplasty and/or stenting or placing a vena cava filter, in the inpatient setting.

10 Centers for Medicare and Medicaid Services, FY14 Final Notice Data, Table 6I - MCC List; http://www.cms.hhs.gov/AcuteInpatientPPS/ (under Acute Inpatient – Files for Download) 11 Ibid; International Classification of Diseases, Ninth Revision, Clinical Modification, 2012 Professional, Ingenix, 2011; and ICD- 9-CM Tabular Addenda, National Center for Health Statistics, June 10, 2011. 12

Table 7: Common MS-DRGs for Endovascular Procedures12 2016 2016 Medicare MS-DRG Description Relative Base Payment Weight Rate 13 034 Carotid artery stent procedure with MCC 3.6851 $21,765 035 Carotid artery stent procedure with CC 2.3048 $13,612 036 Carotid artery stent procedure without CC/MCC 1.7180 $10,147 166 Other respiratory system O.R. procedures with MCC 3.6796 $21,732 167 Other respiratory system O.R. procedures with CC 1.9367 $11,438 168 Other respiratory system O.R. procedures without CC/MCC 1.2950 $ 7,648 252 Other vascular procedures with MCC 3.2872 $19,415 253 Other vascular procedures with CC 2.6028 $15,373 254 Other vascular procedures without CC/MCC 1.7232 $10,177 299 Peripheral vascular disorders with MCC 1.4216 $ 8,396 300 Peripheral vascular disorders with CC 0.9994 $ 5,903 301 Peripheral vascular disorders without CC/MCC 0.7023 $ 4,148 673 Other kidney and urinary tract procedures with MCC 3.3559 $19,820 674 Other kidney and urinary tract procedures with CC 2.3148 $13,672 675 Other kidney and urinary tract procedures without CC/MCC 1.5595 $ 9,211

Table 10 below lists common MS-DRGs which may be assigned when conducting coronary procedures or inserting coronary devices in the inpatient setting:

Table 8: Common MS-DRGs for Coronary Procedures 2016 2016 Medicare MS-DRG Description Relative Base Payment Weight Rate Percutaneous cardiovascular procedure with drug-eluting stent 246 3.2494 $19,191 with MCC or 4+ vessels/stents Percutaneous cardiovascular procedure with drug-eluting stent 247 2.1307 $12,584 without MCC Percutaneous cardiovascular procedure with non-drug-eluting 248 3.0696 $18,129 stent with MCC or 4+ vessels/stents Percutaneous cardiovascular procedure with non-drug-eluting 249 1.9140 $11,304 stent without MCC Percutaneous cardiovascular procedure without coronary artery 250 2.6975 $15,932 stent with MCC Percutaneous cardiovascular procedure without coronary artery 251 1.6863 $ 9,960 stent without MCC 273 Percutaneous intracardiac procedures with MCC 3.5499 $20,966

274 Percutaneous intracardiac procedures without MCC 2.4197 $14,291 Circulatory disorders except acute myocardial infarction, with 286 2.1775 $12,861 cardiac catheterization with MCC Circulatory disorders except acute myocardial infarction, with 287 1.1562 $ 6,829 cardiac catheterization without MCC

12 Centers for Medicare and Medicaid Services, FY16 Final Notice Data, Table 5 - List of Medicare Severity Diagnosis-Related Groups (MS-DRGs), Relative Weighting Factors, and Geometric and Arithmetic Mean Length of Stay; http://www.cms.gov/AcuteInpatientPPS/ (under Acute Inpatient – Files for Download) 13 The MS-DRG payment amounts indicated are estimates only based upon data elements derived from various CMS sources. MS-DRG national average payments were calculated with a base rate of $5,906.14 using the national adjusted operating standardized amounts and the capital standard federal payment rate as issued in the Medicare Inpatient Prospective Payment System Final Rule issued by CMS on 7/31/15 [CMS-1632-F] and published in the Federal Register (Vol. 80, Issue 158) on 8/17/15;Tables 1A and 1D,Table 5, and assume that all hospitals are receiving the full 1.7% quality reporting and meaningful use updates. Actual payment may vary based on various hospital-specific factors not reflected in the source data. 13

HOSPITAL OUTPATIENT ISSUES

Introduction to the 2016 Outpatient Prospective Payment System (OPPS) Final Rule

On October 30, 2015, the Centers for Medicare and Medicaid Services (CMS) released the 2016 Final Rule updating the hospital outpatient prospective payment system (OPPS)14. Medicare reimburses outpatient hospital services under the OPPS, which bases payment on Ambulatory Payment Classifications (APCs), groups of clinical services, supplies, drugs, and devices that are similar clinically and in terms of resource costs. CMS mandated several changes in the OPPS beginning in 2008, including bundling of imaging and ancillary services into an intervention payment and new hospital outpatient quality measures; these initiatives are continuing for CY 2016.

Expanded Bundling of Services

CMS believes that a basic tenet of a prospective payment system is the packaging of all integral, ancillary, supportive, dependent, or adjunctive services into primary services. Reimbursement for surgical Ambulatory Payment Classifications (APCs) includes payment for these supportive services, including intravascular ultrasound (IVUS), angiography, and other types of radiology supervision and interpretation. Therefore, guidance imaging for implantation of Cordis® products is not reimbursed separately. For CY 2016, CMS is finalizing its proposal to conditionally package a limited number of additional ancillary services, in particular certain minor procedures and pathology services, except for cochlear implant and auditory implant programming services. CMS will also package payment for a few drugs that function as supplies in a surgical procedure.

CMS finalized a proposal to reduce the CY 2016 conversion factor to account for approximately $1 billion in inflation in the OPPS payments resulting from excess packaged payment under the OPPS. Specifically, CMS estimated that its policy to classify laboratory services as packaged would result in a $2.4 billion shift in CY 2014 OPPS spending for laboratory tests previously paid at the Clinical Laboratory Fee Schedule payment rates outside the OPPS. However, the CMS Office of the Actuary (OACT) found that about $1 billion in laboratory tests payments that were projected to be packaged into OPPS payment rates continued to be paid separately in CY 2014. To prevent the excess payment from carrying through to the CY 2016 OPPS rates, CMS is reducing the CY 2016 conversion factor by 2.0 percent to account for the approximately $1 billion inflation in OPPS payments.

CMS is also finalizing changes to the laboratory test packaging policy. CMS is creating a new conditional packaging status indicator for laboratory tests that will make it easier for hospitals to receive separate payment for laboratory tests that are provided without other OPPS services.

CMS conducted a comprehensive review of all of the OPPS clinical APCs and had proposed to restructure, reorganize, and consolidate many of them, resulting in fewer APCs overall for nine clinical APC families, which include various surgical and diagnostic procedures. CMS is finalizing the restructuring of the nine clinical families, which has led to a renumbering of nearly all APCs for 2016.

Device pass-through payments are intended to enable initial access to certain new medical devices. CMS currently accepts and reviews applications for device pass-through on a quarterly basis through a subregulatory process. For 2016, CMS is finalizing its proposal to evaluate device pass-through applications through annual rulemaking in addition to the quarterly subregulatory review process. In addition, applications must be submitted within three years of FDA approval/clearance or the date of market availability if there is a documented, verifiable delay in market availability after FDA approval or clearance.15

14 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Short Inpatient Hospital Stays; Transition for Certain Medicare-Dependent, Small Rural Hospitals under the Hospital Inpatient Prospective Payment System; Provider Administrative Appeals and Judicial Review [CMS-1633-FC] was published in the November 13, 2015, Federal Register. 15 CMS Fact Sheet: CMS Finalizes Hospital Outpatient and Ambulatory Surgical Center Policy and Payment Changes, Including Changes to the Two-Midnight Rule and Quality Reporting for 2016. https://www.cms.gov/Newsroom/MediaReleaseDatabase/ Fact-sheets/2015-Fact-sheets-items/2015-10-30-3.html \ 14

Hospital Outpatient Quality Data Reporting Program (HOP QDRP)

The Tax Relief and Health Care Act of 2006 (TRHCA) required the Secretary of Health and Human Services to develop measures in order to assess the quality of care furnished by hospitals in outpatient settings. Medicare requires most hospitals to report data on hospital outpatient department quality measures. Similar to existing quality reporting requirements in the inpatient setting, hospitals that do not report these outpatient data points will not receive complete payments updates. The final 2016 Outpatient Prospective Payment System / Ambulatory Surgical Center Payment System (OPPS/ASC) rule includes a -0.3% annual update for hospital outpatient departments (HOPDs), which would be reduced a further 2% for any facility not meeting quality reporting requirements.16.

The 2016 rule finalized one new measure to the program, for the CY 2018 payment determination and subsequent years - OP-33: External Beam Radiotherapy for Bone Metastases, and finalizing the removal of one measure, OP-15: Use of Brain Computed Tomography (CT) in the Emergency Department for Atraumatic Headache.

Table 9: Outpatient Quality Measures17 Number Descriptor Type OP-1 Median Time to Fibrinolysis Abstraction OP-2 Fibrinolytic Therapy Received Within 30 Minutes of ED Arrival Abstraction OP-3 Median Time to Transfer to Another Facility for Acute Coronary Intervention Abstraction OP-4 Aspirin at Arrival Abstraction OP-5 Median Time to ECG Abstraction OP-8 MRI Lumbar Spine for Low Back Pain Claims OP-9 Mammography Follow-up Rates Claims OP-10 Abdomen CT – Use of Contrast Material Claims OP-11 Thorax CT – Use of Contrast Material Claims OP-12 The Ability for Providers with HIT to Receive Laboratory Data Electronically Directly into Web-based their ONC-Certified EHR System as Discrete Searchable Data OP-13 Cardiac Imaging for Preoperative Risk Assessment for Non Cardiac Low Risk Surgery Claims OP-14 Simultaneous Use of Brain Computed Tomography (CT) and Sinus CT Claims OP-17 Tracking Clinical Results between Visits Web-based OP-18 Median Time from ED Arrival to ED Departure for Discharged ED Patients Abstraction OP-20 Door to Diagnostic Evaluation by a Qualified Medical Professional Abstraction OP-21 Median Time to Pain Management for Long Bone Fracture Abstraction Abstraction; OP-22 ED – Patient Left Without Being Seen Web entry OP-23 ED – Head CT or MRI Scan Results for Acute Ischemic Stroke or Hemorrhagic Stroke Abstraction who Received Head CT or MRI Scan Interpretation Within 45 minutes of Arrival OP-25 Safe Surgery Checklist Use Web-based OP-26 Hospital Outpatient Volume Data on Selected Outpatient Surgical Procedures Web-based OP-27 Influenza Vaccination Coverage among Healthcare Personnel Web-based OP-29 Endoscopy/Polyp Surveillance: Appropriate Follow-up Interval for Normal Colonoscopy in Web-based Average Risk Patients OP-30 Endoscopy/Polyp Surveillance: Colonoscopy Interval for Patients with a History of Web-based Adenomatous Polyps – Avoidance of Inappropriate Use OP-31 Cataracts – Improvement in Patient’s Visual Function within 90 Days Following Cataract Web-based Surgery OP-32 Facility 7-day Risk-Standardized Hospital Visit Rate after Outpatient Colonoscopy Claims

CMS also finalized several policy changes. The Hospital OQR Program is: (1) changing the deadline for withdrawing from the program to August 31; (2) changing the deadline for submitting a reconsideration request to the first business day on or after March 17 of the affected payment year; and (3) shifting the quarters on which payment determinations are based and making conforming changes to the validation process to reflect proposed changes in the payment determination timeframes, requiring a one-time change in the CY 2017 payment determination timeframe to cover three quarters instead of four quarters, and returning to a four-quarter payment determination in CY 2018 and subsequent years. The Hospital OQR program is aligning with the National Healthcare Safety Network (NHSN) measure deadline by changing the data submission timeframe for measures submitted via the CMS Web- based tool (QualityNet Website) from July 1 through November 1 to January 1 through May 15.

16 Ibid, CMS Fact Sheet; https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-10- 30-3.html 17 Hospital Outpatient Quality Reporting Program Specifications Manual v.9.0a; https://www.qualitynet.org. 15

The seven claims-based imaging measures are calculated by CMS using Medicare Part B claims data without imposing on hospitals the burden of additional chart abstraction. An addition eight measures utilize web-based reporting.

Although these measures may not be directly related to implantation of Cordis® vascular products or other percutaneous vascular procedures, we felt it important to include discussion of them as hospitals that choose not to report on these measures will ultimately receive reduced payment for all procedures in 2014 and subsequent years.

CMS has implemented a policy to not pay for medical care that harms patients or leads to complications that could have been prevented; this policy also affects service reporting for outpatient services. For dates of service on or after January 15, 2009, append one of the following applicable HCPCS modifiers to all lines related to the surgical error.

PA Surgical or other invasive procedure on wrong body part PB Surgical or other invasive procedure on wrong patient PC Wrong surgery or other invasive procedure on patient

Hospital Outpatient Reimbursement

Medicare beneficiaries who receive services in the hospital outpatient setting typically have coverage through Medicare Part B. Current Procedural Terminology18 (CPT®) and Healthcare Common Procedure Coding System (HCPCS) codes map to APCs which assign a Medicare hospital outpatient payment rate for the service as illustrated in the example below:

® CPT Code APC 2016 Medicare 19 maps to maps to Base Payment Rate 37221 5192 $ 9,542

Depending upon the services provided, hospitals may receive payment for more than one APC per patient encounter.

If a claim contains services that result in an APC payment but also contains packaged services, separate payment for the packaged services is not made since payment is included in the APC. However, charges related to the packaged services are used for outlier and Transitional Corridor Payments (TOPs) as well as for future rate setting.

Therefore, it is extremely important that hospitals report all HCPCS codes consistent with their descriptors; CPT® and/or CMS instructions and correct coding principles, and all charges for all services they furnish, whether payment for the services is made separately paid or is packaged.

18 2016 Current Procedural Terminology (CPT®), ©2015 American Medical Association. CPT® is a registered trademark of the American Medical Association. 19 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Short Inpatient Hospital Stays; Transition for Certain Medicare-Dependent, Small Rural Hospitals under the Hospital Inpatient Prospective Payment System; Provider Administrative Appeals and Judicial Review [CMS-1633-FC]; Addendum B; http://www.cms.gov/HospitalOutpatientPPS. 16

Device C-Codes

In 2004, CMS reinstated the use of device C-codes for cost tracking purposes.20 The following table lists relevant device C-codes that may apply to Cordis Corporation vascular products:

Code Description C1714 Catheter, transluminal atherectomy, directional C1724 Catheter, transluminal atherectomy, rotational C1725 Catheter, transluminal angioplasty, non-laser (may include guidance, infusion / perfusion capability)21 C1753 Catheter, intravascular ultrasound C1757 Catheter, thrombectomy / embolectomy C1760 Closure device, vascular (implantable / insertable) C1874 Stent, coated/covered, with delivery system22 C1875 Stent, coated/covered, without delivery system C1876 Stent, non-coated/non-covered, with delivery system C1877 Stent, non-coated/non-covered, without delivery system C1880 Vena cava filter C1884 Embolization protective system C1885 Catheter, transluminal angioplasty, laser C1887 Catheter, guiding (may include infusion / perfusion capability) C1888 Catheter, ablation, non-cardiac, endovascular (implantable) C1894 Introducer/sheath, other than guiding, other than intracardiac electrophysiological, non-laser C2623 Catheter, transluminal angioplasty, drug-coated, non-laser C2629 Introducer/sheath, other than guiding, other than intracardiac electrophysiological, laser

Continuing in 2016, CMS requires hospitals to report C-codes on claims for devices used in procedures that are reimbursed under certain device-dependent APCs. This requirement is intended to allow CMS to better calculate the correct relative costs of device-dependent APCs in relation to other OPPS services. For example, the following endovascular and cardiovascular procedure codes require related device C-codes to be reported on the same claim:

• Endovascular revascularization of lower extremities (37220 – 37235) • Transluminal balloon angioplasty, open (35458 – 35460) • Transluminal balloon angioplasty, percutaneous (35470 – 35476) • Transluminal atherectomy; open (35484 – 35485) • Transluminal balloon angioplasty, percutaneous (35490 – 35495) • Transcatheter retrieval of intravascular foreign body (37197) • Transcatheter occlusion or embolization (37241 – 37244) • Transcatheter placement of non-coronary stent(s) (37236 – 37239) • Transcatheter placement of carotid artery stent with embolic protection (37215) • Transluminal coronary balloon angioplasty (92920 – 92921) • Transcatheter placement of intracoronary stent (92928 – 92929) • Transcatheter coronary atherectomy (92924 – 92925) • Transcatheter coronary atherectomy plus stent placement (92933 – 92934) • Revascularization of or through a coronary artery bypass (92937 – 92938) • Revascularization of acute total/subtotal occlusion during acute myocardial infarction (92941) • Revascularization of a chronic total occlusion of coronary artery (92943 – 92944) • Coronary interventions with drug-eluting intracoronary stent (C9600 – C9608)

20 Medicare Claims Processing Manual, Chapter 4 – Part B Hospital (Including Inpatient Hospital Part B and OPPS), §61 - Billing for Devices Under the OPPS; http://www.cms.hhs.gov/manuals/downloads/clm104c04.pdf. 21 C1725 is recommended for reporting use of the FLASH™ Ostial System in an outpatient setting. 22 Medicare instructions indicate that drug-eluting stents should be reported using C1874. (Personal communication – Cordis Corporation on file). 17

CMS will continue to review procedures to determine whether additional device-dependent edits are necessary, and may update the edits on a quarterly basis.23 Hospitals are not required to report C-codes when performing procedures for non-device-dependent APCs, but they are encouraged to report the corresponding C-codes to support cost tracking and more appropriate APC payment in coming years.

For vascular closure devices (VCDs), there is also a companion code for the act of placement: G0269 – Placement of occlusive device into either a venous or arterial access site, post surgical or interventional procedure, which accompanies the device code C1760. There is not a device-dependent edit for C1760 with any procedure, as a VCD is not always used.

Hospital reimbursement for fixed fee payers (eg, Medicare), incremental reimbursement for the use of the device is not available. Established rates of reimbursement are based on historical costs and therefore include the cost of these devices.

• Hospitals should bill payers when a VCD is used. Medicare establishes rates based upon the estimated cost of care rendered to a population of patients.

• Private payers contracting with hospitals are permitted to provide incremental reimbursement for the use of VCDs. The hospital must make a request with the payer.

Although there is no separate payment available under the OPPS for most device C-codes, it is important for hospitals to report the C-code and an appropriate charge on their claims for each item provided. This claims data will be used by CMS to determine future APC payment rates and to ensure that the cost of associated devices is appropriately accounted for in each APC.

Table 10: Common APCs for Coronary and Noncoronary Endovascular Procedures24 Payment 2016 2016 Medicare APC Description Status Relative Base Payment Indicator Weight Rate 5181 Level 1 Vascular Procedures T 11.6990 $ 863 5182 Level 2 Vascular Procedures T 30.4826 $ 2,247 5183 Level 3 Vascular Procedures T 51.4789 $ 3,795 5188 Diagnostic Cardiac Catheterization T 34.5760 $ 2,549 5191 Level 1 Endovascular Procedures J1 62.2875 $ 4,592 5192 Level 2 Endovascular Procedures J1 129.4317 $ 9,542 5193 Level 3 Endovascular Procedures J1 198.1983 $14,612

OPPS payment status indicators (SIs) indicate whether a service represented by a HCPCS or CPT® code is payable under the OPPS or another payment system, and also whether particular OPPS policies apply to the code (eg, multiple procedure discounts or other payment reductions, full separate payment, or is a service packaged with another procedure). Please see complete list of SIs on the following page.

Revenue Codes

Hospitals must continue to assign a revenue code in addition to the C-code for each device reported on a claim.25

23 A complete listing of the current procedure-to-device and device-to-procedure edits may be downloaded from the CMS website: http://www.cms.gov/HospitalOutpatientPPS/02_device_procedure.asp#TopOfPage. 24 Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Addendum D1; http://www.cms.gov/HospitalOutpatientPPS, [CMS-1633-FC]. 25 A revenue code to cost center crosswalk is available on the CMS website at: http://www.cms.gov/HospitalOutpatientPPS, Annual Policy Files. 18

Status Indicators

A total of twenty-five SIs are listed in the calendar year 2016 OPPS Final Rule; several relating to the hospital outpatient case examples provided in this guide are included below for reference. A complete list of SIs can be found in Addendum D1 of the CY 2016 OPPS Final Rule.26

Common OPPS Status Indicators

Indicator Item/Code/Service OPPS Payment Status A Services furnished to a hospital Not paid under OPPS. Paid by Medicare Administrative Contracots outpatient that are paid under a (MACs) under a fee schedule or payment system other than OPPS fee schedule or payment system (eg, ambulance, separately payable clinical laboratory, separately other than OPPS payable non-implantable prosthetics / orthotics, mammography) C Inpatient Procedures Not paid under OPPS. Admit patient. Bill as inpatient. G Pass-Through Drugs and Paid under OPPS; separate APC payment. Biologicals H Pass-Through Device Separate cost-based pass-through payment; not subject to Categories copayment. J1 Hospital Part B services paid Paid under OPPS; all covered Part B services on the claim are through a comprehensive APC packaged with the primary J1 service for the claim, except services with OPPS SI = F, G, H, L and U; ambulance services; diagnostic and screening mammography; all preventive services; and certain Part B inpatient services. J2 Hospital Part B Services That Paid under OPPS; Addendum B displays APC assignments when May Be Paid Through a services are separately payable. Comprehensive APC (1) Comprehensive APC payment based on OPPS comprehensive-specific payment criteria. Payment for all covered Part B services on the claim is packaged into a single payment for specific combinations of services, except services with OPPS SI = F, G, H, L and U; ambulance services; diagnostic and screening mammography; all preventive services; and certain Part B inpatient services. (2) Packaged APC payment if billed on the same claim as a HCPCS code assigned status indicator J1. (3) In other circumstances, payment is made through a separate APC payment or packaged into payment for other services. K Non-Pass-Through Drugs and Paid under OPPS; separate APC payment. Nonimplantable Biologicals N Items and Services Packaged Paid under OPPS; payment is packaged into payment for other into APC Rates services, including outliers. Therefore, there is no separate APC payment. Q1 STV-Packaged Codes Paid under OPPS; Addendum B displays APC assignments when services are separately payable. (1) Packaged APC payment if billed on the same date of service as a HCPCS code assigned status indicator S, T, or V. (2) In all other circumstances, payment is made through a separate APC payment. Q2 T-Packaged Codes Paid under OPPS; Addendum B displays APC assignments when services are separately payable. (1) Packaged APC payment if billed on the same date of service as a HCPCS code assigned status indicator T. (2) In all other circumstances, payment is made through a separate APC payment.

26 Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Addendum D1; http://www.cms.gov/HospitalOutpatientPPS, [CMS-1633-FC]. 19

Indicator Item/Code/Service OPPS Payment Status Q3 Codes That May Be Paid Paid under OPPS; Addendum B displays APC assignments when Through a Composite APC services are separately payable. Addendum M displays composite APC assignments when codes are paid through a composite APC. (1) Composite APC payment based on OPPS composite-specific payment criteria. Payment is packaged into a single payment for specific combinations of service. (2) In all other circumstances, payment is made through a separate APC payment or packaged into payment for other services. Q4 Conditionally packaged Paid under OPPS or CLFS. laboratory tests (1) Packaged APC payment if billed on the same claim as a HCPCS code assigned published status indicator J1, J2, S, T, V, Q1, Q2, or Q3. (2) In other circumstances, laboratory tests should have an SI = A and payment is made under the CLFS. S Significant Procedure, Not Paid under OPPS; separate APC payment. Discounted when Multiple T Significant Procedure, Multiple Paid under OPPS; separate APC payment. Reduction Applies V Clinic or Emergency Department Paid under OPPS; separate APC payment. Visit

For codes with a SI of “Q1, Q2, and Q3”, the APC assignment is the standard APC to which the code would be assigned if it is paid separately – when these procedures are performed in circumstances which do not meet the criteria of the package, reimbursement will be guided by the default status of the applicable APC. If there are multiple STV-packaged and/or T-packaged HCPCS codes on a specific date and no service with which the codes would be packaged on the same date, the code assigned to the APC with the highest payment rate will be paid. All other codes are packaged.

20

AMBULATORY SURGERY CENTER AND INDEPENDENT DIAGNOSTIC TESTING FACILITY ISSUES

Introduction to the 2016 Ambulatory Surgery Center (ASC) Final Rule

Since January 1, 2008, ambulatory surgery centers (ASCs) have been paid under a revised ASC payment system that aligns payment rates to those rates for similar services in the Hospital Outpatient Prospective Payment System (HOPPS) Ambulatory Payment Classifications (APCs) and extended payment to more surgical services in ASCs. To minimize the impact of the revised payment system, the revised ASC payment rates were phased in over four years, with CY 2011 being the final year of the transition.

In general, the ASC payment rate for services is set at approximately 65% of the payment rate for the same service under the HOPPS, with some exceptions. For example, for device-intensive services (where device costs account for more than 50 percent of the total cost of the service), ASCs receive the same payment rate for the device cost as under the HOPPS, with payment for the service portion of the ASC rate calculated at the usual percentage rate of the corresponding OPPS service payment. ASCs will not typically bill separately for these devices.

For ASC services that are predominantly performed in physicians’ offices, the ASC payment is capped at the amount the physician is paid under the Medicare Physician Fee Schedule (MPFS) for practice expenses for providing the same service in an office.

CMS has assigned APC-based payment rates in an Ambulatory Surgery Center only to surgical procedure codes – CPT® codes in the range 10000 – 69999, plus a few Category III codes, C-codes, and G-codes – and so does not include cardiac catheterization codes. Radiology procedures, supplies, and devices are considered ancillary to the surgical procedure; while some are reimbursed additionally, no separate payment is made for angiographic imaging procedures.

CMS continues to add or revise services in the list of ASC procedures for which payment may be made. However, those surgical procedures that would be expected to pose a significant safety risk to beneficiaries or that would be expected to require an overnight stay following the procedure are excluded from the ASC list. Therefore, there are certain procedures which may be considered appropriate for performance in a hospital outpatient setting, but for which Medicare does not provide reimbursement in an ASC – for 2016, this includes certain endovascular interventional procedures. 27

PLEASE NOTE that some commercial insurers are still utilizing the former nine groupers for ASC payment calculations, or have devised their own groupers, and have not converted to the Medicare methodology.

27 Ambulatory Surgical Center Payment System; Addendum EE -- Surgical Procedures to be Excluded from Payment in ASCs for CY 2016, https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/11_Addenda_Updates.html/, [CMS-1633-FC]. 21

ASC Quality Measure Reporting Program

The 2012 Final Rule implemented a new quality reporting program for ASCs. To allow CMS and ASCs to more effectively plan for future measurement requirements, this final rule adopted four outcome and one surgical infection control measures to be reported by ASCs on Medicare claims using quality data codes. Six additional measures are reported through a web-based portal. For 2016, CMS also adopted an outcomes measure (calculated by CMS based on claims submitted) for payment determinations for 2018.

Table 11: ASC Quality Measures for the CY 2016 Payment Determinations 28 ASC-1 Patient Burn Claims ASC-2 Patient Fall Claims ASC-3 Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant Claims ASC-4 Hospital Transfer/Admission Claims ASC-5 Prophylactic Intravenous IV Antibiotic Timing Claims ASC-6 Safe Surgery Checklist Use Web-based ASC-7 ASC Facility Volume Data on Selected ASC Surgical Procedures Web-based ASC-8 Influenza Vaccination Coverage among Healthcare Personnel Web-based ASC-9 Endoscopy/Polyp Surveillance: Appropriate Follow-up Interval for Normal Colonoscopy Web-based in Average Risk Patients ASC-10 Endoscopy/Polyp Surveillance: Colonoscopy Interval for Patients with a History of Web-based Adenomatous Polyps – Avoidance of Inappropriate Use ASC-11 Cataracts – Improvement in Patient’s Visual Function within 90 Days Following Cataract Web-based Surgery ASC-12 Facility 7-Day Risk-Standardized Hospital Visit Rate after Outpatient Colonoscopy CMS

Ambulatory Surgical Center Measure G-Codes (QDCS)

Measure Measure Description QDC ASC-1 Patient Burn G8908: Patient documented to have received a burn prior to discharge G8909: Patient documented not to have received a burn prior to discharge ASC-2 Patient Fall G8910: Patient documented to have experienced a fall within the ASC G8911: Patient documented not to have experienced a fall within the ASC ASC-3 Wrong Site, Wrong G8912: Patient documented to have experienced a wrong site, wrong side, Side, Wrong Patient, wrong patient, wrong procedure, or wrong implant event Wrong Procedure, G8913: Patient documented not to have experienced a wrong site, wrong side, Wrong Implant wrong patient, wrong procedure, or wrong implant event ASC-4 Hospital G8914: Patient documented to have experienced a hospital transfer or hospital Transfer/Admission admission upon discharge from ASC G8915: Patient documented not to have experienced a hospital transfer or hospital admission upon discharge from ASC ASC-5 Prophylactic IV G8916: Patient with preoperative order for IV antibiotic surgical site infection Antibiotic Timing (SSI) prophylaxis, antibiotic initiated on time G8917: Patient with preoperative order for IV antibiotic surgical site infection (SSI) prophylaxis, antibiotic not initiated on time G8918: Patient without preoperative order for IV antibiotic surgical site infection (SSI) prophylaxis G8907: Patient documented not to have experienced any of the following events: a burn prior to discharge; a fall within the facility; wrong site, wrong side, wrong patient, wrong procedure, or wrong implant event; or a hospital transfer or hospital admission upon discharge from the facility. Note: This code may be used in lieu of reporting individual codes for ASC-1 through ASC-4 if all are negative.

28 Ambulatory Surgical Center Quality Reporting Specifications Manual v 5.0a, www.qualitynet.org. 22

Payment Indicators

ASC payment status indicators (SIs) indicate whether a service represented by a HCPCS or CPT® code is payable under the ASC or another payment system, and also whether particular ASC policies apply to the code (eg, multiple procedure discounts or other payment reductions, full separate payment, or is a service packaged with another procedure). A total of eighteen SIs are listed in the calendar year 2016 ASC Final Rule. A complete list of SIs can be found in Addendum DD1 of the CY 2016 OPPS Final Rule.29

Common ASC Payment Indicators

Indicator ASC Payment Indicator Definition A2 Surgical procedure on ASC list in CY 2007; payment based on OPPS relative payment weight. G2 Non office-based surgical procedure added in CY 2008 or later; payment based on OPPS relative payment weight. J7 OPPS pass-through device paid separately when provided integral to a surgical procedure on ASC list; payment contractor-priced. J8 Device-intensive procedure; paid at adjusted rate. K2 Drugs and biological paid separately when provided integral to a surgical procedure on ASC list; payment based on OPPS rate. K7 Unclassified drugs and biological; payment contractor-priced N1 Packaged service/item; no separate payment made. P2 Office-based surgical procedure added to ASC list in CY 2008 or later with MPFS nonfacility PE RVUs; payment based on OPPS relative payment weight. P3 Office-based surgical procedure added to ASC list in CY 2008 or later with MPFS nonfacility PE RVUs; payment based on MPFS nonfacility PE RVUs. R2 Office-based surgical procedure added to ASC list in CY 2008 or later without MPFS nonfacility PE RVUs; payment based on OPPS relative payment weight. Z2 Radiology service paid separately when provided integral to a surgical procedure on ASC list; payment based on OPPS relative payment weight. Z3 Radiology service paid separately when provided integral to a surgical procedure on ASC list; payment based on MPFS nonfacility PE RVUs.

29 Ambulatory Surgical Center Payment System; Addendum DD1 – Final ASC Payment Indicators for CY 2016, https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/11_Addenda_Updates.html/, [CMS-1633-FC]. 23

Independent Diagnostic Testing Facilities (IDTFs)

A freestanding Cardiac Catheterization Clinic or Laboratory may be categorized as an Independent Diagnostic Testing Facility (IDTF). An IDTF is not allowed to bill Medicare for any CPT® or HCPCS codes that are solely therapeutic. Therefore, interventional procedures are not appropriate to or covered when performed in an IDTF, which is more typically a setting for lower-risk, elective diagnostic procedures.

Diagnostic catheterization procedures are often combined with PCI procedures during the same encounter if the diagnostic catheterization indicates a need for intervention. The alternative is a staged approach where the PCI is scheduled for a later visit. Patients who go to freestanding clinics or diagnostic-only hospitals do not have the option of a combined procedure, because the PCI must be performed at a different institution. However, not all patients are considered good candidates for a combined procedure. Although combined procedures may be less costly, they may place certain patients at higher risk of complications.30 Physician treatment decisions should be made according to the most clinically appropriate choice for the individual patient.

Medicare reimbursement to IDTFs will be according to the MPFS for the technical component of the procedure.31

Although Independent Diagnostic Testing Facilities are not presently required to report quality measures, CMS has identified a set of Performance Standards which IDTFs must meet in order to maintain Medicare billing privileges. Among these standards is the requirement that the facility be truly “independent” both of an attending or consulting physician’s office and of a hospital, and states, “with the exception of hospital-based and mobile IDTFs, a fixed base IDTF does not include the following:

(i) Sharing a practice location with another Medicare-enrolled individual or organization.

(ii) Leasing or subleasing its operations or its practice location to another Medicare enrolled individual or organization.

(iii) Sharing diagnostic testing equipment using in the initial diagnostic test with another Medicare-enrolled individual or organization.”32

The supervisory physician for the IDTF, whether or not for a mobile unit, may not order tests to be performed by the IDTF, unless the supervisory physician is the patient’s treating physician and is not otherwise prohibited from referring to the IDTF. If a physician working for an IDTF (or a physician financially related to the IDTF through common ownership or control) orders a diagnostic test payable under the MPFS, the anti-markup payment limitation may apply.33

30 Technology Assessment Report: Cardiac Catheterization in Freestanding Clinics; Agency for Healthcare Research and Quality (AHRQ); September 7, 2005; https://www.cms.gov/determinationprocess/downloads/id28TA.pdf. Referencing: Blankenship JC. Ethics in Interventional Cardiology: Combining Coronary Intervention with Diagnostic Catheterization. Am Heart Hosp J 2004 Winter;2(1):52-4. Kimmel SE, Berlin JA, Hennessy S, Strom BL, Krone RJ, Laskey WK. Risk of Major Complications from Coronary Angioplasty Performed Immediately after Diagnostic Coronary Angiography: Results from the Registry of the Society for Cardiac Angiography and Interventions. J Am Coll Cardiol 1997 Jul;30(1):193-200. 31 Medicare Claims Processing Manual, Chapter 35 – Independent Diagnostic Testing Facility (IDTF); http://www.cms.gov/manuals/downloads/clm104c35.pdf. 32 Independent Diagnostic Testing Facility (IDTF) Performance Standards; http://www.cms.gov. 33 Medicare Claims Processing Manual, Chapter 35 – Independent Diagnostic Testing Facility (IDTF); http://www.cms.gov/manuals/downloads/clm104c35.pdf. 24

PHYSICIAN REIMBURSEMENT ISSUES

Medicare Part B pays for physician services based upon the Medicare Physician Fee Schedule (MPFS). Fee schedule amounts are calculated according to the Resource-Based Relative Value Scale (RBRVS), which determines payment according to the relative resource costs needed to provide each service, quantified as relative value units (RVUs). The relative value for each code is divided into three components: physician work, practice expense [in either a facility (eg, inpatient or outpatient hospital) or non-facility (eg, office) setting], and professional liability insurance. Each of these components is modified by a geographic adjustment (GPCI) to reflect the variances in costs for differing localities. Payments are calculated by multiplying the geographically adjusted total relative values (resource costs) of a service by a conversion factor (CF) which is defined each year in the Final Rule.

[(Work RVU x Work GPCI) + (PE RVU x PE GPCI) + (MP RVU x MP GPCI)] x CF = Payment

The MPFS payment amounts are based upon data elements published by the Centers for Medicare and Medicaid Services (CMS) in the Final Rule [CMS-1631-FC] on October 30, 2015, and published in the Federal Register (Vol. 80, Issue 221) on November 16, 2015, with a conversion factor of $35.8279. CMS may make adjustments to any or all of the data inputs from time to time.

On March 26, 2015, the House passed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). This bill included a provision to replace the Sustainable Growth Rate (SGR) formula used by Medicare to pay physicians with new systems for establishing annual payment rate updates for physicians’ services. Therefore, 2016 is the first PFS Final Rule since the repeal of the SGR formula.

Please note that the 2018 Physician Quality Reporting System (PQRS) payment adjustment (based on 2016 reporting) is the last adjustment that will be issued under the PQRS and the Value-Based Payment Modifier. Starting in 2019, adjustments to payment for quality reporting and other factors will be made under the Merit-Based Incentive Payment System (MIPS), as required by MACRA.

! MACRA consolidates three existing incentive programs — the electronic health records (EHR) meaningful use, PQRS and value-based modifier (VBM) programs — into one program called the Merit-Based Incentive Payment System (MIPS) as of 2019. ! The MIPS grades providers on performance in four categories — quality, resource use, clinical practice improvement activities and meaningful use of certified EHR technology – with penalties increasing to 9% by 2022 for scores below the performance threshold, and bonuses for those above. ! Providers engaged in a qualified advanced payment model (APM), such as a patient-centered medical home or ACO, stand to gain a 5% bonus annually between 2019 and 2024, and they are also excluded from the MIPS penalty system. ! The law states the performance threshold shall be adjusted for the individual beneficiary’s health status and other risk factors (many of which are capture by ICD-10-CM codes).

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Bundling – NCCI and OCE Issues

On October 1, 2007, CMS altered the Chapter notes for the National Correct Coding Initiative (NCCI) manual regarding multiple interventions within the same non-coronary vessel, indicating only the successful procedure was to be reported. Although no NCCI computer edits were developed for the code pairs, this note revision indicated new CMS payment policy. After a number of entities requested this policy change be reconsidered, CMS temporarily rescinded this change. The language was revised again for Version 16.3, effective January 1, 2011:

“When percutaneous angioplasty of a vascular lesion is followed at the same session by a percutaneous or open atherectomy, generally due to insufficient improvement in vascular flow with angioplasty alone, only the more comprehensive atherectomy that was performed (generally the open procedure) should be reported (see sequential procedure policy, Chapter I, Section M). Effective January 1, 2011 there are new lower extremity endovascular revascularization procedure CPT® codes which include in single codes various combinations of angioplasty, atherectomy, and/or placement of stent(s). In addition, effective January 1, 2011, Category I CPT® codes for atherectomy of vessels in other anatomic sites are deleted and replaced by Category III CPT® codes.”

Bundling issues may also affect reporting for other vascular cases – for example, diagnostic imaging services in conjunction with vascular interventions (includes language revisions for 2016)34:

“Open and percutaneous interventional vascular procedures include operative angiograms and/or venograms which should not be separately reported as diagnostic angiograms/venograms. The CPT Manual describes the circumstances under which a provider may separately report a diagnostic angiogram/venogram at the time of an interventional vascular procedure. A diagnostic angiogram/venogram may be separately reportable with modifier 59 if it satisfies CPT Manual guidelines, national Medicare guidelines, and local Medicare Administrative Contractor guidelines. If the code descriptor for a vascular procedure specifically includes diagnostic angiography, the provider should not separately report a diagnostic angiography code.

If a diagnostic angiogram (fluoroscopic or computed tomographic) was performed prior to the date of the open or percutaneous intravascular interventional procedure, a second diagnostic angiogram cannot be reported on the date of the open or percutaneous intravascular interventional procedure unless it is medically reasonable and necessary to repeat the study to further define the anatomy and pathology. Report the repeat angiogram with modifier 59. If it is medically reasonable and necessary to repeat only a portion of the diagnostic angiogram, append modifier 52 in addition to modifier 59 to the angiogram CPT® code. If the prior diagnostic angiogram (fluoroscopic or computed tomographic) was complete, the provider should not report a second angiogram for the dye injections necessary to perform the open or percutaneous intravascular interventional procedure.”

NCCI guidelines also provide the following instructions regarding catheter placements in conjunction with percutaneous interventions (note that the CPT® includes additional bundling with regard to certain specific procedures):

“When a non-coronary percutaneous intravascular interventional procedure is performed on the same vessel at the same patient encounter as diagnostic angiography (arteriogram/venogram), only one selective catheter placement code for the vessel may be reported. If the angiogram and the percutaneous intravascular interventional procedure are not performed in immediate sequence and the catheter(s) are left in place during the interim, a second selective catheter placement or access code should not be reported. Additionally, dye injections to position the catheter should not be reported as a second angiography procedure.”

Bundling considerations may also apply to other combinations of procedures, and occasionally a code is defined in the Medicare Physician Fee Schedule as always bundled (status “B”). For example, G0269 – Placement of occlusive device into either a venous or arterial access site, post surgical or interventional procedure. Reimbursement rates for diagnostic or interventional procedures are inclusive of access and closure, and so there is no additional reimbursement for this procedure. However, it is appropriate to report for statistical and tracking purposes.

The NCCI edits are incorporated into the Outpatient Code Editor (OCE), and are therefore relevant for both outpatient hospital claims and physician professional claims. The NCCI Policy Manual guidance is updated annually, and the specific code edits are updated quarterly – all are available on the CMS website. Although specific to the Medicare program, these bundling guidelines may be adopted in whole or in part by commercial insurance plans.

34 NCCI Policy Manual for Medicare Services – Effective January 1, 2016; https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html 26

CPT® Coding Updates in Recent Years

Significant restructuring of endovascular interventional procedure codes was undertaken by CPT® beginning in 2011, with additional revisions to numerous cardiology and vascular procedures in subsequent years.

Endovascular Revascularization (37220 – 37235)

Effective January 1, 2011, new lower extremity endovascular revascularization procedure CPT® codes were introduced, which include in single codes various combinations of angioplasty, atherectomy, and/or placement of stent(s).35 • These new lower extremity codes no longer distinguish between open surgical exposure and percutaneous access. • ALL codes in this series include angioplasty, either stand-alone or in conjunction with another type of intervention; angioplasty may not be separately reported. • ALL codes in this series include selective catheter placement. Selective catheterization codes for the preceding diagnostic angiography may ONLY be reported if through a separate puncture site (distinct endpoint is now irrelevant). • ALL codes in this section include imaging guidance to perform the intervention and for post-intervention documentation; embolic protection if used; and closure of the arteriotomy site by any method. • Imaging codes for diagnostic angiography (eg, 75630, 75710, 75716, 75774) may be reported additionally; modifier -59 is required if on the same date/session. It is recommended modifier -59 be reported with ALL diagnostic angiography imaging codes immediately preceding intervention, regardless of anatomic site. These procedures all have APC status indicators of Q2 (T-packaged procedure), so the facility would not be paid separately with the interventional procedure. • All codes are defined as unilateral – report opposite leg with modifier -59, or use –LT and -RT. • Definitions are cumulative, and only one code will be reported per vessel, although multiple vessels may potentially be reported per case and receive separate APC payment (status indicator is T). • Three anatomic territories are defined, each of which differ in coding options. • Iliac Territory – Includes common iliac, external iliac, and internal iliac – each vessel treated may be reported separately (up to 3 per leg). Four new codes are found in this section – defined by the criteria of: ! First vessel vs. subsequent vessel (in the same leg); and ! For each vessel, angioplasty only vs. stenting (with or without angioplasty). • Femoral/Popliteal Vascular Territory – ALL vessels from the common femoral through the popliteal are treated as a single vessel; only ONE intervention per leg is reported. Four code choices are available, based on all intervention(s) performed in the entire territory, which may be a combination of therapies on a combination of vessels/lesions: ! Angioplasty only; ! Atherectomy (with or without angioplasty); ! Stenting (with or without angioplasty); and ! Atherectomy plus stenting (with or without angioplasty). • Tibial/Peroneal Territory – Includes anterior tibial, posterior tibial, peroneal. Each vessel treated may be reported separately (up to 3 per leg); the tibioperoneal trunk is bundled into any intervention in either posterior tibial or peroneal; however, if interventions occur in tibioperoneal trunk and anterior tibial, the trunk may be reported separately. This territory contains eight code choices, defined by the criteria of: ! First vessel vs. subsequent vessel (in the same leg), each of which has 4 codes: • Angioplasty only; • Atherectomy (with or without angioplasty); • Stenting (with or without angioplasty); and • Atherectomy plus stenting (with or without angioplasty).

35 Current Procedural Terminology (CPT®) 2016, Professional Edition, ©American Medical Association, 2015. CPT® is a registered trademark of the American Medical Association. 27

Category III Codes for Atherectomy (0234T – 0238T)

Effective January 1, 2011, atherectomy for all supra-inguinal vessels (including the iliac territory noted above) were deleted and replaced by Category III CPT® codes, which may limit coverage by many payors. The Category III codes also do not differentiate between open vs. percutaneous access. These new codes include all radiological guidance, supervision and interpretation to perform the intervention. However it is appropriate to separately report access and selective catheterization; embolic protection, if used; and other intervention used to treat the same or other vessels (including iliac angioplasty or stenting with the new endovascular revascularization codes).

Interventions in Other Vessels • Codes for angioplasty (35450 – 35460 and 35471 –35476) or stenting (37205 – 37208) in the aorta, brachiocephalic/subclavian artery and branches, renal or other visceral artery, or vein remain unchanged: o Open versus percutaneous access for angioplasty or stenting are different codes; o Report selective catheterization separately; o Report code for radiological guidance to perform the intervention; o If angioplasty is performed for a distinct therapeutic intent, it may be reported in combination with stenting in the same vessel; ® o CPT notes do not specifically prohibit reporting angioplasty with atherectomy; however, Medicare guidelines bundle – report only atherectomy. • Percutaneous carotid stenting with embolic protection (37215) also remains unchanged, and includes all ipsilateral selective catheterization and all diagnostic and guidance imaging.

Diagnostic Cardiac Catheterization

Diagnostic cardiac catheterization and angiography procedure codes were also significantly revised for 2011, deleting the majority of previous codes. Most of the new cardiac catheterization codes represent combination or packaged procedures, and in most instances, only ONE code will be reported which describes all elements of the procedure.

The new diagnostic catheterization codes include injection of contrast and radiological imaging and supervision – these are not longer reported as separate components. The code descriptors are cumulative, and the facility should select the code that describes all services performed.

Procedures performed for patients with congenital heart disease continue to be reported with component codes for catheterization (93530-93533), with contrast injection and imaging reported separately with one or more of new codes in the range 93563-93568, and separate reimbursement is expected on physician claims. However, for outpatient hospital service reimbursement, these injection codes and certain other add-on procedures are designated as status N, and receive no additional APC payment

Diagnostic cardiac catheterization procedures may be reported in conjunction with coronary intervention.

Intravascular Vena Cava Filters

For CPT® 2012, three new codes were added relating to intravascular vena cava filters, identifying these percutaneous procedures as distinct from an open ligation of the inferior vena cava. The new procedure codes are also comprehensive packaged services, including vascular access, catheter placement, and radiological supervision and interpretation.

Head and Neck Angiography

Head and neck diagnostic catheterization and angiography procedures were restructured in 2013:

• Codes are all-inclusive, describing both catheter placement and imaging in a single code. • Codes are cumulative – all less selective catheter placement and imaging is bundled into more selective. The code descriptors “stair step,” and specific catheter location and extent of imaging (including distal runoff) are both identified. • All codes include angiography of the cervicocerebral arch, when performed. • All codes are unilateral – report bilateral with modifier -50. If left and right sides not to same level of selectivity, report lesser code with modifier -59. • Add-on codes exist for selective catheterizations of external carotid or additional intracranial branches of the internal carotid or vertebral circulatory systems. 28

Code Catheter Location Vessel(s) imaged 36221 Non-selective, thoracic aorta Extracranial carotid, vertebral, and/or intracranial vessels, unilateral or bilateral 36222 Common carotid or innominate Ipsilateral extracranial carotid 36223 Common carotid or innominate Ipsilateral intracranial carotid, includes extracranial carotid, when performed 36224 Internal carotid Ipsilateral intracranial carotid, includes extracranial carotid, when performed 36225 Subclavian or innominate Ipsilateral vertebral circulation 36226 Vertebral artery Ipsilateral vertebral circulation +36227 External carotid Ipsilateral external carotid circulation +36228 Each intracranial branch of the internal Selected vessel circulation carotid or vertebral arteries (eg, middle cerebral artery, posterior inferior cerebellar artery) Note: Codes 33221 - 33226 include angiography of the cervicocerebral arch, when performed; add-on codes 36227 and 36228 do not, as it would have been captured in a base code.

Coronary Interventions

CPT® 2013 introduced significant revisions to coronary interventional procedures: • Codes are cumulative. The PCI base code that includes the most intensive service(s) performed should be reported. • New codes recognize the concepts of five major coronary arteries, with add-on codes for branch vessels. o Up to two coronary artery branches of the LAD, left circumflex, and right coronary arteries are recognized. The left main and ramus intermedius coronary arteries do not have recognized branches for reporting purposes. o A single graft with multiple sequential anastomoses is one vessel; a branching bypass graft (eg, Y graft) would be an additional branch. • Distinct codes for interventions in or through a bypass graft, as well as PCI during an acute MI, or of a chronic total occlusion. • Only one base code per major coronary artery or bypass graft is reported per vessel; others are reported as “branch” interventions. • PCI of an additional major coronary or bypass graft should be reported using the applicable additional base code(s).

However, Medicare’s valuation of these new procedures in the Medicare Physician Fee Schedules identified additional branches as bundled procedures, which will not be reimbursed.

By comparison, all of these CPT® codes were valued in the Hospital Outpatient Prospective Payment System, as well as a series of mirrored C-codes (C9600 – C9608), which describe the same family of procedures for any case involving drug-eluting stents. However, beginning in 2015, additional branch vessel C-codes are packaged procedures under HOPPS and ASC payment methodologies.

2016 Total CPT® Code Description RVUs 92920 Angioplasty, single vessel 15.87 + 92921 Angioplasty, additional branch Bundled 92924 Atherectomy, single vessel 18.84 + 92925 Atherectomy, additional branch Bundled 92928 Stent, single vessel 17.62 + 92929 Stent, additional branch Bundled 92933 Atherectomy + stent, single vessel 19.71 + 92934 Atherectomy + stent, additional branch Bundled 92937 PCI of or through bypass, any method(s) 17.60 + 92938 PCI of or through bypass, additional branch Bundled 92941 PCI of acute MI, all interventions, single vessel 19.75 92943 PCI of chronic total occlusion, any method(s) 19.51 + 92944 PCI of chronic total occlusion, additional branch Bundled

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Other Vascular Procedures – 2013 Changes

• Transcatheter retrieval of intravascular foreign body. Two existing codes (surgical and radiological) were deleted and replaced with a single new code, 37197, which includes imaging guidance.

• Transcatheter infusion:

o Existing codes revised to state “other than for thrombolysis”. o Codes for catheter exchange deleted. o Four new codes added, all of which include imaging:

37211 Arterial infusion for thrombolysis, initial treatment day 37212 Venous infusion for thrombolysis, initial treatment day 37213 Arterial or venous, subsequent day during course of thrombolytic therapy, including follow-up catheter contrast injection, position change, or exchange, when performed; 37214 cessation of thrombolysis including removal of catheter and vessel closure by any method

• Percutaneous Ventricular Assist Devices. Category III codes 0048T and 0050T have been deleted and replaced with four new codes for percutaneous ventricular assist devices. These codes include radiological supervision and interpretation.

33990 Insertion - arterial access only 33991 Insertion - both arterial and venous access, with transseptal puncture 33992 Removal at separate and distinct session from insertion 33993 Repositioning at separate and distinct session from insertion

• Percutaneous Aortic Valve Replacement. Category III codes 0256T - 0259T were deleted, and a family of five new codes were added for transcatheter placement of prosthetic aortic valves, which are differentiated by approach, as well as one new Category III code for an open thoracic approach other than transaortic.

Transcatheter Stent Placement

CPT® 2014 revised coding for intravascular stent(s) for sites not otherwise classified, deleting existing codes for percutaneous or open stent placement (37205 – 37208), as well as radiological supervision and interpretation (75960), adding new codes which package the imaging and any angioplasty of the same vessel, and also distinguish arterial vs. venous placement and additional vessels at the same operative session. These codes were additionally revised in 2015 to specify that codes 37220 – 37235 would be reported for stent placement for occlusive disease, with 37236 – 37237 to be used for other indications (eg, dissection); in theory, both codes could be reported in a single case.

37236 Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; initial artery + 37237 each additional artery (List separately in addition to code for primary procedure) 37238 Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; initial vein + 37239 each additional vein (List separately in addition to code for primary procedure)

Vascular Embolization and Occlusion

Codes 37204 and 37210 were deleted in CPT® 2014, and replaced with 4 new codes:

37241 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (eg, congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles) 37242 arterial, other than hemorrhage or tumor (eg, congenital or acquired arterial malformations, arteriovenous malformations, arteriovenous fistulas, aneurysms, pseudoaneurysms) 37243 for tumors, organ ischemia, or infarction 37244 for arterial or venous hemorrhage or lymphatic extravasation

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Other Vascular Procedures – 2014 Changes

• Fenestrated Endovascular Repair of the Visceral and Infrarenal Aorta. Category III codes 0078T – 0081T were deleted, and eight new codes introduced for multi-branching fenestrated prostheses.

• Carotid Artery Stent. One new code (37217) for open cervical carotid retrograde approach to place an intrathoracic carotid artery stent.

• New codes 93582 for transcatheter closure of patent ductus arteriosus, and 93583 for transcatheter septal reduction therapy.

2015 Revisions

• Carotid Artery Stenting: Codes 37215 and 37216 were revised to include angioplasty when performed, and radiological imaging. A new code 37218 was added for placement of intrathoracic carotid artery stent.

• Mitral Valve Replacement: Two new codes 33418 and 33419 were added for percutaneous mitral valve repair with prosthesis.

2016 Changes

• Cardiac Valves: New code 33477 (Transcatheter pulmonary valve implantation, percutaneous approach, including pre-stenting of the valve delivery site, when performed) replaces Category III code 0262T.

• Transcatheter Procedures:

• New code 37211 -- Transcatheter therapy, arterial infusion for thrombolysis other than coronary, intracranial, any method -- packages two previously separate codes, 37202 and 75896.

• Three codes for percutaneous transluminal mechanical thrombectomy (37184 – 37186) revised to add the term “non-intracranial”.

• Intravascular Ultrasound Services: Two new codes, 37252 and 37253, bundle radiological S&I and surgical codes together, replacing deleted codes 37250 + 75945 and 37251 + 75946.

• Intracranial Endovascular Interventions: Three new codes were added for intracranial thrombectomy or infusion.

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Modifiers

When submitting a particular service on a claim, it is sometimes necessary to report a modifier with the CPT® code. A modifier allows a way to indicate that a service or procedure that has been performed has been altered by some specific circumstance but not changed in its definition or code. Modifiers also enable health care professionals to effectively respond to payment policy requirements established by other entities. Some modifiers apply to either physician or hospital outpatient claims; some may only be relevant for one or the other. A complete list of modifiers is included in the HCPCS36 and CPT®37 coding books; the concept of modifiers does not apply to ICD-10-PCS procedure codes. In the table below is a list of some of the modifiers which may be common to procedures associated with Cordis® products.

Sample CPT® / HCPCS Modifiers

Modifier Description 22 Increased Procedural Service: When the work required to provide a service is substantially greater than typically required, it may be identified by adding modifier 22 to the usual procedure code. Documentation must support the substantial additional work and the reason for the additional work (eg, increased intensity, time, technical difficulty of procedure, severity of patient’s condition, physical and mental effort required). Note: This modifier should not be appended to an E/M service. 25 Significant, Separately Identifiable Evaluation and Management Service by the Same Physician or Other Qualified Health Care Professional on the same Day of the Procedure or Other Service: It may be necessary to indicate that on the day a procedure or service identified by a CPT® code was performed, the patient’s condition required a significant, separately identifiable E/M service above and beyond the other service provided or beyond the usual preoperative and postoperative care associated with the procedure that was performed. A significant, separately identifiable E/M service is defined or substantiated by documentation that satisfies the relevant criteria for the respective E/M service to be reported. The E/M service may be prompted by the symptom or condition for which the procedure and/or service was provided. As such, different diagnoses are not required for reporting of the E/M services on the same date. 26 Professional Component: Certain procedures are a combination of a physician or other qualified health care professional component and a technical component. When the physician or other qualified health care professional component is reported separately, the service may be identified by adding modifier 26 to the usual procedure number. 50 Bilateral Procedure: Unless otherwise identified in the listings, bilateral procedures that are performed at the same session should be identified by adding modifier 50 to the appropriate 5 digit code. 51 Multiple Procedures: When multiple procedures, other than E/M services, Physical Medicine and Rehabilitation services or provision of supplies (eg, vaccines), are performed at the same session by the same individual, the primary procedure or service may be reported as listed. The additional procedure(s) or service(s) may be identified by appending modifier 51 to the additional procedure or service code(s). Note: This modifier should not be appended to designated “add-on” codes (see Appendix D). 52 Reduced Services: Under certain circumstances a service or procedure is partially reduced or eliminated at the discretion of the physician or other qualified health care professional. This provides a means of reporting reduced services without disturbing the identification of the basic service. 53 Discontinued Procedure: Under certain circumstances, the physician or other qualified health care professional may elect to terminate a surgical or diagnostic procedure. Due to extenuating circumstances or those that threaten the well being of the patient, it may be necessary to indicate that a surgical or diagnostic procedure was started but discontinued. 57 Decision for Surgery: An evaluation and management service that resulted in the initial decision to perform the surgery may be identified by adding modifier 57 to the appropriate level of E/M care. 58 Staged or Related Procedure or Service by the Same Physician or Other Qualified Health Care Professional During the Postoperative Period: It may be necessary to indicate that the performance of a procedure or service during the postoperative period was: a) planned or anticipated (staged); b) more extensive than the original procedure; or c) for therapy following a surgical procedure. This circumstance may be reported by adding modifier 58 to the staged or related procedure. Note: For treatment of a problem that requires a return to the operating/procedure room (eg, unanticipated clinical condition), see modifier 78.

36 Healthcare Common Procedural Coding System (HCPCS) codes are developed by CMS and available in book form from several different publishers. 37 2016 Current Procedural Terminology (CPT®) Appendix A, ©2015 American Medical Association. CPT® is a registered trademark of the American Medical Association. 32

Modifier Description 59 Distinct Procedural Service: Under certain circumstances, it may be necessary to indicate that a procedure or service was distinct or independent from other non-E/M services performed on the same day. Modifier 59 is used to identify procedures or services, other than E/M services, that are not normally reported together, but are appropriate under the circumstances. Documentation must support a different session, different procedure or surgery, different site or organ system, separate incision or excision, separate lesion, or separate injury (or area of injury in extensive injuries) not ordinarily encountered or performed on the same day by the same individual. However, when another already established modifier is appropriate it should be used rather than modifier 59. Only if no more descriptive modifier is available, and the use of modifier 59 best explains the circumstances should modifier 59 be used. Note: Modifier 59 should not be appended to an E/M service. To report a separate and distinct E/M service with a non-E/M service performed on the same date, see modifier 25. 73 Discontinued Outpatient Hospital / Ambulatory Surgery Center (ASC) Procedure Prior to the Administration of Anesthesia: Due to extenuating circumstances or those that threaten the well being of the patient, the physician may cancel a surgical or diagnostic procedure subsequent to the patient’s surgical preparation (including sedation when provided, and being taken to the room where the procedure is to be performed), but prior to the administration of anesthesia (local, regional block(s) or general). Under these circumstances, the intended service that is prepared for but cancelled can be reported by its usual procedure number and the addition of modifier 73. 74 Discontinued Outpatient Hospital / Ambulatory Surgery Center (ASC) Procedure After Administration of Anesthesia: Due to extenuating circumstances or those that threaten the well being of the patient, the physician may terminate a surgical or diagnostic procedure after the administration of anesthesia (local, regional block(s) or general) or after the procedure was started (incision made, intubation started, scope inserted, etc.). Under these circumstances, the procedure started but terminated can be reported by its usual procedure number and the addition of modifier 74. 78 Unplanned Return to the Operating / Procedure Room by the Same Physician or Other Qualified Health Care Professional Following Initial Procedure for a Related Procedure During the Postoperative Period: It may be necessary to indicate that another procedure was performed during the postoperative period of the initial procedure (unplanned procedure following initial procedure). When this procedure is related to the first, and requires the use of an operating/procedure room, it may be reported by adding modifier 78 to the related procedure. 79 Unrelated Procedure or Service by the Same Physician or Other Qualified Health Care Professional During the Postoperative Period: The individual may need to indicate that the performance of a procedure or service during the postoperative period was unrelated to the original procedure. This circumstance may be reported by using modifier -79. (For repeat procedures on the same day, see modifier -76.) CA Procedure payable only in the inpatient setting when performed emergently on an outpatient who expires prior to admission FB Item provided without cost to provider, supplier or practitioner, or full credit received for replaced device FC Partial credit received for replaced device LC Left circumflex coronary artery LD Left anterior descending coronary artery LT Left side (used to identify procedures performed on the left side of the body) LM Left main coronary artery RC Right coronary artery RI Ramus intermedius coronary artery RT Right side (used to identify procedures performed on the left side of the body) TC Technical component

Note: Some of these modifiers may only be appropriate to services reported by certain types of providers (eg, physician professional services vs. facility claims).

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