A Medical Device Daily Staff Report

The FDA warned of potentially life threatening problems with inferior vena cava (IVC) filters. Since 2005, the FDA said it has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism (PE) has subsided.

FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient's risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.

IVC filters are small, cage-like devices that are inserted into the IVC to capture blood clots and prevent them from reaching the lungs. IVC filters are frequently placed in patients at risk for pulmonary embolism (a blood clot in the lungs) when anticoagulant therapy cannot be used or is ineffective. Some patients may require long-term protection from PE, and implantation of permanent IVC filters is often performed in these cases. Others only require short-term protection, in which case retrievable IVC filters are typically used, as these devices have the option to be removed once the patient's risk of PE subsides.

FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from PE is no longer needed.

CARE bill introduced in Senate

The Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy (CARE) bill (S. 3737) was introduced in the U.S. Senate by Sen. Mike Enzi (R-Wyoming), and Sen. Tom Harkin (D-Iowa) last week.

The CARE bill would ensure that basic minimum education and certification standards are established as part of the Medicare program for all medical imaging and radiation therapy personnel.

"ASRT believes that the best way to address concerns about health care quality, radiation safety and safe equipment operation is to enact the CARE bill," said American Society of Radiologic Technologists (Albuquerque, New Mexico) president Jim Temme. "We are encouraged that Sen. Enzi has introduced the CARE bill with Sen. Harkin, and we hope to see both the House and Senate take action on the bill before Congress adjourns in December."

Currently, basic educational standards for medical imaging and radiation therapy professionals are voluntary in many states, allowing some individuals to perform radiologic procedures without any formal education. Five states, along with the District of Columbia, are without any regulations regarding the qualifications of personnel performing medical imaging examinations.

In September 2009, the House CARE bill (H.R. 3652) was introduced by Rep. John Barrow (D-Georgia), and now has 117 bipartisan cosponsors.

Sens. Richard Burr (R-North CArolina), and Al Franken (D-Minnesota) are cosponsoring the CARE bill with Enzi and Harkin. The CARE bill has been referred to the Senate Health, Education, Labor and Pensions Committee.

FDA to host pediatric cardiac trials workshop

The FDA, with support from the American Academy of Pediatrics (AAP; Elk Grove Village, Illinois), the American College of Cardiology (ACC; Washington), Society for Cardiovascular Angiography and Interventions (SCAI; Washington), and the National Institutes of Health, is reporting a public workshop on clinical trials for the development of pediatric cardiovascular devices.

Rarely have devices been developed, evaluated and approved specifically for treatment of children with congenital heart disease. The small, heterogeneous population, need for long-term follow-up, lack of market incentive, and misperceptions of regulatory requirements and costs are a few of the issues that make a standard randomized control trial difficult to conduct in pediatric cardiology.

The purpose of the workshop is to solicit information from clinicians, academia, professional societies, other government agencies, and industry on various efficient and pragmatic clinical trial designs that are conducive to overcoming the challenges in developing devices for the pediatric cardiology patient population. The information gathered in this and future workshops will help to develop future guidance on optimal designs for pediatric cardiology device trials. The marketing approval of more cardiovascular devices specifically designed and/or labeled for pediatric patients would have a significant impact on public health.

The meeting will be held Sept. 30 at the Moscone Center in San Francisco.

CMS releases final PERM rules

As part of the Obama administration's enhanced efforts to reduce improper payments in Federal programs, the Centers for Medicare & Medicaid Services (CMS) yesterday issued the final regulations that will fully implement improvements to the Payment Error Rate Measurement (PERM) for Medicaid and the Children's Health Insurance Program (CHIP).

"Like other large federal programs, Medicare, Medicaid and CHIP are susceptible to errors or improper payments," said CMS Administrator Don Berwick, MD. "Reducing payment errors in federal programs is a key goal of the entire Obama administration and the rules we are issuing today – developed with feedback and input from states and other stakeholders – allow us to implement strategies for reducing the rate of errors in Medicaid and CHIP more effectively."

PERM measures improper payments in Medicaid and CHIP and produces national-level error rates for each program. These reviews are conducted to determine whether the sampled cases meet applicable Medicaid and CHIP fee-for-service, managed care, and eligibility requirements. Generally, PERM is conducted in 17 states annually; therefore a single state typically participates in the program once every three years.

With comments received from states, advocacy groups, and educational institutions, the final regulation implements changes to both programs required by the Children's Health Insurance Program Reauthorization Act (CHIPRA) of 2009, and makes other operational changes to the programs based on stakeholder feedback. The rule changes the process for reviewing cases in which states have used simplified enrollment efforts such as self-declaration for eligibility cases; eliminates duplication of effort between eligibility reviews administered in the same fiscal year; extends the timeframe for providers to submit documentation; and provides states additional time to submit corrective action plans.

As part of the federal-state partnership, CMS will conduct educational sessions with state oversight staff to ensure there is a complete understanding of the changes to the programs set forth by the final rule and will work with them on ways to further reduce payment errors in Medicaid and CHIP.

The entire 1,877-page report can be viewed at http://www.federalregister.gov/inspection.aspx#special.

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