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Cardiac Resynchronization Therapy

An overview of market access challenges for cardiac resynchronization therapy in European countries.

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Procedure coding

Procedure coding is well-established for cardiac resynchronization therapy (CRT) in European countries. The implantation, replacement, and removal of the device for CRT are typically coded separately. Procedure codes for CRT implantation differ depending on its type: cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy defibrillator (CRT-D). 

For example, in Germany, there are specific OPS codes for implantation of the CRT-P (code 5-377.4 “Pacemaker, biventricular stimulation [three-chamber system]”) and implantation of CRT-D (code 5-377.7 “Defibrillator with biventricular stimulation”). The codes differ depending on the availability of the atrial electrode.

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Payment mechanism

The payment model for CRT implantation or replacement is DRG in most European countries.

In most countries, the DRG allocation depends on the CRT type with higher DRG tariffs for CRT-D. For example, in the Netherlands, implantation of the CRT-P system is reimbursed via DRG 099899030 “Surgical placement of a pacemaker that improves the pumping function of both the left and right ventricles during hospitalization, cardiology for a cardiac arrhythmia” with 2024 average cost of €16,485. In contrast, implantation of a CRT-D system is allocated to the DRG 979001242 “Implantation of ICD (defibrillator for two heart chambers), including insertion of electrodes for heart disease/lung disease” with a higher 2024 average cost of €23,590.

In most European countries, CRT systems do not attract additional (top-up) reimbursement, which is paid in addition to the DRG tariff. One exception is England, where there are specific add-on categories “ICD with CRT (Cardiac Resynchronisation Therapy) capability” and “Wireless CRT (Cardiac Resynchronisation Therapy) system” in the High Cost Devices List.

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Policy considerations

Due to the innovative origin and high cost, CRT can be subject to specific policies from payers or national decision-makers in the countries where such frameworks exist. 

For example, in England, the national payer, NHS England, developed so-called Service Specifications for implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy, in which NHS England outlined patient pathways, eligible hospitals, responsibilities of different stakeholders, etc. The policy recommends CRT in patients with symptomatic heart failure on optimal drug therapy, severely impaired left ventricular function, and left ventricular dyssynchrony (through left bundle branch block or single site right ventricular (RV) pacing) manifest as a QRS wider than 120 ms.

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Health technology assessment

Due to the high cost and high clinical risks for patients and the existence of different clinical indications, CRT is often the subject of HTA in different European countries. 

For example, in Italy, the National Agency for Regional Health Services (AGENAS) published the rapid HTA report, in which evidence of CRT-D's effectiveness, safety, and cost-effectiveness was compared with ICD and CRT-P in patients with heart failure. The impact of CRT on heart failure depends on appropriate patient selection. No definite conclusion on the cost-effectiveness of CRT-D in comparison to CRT-P could be drawn due to the contradictory study results. However, the post-procedural costs of CRT-D were lower than those for ICD alone, and cost savings could increase in the long term.

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Future challenges

Standard CRT has established reimbursement and funding in most European countries. New health technology assessments are likely to be relevant for CRT systems with novel stimulation approaches (e.g., stimulation of the conduction system, wireless stimulation, etc.). Novel CRT systems can benefit from innovative payment schemes. 

Novel CRT systems with unique designs or alternative stimulation modes might need to develop specific procedure codes and adjust payment mechanisms to leverage their unique technology or cost profile fully. 

MTRC has experience with more than six projects related to cardiac resynchronization therapy in Europe.

News and insights

Recommendations about add-on reimbursement for medical devices in France in February 2025

The French National Authority for Health (HAS) has released new recommendations about add-on reimbursement of medical devices and medical aids from the February 2025 meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Sixteen favorable opinions were published concerning the registration or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). They relate to cardiovascular and peripheral vascular, neurovascular, endocrinology, interventional radiology, nephrology and urology, orthopedic devices, and medical aids.

Recommendations about add-on reimbursement for medical devices in France in January 2025

The French National Authority for Health (HAS) has released new recommendations about add-on reimbursement of medical devices and medical aids from the January 2025 meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Seventeen favorable opinions were published concerning the registration or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). They relate to cardiovascular, endocrine, e-health, interventional radiology, neurology and neurosurgery, orthopedic devices, and medical aids.

Remote monitoring of patients with chronic heart failure will be reimbursed in Belgium

In December 2024, the National Institute for Health and Disability Insurance (INAMI/RIZIV) launched a new agreement (Convention) allowing reimbursement for remote monitoring of patients with chronic heart failure. It will come into force on January 1, 2025. New codes (pseudonomenclature) with fees for packages of care will be used for reimbursement. The packages include monitoring of clinical parameters by patients at home (e.g., blood pressure measurement or pulmonary artery pressure measured by an implanted sensor) and transmission of data via a health app to the remote monitoring team at the hospital.

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