News

Philips Urges CMS to Withdraw Proposal to Reduce Cardiac CTA Coverage

January 14, 2008

 

Joseph Chin, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

 

ELECTRONICALLY SUBMITTED
Subject: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

 

Dear Dr. Chin:

Philips Healthcare (Philips) strenuously urges CMS to reconsider its proposed Decision Memo for [Cardiovascular] Computed Tomographic Angiography (CCTA). Philips operates in five main business areas:  Diagnostic Imaging Systems, Clinical Solutions, Healthcare Information, Customer Services and Home Healthcare Solutions.  Our product line includes best-in-class technologies in X-ray, ultrasound, magnetic resonance, computed tomography, nuclear medicine, PET, radiation oncology systems, patient monitoring, information management, personal emergency response systems, and resuscitation products.  Of greatest relevance to the issue here, Philips is a market leader in the manufacture and distribution of the medical equipment and related services used in the provision of CCTA.

 

Undoubtedly, CCTA represents one of the most important advances in the diagnosis of coronary artery disease in recent years.  We are extremely concerned that the Proposed Decision Memo, if finalized without change, will eliminate Medicare patients’ access to this important diagnostic service even in those areas where, after careful consideration of the overwhelmingly favorable results reported in peer-reviewed medical journals, local carriers have decided to allow coverage for particular CCTA indications through well-researched and thoughtful local coverage determinations (“LCDs”).

While the proposed Decision Memo would authorize coverage of CCTA for the diagnosis of Coronary Artery Disease (CAD) when the CCTA is performed in conjunction with certain clinical trials, in light of the resources likely to be involved in designing the trials and the time likely to be involved in obtaining agency approval and funding, the Proposed Decision Memo is the functional equivalent of a negative national coverage determination.  In this regard, we note that, while the Proposed Decision Memo appears to condition coverage on a provider’s participation in data-gathering, it does not appear to have been developed in a manner consistent with the “Guidance for the Public, Industry, and CMS Staff; National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development [CED]”(“Guidance Document”) which was issued on July 12.  The Guidance Document, which was developed through a long and painstaking process involving extensive public comment, outlines two different types of Coverage with Evidence Development (CED)—Coverage with Appropriateness Determination (CAD) and Coverage with Study Participation (CSP).  The Proposed Decision Memo fails to even acknowledge the applicability of the Guidance Document and appears to require data gathering that intertwine elements of a CAD and a CSP in a manner that is likely to prove extremely difficult to implement. Moreover, the decision letter, as it stands, suggests that coverage may be provided only in the setting of a randomized trial.  This restriction will preclude participation of patients who may benefit from access to this technology according to the appropriateness criteria established by the ACC/AHA/ACR, but who do not meet all of the inclusion/exclusion criteria established for participating in a particular study or for whom randomization to an alternative diagnostic strategy may be inappropriate. 

 

For the reasons set forth below, we respectfully request that CMS withdraw the proposed Decision Memo and continue to authorize coverage of CCTA based on local carrier policies. If CMS is unwilling to do so, we request that CMS, at the very least:

 

• Reconsider using health care outcomes as an endpoint in making coverage decisions for diagnostic technologies, such as CCTA.  It is inappropriate to require that a diagnostic technology, such as CCTA, demonstrate “improved patient health outcomes” –especially for complex diseases, such as CAD—which are difficult to diagnose and manage.  In fact, numerous factors contribute to ultimate health outcomes, including most prominently the quality and efficacy of the available therapies available and patient compliance with medication and other instructions provided by health care professionals.
  
  In this regard, please note that the Medicare Act does not cover only those diagnostic services that can demonstrate that they are “reasonable and necessary for “improved patient health outcomes” but rather those that are “reasonable and necessary” for (among other things) the diagnosis of disease or injury.  To determine whether the “reasonable and necessary” standard is met, the appropriate question is whether CCTA has the potential to facilitate diagnosis of CAD or other cardiac conditions with a high degree of sensitivity and specificity, and whether it provides valuable information that may affect clinical decision-making—not whether CCTA can be demonstrated to result in “improved health outcomes
  
  
• Conduct a more thorough and objective review of the clinical literature and other available data on the clinical utility of CCTA in the diagnosis of CAD, and especially the negative predictive value of 64 slice CCTA.    We are particularly disturbed that the clinical literature review conducted by CMS generally fails to adequately distinguish 64 slice CCT/CCTA from older technologies. The Proposed Decision Memo’s mega-analysis generally lumps all published studies (including outdated studies of the sensitivity and specificity of  4 and 16 slice equipment), thereby seriously distorting the assessment of sensitivity and specificity of the more recent and advanced CCTA technologies.  Moreover, CMS’s clinical literature review is highly selective.  For example, while the Proposed Decision Memo suggests that CMS is particularly interested in the clinical utility of CCTA in the emergency room, the Proposed Decision Memo does not cite the available emergency medicine literature. Perhaps most importantly, however, the Proposed Decision Memo fails to give appropriate weight to CCTA’s extraordinary negative predictive value.  In fact, every 64 slice study CMS cites shows extraordinarily high NPV (Ehara 95%, Ropers 100% per segment, Heuschmid 99%, Weustink 95%, Scheffel 99.4%, Olivetti 97.3%).  Thus, not only does CMS fail to cite much of the available clinical literature, the clinical literature that the agency does cite clearly establishes that at least the more advanced CCTA technology is a highly effective non-invasive tool for diagnosing CAD. Hundreds of studies evaluating the clinical utility of 64-slice CCTA were not included for review for the proposed NCD.  These are detailed in the comments submitted by the ACC, ACR, SCCT, ASNC, NASCI, and SCAI. 
  
  For these reasons, we urge CMS to revisit its analysis of the clinical literature to ensure that (a) 64 slice technology is reviewed separately; (b) all of the available data—both published and unpublished—is taken into account; and (c) the negative predictive value of CCTA is given appropriate weight.

• Specifically confirm that any final decision in this matter will have no applicability to the use of CCTA or cardiovascular CT (CCT) in the diagnosis of cardiovascular conditions other than CAD, and direct carriers to continue current CCT/CCTA coverage policies for non-CAD indications.   For example, the Appropriateness Criteria approved by the ACC indicate that CTA/CCTA is clinically appropriate for the diagnosis of a number of cardiovascular conditions other than CAD.   While it appears that non-CAD indications for CCTA are excluded from the Proposed Decision Memo, we request that CMS specifically instruct local carriers that LCDs that provide CCTA coverage for non-CAD indications are to remain in effect.
  
  
• Retain coverage of CCTA for the diagnosis of CAD as established through LCDs, pending CMS approval of appropriate clinical trials (or a CCTA registry as described below) and enrollment of patients in those trials.  Unlike a number of other situations involving the CED process, which generally involve the expansion of Medicare coverage to a technology during the data-gathering phase, in this case, CMS is essentially proposing to withdraw coverage and to reverse many current LCDs. Recent discussions with CMS suggest that the agency has not yet considered a number of the very practical issues that may be involved in implementing the Proposed Decision Memo and that it may be quite some time until the agency is truly prepared to approve the clinical trials that the proposed Decision Memo calls for, institute a mechanism for tracking enrollment and coverage, or define the necessary burden of proof that clinical investigators will be required to meet to obtain approval. Any delay in approving or implementing the required clinical trials will deprive Medicare beneficiaries of access to an enormously powerful diagnostic tool in the face of impressive (and growing) clinical literature demonstrating CCTA’s utility.  Extending CCTA coverage based on current LCDs will not only facilitate the accumulation of additional data on the clinical utility of CCTA outside of the context of CED process, but will also provide CMS an incentive to establish an effective clinical trial approval process quickly.  For similar reasons, we urge CMS to retain the CCTA coverage policy established under the local LCD in any carrier jurisdiction where an approved clinical trial is not open for enrollment.

• Consider requiring participation in a national registry in lieu of enrollment in a CMS-approved clinical trial. As discussed above, the Guidance Document outlines two very different types of CEDs: CADs and CSPs. In the case of CAD, CMS has decided that there is adequate evidence to determine that an item or service is covered, but that additional clinical data is needed that is not routinely available on claims forms to ensure that the item or service is being provided to appropriate patients. When an NCD requires CAD, only items or services for patients who are included in the data collection are covered; accordingly, a number of the CEDs that mandate participation in a registry as a precondition of coverage are CADs. By contrast, a CSP may be appropriate for less developed technologies for which the evidence is not adequate to support coverage, but where additional data gathered in the context of a controlled clinical trial would be helpful.  Thus, a CSP requires a provider to participate in a CMS-funded clinical study as a precondition of coverage of an otherwise uncovered technology. While the proposed Decision Memo does not refer to these two types of CEDs (or otherwise acknowledge the Guidance Document at all), it appears to follow the data-gathering model applicable to a CSP rather than a CAD, by requiring provider participation in clinical studies approved by CMS, rather than registry participation.

We believe that, to the extent that CMS determines that additional evidence is necessary as a precondition of coverage of CCTA for CAD, a CAD, rather than a CSP is appropriate. There is clearly a great deal of clinical literature that supports the negative predictive value of CCTA in the diagnosis of CAD; in our view, there can be no serious question about whether CCTA is “reasonable and necessary” for the diagnosis of CAD and therefore eligible for coverage.  The real questions relate to the types of circumstances under which CCTA should be used, as opposed to alternative diagnostic modalities.  It is precisely this type of question that a CAD (which generally requires participation in a patient registry) is designed to answer.  is g that CMS has accepted a registry approach for a number of technologies that were determined to be appropriate for CED, and this approach has the potential to gather the needed data on the clinical utility of CCTA in ruling out the need for diagnostic cardiac catheterization and in reducing the need for more costly nuclear studies in intermediate risk patients with suspected CAD.  The registry approach is likely to require far fewer agency resources on an ongoing basis, and is likely to gather the necessary clinical data far more quickly and effectively.  Unlike a clinical trial approach, which by definition involves a limited number of investigators and sites, a national registry could be made available on a national basis, in a broad range of practice settings and patients with a broad array of symptoms and Framingham scores.

 

In short, we respectfully request CMS to withdraw the proposed Decision Memo and to allow CCTA in accordance with current LCDs. To the extent that CMS determines that additional evidence of the clinical utility of CCTA in the diagnosis of CAD is necessary, we urge the agency to adopt a CED that allows payment to providers who participate in a national registry, with LCDs remaining in effect pending the registry’s establishment.

 

We appreciate the opportunity to comment on this important issue.

 

Sincerely,

 

Laurel Sweeney
Sr. Director, Reimbursement & Legislative Affairs
Philips Healthcare
3000 Minuteman Road
Andover, MA  01810

(978) 659-2972

laurel.sweeney@philips.com

 

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¹ These include, for example: Evaluation of suspected coronary anomalies;  Assessment of complex congenital heart disease including anomalies of coronaries, great vessels, and cardiac chambers and valves;. Evaluation of coronary arteries in patients with new onset heart failure to assess etiology;  Evaluation of cardiac mass;  Evaluation of pericardial conditions;  Evaluation of pulmonary vein anatomy prior to invasive radiofrequency ablation for atrial fibrillation; Non-invasive coronary vein mapping prior to placement of biventricular pacemaker; Noninvasive coronary arterial mapping, including internal mammary artery, prior to repeat cardiac surgical revascularization; Evaluation of suspected aortic dissection or thoracic aortic aneurysm; and  Evaluation of suspected pulmonary embolism.  Furthermore, the American Heart Association (AHA) has published a Scientific Statement on CCT, which accepts CCT as an appropriate imaging modality in the workup of known and suspected coronary anomalies as a Class IIa indication, in addition to assessment of obstructive disease in symptomatic patients (also Class IIa). See Budoff MJ, Achenbach S, Blumenthal RS, et al. A Scientific Statement from the American Heart Association Committee on Cardiovascular Imaging and Intervention, Council on Cardiovascular Radiology and Intervention, and Committee on Cardiac Imaging, Council on Clinical Cardiology. AHA Scientific Statement: Assessment of Coronary Artery Disease by Cardiac Computed Tomography. Circulation. 2006; 114:1761-1791

 

² The Guidance Document states that some concerns that may lead to a coverage decision that requires CAD as a condition of coverage include the following:

1. If the newly covered item or service should be restricted to patients with specific conditions and criteria.
2. If the newly covered item or service should be restricted for use by providers with specific training or credentials.
3. If there is concern among clinical thought leaders that there are substantial opportunities for misuse of the item or service.
4. If the coverage determination significantly changes how providers manage patients utilizing this newly covered item or service.

 

These are the types of concerns that have been the focus of consideration for CCTA.