HEALTH ECONOMICS AND REIMBURSEMENT

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HEALTH ECONOMICS AND REIMBURSEMENT VASCULAR CY 2016 MEDICARE PHYSICIAN FEE SCHEDULE (PFS) UPDATE Abbott Vascular is pleased to provide you with this summary of the Medicare Physician Fee Schedule (PFS) Update for Calendar Year (CY) 2016. 1 The information in this document is effective January 1, 2016 to December 31, 2016. PFS HIGHLIGHTS CY 2016 Payment Update The Centers for Medicare & Medicaid Services (CMS) released the CY 2016 final rule for the Medicare Physician Fee Schedule (PFS) on October 30, 2015. This is the first PFS final rule since the repeal of the Sustainable Growth Rate formula by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), and therefore implements the Merit-Based Incentive Payment System. The conversion factor for 2016 is $35.8279. The simple average changes for Abbott Vascular-specific procedures are as follows: Peripheral arterial diagnostic & interventional procedure payment rates increase: Facility 0% Non-Facility 0% HIGHLIGHTS CY 2016 Payment Update...1 SGR Repeal and Medicare Provider Payment Modernization....2 New CPT Codes for IVUS...3 Physician Quality Incentives...3 Two-Midnight Policy...4 CY 2016 Payment Look-Up...4 Coronary arterial diagnostic & interventional procedure payment rates increase: Facility -4% Non-Facility -4% Transcatheter mitral valve repair procedure payment rates decrease: Facility -3% 1 Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2016; 42 CFR Parts 405, 410, 411, 414, 425 and 495; Accessed November 16, 2015 at http://www.gpo.gov/fdsys/pkg/fr-2015-11-16/pdf/2015-28005.pdf

Sustainable Growth Rate (SGR) Repeal and Medicare Provider Payment Modernization On April 16, 2015, President Obama signed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). This legislation makes four important changes to physician payments: 1. Ends the SGR formula. 2. Establishes a new framework for rewarding providers for giving better care over volume. 3. Combines existing quality reporting programs into one new system termed the Merit-Based Incentive Payment System (MIPS). The MIPS will include the Physician Quality Reporting System (PQRS), Medicare Electronic Health Record (EHR) Incentive Program, and the Value-Based Payment Modifier. Based on the MIPS composite performance score, physicians and practitioners will receive positive, negative or neutral adjustments for annual payment updates. 4. Provides bonus payments for participation in eligible alternative payment models (APMs). Most physicians and practitioners who participate in APMs will be subject to MIPS and will receive favorable scoring under the MIPS clinical practice improvement activities performance category. Those who participate in the most advanced APMs may be determined to be qualifying APM participants ( QPs ). As a result, QPs: a. Are not subject to MIPS, b. Receive 5 percent lump sum bonus payments for years 2019-2024, and c. Receive a higher fee schedule update for 2026 and onward. The final comments for MACRA MIPS and APMs were due November 17, 2015. CMS plans to issue a proposed ruling in the spring of 2016 with a final rule and implementation in fall of 2016. For services paid under the physician fee schedule and furnished during calendar years 2016 through 2019, Medicare s payment rates will increase by 0.5 percent a year. Payment rates for services on the physician fee schedule will remain at the 2019 level through 2025, but, starting in 2019, the amounts paid to individual providers will be subject to adjustment through one of two mechanisms, participating in the APM or MIPS program. For 2026 and subsequent years, there will be two payment rates for services on the physician fee schedule. For providers paid through an APM program, payment rates will be increased each year by 0.75 percent. Payment rates for other providers will be increased each year by 0.25 percent. 2

New CPT Codes for Intravascular Ultrasound New CPT codes for non-coronary intra-vascular (IVUS) are effective January 1, 2016. The previous codes 37250, 37251, 75945 and 75946 are deleted. The new codes combine the IVUS procedure with radiological supervision and interpretation into a single comprehensive code. Code 37252 is for reporting the initial vessel in which IVUS is performed and code 37253 is for reporting each additional vessel, when applicable. The reimbursement rates for CY 2016 provide payment for IVUS in the physician office (non-facility) setting, in addition to the facility setting. CPT Code Description 37252 Intravascular ultrasound (non-coronary vessel) during diagnostic evaluation and/or therapeutic intervention, including radiological supervision and interpretation; initial non-coronary vessel (List separately in addition to code for primary procedure) 37253 Intravascular ultrasound (non-coronary vessel) during diagnostic evaluation and/or therapeutic intervention, including radiological supervision and interpretation; each additional non-coronary vessel (List separately in addition to code for primary procedure) Physician Quality Incentives Physician Quality Reporting System (PQRS) The PQRS encourages physicians to report quality of care information to Medicare. If an individual eligible professional (EP) or group practice does not meet PQRS reporting or participation requirements for 2016, a negative payment adjustment of 2 percent will apply to professional services furnished during 2018. There are 281 measures in the PQRS measure set for 2016. CMS is also adding an option that will allow group practices to report quality measure data using a Qualified Clinical Data Registry (QCDR). MACRA established new mandates that will have a direct effect on the physician quality reporting programs: the MIPS and the incentive payments for participation in eligible alternative payment models for EPs. These are scheduled to be implemented beginning in January 2019 with performance period CY 2017. Starting in 2019, adjustments to payment for quality reporting and other factors will be made under the MIPS. CMS adds a new measure to the Cardiovascular Prevention measures group in the CY 2016 final rule that supports the Million Hearts initiative with overall cardiovascular health. The new measure is Statin Therapy for the Prevention and Treatment of Cardiovascular Disease: Percentage of the following patients all considered at high risk of cardiovascular events that were prescribed or were on statin therapy during the measurement period: Adults aged 21 years who were previously diagnosed with or currently have an active diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD); OR Adults aged 21 years with a fasting or direct low-density lipoprotein cholesterol (LDL-C) level 190 mg/dl; OR Adults aged 40-75 years with a diagnosis of diabetes with a fasting or direct LDL-C level of 70-189 mg/dl. 3

Physician Value-Based Payment Modifier (Value Modifier) The Value Modifier provides for differential payments (both increased and decreased payments) under the PFS based on the quality and cost of care they provide. The Value Modifier is set to expire at the end of CY 2018 and will be incorporated into the MIPS beginning in CY 2019. The final policies established in the CY 2016 final rule are intended to help transition to MIPS. Medicare Shared Savings Program (MSSP) The MSSP was established to promote accountability, coordination of items and services under Parts A and B, and investment in infrastructure and care processes through an Accountable Care Organization. The measure of Statin Therapy for the Prevention and Treatment of Cardiovascular Disease has been added to the Preventive Health domain of the MSSP quality measure set. This aligns with updated clinical guidelines and PQRS reporting. The program will end in CY 2018 and will be incorporated into the APM Program. Two-Midnight Policy CMS will revise the previous rare and unusual exceptions policy to allow for Medicare Part A inpatient payment on a case-by-case basis for inpatient admissions that do not satisfy the two-midnight benchmark, if the documentation in the medical record supports the admitting physician s determination that the patient requires inpatient hospital care despite an expected length of stay that is less than two midnights. Quality Improvement Organizations (QIOs) assumed medical review responsibilities of short-stay hospital claims on October 1, 2015 based on the existing two-midnight policy in effect for 2015. Beginning on January 1, 2016, QIOs will conduct these medical reviews based on the revised two-midnight policy. In conducting these reviews, QIOs will use the information documented in the patient s medical record, and may use evidence-based clinical guidelines and other relevant clinical decision support materials, as components of their review activity in order to determine whether an inpatient admission where the patient stay is expected to be less than two midnights is nonetheless appropriate for Medicare Part A inpatient payment. Physician Fee Schedule CY 2016 Payment Look-Up To look up 2016 or prior year locality-specific physician payment rates, payment policy indicators or relative value units, visit: https://www.cms.gov/apps/physician-fee-schedule/overview.aspx Unsure how to utilize CMS Web-based physician fee look-up tool? Contact the Abbott Vascular Reimbursement Hotline. A trained specialist can help you navigate the tool. 4

Please visit the Abbott Vascular Reimbursement website at: www.abbottvascular.com/us/reimbursement.html For questions regarding this Reimbursement Update and other questions regarding reimbursement for Abbott Vascular products and related services, please contact: Abbott Vascular Reimbursement Hotline 800.354.9997 Questions@AskAbbottVascular.com DISCLAIMER The information provided in this document was obtained from third-party sources and is subject to change without notice as a result of changes in reimbursement laws, regulations, rules, policies and payment amounts. All content is informational only, general in nature, and does not cover all situations or all payers rules and policies. It is the responsibility of the hospital or physician to determine appropriate coding for a particular patient and/or procedure. Any claim should be coded appropriately and supported with adequate documentation in the medical record. A determination of medical necessity is a prerequisite that Abbott Vascular assumes will have been made prior to assigning codes or requesting payments. Any codes provided are examples of codes that specify some procedures or which are otherwise supported by prevailing coding practices. They are not necessarily correct coding for any specific procedure using Abbott Vascular s products. Hospitals and physicians should consult with appropriate payers, including Medicare Administrative Contractors, for specific information on proper coding, billing and payment levels for healthcare procedures. Abbott Vascular makes no express or implied warranty or guarantee that (i) the list of codes and narratives in this document is complete or errorfree, (ii) the use of this information will prevent difference of opinions or disputes with payers, (iii) these codes will be covered [or (iv) the provider will receive the reimbursement amounts set forth herein]. Reimbursement policies can vary considerably from one region to another and may change over time. The FDA-approved/cleared labeling for all products may not be consistent with all uses described herein. This document is in no way intended to promote the off-label use of medical devices. The content is not intended to instruct hospitals and/ or physicians on how to use medical devices or bill for healthcare procedures. All codes and descriptors, Current Procedural Terminology (CPT ) 2015 American Medical Association. All Rights Reserved. 5