Thursday, February 4, 2016

Cardiac Device Gets "Substantial Benefit" from CMS, But MACs Block Coverage of Claims

CardioMEMS is a sophisticated heart failure monitoring device which won the rarely awarded endorsement of "substantial clinical benefit" from the CMS DRG system.  However, some MACs have declined to cover the device.

CardioMEMs is a sophisticated electronic implantable cardiac monitoring device for managing patients with heart failure (home page here).  It won a difficult-to-obtain new technology inpatient add on payment, or NTAP, from CMS.  (A St. Jude Medical PDF explaining the payment status is online here; a CMS PDF here.)   This payment category requires both novelty and a "substantial clinical benefit."

According to the CardioMEMS website:

The CardioMEMS™ HF System is the first and only FDA-approved heart failure (HF) monitoring system proven to significantly reduce HF hospital admissions and improve quality of life in NYHA class III patients.

Fierce Medical Devices reports that one MAC (First Coast, Florida) has published a non coverage LCD and another MAC has promulgated one (see story here).   According to the story and the transcript of the St. Jude CEO's January 2016 earnings call (here; brief excerpt here), the company has petitioned CMS for a uniform national coverage determination, or NCD, which would override the local policies.  An NCD can require a year or more to complete.

In September 2015, the Institute for Clinical and Economic Review in Boston issued a report that CardioMEMS was unusually expensive in cost/benefit terms (press here, ICER topic page here.   See however St. Jude's response here).

The CMS Final Rule providing the CardioMEMS pass through payment, and rationale for it, is here or here (full rule); see pages 49937ff also in the cloud here.

A FCSO MAC Article "Noncovered Services" was updated as recently as 1/21/2016 and lists CardioMEMS as non covered, here:

...First Coast is not responsible for the continued viability of websites listed. The following is a list of the references that were reviewed and considered for each service or item added to the Noncovered Services LCD.
C2624/C9741 Right heart catheterization with implantation of wireless pressure sensor in the pulmonary artery, including any type of measurement, angiography, imaging supervision, interpretation, and report, includes provision of patient home electronics unit.
CARDIOMEMS™, PA Sensor and Delivery System Model CM2000.  
     User’s Manual. Retrieved on September 11, 2014 from the FDA site.
     ...O’Riordan, M. (2013). “CARDIOMEMS HF Implant Narrowly Passes FDA Advisory”. Medscape Multispecialty. Retrieved September 17, 2014.]