Knowledge Base Article

The human race continues to make amazing strides in technology that are wondrous and change the very ways we live and even how long we may live. There are devices that monitor how many steps we take in a day, that allow us to control our home electrical systems from our smart phones and that track our “global positioning” wherever we go. And in the medical realm, there is a new FDA-approved device to clip mitral valve leaflets together and potentially prevent the heart failure that could result from mitral regurgitation. This device is inserted via a Transcatheter Mitral Valve Repair (TMVR) procedure.

A National Coverage Determination (NCD) for coverage of TMVR was announced in MLN Matters Article MM9002 effective for dates of service on and after August 7, 2014. Medicare will cover TMVR for treatment of Mitral Regurgitation (MR) when furnished under Coverage with Evidence Development (CED). This means that patients receiving this procedure must be entered into a national qualified registry or part of a FDA-approved, randomized clinical trial.

Some of the requirements for coverage of TMVR for mitral regurgitation include:

• The TMVR procedure must be performed by an interventional cardiologist and/or cardiac surgeon
• For treatment of significant, symptomatic, degenerative mitral regurgitation for FDA-approved indication or for non-listed indications for MR within context of approved clinical trial
• Face-to-face examination and evaluation of patient prior to TMVR by cardiac surgeon and cardiologist experienced in mitral valve surgery with documentation of their decision and rationale
• Performed in a hospital with appropriate infrastructure and with a surgical program, interventional cardiology program, and heart team that meets certain specific requirements. There are numerous and very detailed requirements that the hospital must meet – refer to the NCD for the specifics of these requirements.

TMVR is non-covered for the treatment of MR when not furnished under CED according to the NCD criteria. TMVR used for the treatment of any non-MR indications are non-covered by Medicare.

Hospital Claim Requirements

This is an inpatient-only procedure. Hospital inpatient claims (11x type of bill) must contain:

• ICD-9 Procedure Code - 35.97 - Percutaneous mitral valve repair with implant
• ICD-9 Diagnosis Code for TMVR for MR Claims is - 424.0 – Mitral valve disorder
• Secondary ICD-9 diagnosis code V70.7
• Condition Code 30
• An 8-digit National Clinical Trial Number

For complete information, including instructions for physician claims, see the MLN Matters article referenced above.

This month’s coverage updates include a number of retired LCDs from the MACs within our client regions and Palmetto finalized the LCD on Wound Debridements. Please refer to our coverage article from July 2014 for more information about the various wound care/debridement local coverage policies.