How to Setup a Successful Left Atrial Appendage Closure (LAAC) Program

Slides:



Advertisements
Similar presentations
Understanding Private Payers & Maximizing Private Payer Reimbursement Strategies: Understanding the Process Barbara Grenell, Preferred Health Strategies.
Advertisements

Care Coordinator Roles and Responsibilities
Tips to a Successful Monitoring Visit
MEDICAL HOME 1/2009 Mary Goldman, D.O., President of MAOFP.
Prepare Understand the accommodation process & choose level of engagement. Engage Follow procedures for receiving accommodations.
The Hospital Elder Life Program Central Website
“ Linking Blood Pressure and Cardiovascular Health” Welcome We invite you to explore what a membership in the American Society of Hypertension, Inc. (ASH)
Copyright © 2008 Delmar Learning. All rights reserved. Chapter 4 Life Cycle of an Insurance Claim.
Overview Clinical Documentation & Revenue Management: Capturing the Services Prepared and Presented by Linda Hagen and Mae Regalado.
POH/DMC UROLOGY Grand Round Conference Presented by: Spectrum Billing Technologies, LLC.
Utilization Review Update Durham Center Access February 23, 2011.
Identification & Distinction of Clinical Trial Participant Charges Bethany Martell Office of Clinical Research Associate Director- Financial Operations.
Chapter 11 OFFICE MANAGEMENT.
Introduction to Vocational Rehabilitation for Medical Providers.
STEP-BY-STEP – THE PROGRAM PROCESS 1st Step: Sign up for a free information session by contacting our office at (503) or via the website at
The Big Puzzle Evolving the Continuum of Care. Agenda Goal Pre Acute Care Intra Hospital Care Post Hospital Care Grading the Value of Post Acute Providers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Standard 5: Patient Identification and Procedure Matching Nicola Dunbar, Accrediting Agencies Surveyor Workshop, 10 July 2012.
FDA Recalls Risk Communication Advisory Committee David K. Elder Director, Office of Enforcement.
This would the icon as seen on the website Audio Starts on this slide Estimate 5 mins total of audio.
Affiliated with Children’s Medical Services Affiliated with Children’s Medical Services Introduction to the Medical Home Part 2 How does a Practice adopt.
Morning Briefings and Huddles
Community-wide Coordinated Care. © 2011 Clarity Health Services The typical primary care physician has 229 other physicians working in 117 practices with.
Disclosure I have no relevant financial relationships with the manufacturers of any commercial products and/or provider of commercial services discussed.
2014 Physician Quality Reporting System Webinar 2 – PQRS Ready To Start Claims Reporting Presented by: Marcy Le.
Beginning Billing Workshop Practitioner Colorado Medicaid 2015.
Organized Diagnostic Assessment Demonstration Projects Organized Diagnostic Assessment Demonstration Projects Grand River Regional Diagnostic Assessment.
Health Records in Other Settings Ambulatory CareRehabilitation Long Term CareHome Care Mental Health Hospice.
Chapter 15 HOSPITAL INSURANCE.
Implementing universal Lynch Syndrome screening in a large healthcare system.
Chapter 6 CRISIS MANAGEMENT. Introduction - Crisis: ◦is a situation that specifically involves a pharmaceutical product, medical device or activity with.
Chapter 15 HOSPITAL INSURANCE.
© 2009 The McGraw-Hill Companies, Inc. All rights reserved. 1 McGraw-Hill Chapter 2 The HIPAA Privacy Standards HIPAA for Allied Health Careers.
VACAA – The Choice Program / Choice Card Fast Facts Overview
Building Clinical Infrastructure and Expert Support Michael Steinberg, MD, FACR ULAAC Disparity Project Centinela/Freeman Health System.
Managed Care. In the broadest terms, Kongstvedt (1997) describes managed care as a system of healthcare delivery that tries to manage the cost of healthcare,
Site Management Organization (SMO) Making Clinical Trials More Efficient.
CMS National Conference on Care Transitions December 3,
SHOPS is funded by the U.S. Agency for International Development. Abt Associates leads the project in collaboration with Banyan Global Jhpiego Marie Stopes.
On the CUSP: STOP BSI Improving Situational Awareness by Conducting a Morning Briefing.
INTRODUCING WATCHMAN How to Setup a Successful Left Atrial Appendage Closure (LAAC) Program SH AB June 2015.
Key Terms Business Continuity Plan (BCP) – A comprehensive written plan to maintain or resume business in the event of a disruption Critical Process –
On the CUSP: STOP BSI Improving Situational Awareness by Conducting a Morning Briefing.
Investigational Devices and Humanitarian Use Devices June 2007.
Important Information
Comprehensive Health Insurance: Billing, Coding, and Reimbursement Deborah Vines, Elizabeth Rollins, Ann Braceland, Nancy H. Wright, and Judith S. Haynes.
MiPCT Launch Tier 1 and Tier 2 Mary Ellen Benzik,MD Associate Medical Director MiPCT.
Uses of the NIH Collaboratory Distributed Research Network Jeffrey Brown, PhD for the DRN Team Harvard Pilgrim Health Care Institute and Harvard Medical.
Boston Medical Center Provider Onboarding Overview Boston Medical Center Provider Onboarding Overview Bob DeMayo Director, Medical Staff Affairs & Credentialing.
SCRIPPS CLINIC A Cost Analysis of Bleed Complications from Two Stroke Prevention Strategies in Non-valvular Atrial Fibrillation: Left Atrial Appendage.
Making Clinical Trials More Efficient Site Management Organization (SMO)
Purpose Of Training: To guide Clinicians in the completion of screens and development of Alternative Community Service Plans.
Clinical Decision Support Implementation Victoria Ferguson, COO - Program Manager Christopher Taylor, CIO – Business Owner Monica Kaileh, CMIO – Steering.
Responsibilities of Sponsor, Investigator and Monitor
Clinical Trial Billing and Patient Remuneration
How to Setup a Successful Left Atrial Appendage Closure (LAAC) Program
Documentation in Medical Settings
Utilizing Your Business Continuity Plan.
Responsibilities of Sponsor, Investigator and Monitor
Clinical Practice evaluations and Performance Review
LAAO with Watchman Device Post-Procedure Best Practices
David R. Holmes, Jr., M.D. Mayo Clinic, Rochester
Disclaimer This presentation is intended only for use by Tulane University faculty, staff, and students. No copy or use of this presentation should occur.
Guide to Stanley Stephens plan options
Phase 4 Milestones.
DRAFT - FOR REVIEW PURPOSES ONLY
What would help your resume, help you stand out?
Eric L. Sarin, MD Co-Director, Structural Heart and Valve Program
Optum’s Role in Mycare Ohio
Presentation transcript:

How to Setup a Successful Left Atrial Appendage Closure (LAAC) Program SH-303719-AA

Program Agenda A) Institution Evaluation B) Key Players in LAAC Team C) Hospital Support D) Patient Flow E) Patient Selection F) Identify and Educate the Internal and External Referral Pathways G) Market Yourself as a Center of Excellence Backup Tools & Materials SH-303719-AA

A) Institution Evaluation SH-303719-AA

A) Institution Evaluation Your Site Academic or Private LAA Clinical or Commercial EP, IC or Both Structural Heart Program Afib or Complex EP Program Understanding Site Academic or Private: how to will a LAA program successfully work (similar goals vs. competing goals) Clinical or Commercial: starting from the ground floor vs. making changes to the existing clinical structure EP, IC or Both: What specialty is leading the therapy will be key to understanding program administration Structural Heart Program: Will have a program to learn from (positive & negatives) Existing AFIB / complex EP program: Understanding of current AFIB patients and their flow SH-303719-AA

A) Institution Evaluation Institutional Qualifications: Minimum requirements (i.e. transseptal experience, TEE, surgical back-up) Access to AF patients/referral network (ability to maintain case volume) EP/IC collaboration (Heart Team): clinical experience demonstrates more successful adoption in accounts Clinical/Implanter Qualifications: Physician skills/experience - transseptal experience, AF ablations, structural heart procedures Transseptal experience - 25 punctures in career, 10 within last 12 months (ASD/PFO not applicable) TEE echocardiography experience / skills Commitment to complete the required WATCHMAN training program Business Qualifications: Ability to commit to initial order – No consignment or rep trunk stock Boston Scientific partnership / collaboration SH-303719-AA

B) Key Players in LAAC Program SH-303719-AA

B) LAAC Team Left Atrial Appendage Team Operators (EP/IC/Echo) Hospital Admin (Marketing, Coding, Finance, data support) LAA Coordinator Left Atrial Appendage Team Referral Community Imaging Surgery Backup Anesthesiologist Dedicated Lab Staff Success Factors in Building a LAAC Team Collaboration & coordination is key Coordinator who understands therapy, program and patient flow Block WATCHMAN Days (anesthesia set time, imaging set time & consistent lab staff) Hospital and administration support Education of referral community to understand procedure as well as ensure appropriate patients Identification of a viable referral base who believes in LAA closure therapy SH-303719-AA

B) LAA Program Key Players Operator: Based on operator (EP / IC / Both) will change techniques through out case LAA Coordinator: Identify the LAAC Coordinator / Champion that understands the clinical pathway, process and the procedure Imaging: Small group of physicians that are trained on views. Consistent measuring pre, during and post. Understand needs for trans septal puncture, standardized protocols, sonographer competency with check off to ensure imaging quality Anesthesia: Ability to understand LAA vs TAVR, block time with anesthesia will ensure on time cases LAAC Lab Staff: Educated staff on patient needs, procedure and flow will help with outcomes Surgery: Establish relationship and understanding of possible back up needs and alt therapies Referrals Community: Educated and bought in community that will identify optimal patients for left atrial appendage procedure Hospital Admin: Ensure buy in at all administrative levels of the procedure value for patients and hospital / Marketing / PR SH-303719-AA

B) Program Structure Options Operators: IC and EP with the support of Echo Coordinator: Supports operators in all program structures Structural Heart Complement to existing structural heart program LAAC can complement current structural program including TAVR, Mitral, ASD/PFO Complex EP / Arrhythmia Complement to existing complex left sided EP procedures LAA can complement current complex EP program including extractions, afib and VT ablations Afib Center Complement or new to afib center which manages afib patients and offers all medical and device option to patients LAAC can be another offering to your afib patients that suffer from a variety of oral anticoagulation side effects LAA Program Offer a full suite of LAA closure options which include surgical and noninvasive LAAC can be another offering to current surgery options offered to patients This looks good! SH-303719-AA

C) Hospital Support SH-303719-AA

C) Hospital Support Better Serve your Community Improve patient outcomes compared to oral anticoagulation Reduce oral anticoagulation burden on your patients’ QOL Competitive Advantage Marketing differentiator Physician retention and recruitment Comprehensive AF/Stroke treatment program Hospital Opportunity Incremental patient growth SH-303719-AA

“Reimbursement” = Coding + Coverage + Payment Rates C) Hospital Support “Reimbursement” = Coding + Coverage + Payment Rates Upon FDA approval, we will have Coding and Payment Rates established. Will apply for Coverage when eligible… immediately after approval. Key Points Coverage gaps are routine for new novel technologies (e.g., SAPIEN, MitraClip) BSC is proactively working with CMS and FDA with the goal of facilitating Medicare coverage as soon as possible after FDA approval If coverage is not in place upon FDA approval, it will be necessary for clinicians/hospitals to seek coverage on a case-by-case basis by appealing denials if they occur IN-PATIENT ONLY procedure and anticipate patient population to be primarily Medicare. Not subject to the two midnight rule. Coverage gaps examples SAPIEN Valve (TAVR) – approved 11/2/2011, NCD analysis initiated, final determination in May 2012 http://www.cardiosource.org/en/News-Media/Publications/Cardiology-Magazine/TAVR-Analysis.aspx MitraClip – approved 10/24/2013, CMS opened the NCD process following FDA approval, currently awaiting coverage http://www.cms.gov/medicare-coverage-database/staticpages/public-comment.aspx?commentID=27537&ReportType=nca   SH-303719-AA

Hospital Reimbursement: Will I get paid? SH-303719-AA

Implanting Physician Reimbursement: Will I get paid? SH-303719-AA

C) Hospital Support Tools Available Download Central (click above) WATCHMAN Comprehensive Reimbursement (coding, coverage, and payment) Guide WATCHMAN Prior Authorization template WATCHMAN Appeals template WATCHMAN Economic Value Presentation (via Economic Navigator web tool) Physician Category III Code Guide Documentation & MS-DRG Guide Hospital Appropriateness of Charging Guide WATCHMAN Value Toolkit Health economic and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules and policies. This information is presented for illustrative purposes only and does not constitute reimbursement or legal advice. Boston Scientific encourages providers to submit accurate and appropriate claims for services. It is always the provider’s responsibility to determine medical necessity, the proper site for delivery of any services and to submit appropriate codes, charges and modifiers for services that are rendered. Boston Scientific recommends that you consult with your payers, reimbursement specialists and/or legal counsel regarding coding, coverage and reimbursement matters. Boston Scientific does not promote the use of its products outside their FDA-approved labeling. Payer policies will vary and should be verified prior to treatment for limitations on diagnosis, coding or site of service requirements. The coding options listed within this guide are commonly used codes and are not intended to be an all-inclusive list. Providers are responsible for making appropriate decisions related to coding and reimbursement submissions. We recommend consulting your relevant manuals for appropriate coding options. Payer policies will vary and should be verified prior to treatment for limitations on diagnosis, coding or site of service requirements. The coding options listed within this guide are commonly used codes and are not intended to be an all-inclusive list. We recommend consulting your relevant manuals for appropriate coding options. SH-303719-AA

C) Hospital Support Other Efforts to be Coordinated (if applicable): Quality Team Ensure understanding of WATCHMAN product and support from quality team Value Analysis Team Meeting Secure date and meeting time for WATCHMAN product LAAC Credentials Define credentials are in place at time of launch Reimbursement & Economics Support of WATCHMAN procedure reimbursement process (resources available) Data Support Ability to support tracking and collecting data for study, registry and additional procedures performed on LAAC patients SH-303719-AA

D) Patient Flow through LAAC Procedure SH-303719-AA

D) Patient Flow through LAAC Procedure Education Educate patients and families about disease and treatment options Educate on the LAAC procedure Explanation of risks and benefits of procedure Explanation of the process from screening >> procedure >> follow up Screening Secure insurance pre-authorization for procedure Ensure patient is appropriate candidate for LAAC procedure (indication)/supporting documentation Review previous TEE (if available) or schedule new TEE to ensure patient in a good candidate (size, thrombus, etc.) Scheduling Schedule pre-procedure diagnostic studies, labs, echo, etc. Schedule procedure date for lab time, implanter, anesthesia, TEE physician, patient, company representative (LAAC team) Schedule post-procedure follow-up office visit, labs and TEE @ time of discharge (if registry req) Procedure Ensure patient has followed pre procedure instructions Ensure all key players in the LAAC team are present for procedure Post procedure ensure that patient and family understand post procedure instructions (medication, follow up TEE date, etc.)

D) Patient Flow through LAAC Procedure Patient Education Disease State Disease Treatment (drug vs. device) Procedure Risks & Benefits Procedure Process Tools Available Download Central (click above) Patient Material Patient Brochure Patient video / animation Device example Additional Materials WATCHMAN Patient Website click Post Implant FAQ Pre and Post Procedure samples Website(s) StopAfib.org click Add when available iPAD Applications Cardio teach click SH-303719-AA

Screening Tools Available Patient Identification Tools D) Patient Flow through LAAC Procedure Patient Screening Ensure patient is appropriate candidate for LAAC procedure Secure insurance pre-authorization for procedure Review previous TEE (if available) OR schedule new TEE (Views, size, thrombus) Screening Tools Available Download Central (click above) Indication Material Echo protocols (view, size, thrombus) Patient Identification Tools EMR queries / workflow Patient database / worksheet LAAC Patient Sources (Coumadin clinics, GI clinic, ER) SH-303719-AA

Scheduling Tools / Best Practices D) Patient Flow through LAAC Procedure Scheduling Patients Schedule pre-procedure diagnostic studies, labs, echo, etc. Schedule procedure date (LAA day) for lab time, implanter, anesthesia, TEE physician, patient, company representative (LAAC team) Ensure discharge protocol is understood prior to procedure and re-iterated at discharge Schedule post-procedure follow-up office visit, labs and TEE Scheduling Tools / Best Practices Dedicated LAA days (operator, anesthesia, echo, lab staff) Ensure ample inventory and supplies WATCHMAN Checklist Ensure patient understands pre and post procedure expectations Standard Discharge worksheet SH-303719-AA

Pre Procedure Procedure Post Procedure D) Patient Flow through LAAC Procedure Pre Procedure Procedure Post Procedure SH-303719-AA

D) Patient Flow through LAAC Procedure Pre-Procedural Screening Understanding the indication and patient selection is key Ensure patient qualifies for a WATCHMAN Imaging requirements (size, thrombus, etc) Educate patient and family on procedure Consent patient Pre-Procedural Screening Tools / Best Practice Download Central (click above) Patient Education Material Sample Documents (WATCHMAN homework and Information Sheet) SH-303719-AA

Procedure Understanding Understanding of Potential Complications D) Patient Flow through LAAC Procedure Procedure Understanding Download Central (click above) Procedure explanation & video (click above) Understanding of Potential Complications Pericardial Effusion Device Migration Peri-Procedural CVA Assess complication SH-303719-AA

D) Patient Flow through LAAC Procedure Post Procedure Patient Post Procedure Hospital Stay 1 night overnight (in most cases) Follow Up Office Visits Follow Up Office visit 7 – 10 post procedure (or your protocol) TEE Follow Up at 45 days Drug Regimen Stay on same drugs until physician changes regimen Coordinator / Hospital Post Procedure Data collection for internal database/required registry Discharge Instructions completed by NP / Physician Follow up and TEE scheduled Update Referral MD on procedure and patient outcome SH-303719-AA

E) Patient Selection SH-303719-AA

E) Patient Selection INDICATIONS FOR USE The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who: Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc[1] scores and are recommended for anticoagulation therapy; Are deemed by their physicians to be suitable for warfarin; and Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin SH-303719-AA

E) Patient Selection Patients with high risk for ischemic events Patients with reasonable anatomy and access Patient must be a candidate for long-term anticoagulation Reasonably high risk enough for the patient to notice or comprehend the complications of anticoagulation Expansion slides with anatomy and early vs later SH-303719-AA

F) Identify and Educate the Internal and External Referral Pathways SH-303719-AA

Referral Patterns Within implanter’s practice Inside the hospital Private practice (GC, GP, Geriatrics…) Patients External Referring centers (EP, IC, cards, Neuro, GI, ER) Inside the hospital (EP, IC, clin cards, Neuro, GI, ER) Within implanter’s practice SH-303719-AA

Steps to Building Awareness Begin Plan your referral strategy and educate your business partners Act Publicize through local media and build your referral base Share Accelerate adoption by deepening referring physician understanding Educate Guide patient flow through education SH-303719-AA

F) Identify and Educate the Internal and External Referral Pathways Identify Internal & External Referral Pathways Educate Internal & External Referral Pathways Internal External Clinic (current patients) Afib Clinic (internal) + Coumadin clinic Cardiologist AHPs Geriataric ER / hospitalist (onset or AFIB / stroke) EMR Data query (existing patients) TEE Screening GI Neurologist Current external referrals (cardiologist, GPs, GI, Neurologist, etc) New referrals due to exclusive technology Internal External Grand rounds Lunch & Learns Morning conference Marketing team (website, newsletter to internal employees) Marketing team (News, media & print to external stakeholders) Dinner engagements Local society meeting SH-303719-AA

Referral Education and Materials F) Identify and Educate the Internal and External Referral Pathways Referral Education and Materials Download Central (click above) Education Tools: WATCHMAN Device Overview and WATCHMAN Economic Value Proposition Media Kit Tools: Hospital Press Release, Hospital Newsletter, Video, Images and Product messaging Tools to Engage Referring Physicians Email Blast Template, Letter of Introduction, Education Event Invite, Education Event Thank You letter Additional Tools Therapy Awareness Toolkit (hard copy & electronic) Implanters step-by-step instruction & easily accessible tools for how to drive awareness for their WATCHMAN program with their referring physicians. SH-303719-AA

G) Market Yourself as a Center of Excellence SH-303719-AA

Potential Marketing Opportunities Use the WATCHMAN™ Device as a proof point for why referring physicians and their patients should seek out care at your institution by incorporating the WATCHMAN Device into: Hospital website/newsletter Newsletters for referring physicians Social media outlets Identify a patient who was enrolled in the clinical study who would be willing to share their story Consider inviting local media to your institution to coincide with an implant Use a patient story you may have identified Interview the implanting physician Issue hospital press release Engage hospital switchboard so they know who to direct patients to when asked about stroke/WATCHMAN Device SH-303719-AA The WATCHMAN™ LAA Closure Device is CE Marked and is currently available For Investigational Use Only in the United States. Not for sale in the United States.

Hospital Marketing Resources Hospital Press Release Template Product Messaging Guide Hospital Newsletter Template Product Images (.jpg files) Implant animation video Patient Brochure Patient Website Patient Testimonials *** Link to Resources **** SH-303719-AA The WATCHMAN™ LAA Closure Device is CE Marked and is currently available For Investigational Use Only in the United States. Not for sale in the United States.

Summary: Starting a left atrial appendage program takes a dedicate team to support patient flow, LAAC cases and new patients Appropriate and optimal patient selection is key to success Education at all levels of the hospital: administration, operators, coordinator, lab, anesthesia, cv surgery, referral community is key to long term program success Build and educate referral pathways to ensure patient flow SH-303719-AA