HRS Focuses on Imminent Impact of Pulsed Field Ablation
February 22, 2024 — With the culmination of many clinical trials, recent and pending Food and Drug Administration (FDA) approval, and growing clinical interest, Pulsed Field Ablation (PFA) for the treatment of atrial fibrillation has garnered a great deal of attention in the field of cardiology, especially electrophysiology. The use of PFA for the treatment of atrial fibrillation has proven effectiveness and safety, and its expanding use in the field of EP has raised concern about proper reimbursement for providers and coverage policy from payors. The Heart Rhythm Society (HRS) has been a leader in advancing knowledge of PFA as it has evolved. Now, HRS is taking the lead in ensuring effective clinical acceptance and adoption.
Last week, the Society’s Health Policy and Regulatory Affairs Committee (HPRAC) met to continue work on addressing concerns for coverage approvals and proper reimbursement for cardiac arrhythmia ablation procedures using PFA. The Committee concluded that providers may face challenges with payment coverage of ablation procedures using PFA, with some commercial payors recently announcing PFA as “experimental or investigational” and, therefore, not medically necessary for various uses, including for ablation of cardiac arrhythmias. While receiving FDA approval (and other regulatory approval around the world), the costs of PFA systems are expected to be significant (like other new technologies), and cost efficiencies may not be immediately recognized, which may influence coverage decisions by some payors.
The Committee recommends providers encourage their administrators to advise payors that they plan to use this approved technology and to discuss the best way to ensure appropriate authorizations and reimbursement. The Committee is drafting an HRS letter of support for the use of approved PFA technology for atrial fibrillation that providers can use to obtain pre-authorization or appeal denials of reimbursement from payors. Insurers must be mindful that coverage delays and denials can be life-threatening for some patients. The decision to use PFA or another ablation energy source as an appropriate treatment pathway should be made between the physician and patient for the best care and improved outcomes. The Committee also suggests that administrators consider including the cost of PFA technology in their payor contracts to ensure appropriate reimbursement.
The Society will continue to keep its members and the provider community abreast of reimbursement policy considerations and issues for PFA to ensure the safest, most effective treatments are available to heart rhythm patients worldwide.
In the coming weeks, HRS will share further details on the Society’s work to assure support for PFA through HRS social media channels and Heart Rhythm TV interviews.
HRS is also launching a monthly focus on various clinical educational topics through Heart Rhythm 365, Heart Rhythm TV, and other HRS online channels. The focus for March will be pulsed field ablation. HRS has curated easy-to-access educational content and interviews that will be promoted and featured through these HRS platforms. Heart Rhythm 2024 in Boston will also feature a significant number of sessions focusing on PFA.