COVERAGE WITH EVIDENCE DEVELOPMENT FOR CARDIAC COMPUTED TOMOGRAPHIC ANGIOGRAPHY PROPOSED BY MEDICARE
The Centers for Medicare & Medicaid Services (CMS) today proposed coverage for the use of cardiac computed tomographic angiography (CTA) in Medicare beneficiaries with two clinical indications of coronary artery disease (CAD), under the Coverage with Evidence Development process. CTA has been developed for evaluation of the coronary arteries in patients with chest pain.
The proposed National Coverage Determination issued today defines the questions that studies must address and the standards those studies must meet as a condition of coverage. Both CMS and the Agency for Healthcare Research and Quality believe these questions and standards meet the requirements of Section 1862(a)(1)(E) of the Medicare statute, which allows coverage in connection with certain medical research when the evidence for coverage is still preliminary but promising.
“Our proposed policy provides consistent coverage and uniform access to computed tomographic angiography for Medicare beneficiaries while stimulating the additional research needed to develop evidence on patient outcomes,” said CMS Acting Administrator Kerry Weems. CMS proposes that the risk of CAD be determined by the Framingham risk score, developed by scientists using information from a major NIH-sponsored study.
CTA generally describes noninvasive imaging of the arteries with various types of computed tomography (CT) machines, such as multislice CT (MSCT), multidetector CT (MDCT), and dual source CT (DSCT). The use of CTA has increased in recent years due to advances in the technology and rapid utilization of the machines outside the hospital setting.
The CMS proposes to cover CTA when performed as part of a qualified research study using 32-slice or higher CT equipment to evaluate:
· Symptomatic patients with chronic stable angina at intermediate risk of CAD; or
· Symptomatic patients with unstable angina at a low risk of short-term death and intermediate risk of CAD.
The types of questions studies must address as a condition of coverage include:
· 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?
Proponents of the imaging procedure believe that coronary CTA may reduce the need for invasive coronary angiography for certain patients. However, others have noted a lack of evidence on outcomes and limitations in the technology, including segments that may be uninterpretable and health risks from the radiation exposure.
The CMS plans to issue a final national coverage determination in March 2008. CMS invites public comments on its proposed decision, which is available on the CMS Web site at http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=206. Instructions for the submission of comments may be found at https://www4.cms.hhs.gov/InfoExchange/02_publiccomments.asp#TopOfPage