Expanding Coverage for Cardiovascular Procedures in the Ambulatory Surgery Center Modernizing ASC Poi?ey I Participants On behalf of NCP: - Brian Gauger, CEO, National Cardiovascular Partners Cam SVP, Fresenius Medical Care North America Dr. Neil Marwah, SVP, Fresenius Medical Care North America Stacey Fahrner, Vice President, Fresenius Medical Care North America Christopher Young, The Moran Company 1? .ll r;?4 5 4 National Cardiovascular Partners Our Mission: To provide superior quality healthcare services that: PATIENTS recommend to families and friends, PHYSICIANS prefer for their patients, and EMPLOYEES take pride in. About Us: National Cardiovascular Partners creates, sustains and grows independent, outpatient cardiac catheterization and vascular labs in unique business partnerships with physicians. - NCP has partnered with over 250 physicians in 22 outpatient cardiac catheterization vascular labs in Texas, Arizona, California, Louisiana and Kansas, with expansion into numerous additional states to take place in the coming yearsCMS should expand access to ASCs for Medicare beneficiaries needing certain cardiac procedures Objective: Expanding the range of endovascular cardiology procedures that are covered and paid in the ASC to create a seamless site of service for diagnosis and treatment consistent with care for many commercially insured patients. 1) Cl. 0% 41/ @015 . . si?Wr . Mb Why? Ex anded access IS good for atlents: madame pair, dead 2% . Procedures performed in an ASC are less expensive W373 50A {Wit 6 I - Modernizing the coverage and payment rules will bring Medicare up to date with commercial/payers - Clinical guidelines support performing most procedures in an ASC?like (non-hospital) setting* Current Medicare coverage by setting ASC Physician of?ce Cardiac Dx CoronaryTx $375; a from cad/owl" lot a i\ NRA?baffl? os a?fmhenlf Minor changes in ASC methodology to align with OPPS M) A l?l? Watsfer? - A single point of service is more convenient for patients Pacemakers/AICD How? NCP recommendations include: - Adding a number ofdiagnostic and interventional procedures to the ASC payment list (based on data analysis by The Moran Company) Many procedures are already performed in the physician office setting Updating regulations to reflect clinical guidelines and advancements Expert Consensus Document: 2014 Update on Percutaneous Coronary Interventions Without On-Site mi Surgical Backup on Cardiac Catheterization Laboratory Standards Update 4 Q50 . evuapvxa Randomized controlled clinical trials show that Percutaneous Coronary Intervention (PCI) outcomes at sites without surgical backup are the same Two randomized clinical trials support the safety of non-emergent procedures in ASC-like settings (sites without onsite surgical backup) CPORT-E: Eng? Med 2012; 366: 1792-1802 18,867 patients with stable CAD or ACS underwent non?emergency PCI at a hospital with (n 4,718) or without (n 14,149) on?site cardiac surgery from April 2006 to March 2011. Findings: Elective percutaneous coronary intervention (PCI) performed at hospitals without on?site cardiac surgery is non-inferior to similar procedures performed at hospitals with surgical capabilities. 9 Month Outcomes No on-site surgery On-site surgery 14,149) Death 3.2% 3.2% TVR 6.5% 5.4% 0.01 (for superiority) MI 3.1% 3.1% MACE 12.1% 11.2% 0.01 (for non- inferiority) a Summary of randomized controlled studies cont. MASS COMM: Eng? Med 2013; 368: 1498-1508 3,691 patients who presented for elective PCI at hospitals in Massachusetts without on-site surgery capabilities between July 7, 2006, and September 29, 2011. The patients were randomized in a 3:1 fashion to undergo PCI at the initial hospital (n 2,774) or be transferred to another with on?site surgical back?up (n 917). Findings: Patients undergoing non-emergency percutaneous coronary intervention (PCI) experience similar outcomes whether they are treated at hospitals that possess on-site cardiac surgery capabilities or do not offer such services. 30 Day Outcomes 1 Year Outcomes No on-site On-site No on-site On-site surgery surgery 2,774) (n=917) surgery surgery 2,774) (n=917) MACE 9.5% 9.4% <0.001(for MACE 17.3% 17.8% <0.001 (for non? non- inferiority) inferiority) DEATH 0.7% 0.3% 0.39 DEATH 2.3% 2.4% 0.89 Ml 6.5% 6.5% 1.00 MI 8.6% 7.8% 0.55 Repeat revascularization 2.7% 3.5% 0.25 Repeat revascularization 8.5% 9.9% 0.24 Stroke 0.4% 0.1% 0.21 Stroke 1.0% 0.8% 0.83 1:9 7 Recent observational study findings support PCI at facilities without on?site surgery for all indications Outcomes and Temporal Trends of Inpatient Percutaneous Coronary Intervention at Centers With and Without On-Site Cardiac Surgery in the United States (Kashish Goel, Tanush Gupta, Dhaval Kolte, MD, et al JAMA Cardiol. A national inpatient sample (N 6,912,232) was used to identify patients who underwent inpatient PCI in the United States from January 1, 2003, to December 31, 2012. Of these PCls, 396,741 were conducted at - centers without on?site cardiac surgery. Findings: There was a 7?fold increase in the proportion of at centers without on-site cardiac surgery from 2003 to 2012 in the United States, with the adjusted in-hospital mortality after inpatient PCI being similar at centers with and without on?site cardiac surgery. These data provide evidence that PCI at centers without on- site cardiac surgery may be safe in the modern era. E. a Summary of evidence: Meta analyses Three studies conducted primarily with registry data have examined the use of non-emergent (non?primary) PCI at facilities with and without on?site surgery. Findings: Overall, mortality and the need for emergency CABG surgery did not differ between hospitals with and without on-site surgery. On-site surgery No. of Patients Incidence OR (95% Cl) Incidence Emergency CABG OR (95% CI) Comments Zia (2011) Singh (2011) Singh PP (2011Yes 28,552 881,261 30,423 883,865 1,812 4,039 1.6% 2.1% 0.9% 0.8% 0.17% 0.72% 1.03 (0.64? 1.66) 1.15 (0.93- 1.41) 2.3 (0.60- 12.97) 1.0 0.9 0.17 0.29 0.11 0.02 1.38 (0.65- 2.95) 1.21 (0.52- 2.85) 0.47 (0.07? 3.19) 6 studies included in analysis 9 studies included in analysis 4 studies included in analysis (2 with data on mortality and RR calculated rather than OR Q) (-I- Q) NCP 2016 clinical outcomes Show cardiac catheterization and PCI in the ASC is safe forpatients NCP promotes a culture of safety and excellence. The data below reflects outcomes and complications for over 33,000 cases across our 22 facilities. Variance Cath Labs 2015 Cath Labs Jan-June ASC 2016 Jan- 2015 Results Jan-June 2016 2015 June 2016 Results Results Sentinel Events: 8 0.07% 2 0.03% 3 0.03% 0 0% Death 4 0.04% 2 0.03% 0 0.00% 0 0% Wrong 1 0.01% 0 0% 3 0.03% 0 0% Loss of Limb 0 0.00% - 0 0% 0 0.00% 0 0% Loss of function 2 0.02% 0 0% 0 0.00% 0 0% Retained Foreign Body 1 0.01% 0 0% 0 0.00% 0 0% Transfers: 36 0.32% 24 0.35% I 17 0.19% 14 0.22% Falls 3 0.03% 2 0.03% I 1 0.01% 0 0 Infections 5 0.04% 1 0.01% I 0 0 3 0.05% Complications 68 0.60% 43 0.64% 13 0.14% 8 0.13% Return to Surgery/Lab 25 0.22% 28 0.41% 6 0.07% 3 0.05% RP Hematoma 20 0.18% 5 0.070.00% 1 0.01% 0 0% 0 0% Stroke 4 0.04% 2 0.03% 0 0% 0 0% Other 19 0.17% 7 0.10% 7 0.08% 5 0.08% *Cath Labs: 11,250 Cases performed in 2015; 6767 Cases performed in Jan?June 2016 11 9048 Cases performed in 2015; 6286 Cases performed in Jan?June 2016 PCI experience is consistent with published studies Adverse event and complication rates are low, and PCI in an ASC setting is safe and convenient for patients. Jan-June 2016 Left Heart Cath (LHC) 5775 5930 6071 3930 21,706 Procedures Performed Percutaneous Coronary 643 728 650 354 2375 Intervention (PCI) Procedures Performed of PCI Procedures 11.1% 12.28% 10.7% 9.0% 10.9% Complication Rate 0.3% 0.8% 0.9% 0.9% 0.7% While clinical outcomes are consistent with hospital facilities, patient satisfaction surveys suggests patients prefer the ASC setting 2015 Patient Satisfaction Cath Labs HCAHPS Overall Satisfaction 97.9% 71% Patient Would Recommend 98.6% 71% Return Rate 61.0% 31% 13 NCP recommendations for ASC coverage and payment Coverage and payment for the codes identified in the attached spreadsheet would provide a more seamless point of service for diagnosis and treatment of certain cardiac conditions, would reflect recent clinical advancements, and would better align Medicare with commercial payers. NCP recommends: 1. Coverage for procedures allowed in the physician office, but most often performed in the OPPS. I Payment based on OPPS weights reduced according to ASC policy 2. Coverage for procedures allowed in both the OPPS and physician office, but are performed a majority of the time in the physician office. . Payment based on the MPFS rate 3. Creating a ?conditional packaging? policy for ASCs consistent with the current OPPS policy to allow for reimbursement for procedures that are performed more than half the time without another major procedure. . Separate payment for procedures packaged in the ASC, but separately payable in both the physician office and OPPS ?(conditionally packaged). Claims analysis suggests these procedures are performed more than halfthe time in the OPPS without another major procedure. 4. Coverage of codes that are "safe? when performed in the OPPS. Claims analysis shows little evidence of hospital admission, emergency room visit, or death. Recent clinical guidelines support provision of these services in non hospital settings for appropriate patients. 5. Align ASC payment policy with recent OPPS comprehensive APC methodology to recognize particularly complex procedures. 14 ii - Fl- BUB NCP has established admission criteria and a screening process that promotes safe and effective patient care in the outpatient setting Patient Selection Admission Criteria Contraindications - Physician?s order for the procedure with a provisional - Creatinine 2.0 (unless on Dialysis) diagnosis - Potassium 5.8 (unless on Dialysis) - History and Physical performed within the last 30 days Weight 450 - Patient must be 18 years of age or older - Hemoglobin 8.0 (unless chronic anemia) Diagnostic test results, as required. (Must be within 30 - INR 1.8 days of procedure) Active, untreated infection - ASA Classification documented. (ASA 1, 2 or 3) Hx of Anaphylactic shock with Iodine exposure - Patient must demonstrate ability to use judgement and - Unable to lie flat clue to Hypoxia follow instructions - Type Lesions A responsible adult must be available to accompany - Unprotected Left Main patient Acute Coronary *American Society of Anesthesiologists Patient Ciasmlfication Credentialing Procedure Required documentation for initial appointment Diagnostic Cardiac Must have an appointment/privileges for Cardiac Cath in good standing at a hospital lnterventional Cardiac Must have an appointment/privileges for intervention in good standing at a hOSpital a? :i 16 Discussion How can NCP help? What additional data or information do you need? 1a I 17 g,