Translational Pathway for Catheter Ablation
Tonya Dowd, MPH
U.S. Reimbursement and Market Access for Cardiac Ablation
In the United States, the reimbursement landscape for intracardiac catheter ablation is well established. Codes are available within all coding systems to describe the various types of mapping and ablation procedures. Government plans including Medicare and Medicaid, as well as commercial third-party payers have recognized the procedure as medically necessary, ensuring patient access to this therapy when medical criteria guidelines are satisfied based on the specific type of arrhythmia.
Payment for all provider stakeholders is well established. Medicare, Medicaid, and commercial payers have established fee schedules and other methodologies to reimburse physicians and facilities for intracardiac catheter ablation procedures whether performed as a hospital outpatient procedure or an inpatient admission. The recognition by Medicare to reimburse either hospital site of service allows physicians the flexibility to perform these arrhythmia procedures in a hospital setting of care that will adequately accommodate individual patients and their current clinical needs and management of any preexisting comorbidities.
Coding and Payment
Procedure-specific codes for intracardiac catheter ablation procedures are established for all provider stakeholders including physicians and hospitals for both inpatient and outpatient procedures.
For physician and hospital outpatient procedure coding, Current Procedural Terminology (CPT®)-4 codes specify the type of ablation performed differentiated by the arrythmia (i.e., atrial fibrillation [AF], atrial flutter, supraventricular tachycardias, ventricular tachycardia). Some ablation CPT codes represent a “packaged procedure” and contain services integral to performing the primary ablation procedure, including a diagnostic study, and the ablation itself into the single code.
For physician payment, each CPT code is assigned a value based on the Resource Based Relative Value Scale. This system is representative of the physician work, practice expense, and procedure liability associated with the CPT code-specific procedure. Under Medicare, payment to the physician will be based on the total relative value units or RVUs of the CPT code multiplied by a national monetary conversion factor assigned annually by the U.S. Centers for Medicare and Medicaid Services (CMS). Payment from commercial payers will vary based on contracts for service, although most benchmark some aspect of the Medicare payment system.
Hospital Outpatient Payment
Under the Medicare system, hospital outpatient payment is based on the Ambulatory Payment Classification (APC) to which the CPT code is grouped. For ablation procedures, hospitals will be paid according to a “comprehensive” APC payment methodology and receive one all-inclusive payment for the entire operative episode, which is the payment value of the APC of the primary ablation procedure.
Hospital Inpatient Payment
For inpatient admissions, hospitals will utilize the ICD-10-PCS (procedure) code set to describe the type of intracardiac catheter ablation procedure performed. ICD-10-PCS codes are assigned to a Medicare Severity Diagnosis-Related Group (MS-DRG) for payment under the Medicare Inpatient Prospective Payment System (IPPS). Under the IPPS, hospitals are paid one MS-DRG per patient admission.
In 2016, CMS implemented a change to the hospital inpatient MS-DRG grouping and payment for intracardiac catheter ablation procedures that proved economically advantageous to intracardiac procedures. Two new MS-DRGs were created to allow for the differentiation between “intracardiac” percutaneous procedures and “intracoronary” percutaneous procedures. This change resulted in improvements in clinical homogeneity and an increased hospital inpatient procedure payment that more accurately reflected the cost of hospital resources associated with performing these procedures, which includes all ablation procedures. Under this change, intracardiac catheter ablation procedures are assigned to the following MS-DRGs under Medicare:
- DRG 273 Percutaneous Intracardiac Procedures with Major Complication or Comorbidity (MCC)
- DRG 274 Percutaneous Intracardiac Procedures without MCC
Commercial third-party payers will reimburse hospitals for both inpatient and outpatient intracardiac catheter ablation procedures according to methodologies established in provider network contracts. Some may reference the Medicare payment methodologies for benchmarking purposes.
Global Reimbursement and Market Access for Cardiac Ablation Procedures
Germany is the largest cardiac catheter ablation market in the European Union. In Germany, all new inpatient procedures are covered and reimbursed by the German health care system. As in the United States, German hospitals are reimbursed on a DRG payment system (called the G-DRG). The procedure codes for cardiac catheter radiofrequency (RF) ablation are grouped within very detailed subdivisions of the codes. Subdivisions include the exact type of ablation, patient age, complexity, and implantation of a loop recorder.
Each time a procedure is performed, the hospital receives the tariff for that particular procedure. The current tariffs are set for 2017 to 2019 by NHS England. Ablation catheters included on the list of high-cost devices that are not included in the main tariff:
- 3-dimensional mapping and linear ablation catheters used for complex cardiac ablation procedures
- RF, cryotherapy, and microwave ablation probes and catheters (except where used for complex gastrointestinal tract endoscopy procedures)
In the United Kingdom, the National Institute for Health and Care Excellence (NICE) issues technology appraisal guidance for selected drugs and devices, which emphasize cost effectiveness in addition to effectiveness and safety. These guidance documents serve as recommendations on the use of new and existing medicines and treatments within the National Health Service and apply to medicines, medical devices, diagnostic techniques, surgical procedures, and health promotion activities.
NICE initially published the Clinical Guidance 36 (CG36) for atrial fibrillation in 2006, with an update in 2014, Clinical Guidance (CG180) for Atrial Fibrillation: Management (1). Surveillance of the CG180 in 2017 has led to the decision that there will be a partial update of the guidelines and a number of questions will be addressed, including:
- What is the clinical and cost effectiveness of left atrial appendage occlusion (LAAO) compared to antithrombotic therapy in the prevention of stroke in people with AF?
- A clearer identification of patients in whom the procedure is thought to be cost effective
- A review of the comparable efficacy between the LAAO devices, surgical closure and novel oral anticoagulants is needed, including a cost-effectiveness analysis
- What is the clinical and cost effectiveness of catheter ablation compared to non-ablation therapies in people with AF?
- The collective new evidence indicates that RF catheter ablation in particular, and possibly cryoballoon ablation, may be more effective than antiarrhythmic drug (AAD) management in reducing AF in both paroxysmal and persistent The evidence also suggests that the acute complication rate of catheter ablation may have decreased over time and could be comparable to that of medical therapy
- A comparison between surgical and catheter ablation
- A comparison between cryoablation and RF ablation
- What is the effectiveness of short-term AADs following ablation for the prevention of AF recurrence? (This is a new question to be added to the review based on new evidence indicating the use of AADs following catheter ablation may reduce the incidence of early recurrent atrial tachyarrhythmias within 3 months but did not prevent late recurrence of AF beyond 3 months of ablation.)
The next clinical guidance update for AF is expected for publication by NICE in 2020.
In Japan, all new drugs and medical devices approved by the Pharmaceutical and Medical Devices Agency (PMDA) are generally reimbursed by public health care insurance without any cost-effectiveness data. The Ministry of Health, Labor and Welfare (MHLW) determines official reimbursement prices of medical devices, which are uniform throughout Japan. In a manner that is different from most other countries, the official price is calculated by the detailed pricing rule, not price negotiation. The calculated price is approved by the Central Social Insurance Medical Council, known as the Chuikyo. Usually, the price suggested by the MHLW is approved by the Chuikyo without any revision. However, if manufacturers do not agree with the price calculated by the MHLW, they can submit their opinion to Chuikyo once (2).
The price of medical devices is determined using a similar method as that used for drugs. However, the price applies to every reimbursement category (called the “similar function category”) of medical devices, not each product. If a new medical device is not very innovative, the device is included in the existing category, and carries the same price as other products in that category. In the case of innovative devices, the creation of a new reimbursement category is allowed.
There are five major reimbursement categories for medical devices. Reimbursement of medical devices follows this classification system. Special Treatment Materials that fall into Categories C1 (novel device within existing procedure) or C2 (novel device and procedure) can lead to premium payment for the device. The reimbursement approval rate remained unchanged for the period between 2013 and 2017, as 25 new devices were classified Category C1, and 26 new devices were classified Category C2 for reimbursement.
Currently, RF catheter ablation is covered and reimbursed in Japan with both a technical and medical materials fee for the catheters required for the procedure.
- National Institute for Health and Care Atrial fibrillation: management. Clinical guideline [CG180]. Available at https://www.nice.org.uk/guidance/cg180. Accessed May 29, 2019.
- Shiroiwa T, Fukuda T, Ikeda S, Takura T. New decision-making processes for the pricing of health technologies in Japan: The FY 2016/2017 pilot phase for the introduction of economic evaluations. Health Policy. 2017;121:836-41.