CMS Proposals Would Revise End-Stage Heart Failure Device Coverage

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The Medicare agency has proposed revised coverage determinations for artificial hearts and LVADs that CMS says better align with advancements in heart failure device technology, evolving patient indications, and professional guidelines. Here, two industry stakeholders comment on the contentious points in both proposals, with a final CMS decision due in mid-November.

Heart failure (HF) is the leading cause of hospitalization among older adults, and Medicare beneficiaries with this often-progressive disease have the highest readmission rate of any health condition, according to CMS. Two important mechanical circulatory support technologies that are used in the management of end-stage HF, ventricular assist devices (VADs) and total artificial hearts (TAHs), are now being examined for possible coverage policy updates by CMS, with the goal of providing additional flexibility for patients and providers to choose the most appropriate treatment as technology has evolved.

In the case of artificial hearts, CMS proposes to eliminate the existing national coverage determination (NCD) for these devices and end coverage with evidence development (CED), permitting coverage determinations to be made by Medicare Administrative Contractors (MACs) instead.

With VADs, the agency proposes to remove current intent-to-treat criteria for bridge-to-transplant (BTT) and destination therapy (DT), and to extend evidence-based patient-selection criteria, that previously applied only to DT, to all LVAD procedures for short- and long-term mechanical support.

More than 40 industry stakeholders, including AdvaMed, physicians, medical centers, health systems, professional societies including the Society of Thoracic Surgeons (STS), American College of Cardiology, Heart Failure Society of America, American Association for Thoracic Surgery, and American Heart Association, device manufacturers including Abbott Laboratories Inc., Medtronic plc, SynCardia Systems LLC, Berlin Heart GmbH, and Carmat SA, submitted responses during the most recent public comment period that ended on September 11. Overall, respondents cited their support of the updated NCD, but there was also general disagreement with a few revisions that CMS is proposing. An initial comment period following the issuance of the national coverage analysis (NCA) ran from February 3 to March 4, 2020. The policy updates, if approved, will become effective for Medicare beneficiaries on the date of publication of the final NCD in mid-November.

Market Pathways spoke with two key participants in these important NCDs: Chandra Branham, Vice President of Payment and Healthcare Delivery Policy at AdvaMed who authored comment letters in March and September to CMS regarding these two NCDs; and Francis Pagani, MD, PhD, chair of the STS Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Database Task Force, a group of surgeons and cardiologists within STS that oversees the INTERMACS patient registry. Dr. Pagani, whose research is cited throughout the proposed NCD, is the Otto Gago MD Endowed Professor of Cardiac Surgery at Michigan Medicine at the University of Michigan, and head of the internationally recognized Michigan Medicine VAD Program.


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