Translational Pathway for Transcatheter Mitral and Tricuspid Valve Development
Christopher J. Panarites, PhD
Elizabeth Thoma, MBA
Transcatheter Mitral Valve Repair Reimbursement in the United States
Transcatheter mitral valve repair (TMVr) with MitraClip™ has undergone an evolution in reimbursement since initially approved by the U.S. Food and Drug Administration (FDA) in 2013. Like other transcatheter structural heart procedures, TMVr is covered by Medicare under a ‘Coverage with Evidence Development’ (CED) framework that includes hospital and physician criteria, as well as submission of data to an independent registry organization, the Society of Thoracic Surgeons/American College of Cardiology transcatheter valve therapy registry (STS/ACC TVT Registry™).
After the FDA approved the first TMVr device, MitraClip, in late 2013, the Centers for Medicare and Medicaid Services (CMS) issued a National Coverage Decision (NCD) in the summer of 2014 (1). As noted above, the TMVr NCD establishes a CED framework and outlines requirements in order to qualify for Medicare reimbursement.
The initial 2013 FDA-approved indication for MitraClip was limited to patients with degenerative (primary) mitral regurgitation who were at prohibitive risk for mitral valve surgery (2). This resulted in a patient population of advanced age, typically greater than 80 years of age. Since the primary payer for elderly (over age 65) Americans is the federal Medicare program, establishing coverage by CMS was critical for the adoption of TMVr with MitraClip by hospital structural heart programs.
Medicare’s NCD for TMVr includes relatively straightforward facility requirements (2+ cardiothoracic surgeons on staff, noninvasive imaging capabilities, etc.) (1). Additionally, the TMVr NCD specifies procedural volume requirements for both hospitals and physicians performing the procedure. Briefly, a hospital must have a surgical program that performs ≥25 total mitral valve surgical procedures per year, with 10 of these 25 procedures being mitral valve repairs. A hospital also must have an interventional cardiology program that performs ≥1,000 cardiac catheterizations, including 400 percutaneous coronary interventions per year. Turning to physician volume requirements, the interventional cardiologist(s) billing for TMVr must have performed ≥50 structural procedures per year including atrial septal defects, patent foramen ovale, and trans-septal punctures. All physicians billing Medicare for TMVr with MitraClip must be board-certified in interventional cardiology or cardiothoracic surgery.
On March 14, 2019, the FDA expanded the indication for MitraClip to include secondary mitral regurgitation. At the same time, the text of the NCD duplicated portions of the FDA-approved indication as coverage requirements (e.g., primary MR only, prohibitive risk for surgery). As MitraClip gained expanded indications approved by FDA, the NCD did not automatically extend coverage to these newly indicated patient groups. Instead, CMS, industry, specialty societies, and individual care providers had to work through a lengthy administrative process during which TMVr was not covered for certain patients. In order to align Medicare coverage with the new FDA indication, CMS will have to reopen an update to the current TMVr NCD. After officially reopened, it will take CMS 9 to 12 months to revise and finalize the NCD. During the process, stakeholders will have multiple opportunities to provide input to CMS.
The NCD for TMVr establishes coverage for Medicare beneficiaries; it does not specify reimbursement rates for hospitals or physicians performing the procedure. For inpatient hospitalizations, Medicare reimburses providers using Medicare-Severity Diagnosis Related Group (MS-DRG) payments. MS-DRG payments are calculated and adjusted based on a national average of historical cost and resource utilization for specific procedures. As previously noted, reimbursement for TMVr with MitraClip changed from year to year. Below is a summary of the DRG assignments and ‘new technology add-on’ payment (NTAP) eligibility.
Table 1. DRG Assignments for Transcatheter Mitral Valve Repair
|Federal Fiscal Years*||DRG Assignment||Description||Cases Eligible for NTAP?|
|Prior to October 1, 2014||250/251||Percutaneous cardiovascular procedures without coronary artery stent, w/ & w/o MCCs||No|
|FY15||250/251||Percutaneous cardiovascular procedures without coronary artery stent, w/ & w/o MCCs||Yes|
|FY16||273/274||Percutaneous intracardiac procedures w/ & w/o MCCs||Yes|
|FY17 and subsequent years||228/229||Other cardiothoracic procedures w/ & w/o MCCs||No|
The original procedure code for TMVr with MitraClip was established under the prior International Statistical Classification of Diseases and Related Health Problems (ICD)-9 Procedural Coding System; today, ICD-10 is used. This newly established code mapped TMVr with MitraClip to MS-DRGs 250/251, similar to coronary angioplasty. This led to severe underpayments to hospitals during clinical trials and immediately after approval. Beginning in FY15 (which started on October 1, 2014), TMVr claims with MitraClip were eligible for Medicare NTAPs of up to $15,000. NTAP is a program that provides temporary additional payments for new technologies that are new, provide substantial clinical improvement, and meet incremental cost thresholds established by CMS (3). The introduction of NTAPs reduced but did not eliminate hospital losses. In FY16, CMS created a new DRG family for intracardiac procedures and TMVr was included in the family of codes that shifted from 250/251 to 273/274 (4). While payments did increase, hospitals still experienced losses when TMVr was paid under 273/274. As a result, NTAP payments continued in FY15. With the end of NTAP eligibility, CMS shifted TMVr claims with MitraClip to another DRG family: 228/229, where claims continue to map today.
In April 2019, CMS proposed to revise the mapping for TMVr (5). It is expected that CMS will announce its final decision in August 2019. If finalized as proposed, TMVr claims involving an implant would map to MS-DRGs 266/267, the MS-DRG family to which TAVR maps currently. This change would increase Medicare reimbursement to hospitals by 15% to 20%, depending on a number of hospital-specific factors, and better align reimbursement with hospital’s costs of care.
Multiple reimbursement changes with TMVr with MitraClip over many years is not unique. It often takes years and many policy changes and adjustments before a new technology is adequately reimbursed. New technologies are often expensive, but they also come with health trade-offs, such as less time in the hospital.
Physician payment for TMVr with MitraClip was formalized with a new Category I Current Procedural Terminology (CPT) code that was effective January 2015. At the same time, the American Medical Association created a new CPT code for intraprocedural echocardiography for structural heart procedures. While the intraprocedural echocardiography code is broadly applicable to a range of structural heart procedures (e.g., TMVr, TAVR), the TMVr procedure code is specific to mitral repair, as it is understood today (mitral leaflet approximation/coaptation). New repair devices that target different parts of the mitral valve apparatus (e.g., mitral annulus) may require additional CPT code(s).
Transcatheter Mitral Valve Repair Reimbursement Outside the United States
Germany is the most important market for TMVr outside the United States and commercialization began much earlier than in the United States as a result of CE Mark in 2008. Like in the United States, German hospitals are reimbursed using a DRG payment system, called the German-DRG-System, or G-DRG. Similar to the MS-DRGs, the G-DRGs use an algorithm that factors in diagnoses, procedures, and patient characteristics to determine hospital payments.
As happened in the United States, the initial G-DRG assignment for TMVr with MitraClip resulted in low payments to hospitals. In Germany, individual hospitals may apply for innovation funding, called NUB (an abbreviation for Neue Untersuchungs- und Behandlungsmethoden, which translates to in English) payments when the complete costs of care significantly exceed payments, as was the case post-approval. These NUB payments are on top of base G-DRG payments. A number of hospitals received these NUB payments until a new specific G-DRG was implemented in 2013. With the creation of the new G-DRG, hospitals’ costs of care were better aligned with reimbursement with the costs of care.
Since CE mark approval, TMVr with MitraClip has been funded at a limited number of hospitals in England, through budgets controlled by these institutions and by National Health Service (NHS) England under the ‘Commissioning through Evaluation’ scheme. More recently, NHS England’s Clinical Panel has recommended the procedure for routine commissioning, subject to a funding prioritization decision in May 2019.
TMVr with MitraClip has been approved by Australia’s regulatory authority, the Therapeutic Goods Administration (TGA), since 2011. To date, reimbursement is available only in Australia’s public system. TMVr with MitraClip is not reimbursed in Australia’s commercially important private sector, and this lack of TMVr reimbursement in the private sector limits patient access to the technology in Australia.
In the past, multiple submissions to the Medical Services Advisory Committee (MSAC) for private sector reimbursement have been made and were denied, based on lack of comparative clinical effectiveness and cost effectiveness data. A subsequent request for MSAC evaluation was more recently submitted and is currently under review.
TMVr with MitraClip received regulatory approval in 2017 and gained reimbursement approval from the Ministry of Health, Labor & Welfare effective April 2018. Somewhat unique to Japan, MitraClip is reimbursed on a per-clip basis; in the United States and Germany, MitraClip is reimbursed on a per-procedure basis, regardless of the number of clips implanted.
Considerations for New Transcatheter Mitral Valve Devices
At this time, MitraClip is the only TMVr device with FDA approval. In Europe, MitraClip and Edwards Lifesciences’ Pascal™ have CE Mark approval. At this early point, it would appear that Pascal is being reimbursed similarly to MitraClip in Germany, owing the similarities of these devices (mitral leaflet approximation/coaptation).
Other TMVr devices utilizing novel mechanisms of action (e.g., transcatheter annuloplasty ring and transapical chordae tendineae replacement) remain in clinical development with their ultimate reimbursement to be determined. The same applies to transcatheter mitral valve replacement devices.
- S. Centers for Medicare and Medicaid Services. Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438N). Available at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=273. Accessed May 26, 2019.
- S. Food and Drug Administration. MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System – P100009/S028. Available at https://www.fda.gov/medical-devices/recently-approved-devices/mitraclip-nt-clip-delivery-system-and-mitraclip-ntrxtr-clip-delivery-system-p100009s028. Accessed on May 26, 2019.
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- S. Centers for Medicare and Medicaid Services. Fiscal Year (FY) 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective Payment System Proposed Rule. Available at https://www.govinfo.gov/content/pkg/FR-2019-05-03/pdf/2019-08330.pdf. Accessed on May 26, 2019.