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CMS Jolts Shockwave; Ups Payment For Coronary Artery Disease Treatment

Executive Summary

The US Medicare agency increased payment for peripheral Intravascular Lithotripsy (IVL) procedures in a final rule. The increase is good news for Shockwave Medical, whose proprietary IVL treatment uses a novel approach to treating calcified arteries.

In its final payment schedule released on 2 November, the US Centers for Medicare & Medicaid Services (CMS) reassigned the payment for peripheral Intravascular Lithotripsy (IVL) procedures performed on above-the-knee (ATK) arteries in the hospital outpatient setting for calendar year 2022. The resulting payment increases for the procedures take effect on 1 January.

Included in the final rule are new Ambulatory Payment Classification (APC) assignments for three Healthcare Common Procedure Coding System (HCPCS) codes that describe procedures in iliac, femoral and popliteal arteries when IVL is performed by itself or adjunctively with drug-coated balloons (DCB), stents or atherectomy.

The new APC assignments will increase payment for revascularization – restoring proper blood flow – with IVL, including angioplasty within the same vessel, from $4,957 in 2021 to $10,259 in 2022, while payments for procedures with IVL for both transluminal stent placements as well as atherectomy also increased, from $10,043 in ’21 to $16,402 in ’22.

Shockwave Medical Inc. developed IVL to treat complex calcified peripheral and coronary artery disease. The IVL system, which the FDA approved in February, builds on technology used to pulverize kidney stones to break up plaque accumulation that can lead to heart attack or stroke.

The CMS in June approved transitional pass-through (TPT) payment for the system, broadening access to the therapy for Medicare patients. (Also see "New Treatment From Shockwave Medical For Clogged Arteries Gets CMS Pass-Through Payment" - Medtech Insight, 18 Jun, 2021.)

“We believe the APC reassignment of these HCPCS codes and subsequent increased payment for IVL procedures performed ATK will further facilitate access to IVL technology for Medicare patients.” – Doug Godshall

Robert Riley, an interventional cardiologist specializing in high-risk coronary artery disease and cardiogenic shock at The Christ Hospital in Cincinnati, told Medtech Insight that IVL is unique in that it uses sonic waves to crack the calcium, allowing for better stent placement within the diseased artery.

As Riley explained, only cracking the plaque rather than smashing it like a kidney stone prevents broken-off shards from being carried away in the bloodstream, which can lead to further complications, including blockages elsewhere.

Riley said the other benefit of sonic pulses to crack the calcium is that it doesn’t damage the tissue surrounding the plaque – all of which result in more successful stent placement.

Shockwave, in Riley’s view, has changed the paradigm in treating clogged arteries because it reduces the risks associated with more invasive procedures, especially when the vessel being treated has a side branch attached. In these cases, more invasive surgery can result in a heart attack if the attached branch gets shut off.

Riley, who uses Shockwave regularly in his practice, said the system is user-friendly and that physicians will be able to adapt to it quickly. And with the recent adjustments to Medicare payments, that’s bound to happen. There are more than 2 million patients a year in the US receiving stents, according to iData Research.

“We believe the APC reassignment of these HCPCS codes and subsequent increased payment for IVL procedures performed ATK will further facilitate access to IVL technology for Medicare patients,” said Doug Godshall, president and CEO of Shockwave Medical.

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