And the Beat goes on Authorizations and Reimbursement for VADs

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1 And the Beat goes on Authorizations and Reimbursement for VADs Presented By: Pam Combs, Manager, Heart Failure/Ventricular Assist Devices-Jewish Hospital & Lori Almand, Director Market Access, National Payers and Reimbursement-HeartWare 1

2 Objectives: What is Reimbursement? Approved Indications Steps to Secure Reimbursement Reasonable and Necessary Tools for Reimbursement Clinical Scenarios 2

3 Disclaimer DISCLAIMER: HeartWare has provided this presentation in order to help the recipient understand the reimbursement process. All information included herein (including all CPT, HCPCS, DRG, ICD- 10 codes) has been provided for informational purposes only. HeartWare makes no express or implied statement, promise or guarantee related to: (1) The propriety of seeking reimbursement for any item; (2) A payer organization s decision whether to reimburse; or (3) Any level of reimbursement, payment or charge. The presentation is not intended to increase reimbursement by any payer. This presentation includes information from the Centers for Medicare & Medicaid Services (CMS). CMS frequently updates information. It is the responsibility of the recipient to obtain current CMS information. It is also the responsibility of the recipient to contact local Medicare carriers, fiscal intermediaries and commercial payers in order to: (1) Confirm appropriate coding; and (2) Identify and learn more about local reimbursement policies and practices. 3

4 Objectives Gain basic understanding of HVAD reimbursement Be aware of the differences in U.S. payers Identify the steps to help secure HVAD reimbursement including medical necessity and best practices for documentation Become familiar with the HW Reimbursement Tools Recognize strategies to develop successful programs 4

5 Reimbursement Drivers Reimbursement is composed of coverage, coding, and payment Coverage Coding Payment Example: Medicare NCD ICD-10 02HA0QZ MS-DRG 001 or 002 CPT Each aspect of the process can be influenced. Reimbursement is the end result of the interaction of these drivers. Coverage: CMS National Coverage Determination (NCD), Commercial Payer Policies or Heath Technology Assessments (HTAs) Coding: Unique ICD-10 diagnosis codes or CPT procedure codes for implant Payment: Appropriate MS-DRG Assignment or % of charges depending on contract 5

6 Understanding Approved Indications HVAD System is approved in the US for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out of hospital setttings, including transport via fixed wing aircraft or helicopter* Anything outside of this indication is considered off-label use of the HVAD System Examples of off-label use: Destination Therapy Pediatrics RVAD BiVAD Thoracotomy Of Note: Under 21 U.S.C 396, Practice of Medicine, physicians may use the device as they feel is best for the patient *CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the Instructions For Use for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device. The IFU can be found at 6

7 Bridge to Decision - BTD BTD (also referred to as Bridge to Candidacy (BTC)) is a common indication listed in INTERMACS* as a branch of BTT For reimbursement, BTD indication may be used when: The best option for a patient is unclear for either medical or social reasons at the time of VAD implantation Patient s transplant evaluation is not yet completed but where no contraindications for transplant are anticipated Patient in whom a current contraindication to transplant is anticipated to resolve Many insurance providers recognize BTD/BTC indication The Joint Commission Disease-Specific Care Certification does not have specific guidelines in regards to BTT/BTD at this time The Joint Commission reviewer may review BTT/BTD patients during their visit to determine if the center is following their own inclusion/exclusion criteria reflected in their practice Some centers include BTD as an indication in their patient selection policy Patient selection inclusion/exclusion criteria is often similar or same as BTT *Source INTERMACS Quarterly Report Dec

8 Government Payers Centers for Medicare and Medicaid Services (CMS): (Largest Single Payer) Medicare (Traditional, Fee-for-Service (FFS), A&B) 8 Administrative Contractors (MAC) Medicare Part A Inpatient hospital services, SNFs/nursing homes, Home Health >65 yrs old or disabled, ESRD, annual deductibles & coinsurance Medicare Part B Physician services, Outpatient hospital services, DME, Ambulance Voluntary, monthly premiums, deductibles, coinsurance Policies = National & Local Coverage Determinations (NCDs & LCDs) Reasonable and Necessary Safe & effective, medically necessary, NOT experimental Does not recognize the term compassionate use Case by Case Decisions NO PRIOR AUTHORIZATION May be reviewed by MAC after claims submitted No GUARANTEE of payment State Medicaid (FFS) Low-income persons Federal-State matching program Utilizing more & more Managed Care programs Most have prior authorization process Tricare DoD healthcare program Managed by commercial payers (UHC, Humana, Health Net) Veterans Affairs 8

9 Medicare Administrative Contractors (MACs) Regional A/B MACs Noridian (JF, JE) WPS (J5, J8) Novitas (JH, JL) NGS(J6, JK) CGS (J15) Cahaba (JJ) First Coast (JN) Palmetto (JM) Published fee schedules For most up to date MAC Map: Contractors/Downloads/AB-MAC-Jurisdiction-Map-Dec-2015.pdf 9

10 Medicare s National Coverage Determination (NCD) Most recent NCD Implemented September 30, 2014 (20.9.1) Bridge to Transplant = UNOS listed 1A, 1B or 2 at time of implant Non-transplant implanting site must receive written permission from Medicare-approved heart transplant center where patient is listed prior to VAD implant. No other clinical patient selection criteria specified for BTT Source: 10

11 Medicare s National Coverage Determination (NCD) Other: The NCD does not address coverage of VADs for: right ventricular support biventricular support use in beneficiaries under the age of 18 use in beneficiaries with complex congenital heart disease use in beneficiaries with acute heart failure without a history of chronic heart failure Coverage under section 1862(a)(1)(A) of the Act for VADs in these situations will be made by local Medicare Administrative Contractors within their respective jurisdictions. Medicare will NOT Prior Authorize cases but rather consider Medical Necessity on a case by case basis based on solid documentation after the claims have been submitted. Source: 11

12 Commercial (Private) Payers COMMERCIAL PAYERS Almost always require prior-authorization process before implant Managed Medicare / Medicaid (Advantage Plans) Patients eligible for Medicare may ELECT for a Medicare Advantage Plan May offer more benefits than Traditional Medicare May be more expensive & limiting (directing patients to specific networks) May follow NCD or commercial policies National & Regional Payers Benefit Designs HMO: gate-keeper, referrals necessary, no out-of-network coverage POS: requires referrals, some out-of-network coverage PPO: least restrictive, more choice / no referrals, more out-of-network coverage Self-Funded Employers / Benefit Funds (small-large) May make coverage decisions independent from insurance company they use Health Exchanges Private & Affordable Care Act (ACA) Supplement plans do not require prior authorization for VAD Help patients with copayments, coinsurance, deductibles Logos for HUMANA, UNITEDHEALTHCARE, KAISER PERMANENTE, AETNA, CIGNA and ANTHEM BLUECROSS BLUESHIELD are trademarks of their respective owners 12

13 Commercial Payer VAD Policies EVERY PATIENT IS DIFFERENT! Commercial payer policies specify coverage guidelines: Conditions that must be met to receive payment for VAD as BTT/BTD May specify how to appeal for special considerations or medical necessity Most health plans do not follow Medicare s NCD BTT rule of active UNOS-listing Many have alternative requirements such as candidate for BTT, or under consideration/evaluation BTD/BTC: Language found in many commercial policies under BTT definition Acknowledges modifiable risk factors that, at present, prevent patient from being listed for heart transplant but if resolved, may result in listing BTT does not necessarily mean UNOS-listed Almost all commercial payers require PRIOR AUTHORIZATION or approval for coverage before the implant occurs! 13

14 Payer Policies EXAMPLES Clinical policy is not intended to pre-empt the judgment of the reviewing medical director or dictate to health care providers how to practice medicine. Health care providers are expected to exercise their medical judgment in rendering appropriate care. Identification of selected brand names of devices, tests and procedures in a medical coverage policy is for reference only and is not an endorsement of any one device, test or procedure over another. October ntricular+assist+device&searchtype+freetext&policytype=both FDA approved VADs are considered medically necessary as a bridge to transplantation when one of the following criteria have been met: currently listed as a heart transplant candidate OR undergoing evaluation to determine candidacy for heart transplant. January htm Employer-based plans may have restrictions on coverage that the administrative entity would otherwise allow. The employer restriction of coverage may take precedence. Logos for HUMANA AND ANTHEM BLUECROSS are trademarks of their respective owners. 14

15 Payer Medical Policy Links National Payers Aetna UnitedHealth Care/OPTUM Cigna Anthem Humana

16 Payer Medical Policy Links Regional / Local Payers BCBS Amerigroup AmeriHealth Kaiser Community Connect Group Health HealthPartners Health Net Priority Health NOTE: Payers update coverage policies on a periodic basis Please notify reimbursement@heartware. com if a link does not work

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18 Steps to help secure reimbursement 1. Identify the patient s specific health plan 2. Obtain copy of current coverage policy and interpret 3. Establish deadline for approval response with payer case manager 4. Write a compelling letter of medical necessity if needed for coverage request or appeal 5. Coordinate a peer-to-peer discussion between your physician and the health plan s medical director, if necessary 18

19 Medical Necessity Commercial Use HVAD Compassionate Use or Emergency Use NOT REQUIRED The HVAD System is a legally marketed device in the U.S. Under 21 U.S.C 396, Practice of Medicine, physicians may use the device as they feel is best for the patient Be well informed, use scientific rationale, sound medical evidence 19

20 Compassionate Use in Clinical Trials Clinical Trials Compassionate Use or Emergency Use is REQUIRED to implant a device not legally marketed in the U.S. Using the term COMPASSIONATE USE may trigger a payer to think experimental and deny the request 20

21 Documenting Medical Necessity Regardless of indication for use or payer authorization, documentation must include proof that the VAD implant was reasonable and necessary Be consistent The Joint Commission (THC)/Det Norske Veritas (DNV) & payers looking for transparency in medical record Criteria patient met for implantation Follow program s internal guidelines / policies / procedures Does the documented indication coincide with the program s inclusion / exclusion guidelines for VAD implant? BTT, BTD/BTC Payers may review patient s medical record months after implant and reserve the right to deny payment if it is not clear WHY the patient needed the VAD Audits may appear as internal controls or external review to examine medical necessity and compliance with criteria 21

22 Documenting Medical Necessity, Cont. When use of the HVAD does not meet a payer s BTT/BTD criteria, compose a Letter of Medical Necessity (LOMN) for coverage review Documentation may include: What is being done/necessary Why it is being done (include details of the patient s medical history) Options and consequences for the patient if the HVAD System is not used Physician signs the letter and places it in the patient s medical record Entire medical team should be in agreement reflected in all medical record notes BEST practice: Internal independent review by physician not directing this patient s care should be documented as well 22

23 Documenting Medical Necessity, Cont. Letter of Medical Necessity (LOMN) Commercial / Private Payers / Managed Medicare Use LOMN as REQUEST for COVERAGE or APPEAL of DENIAL Include following information: Please expedite the review of this request for coverage Physician s cell phone number and availability for a peer-to-peer discussion with the payer s Medical Director Follow up at least daily or establish a deadline with the payer s case manager requesting a decision Prior authorization - especially in requesting coverage of special circumstances - may take extra time and effort! Traditional Medicare (FFS/A&B) The Medicare Administrative Contractor (MAC) does not prior authorize VAD cases. The Medical Director of your specific MAC may review the case for medical necessity and approval after the claims have been submitted The site assumes the RISK Medical necessity can be a mitigating circumstance 23

24 Reimbursement Tools HVAD Reimbursement Resource Kits Newly Created Tools Basic Steps for Reimbursement Payer Medical Policy Links DRG Reimbursement by State HCPCS Codes by State DRG, DME, CMS MAC Maps & contact information Case Scenarios Case-by-Case Support REMEMBER TO UTILIZE

25 DRG Reimbursement By State

26 DMEPOS (HCPCS Codes) By State

27 Interactive DME / DRG / CMS Maps 27

28 Test Your Knowledge! What are the 3 drivers of reimbursement? Coding Coverage Payment 28

29 Test Your Knowledge! According to 21 U.S.C 396 FDA Practice of Medicine physicians can use legally available drugs, biologics and devices according to their best knowledge and judgement. True or False? TRUE 29

30 Test Your Knowledge! Use of any legally available drug, biologic or device outside of it s FDA approved/cleared indication is considered off label use. TRUE 30

31 Test Your Knowledge! Which of the following is NOT a good example of medical necessity? a. A HMII will not fit in this patient due to her small body habitus. b. I think HVAD is the best pump and the surgeon wants to use it. c. This patient is in need of a future gastric surgery to assist with weight loss. HVAD s versatility allows avoidance of an abdominal pump pocket, keeping the pump intrapericardial. 31

32 Test Your Knowledge! If HVAD is implanted as medical necessity into a patient with Medicare A/B, but the patient did not meet BTT criteria in the NCD, the hospital is guaranteed to get paid as long as medical necessity was documented. True or False? FALSE 32

33 Test Your Knowledge! 5. Which steps below may help your program improve financially? a. Initiate quarterly program financial reviews. b. Implement safe and effective ways to decrease patient length of stay in the ICU. c. Review all MCS cases with the hospital compliance and coding teams to ensure correct coding, nomenclature and documentation. d. All of the above 33

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