A Medical Device Daily

The Centers for Medicare & Medicaid Services (CMS) 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 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 (AHRQ) 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 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.

FDA issues 2nd fentanyl patch warning

The FDA issued its second safety warning about the fentanyl transdermal system, an adhesive patch that delivers a potent pain medicine through the skin. In July 2005, the agency issued a similar warning to the public and to healthcare providers, saying that the directions on the product label and on the patient package insert should be followed exactly in order to avoid overdose (Medical Device Daily, July 19, 2005).

FDA said it has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it.

In addition, the agency is asking manufacturers of all fentanyl patches to update their product information and to develop a medication guide for patients.

The fentanyl skin patch contains the opioid fentanyl, a potent narcotic. The skin patch was approved by FDA in 1990 for use in patients with persistent, moderate-to-severe pain who have become opioid tolerant – meaning that they have been using another strong opioid narcotic pain medicine around-the-clock, and have been using the medicine regularly for a week or longer. The skin patch is most commonly prescribed for patients with cancer.

Recent reports to FDA describe deaths and life-threatening side effects after doctors and other healthcare professionals inappropriately prescribed the patch to relieve pain after surgery, for headaches, or for occasional or mild pain in patients who were not opioid tolerant. In other cases, patients used the patch incorrectly: The patients replaced it more frequently than directed in the instructions, applied more patches than prescribed, or applied heat to the patch – all resulting in dangerously high fentanyl levels in the blood.

“There is an unmet need to provide patients suffering from chronic pain with safe and effective products that will not only alleviate their pain, but that will also be tolerable when used chronically,” said Bob Rappaport, MD, FDA’s director of the Division of Anesthesia, Analgesia and Rheumatology Products. “While these products fill an important need, improper use and misuse can be life-threatening. Therefore, it is crucial that doctors prescribe these products appropriately and that patients use them correctly.”

The fentanyl skin patch is marketed under the brand name Duragesic by Johnson and Johnson (New Brunswick, New Jersey), and generic versions of the product are sold by other manufacturers.