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CMS' Final Verdict on TAVR: A Boon or Bane for MedTech?

Urmimala Biswas

The transcatheter aortic valve replacement (TAVR) market, which is projected to witness a CAGR of 18.3% between 2017 and 2022 (per a report by Azoth Analytics published on ReportsnReports), has been constantly on the radar of investors.

Recently, the Centers for Medicare and Medicaid Services’ (CMS) final update on national coverage determination (NCD) related to TAVR programs, has once again caused a stir on the bourse as this policy revision is inviting mixed reviews from the industry members.

The industry players, who are always neck and neck in modernizing their TAVR procedures, consider this decision a major progress in terms of increased flexibility in treatment options. However, the medical device organisations are raising questions about any deterioration of the standard of care as a result of this. Let us delve deeper.

The Final Update at a Glance

Per the final update, TAVR is covered for the treatment of symptomatic aortic valve stenosis when furnished according to an FDA-approved indication and when certain conditions are met.

In a gist, going by a MEDTECHDIVE report, the new rules will overall ease volume requirements for hospitals and physicians to begin TAVR programs. However, this will increase the number of valve procedures necessary to maintain a program. This is going to expand patient access to TAVR by lessening the requirements that hospitals and clinicians must meet to start the programs. For investors’ knowledge, earlier in March, CMS announced a draft NCD with the aim to broaden the NCD guideline so that low-volume heart institutes get the eligibility to offer TAVR to ramp up patient access.

MedTech Majors in Favour of the Rule

According to Edwards Lifesciences EW, majority of the core element of the updated NCD provides better reflection of modern-day treatment of patients with severe Aortic stenosis (AS). Per the company, this will widen the access of TAVR procedure. Management stated: “We are encouraged that CMS is open to moving toward a quality measure focused on patient outcomes, not procedural volume, in evaluating hospitals eligible to provide TAVR in the U.S.”

Another entity enthusiastic about the final update by CMS is Medtronic MDT as this too feels that the development will result in higher patient access to TAVR therapy. The company believes that the new coverage policy will enable appropriate patient access to TAVR especially for patients in rural communities.

Per a MEDTECHDIVEr report, Boston Scientific BSX also (who became the third manufacturer to gain an FDA approval for a TAVR system in April) lent its support to CMS' proposed volume requirements.

Others Contradict

While the industry behemoths are going gaga over the new CMS update, organisations like Heart Valve Voice US are not far behind either in expressing doubts over the updated policy. Per a Cision report, Lisa M Tate, interim executive director for Heart Valve Voice, said: "CMS's decision to judge hospitals on volume, rather than quality outcomes, will further deny patient access to this innovative procedure. This is despite seven years of data showing that lower volume hospitals and higher volume hospitals have nearly equal outcomes."

Earlier in April, four medical societies, namely the Society of Thoracic Surgeons, American College of Cardiology, American Association for Thoracic Surgery and the Society for Cardiovascular Angiography and Interventions also put forward their respective statements against any revision in the TAVR policy. Alike Heart Valve Voice, these institutes were apprehensive about the growing risk in having suboptimal outcomes of this policy revision.

Investors' Take

Irrespective of the shortcomings of the ongoing policy-related dispute, we expect the TAVR technology to nonetheless succeed in deepening its penetration level as it successfully did over the past several years. Investors may continue to keep close tabs on the industry movement as it is a much-coveted area within the medical devices space with many players currently adopting the acquisition route to harness the billion-dollar market opportunity.

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