Dear colleagues,

I am writing to you about a critical development pertaining to cardiac CT that occurred silently 2 weeks ago as the medical community went into the holiday break.

What happened?
On Dec 13, 2007, the Centers for Medicare and Medicaid Services (CMS) released a proposed NCD (National Coverage Determination) for Cardiac CTA coverage that is extremely restrictive and a ruling that is unprecedented in Cardiology. (http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=206)

In short, no widely-used imaging modality in the last five decades had to deal with an NCD that was so premature or so restrictive as to severely deny access to technology for Medicare beneficiaries.

Briefly, the new proposal eliminates payment for coronary CTA from March 2008 onward unless the CTA 

  • Is done as a part of a registered clinical trial (approved by the CMS)
  • Is done for only 2 indications as noted below. 
    • symptomatic patients with chronic stable angina at intermediate risk for CAD
    • symptomatic patients with unstable angina at low-intermediate risk for CAD

This development falls into the category that CMS calls Coverage with Evidence Development (CED).   This means that anytime you would like to request coronary CTA for patient care you will need to consent the patient for a research study and have the resources to support the study. 

CMS is proposing that covered clinical studies would be required to address one or more of the following questions:

  • Does Cardiac CTA have the ability to diagnose or exclude coronary artery disease as well as invasive coronary angiography?
  • Does Coronary CTA reduce the need for invasive coronary angiography?
  • Does Coronary CTA improve health outcomes for patients with acute chest pain who present in the emergency room or other setting?

Is there a precedent to this development?
The new proposed expectations of CMS are unprecedented across all of cardiology practice or in diagnostic imaging in general for a widely used imaging modality. Specifically, the new proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CTA is applied in the clinical setting and long-term data is collected and analyzed. However, CMS is effectively eliminating that possibility by closing the door at the outset even before long-term outcome data could be collected in the clinical setting.  Simply stated, these rules did not exist for echocardiography, nuclear Cardiology or cardiac MRI making it possible to collect outcomes data over the long term.

What is a simple concept that CMS overlooked?
CMS chose to overlook a key concept: that robust supportive evidence for cardiac CT is accumulating at such a rapid pace (unlike any other imaging modality in the past) that it is premature to jump to a NCD especially when all 50 states have approved LCDs in place.  Leaving these LCDs in place would allow for this unprecedented collection of data while allowing access to Medicare beneficiaries to cutting-edge technology that reduces costs and complications by avoiding invasive evaluation in patients at intermediate risk for CAD and avoiding layering of tests. In fact, there has not been a single published study which shows that CTA leads to layering of tests or increases costs or complications when applied in the real world. 

What data is already available with cardiac CTA?
Data is already available about improved short-term health outcomes compared to avoiding complications related to invasive angiography, data about significantly reduced need for invasive angiography along with cost savings, data related to high negative predictive value of coronary CTA (99% NPV) and data related to safety of this technology when applied in multi center trials in the real world.  However, CMS did not consider these studies in their review. In addition, CMS also did not include several key studies with 64 slice CT scanners that were published in 2006 and 2007 (>25 studies) and chose to rely heavily on old data and data from an old TEC analysis performed by Blue Cross Blue Shield.

What does this mean for our patients?
If this proposed NCD goes into effect after March 13, 2008, it will severely limit Medicare beneficiaries’ access to Cardiac CTA for the diagnosis of CAD unless the patients are willing to pay for the option of non-invasive coronary angiography. Your patients may need to pursue other more expensive and invasive modalities with added risks.  A simple example may be the need to refer symptomatic patients for diagnostic angiography when there are equivocal, mildly positive or suspected inaccurate stress tests which could be very easily evaluated by non-invasive angiography. 

It is expected that cardiac CTA for other indications at this time (EP, structural heart disease, congenital anomalies, and vascular studies) will not be affected and will remain at the discretion of the local coverage determination of our Medicare intermediary.    

What can we do now?
The proposed NCD is open for a 30-day public comment period that ends on Jan 12, 2008.   I therefore urge you all to post comments on the CMS website ASAP.  It is important that the voice of the physicians who regularly use CTA to enhance diagnostic evaluation and those of patients that benefit from this evaluation be heard now. We also hope to request our patients to share their individual stories with Medicare about this issue. Please review comments at this site (http://www.cms.hhs.gov/mcd/viewpubliccomments.asp?nca_id=206)

And then submit your comments HERE.

What are the important points to include in your comments? (Consider personalizing these comments as there are many variations that may ring true based on your experience)

  • CMS has not examined the full impact this proposal will have on the Medicare beneficiary. If the driver for this proposal is the fear of misuse of a technology, there is no credible published evidence to substantiate that from any 3rd party payers (Medicare or Private insurance). Imposing such sudden restrictive rules and guidelines on the presumption of abuse or harm to Medicare beneficiaries when there is a rapidly accumulating wealth of literature to the contrary runs the risk of suffocating a rapidly evolving technology.
  • The CMS proposal unfairly excludes Medicare beneficiaries access to cutting edge medical care that is already approved by a majority of large 3rd party payers that have and continue to carefully review the evidence to date. We request a similar approach by the CMS.
  • It is premature to propose a new set of coverage criteria without a thorough review of the available published evidence. This is especially true as data is rapidly accumulating for CCTA and at a much faster pace than many other  imaging based indications  approved by CMS. A large number of studies cited in the CMS report are based on older technology or depend on expert reviews which did not include the state-of-the-art-literature.
  • Request CMS to allow the coverage to remain at the local level until requirements outlined by the CMS are met and in the interim continue to work with all parties involved to facilitate the process with meaningful deadlines, data collection points and timelines for clinical trial development and approval process.
  • Request CMS to work with specialty multidisciplinary societies (SCCT, ACC, and ACR) to define the appropriate indications for CCTA and to better develop criteria for the types of clinical research that are appropriate for CED to minimize the impact on the delivery of appropriate care to beneficiaries.

CMS is accepting comments from all concerned parties until Jan 12, 2008. After this comment period we will wait for 60 days before knowing if CMS will be willing to modify or postpone the new ruling. Thank you.