2023: Welcome in the New Year with New Reimbursement
Improved Reimbursement for Coronary IVL in Germany
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Another welcome announcement from our reimbursement team, this time in one of our largest international markets, Germany.
Until now, German hospitals faced an imbalance between the costs of most coronary IVL procedures and the associated procedural reimbursement, a fact which has limited availability of coronary IVL to German patients. From 1st January 2023, there will be a remapping of the DRGs associated with the IVL procedure code 8-83d “Andere perkutantransluminale Gefäßintervention an Herz und Koronargefäßen: Koronare Lithoplastie”. Using Coronary IVL will now map to the DRG F19B (relative weight 1.538) or to the DRG F56B (relative weight 1.048). Using the 2023BVMed estimated federal base rate of €4,000 this gives a reimbursed amount of €6,152 for F19B or €4,192 for F56B.
With these positive changes, German cardiologists and hospital controllers no longer face a challenging reimbursement barrier when deciding if IVL should be offered to patients with calcified coronary artery disease.
Shockwave Medical thanks all the stakeholders who supported this change and submitted the DRG change request to INEK early in 2022, especially the German Society of Cardiology (DGK). We thank all the hospitals and physicians involved in the CALC economic study which enabled us to demonstrate the significant and consistent level of underfunding across the multiple DRGs which the IVL code previously mapped to and everyone that continued to use IVL in such large numbers that the INEK were able to see the consistent level of underfunding across multiple German regions and hospitals.
- The two DRGs can be considered as reimbursement for simple and complex cases.
A simple case will now map to the DRG F56B which will reimburse hospitals €4,192 .
An example of a simple case is performing IVL in a patient with a primary diagnosis of unstable angina or chronic ischaemic heart disease (diagnosis codes I20 or I25 with or without the implantation of a stent). This case would have previously mapped to the DRG F58B in 2022 which provided reimbursement to the hospital of €2,966.8 after a 2-day admission. In 2023 this case will now map to the DRG F56B and the hospital will be reimbursed €4,192, an increase of €1,225.20. Adding a drug-eluting stent to this procedure does not increase the reimbursement to the hospital but the hospital will receive an additional reimbursement via the ZE payment associated with drug-eluting stents.
Complex cases will now map to the DRG F19B which will reimburse hospitals €6,152
Examples of complex IVL cases are:
- 1. Performing IVL and placing a drug-eluting stent in a patient with a primary diagnosis of acute or recurrent myocardial infarction (primary diagnosis code of I21 or I22).
- 2. Performing IVL with intravascular imaging and placing one or more drug-eluting stents.
Both examples were previously mapped to F52B which reimbursed €4,078.39. In 2023 hospitals will now receive €6,152, an increase of €2073.61 vs 2022.
 We are currently calculating the 2023 reimbursements with the 2023 BVMed estimated federal base rate https://www.bvmed.de/de/versorgung/krankenhaus/bundesbasisfallwert.
Coronary Important Safety Information:
In the United States: Rx only.
Indications for Use—The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.
Contraindications—The Shockwave C2 Coronary IVL System is contraindicated for the following: This device is not intended for stent delivery. This device is not intended for use in carotid or cerebrovascular arteries.
Warnings— Use the IVL Generator in accordance with recommended settings as stated in the Operator’s Manual. The risk of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment, including IVL. Appropriate provisional interventions should be readily available. Balloon loss of pressure was associated with a numerical increase in dissection which was not statistically significant and was not associated with MACE. Analysis indicates calcium length is a predictor of dissection and balloon loss of pressure. IVL generates mechanical pulses which may cause atrial or ventricular capture in bradycardic patients. In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required. In the event of clinically significant hemodynamic effects, temporarily cease delivery of IVL therapy.
Precautions— Only to be used by physicians trained in angiography and intravascular coronary procedures. Use only the recommended balloon inflation medium. Hydrophilic coating to be wet only with normal saline or water and care must be taken with sharp objects to avoid damage to the hydrophilic coating. Appropriate anticoagulant therapy should be administered by the physician. Precaution should be taken when treating patients with previous stenting within 5mm of target lesion.
Potential adverse effects consistent with standard based cardiac interventions include– Abrupt vessel closure – Allergic reaction to contrast medium, anticoagulant and/or antithrombotic therapy-Aneurysm-Arrhythmia-Arteriovenous fistula-Bleeding complications-Cardiac tamponade or pericardial effusion-Cardiopulmonary arrest-Cerebrovascular accident (CVA)-Coronary artery/vessel occlusion, perforation, rupture or dissection-Coronary artery spasm-Death-Emboli (air, tissue, thrombus or atherosclerotic emboli)-Emergency or non-emergency coronary artery bypass surgery-Emergency or non-emergency percutaneous coronary intervention-Entry site complications-Fracture of the guide wire or failure/malfunction of any component of the device that may or may not lead to device embolism, dissection, serious injury or surgical intervention-Hematoma at the vascular access site(s)-Hemorrhage-Hypertension/Hypotension-Infection/sepsis/fever-Myocardial Infarction-Myocardial Ischemia or unstable angina-Pain-Peripheral Ischemia-Pseudoaneurysm-Renal failure/insufficiency-Restenosis of the treated coronary artery leading to revascularization-Shock/pulmonary edema-Slow flow, no reflow, or abrupt closure of coronary artery-Stroke-Thrombus-Vessel closure, abrupt-Vessel injury requiring surgical repair-Vessel dissection, perforation, rupture, or spasm.
Risks identified as related to the device and its use: Allergic/immunologic reaction to the catheter material(s) or coating-Device malfunction, failure, or balloon loss of pressure leading to device embolism, dissection, serious injury or surgical intervention-Atrial or ventricular extrasystole-Atrial or ventricular capture.
Prior to use, please reference the Instructions for Use for more information on warnings, precautions and adverse events. https://shockwavemedical.com/IFU
Please contact your local Shockwave representative for specific country availability and refer to the Shockwave C2 instructions for use containing important safety information.