June 27, 2019

ACR Assists Effort to Develop LCD for Fractional Flow Reserve CT

Cardiac CT (CCT) and vascular radiologists representing the American College of Radiology (ACR) participated in a second multi-jurisdictional Contractor Advisory Committee (CAC) meeting convened June 18 by Medicare Administrator Contractor (MAC) Noridian Healthcare Solutions to discuss the clinical value of fractional flow reserve CT (FFRct) for future Local Coverage Determination (LCD) development.

FFRct is a non-invasive CT technique similar to an invasive technique originally developed in the cardiac catheterization lab. It uses mathematical modeling of blood flow to predict the hemodynamic significance of coronary stenoses.

CAC members and designated subject matter experts (SMEs) reported on the strength of the published peer-reviewed clinical literature for FFRct. Medicare contractors often seek clinical advice from CAC representatives and SMEs for draft LCD development. CAC representatives do not make coverage determinations, but MACs benefit from their input and advice. Noridian is Medicare’s administrative contractor for 13 western states and three U.S. territories.

The following questions were distributed for considerations before the web conference:

  • Is FFRct a reliable reflection of fractional flow reserve as determined by catheterization and pressure wire assessment?
  • Is there a standard definition of intermediate coronary stenosis (40 to 70 percent of luminal narrowing by visual assessment of an epicardial stenosis measured in the “worst view” angiographic projection)?
  • What are the relative values of non-invasive stress imaging and FFRct in the assessment of stable ischemic heart disease?
  • It has been reported that FFRct is of limited value in patients with body mass indexes (BMI) of greater than or equal to 35. Are there other physical limitations or patient characteristics to be avoided with this technology?
  • Does the general consensus regarding CCTA findings of high-risk lesions, low-risk lesions and more than 2 intermediate risk lesions preclude FFRct analysis?
  • Is there a standard clinical definition of low to intermediate risk patients for CAD?
  • Should risk factor assessment factor into the ordering of FFRct or should its use be based on anatomic criteria?
  • What is the clinical utility of performing this test on an asymptomatic patient with risk factors?

ACR cardiac CT experts contributed facts and informed opinions during the two-hour call facilitated by Internist Laurence J. Clark, MD, FACP, a contractor medical director with National Government Services. The meeting featured a robust discussion of the key questions, with descriptions of additional supportive outcome data and evidence regarding the value of FFRct from radiology and cardiology subject matter experts during the call.

Planned future steps and key dates include the following:

  • An opportunity to submit comments or additional references/studies in writing to Noridian. They will be taken into consideration when the draft LCD is written. Comments may be submitted to policydraft@noridian.com. Noridian plans to hold an open meeting in October to present the draft FFRct LCD.
  • A 45-day comment period beginning with the open meeting in October. Comments on the draft LCD must be submitted in writing.
  • Final LCD preparation and a “Response to Comment” article published within a year of the comment period deadline.
  • The final LCD and RTC article are published on the Medicare Coverage Database (MCD), and a notice article is published on the Noridian website. A 45-day notice period begins; the policy is effective on day 46.

The ACR applauds Noridian for stepping forward to develop an explicit policy for category III CPT codes for FFRct. The College thanks cardiac CT and imaging payment policy experts Mark Alson, MD, FACR; Sammy Chu, MD, FACR: Diana Litmanovich, MD; Geoffrey Rubin, MD, MBA, FACR; Joseph Schoepf, MD, FACR; Pamela K. Woodard, MD, FACR; Mark Yeh, MD, FACR; Kent Yucel, MD, FACR and Robert K. Zeman, MD, FACR.

The ACR staff and the CAC network will continue to track development of a draft LCD for FFRct.

Questions and comments may be directed to Alicia Blakey, ACR economics and health policy analyst.