National Cardiovascular Partners NCP CY 2020 ASC Policy

National Cardiovascular Partners (NCP) CY 2020 ASC Policy Discussion Meeting with Office of Management and Budget April 24, 2019 Attendees: Dr. Donald Cross, Waco Cardiology Associates Dr. Neil Marwah, EVP and Management Board, National Cardiovascular Partners Stacey Fahrner, Vice President, Fresenius Medical Care North America Rudy Missmar, Partner, Lincoln Policy Group Caitlin Sheetz, The Moran Company

Agenda • Background – NCP – Cardiac Catherization Laboratories (“Cardiac Cath Labs”) • Medicare Ambulatory Surgical Center (ASC) Reimbursement – ASC Coverage of Cardiac Cath Procedures – Recommendation to CY 2020 ASC Policies – Rationale • Discussion 2

Background: NCP and Cardiac Cath Labs • NCP partners with physicians to create, sustain, and grow independent, outpatient cardiac cath and vascular labs – NCP physicians and allied clinical staff perform cardiac cath procedures, outpatient procedures used to diagnose and treat certain cardiovascular conditions – Cardiac cath can be conducted in a variety of settings such as hospitalbased cardiac cath labs or freestanding cardiac cath labs that include physicians’ offices and ASCs • To date, NCP has partnered with over 300 physicians in 21 outpatient cardiac catheterization & vascular labs in Texas, Arizona, California, Louisiana and Kansas; performed over 100, 000 outpatient cases 3

Background: Cardiac Cath Procedures DIAGNOSTIC PROCEDURES • • physician performs diagnostic tests to measure blood flow, pressure, and oxygen content of the heart; detect blockages or defects; take x-rays; remove tissue for biopsy; and examine overall heart health diagnostic procedure generally involves inserting catheter into artery or vein; catheter then threaded through blood vessels to the heart INTERVENTIONAL PROCEDURES Cardiovascular conditions detected • if cardiovascular conditions are detected during a diagnostic cardiac cath, some interventional treatments can be performed immediately without requiring the patient to be recatheterized • • interventions include cardiac ablation and percutaneous coronary interventions (PCI) such as coronary angioplasty with stenting to open up segments of a coronary artery after intervention is complete, patients are monitored in a recovery room for up to several hours and discharged with home care instructions 4

Medicare ASC Coverage of Cardiac Cath Procedures • Medicare only covers diagnostic cardiac cath procedures in an ASC (interventional procedures are not covered) – Diagnostic and interventional cardiac cath procedures are covered in a hospital outpatient department (HOPD) but not in an ASC • If cardiovascular conditions are detected during a diagnostic cardiac cath in an ASC, interventional treatments cannot be performed immediately – May result in delay of critical treatment, and burden to beneficiaries (i. e. , recatheterization, duplicate procedures/medications, additional copayments, seeking new providers) • CY 2019 ASC Final Rule – 12 diagnostic cardiac cath procedures added to ASC covered procedures list (CPL) CMS notes that if new evidence, clinical studies, or data become available that may support adding procedures to the ASC CPL, “we will consider the commenters’ recommendations in future rulemaking”

Medicare ASC Recommendation: • For CY 2020, CMS should add cardiac interventional procedures to the ASC covered procedures list (CPL), to align with diagnostic procedures – Interventional procedures include percutaneous coronary intervention (PCI) and cardiac ablation Creates Economic Efficiencies • Results in estimated savings of $464 million to Medicare and $116 million to beneficiaries over 10 years Provides Seamless Point of Service • Provides seamless point of service for diagnosis and treatment Meets ASC Definitions • Meets definition of ASC “covered surgical procedures” Poses No “Significant Safety Risk” • • Poses no significant safety risk when performed in an ASC Supported by clinical studies and data Reflects Technology Advancement • Technological advancements have made PCI safer and faster; same day discharge appropriate for many beneficiaries Aligns with State and Commercial Payers • Better aligns Medicare with state regulations and commercial payers

Meets ASC “Covered Surgical Procedures” Criteria • Interventional cardiac cath procedures meet “covered surgical procedures” definition* Covered surgical procedures are surgical procedures “…that are separately paid under the OPPS, that would not be expected to pose a significant safety risk to a Medicare beneficiary when performed in an ASC, and for which standard medical practice dictates that the beneficiary would not typically be expected to require active medical monitoring and care at midnight following the procedure. ” - Source: 42 CFR § 416. 166 • Interventional cardiac cath procedures do not pose a “significant safety risk” when performed in an ASC Not expected to pose a No Significant significant risk to beneficiary Safety Risk safety when performed in ASC No Active Medical Monitoring Separately Paid Under OPPS Not expected to require active medical monitoring and care of beneficiary at midnight following procedure Separately paid under OPPS *General exclusions in 42 CFR § 416. 166(c) do not apply No Significant Safety Risk Claims analysis shows little evidence of hospital admission or emergency room visit Recent clinical trials and registry studies found similar outcomes between hospitals with and without on-site surgery NCP experience consistent with low adverse events and complication rates Clinical guidelines support these procedures in non-hospital settings for appropriate patients

Claims Analysis: No Significant Safety Risk • Claims analysis shows little evidence of hospital admission, emergency room visit or death from cardiac catherization procedures when performed in an HOPD – Note: claims analysis does not reflect Medicare usage in ASC, given procedures are not currently covered in an ASC Claims Data Analysis for PCI HCPCS Description Number of Procedures 2017 2016 2015 Inpatient Admission w/n 1 day ER visit w/n 1 day C 9600 Percutaneous transcatheter placement of a drug eluting intracoronary stent(s) with coronary angioplasty when performed; single major coronary artery or branch 119, 559 106, 128 107, 316 1. 8% 1. 9% 92928 Perc transcatheter placement of intracoronary stent; single major coronary artery or branch 12, 250 12, 616 17, 533 3. 9% 2. 2% Source: Moran Company analysis for Standard Analytic Files, Addendum B of 2017, 2018, and 2019 Final OPPS Rules 8

Clinical Trials Support No Significant Safety Risk • Two randomized clinical trials support safety of non-emergent procedures in ASC-like settings (sites without onsite surgical backup) – Note: large-scale studies demonstrating safety in the ASC are not possible without Medicare ASC coverage; nevertheless, sites without onsite surgical backup are nearly identical to ASC settings • Both studies compared outcomes for patients who underwent elective PCI in outpatient departments with onsite surgical backup (SB) and without SB – Average of patients in both studies: ~64 years 1. CPORT-E Trial NEJM 2012: “Outcomes of PCI at Hospitals with or without On-Site Cardiac Surgery” Findings Elective PCI performed at hospitals w/o SB is “non-inferior to similar procedures performed at hospitals with surgical capabilities” 2. MASS COMM Trial NEJM 2013: “Nonemergency PCI at Hospitals with or without On-Site Cardiac Surgery”* Findings Patients undergoing non-emergency PCI experience similar outcomes whether they are treated at hospitals that possess on-site cardiac surgery capabilities or do not offer such services 9

NCP Data and Registry Studies Support No Significant Safety Risk • NCP’s experience is consistent with published studies – Adverse event and complication rates are low, and PCI in an ASC setting is safe for patients • 2013 2014 2015 2016 2017 2018 Total Left Heart Cath Procedures 5, 775 5, 930 6, 071 6, 526 6, 988 7, 249 38, 539 PCI Procedures 643 728 650 675 854 814 4, 364 % of PCI Procedures 11. 1% 12. 3% 10. 7% 10. 3% 12. 2% 11. 3% Complication Rate 0. 3% 0. 8% 0. 9% 0. 7% Registry studies support safety of procedures – Three registry data studies examined use of non-emergent PCI at facilities with and without on-site surgery – Overall, mortality and need for emergency coronary artery bypass grafting (CABG) surgery did not differ between hospitals with and without on-site surgery On-site Surgery No. of Patients Mortality Incidence Emergency CABG Incidence Zia (2011) No 28, 552 1. 6% 1. 0 Yes 881, 261 2. 1% 0. 9 Singh M (2011) No 30, 423 0. 9% 0. 17 Yes 883, 865 0. 8% 0. 29 Singh PP (2011) No 1, 812 0. 17% 0. 11 Yes 4, 039 0. 72% 0. 02 10

Additional Support for Coverage of Procedures in ASC • • Clinical Guidelines Recent clinical guidelines support provision of these services in nonhospital settings except for high risk patients at the physician’s discretion • SCAI/ACC/AHA Expert Consensus Document: 2014 Update on Percutaneous Coronary Interventions Without On-Site Surgical Backup on Cardiac Catheterization Laboratory Standards Update Recent clinical guidelines support decreased length of stay for PCI • SCAI Expert Consensus Document: 2018 Length of Stay Following Percutaneous Coronary Intervention: An Expert Consensus Document Update From the Society for Cardiovascular Angiography and Interventions Advancements in Technology – CMS recognizes that “ongoing review is necessary to determine if changes in technology and/or medical practice affect the clinical appropriateness” of procedures for the ASC setting – Technological advancements have made PCI safer and faster making same day discharge appropriate for a broader population of patients • • Transradial Approach: significant reductions in mortality, major bleeding, and major vascular access site complications in high-risk patient groups (compared to femoral artery access) Improved Vascular Closure Devices: reduced bleeding complications, reduced post-procedural nursing care time required, increased patient satisfaction and faster patient ambulation

Covering Procedures Aligns with State Regulation and Commercial Payers Access to cardiac catheterization (specifically PCI) in sites without on-site, openheart surgery backup has increased dramatically Change in the availability of PCI without on site surgery 2007 2013 2018 States allowing both primary and elective allowed 28 45 48 States allowing primary PCI only 12 4 2 Not allowed 10 1 0 JACC Vol. 63, No. 23 2014; 2018 update reflects rule changes in Michigan, California, and Mississippi There should not be a separate standard of care for Medicare patients compared to patients with commercial coverage • Most commercial insurers are increasingly covering PCI in ambulatory surgery centers. NCP facilities are in network for: • United Healthcare • Cigna • Aetna • Humana • Blue Cross Blue Shield 12

Summary and Discussion Recommendation: • For CY 2020, CMS should add cardiac interventional procedures to the ASC covered procedures list , to align with diagnostic procedures – Interventional procedures include PCI and cardiac ablation • How can NCP help? • What additional data or information do you need? 13