1. Reimbursement Landscape for the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device

2. Important Information
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.
CPT Copyright 2014 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein
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.
Prior to beginning this presentation, I would like to review the following disclaimer:
Information provided by Boston Scientific is for illustrative purposes only and it is obtained from publically available sources
Since reimbursement information is complex and subject to change, it is the responsibility of the physicians and providers to verify the information provided with your local payers and/or coding specialists.
It is always the responsibility of the provider to provide appropriate documentation and clinical rationale for submitting claims to Medicare and other payers.
Boston Scientific cannot make specific coding recommendations outside publically available sources and does not promote the use of its products outside our FDA approved labeling.

3. Agenda Overview of WATCHMAN Reimbursement Landscape
Coverage
Other structural heart technologies
Physician Coding and Payment
Hospital Coding and Payment
Appeals Process
Reimbursement Resources
My name is ________________ and I work in the Health Economics and Reimbursement group supporting the WATCHMAN technology.
Our agenda for this webcast presentation includes the following:
A review of Atrial Fibrillation (AF) and Left Atrial Appendage (LAA)
The WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device
An Overview of the WATCHMAN Reimbursement Landscape including
Coverage and
Other structural heart technologies
Physician Coding and Payment
Hospital Coding and Payment
The Appeals Process
As well as Reimbursement Resources available to you from Boston Scientific

4. Overview of Reimbursement Landscape for the WATCHMAN™ Device

5. Medicare Reimbursement Status for WATCHMAN™ Device: CAP II vs. FDA
Reimbursement equation = Coding + Coverage + Payment
Coding
Pre-FDA Approval
FDA Approval
Coverage
Payment
Hospital Inpatient
Report with ICD-10 procedure code (02L73DK) occlusion of left atrial appendage with intraluminal device, percustaneous approach
CAP II Covered
Most common assignment are DRG 251 or 250
Expect Implicit
Non-coverage
If covered, most common assignments are DRG 273 and 274
Hospital Outpatient
Category III code 0281T
Designated as “Inpatient Only” NA
Physician
Category III code
0281T
At local MAC’s discretion;
Requires add’l documentation
Expect Explicit
If covered, at local MAC’s discretion; Requires add’l documentation
This slide provides a “look” at the reimbursement landscape for the WATCHMAN Device.
Prior to FDA approval, the WATCHMAN Device was covered under Medicare’s clinical trial reimbursement for approved IDE clinical trials. As a result, physicians and hospitals that participated in these approved trials received coverage and reimbursement from their local Medicare contractors.
What happens to the reimbursement landscape upon FDA approval?
Remember when we refer to reimbursement, it involves three components: coding, coverage, and payment. Now that we have FDA approval, we have coding for WATCHMAN with associated hospital payment. BUT, we will NOT have coverage defined.
Why will there be challenges with WATCHMAN coverage? Because the WATCHMAN procedure is reported under a Category 3 code and most local contractors and private payers have explicit non-coverage for Category 3 codes as they typically consider these types of procedures to be investigational and experimental.
As a result, we anticipate that WATCHMAN will be treated as non-covered by most Medicare contractors and private payers in the absence of a positive local or national coverage decision. Although inpatient hospitals report these procedures using the ICD-9 procedure code system, we anticipate that the non-coverage for the Category 3 code will also translate to non-coverage for hospitals regardless of the coding system in place.
Medicare restricts the WATCHMAN procedure to the inpatient hospital site of service; thus, this procedure cannot be performed in the outpatient hospital setting for Medicare beneficiaries.
In the absence of a local or national coverage decision, Medicare administrative contractors (MACs) have explicit non-coverage of Category III codes.

6. “Reimbursement” = Coding + Coverage + Payment Rates
WATCHMAN™ Reimbursement pathway is not uncommon for new and innovative technologies
Coverage gaps are routine for new technologies as Medicare and payers do not make coverage decisions prior to FDA approval
Recent
Technology
FDA Approval
Coding
Coverage
Payment
MitraClip™ (TMVR)
10/24/2013
Unlisted code: prior to 2014
Cat III code: Jan 2014
Obtained NCD in August 2014
DRG 273 or 274, New Tech Add-on payment effective
SAPIEN™ Valve (TAVR)
11/2/2011
Cat. III code: Jan 2011;
CPT code: Jan 2013
Obtained NCD May 2012
New DRGs effective FY2015
WATCHMAN™
03/13/2015
Cat III code: Jan 2012
TBD
DRG 273 or 274
It is important to note that coverage gaps are routine for novel technologies such as WATCHMAN. Medicare as well as other payers typically take longer to deliberate how these technologies will impact their populations outside of the clinical setting and tend to be more conservative in their review processes.
If we look at other advanced structural heart technologies in our space such as TAVR (transcatheter aortic valve replacement) and TMVR (transcatheter mitral valve replacement) technologies, both experienced similar coverage gaps where national coverage was not formally established until 6 to 9 months post FDA approval. It is important to understand that local Medicare contractors and private payers have mechanisms to petition case-by-case coverage or an exception to their current policies through their appeals processes.
Boston Scientific will work proactively with CMS and the physician societies to define coverage for WATCHMAN to ensure physicians and hospitals have criteria to identify which patients are appropriate candidates for the WATCHMAN Therapy.
“Reimbursement” = Coding + Coverage + Payment Rates
The WATCHMAN Therapy has established Coding,
with associated Hospital Payment.
Boston Scientific is working with CMS to define the Coverage Pathway
Denials may be common so providers should seek coverage on a case-by-case basis by appealing denials if they occur.

7. Physician Coding and Reimbursement

8. Physician Reimbursement: Category III Code for WATCHMAN™ LAA Closure Procedure
Category III CPT Code –
Effective January 1, 2012
Code
Code Description
RVU
Payment
0281T
Percutaneous transcatheter closure of the left atrial appendage with implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, radiological supervision and interpretation
Not assigned
Payer Discretion with supporting documentation
Category III CPT codes:
Claim manually reviewed by payers.
No national payment rate established. Payment will vary and will be at discretion of the payer.
To ensure appropriate payment, physicians will select an existing CPT code (i.e. PFO or ASD procedure) as a reference to benchmark work and resources similar to WATCHMAN LAA closure procedure.
The physician coding for WATCHMAN procedures is defined by the Category 3 CPT code 0281T. This code describes the procedure as follows:
Percutaneous transcatheter closure of the left atrial appendage with implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, radiological supervision and interpretation
Since Category 3 codes are reserved for new or novel technologies that may or may not have FDA approval, they do not have assigned relative value units, or RVUs, for calculating a physician payment rate. Therefore, physicians will need to benchmark this code to a CPT code with equivalent resources, technical competencies, and work for appropriate payment consideration from payers. The payment rate for WATCHMAN will be at the discretion of the Medicare local contractor and may vary by geography.
CPT Copyright American Medical Association.  All rights reserved. CPT is a registered trademark of the American Medical Association.  Applicable FARS/DFARS Restrictions Apply to Government Use.  Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use.  The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein

9. Describe the Equipment /device utilized
Physician Category III code claims: Benchmarking a comparator CPT code to WATCHMAN™ Device
Process for submitting Category III code to payers includes:
For private payers, physicians should seek prior authorization. (Traditional Medicare does not perform prior authorizations.)
Definition or description of the nature, extent, and need for the procedure
Provider’s time & effort - Utilize a comparator CPT code (with similar work, resources, time, competencies, and risk) for establishing equivalent work units as Category III codes do not have RVUs.
Equipment /device utilized
Copy of the FDA approval letter (BSC can supply)
Published clinical literature supporting the use of LAA closure with the WATCHMAN Device indicated for patient population
Here are some of the best practices that we have put together for submitting physician claims for WATCHMAN procedures.
Provide a definition or description of the nature, extent, and need for the procedure
Since Category III codes do not have assigned RVUs or established payment rates, physicians will utilize a comparator CPT code (with similar work, resources, time, competencies, and risk) to establish equivalent work units.
Describe the Equipment /device utilized
Provide a Copy of the FDA approval letter (BSC can supply this to you)
Provide Published clinical literature supporting the use of LAA closure with the Watchman device indicated for patient population.
For physicians who are paid based on productivity measured by RVU’s, an appropriate RVU value should be negotiated prior to performing the WATCHMAN implant procedure.
Salaried physicians will need to identify RVU benchmark in communicating with their hospital administrators prior to performing WATCHMAN LAAC.

10. Inpatient Hospital Coding and Reimbursement

11. Hospital Inpatient Reimbursement
Inpatient Coding
ICD-10 procedure code: 02L73DK Occlusion of left atrial appendage with intraluminal device, percutaneous approach
DRG Assignment
Hospital inpatient payment rates will vary by hospital and are highly dependent on: patient’s condition, market conditions (capital and labor), new technology payments, medical education payments, disproportionate share payments, outlier payments and quality-based initiatives (readmissions reduction policy, and value-based incentive programs).
Medicare restricts WATCHMAN procedures to inpatient only site-of- service
“2-Midnight Rule” not applicable to procedures restricted to inpatient only list.
MS-DRG
Descriptor
FY2016 National Base Payment Range
273
Percutaneous Cardiovascular Procedure without Coronary Artery Stent with MCC
$20,961
274
Percutaneous Cardiovascular Procedure without Coronary Artery Stent without MCC
$14,288
The ICD9 procedure code for reporting the WATCHMAN procedure is which describes insertion of a left atrial appendage device, transseptal catheter technique
It is important to reiterate that the WATCHMAN procedure is restricted to the inpatient only site of service. Medicare states that the inpatient hospital is the only site of service where the WATCHMAN procedure can be performed. Note that the “2-Midnight Rule” does not apply to “inpatient only” procedures.
If WATCHMAN is covered by the local Medicare contractor or private payer, it will typically map to MS-DRGs 250 and 251 with an associated national base payment of $17,529 and $11,965 respectively. Of course, payment rates will vary by geography, patient acuity level and demographics.
* Medicare Program: FY2016 Hospital Inpatient Prospective Payment System, Final Rule; Updated October, 2015.

12. Best practices: Prior authorization and Appeals
Let’s discuss some of the best practices for obtaining case-specific coverage and payment for WATCHMAN during the coverage gap.

13. Appeals Process: Medicare
Traditional Medicare does not offer prior authorizations
Providers perform procedure based on medical necessity
Consider Advanced Beneficiary Notice (ABN)
Providers submit claims to MAC for processing
Providers either receive payment or denial
(*For Medicare Advantage Plans- physicians & hospitals should seek prior authorization)
Medicare has defined appeals process
Redetermination by CMS contractor (i.e. Medicare administrative Contractor- MAC) is the first step
Most providers generally proceed at initial “Redetermination” level
120 day filing deadline from receipt of denial
Form CMS available to submit appeal
Traditional Medicare does not offer prior authorizations so physicians and hospitals will perform the procedure and submit claims to their local contractors.
It is likely that the local Medicare contractor will deny the claim based on potential non-coverage policies as we mentioned earlier. In that case, it would be necessary for physicians and hospitals seek a case-by-case exception to those policies through the appeals process.
For Traditional Medicare, the appeals process begins with the “Reconsideration” process with the Medicare contractor. It is important that providers file claims in a timely manner and do not hold claims until coverage has been established for the WATCHMAN Device. Coverage is not retroactive and is based on the time services are rendered to patients.
Please use Form CMS to initiate the Redetermination process. It is important to note that providers have 120 days from the date of the initial denial to submit the first level appeal.
Providers should anticipate appealing WATCHMAN ™ Device Medicare cases as this is the only mechanism for payment reconsideration.

14. Appeals Process: Private Payers
Providers have the opportunity to request prior authorizations
Seek prior authorization from Private Payers
Payers may have non-coverage policies for Category III codes and LAAC procedures
Check payers’ policies as plans vary
BSC has sample prior authorization templates available
Providers should anticipate denials for prior authorizations.
This is not uncommon for new technologies
Verify payer timelines & processes for submitting appeals
Providers need to APPEAL pre-surgical prior authorizations upon receipt
Provide supporting clinical documentation
Defend WATCHMAN Implant therapy as most appropriate for your patient
Request peer-to-peer review with like specialty (i.e. EP or cardiologist)
Continue to follow up until decision obtained
Request second level appeal if necessary
Unlike Medicare, private payers provide physicians and hospitals the opportunity to request prior authorizations prior to performing the WATCHMAN implant.
It is important to seek prior authorizations as payers may have clear non-coverage policies for Category 3 codes.
Providers should anticipate receiving a denial for the prior authorization requests and be prepared to appeal that denial.
Most appeals include petitioning for an exception to the payer’s non-coverage policy. Specifically, providers will generally be required to take the following steps to be successful in their appeals:
Provide supporting clinical documentation as to the medical appropriateness/necessity for the WATCHMAN Device
Request a peer-to-peer review with a like specialty (i.e., EP or interventional cardiologist)
Continue to follow up until you receive a decision from the payer
Understand that you may need to request a second level appeal if you are unsatisfied with your payer’s decision.

15. Common themes of a successful appeal
Paint the Clinical Picture- Be specific!
Describe the WATCHMAN™ LAAC procedure
Provide rationale on why WATCHMAN Device is a medically appropriate alternative (compared to warfarin) for your patient
Provide clinical documentation (prior attempted treatments that failed)
Talk about patient quality of life
Highlight the extensive body of WATCHMAN clinical trials
Most studied device in the LAAC space with four pivotal trials
Over 2,000 patients studied to date
Demonstrated safety of WATCHMAN Device in most recent clinical data (e.g. PREVAIL and PROTECT 4 year)
Provide copy of FDA approval letter
WATCHMAN Device is not an investigational device
Established safety and efficacy
It is important to consider the following in your appeals:
Paint the Clinical Picture and be specific in providing the clinical rationale in justifying the WATCHMAN therapy for your patient.
Describe the patients quality of life on warfarin and why he/she is seeking a clinical rationale over long-term oral anticoagulants.
2. Highlight the extensive body of clinical literature supporting WATCHMAN in being the most studied Left atrial appendage closure device and the only device with long term clinical follow up.
3. Demonstrate that the WATCHMAN Device is not investigational by providing a copy of the FDA approval letter (found on the Boston Scientific website).
- This should establish that the device is safe and effective based on the indicated population

16. When should I anticipate coverage?
Coverage is dependent on timing & review cycles of payers & policy makers that are beyond BSC’s direct control
What should I expect:
Coverage gaps are routine for novel technologies
Establishing coverage could not begin until after FDA approval
BSC has been working proactively with FDA, CMS, and physician specialty societies to minimize coverage gap
A coverage gap is anticipated now that we have FDA approval
BSC is proactively working with CMS to define coverage
In the near-term, it will be necessary for clinicians/hospitals to seek coverage on a case-by-case basis, and appeal denials if they occur
Although it is difficult to predict when we will have coverage established for WATCHMAN. It is important to note the following in terms of level setting appropriate expectations:
Coverage gaps are routine for new novel technologies
Establishing coverage cannot begin until after FDA approval
BSC has been working proactively with FDA, CMS, and physician specialty societies to minimize coverage gap
A coverage gap is anticipated now that we have FDA approval. BSC is working with CMS to define coverage.
In the near-term, it will be necessary for clinicians/hospitals to seek coverage on a case-by-case basis, and appeal denials if they occur.

17. HE&R Resources for WATCHMAN

18. BSC has Reimbursement Tools & Resources for WATCHMAN™ LAAC Device
WATCHMAN Reimbursement Guide
Pre-authorization and Appeals Templates
WATCHMAN Hospital Economic Analysis (request from WATCHMAN Sales Manager)
Physician Category III Code Guide
Documentation & Impact on MS-DRG Guide
BSC Reimbursement Support Line at
1-800-CARDIAC
Boston Scientific offers resources that we have created for physicians and providers to assist with understanding the WATCHMAN coverage, coding, and payment landscape.
These resources which include the following:
WATCHMAN Reimbursement Guide
Pre-authorization and Appeals Templates
WATCHMAN Hospital Economic Analysis (available via Economic Navigator)
Physician Category III Code Guide
Documentation & Impact on MS-DRG Guide
are conveniently located on our website
We will update the WATCHMAN Reimbursement resources as we continue to get updates from Medicare and private payers.
If you require additional assistance, please feel free to call CARDIAC and ask for “WATCHMAN Reimbursement.”
Thank you in advance for your support of this novel technology in providing a treatment alternative for non-valvular Afib patients.
All Reimbursement resources are easily accessible at
As BSC continues to receive reimbursement updates on WATCHMAN, we will provide you timely communications.
WATCHMAN is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners.