Medical device recalls nearly double over decade   03/24/2014
The annual number of medical device recalls increased by 97% between fiscal years 2003 and 2012, to 1,190, according to a new report from the Food & Drug Administration’s Center for Devices and Radiological Health. “The most frequent causes for recalls are related to device design, software, and non-conforming material or component issues,” the report states. “If industry and CDRH can address these problems jointly, we may be able to prevent as many as 400 recalls each year.” The number of Class I recalls, the highest risk category, rose from 7 in FY 2003 to 57 in FY 2012, while Class II recalls rose from 460 to 1,043. The report attributes the increase largely to greater focus and attention on improving product quality in certain areas, including radiology devices, ventilators, infusion pumps and external defibrillators.
Deadline for low-volume payment adjustment approaching   03/24/2014
Eligible inpatient prospective payment system hospitals must notify their Medicare Administrative Contractor before April 1 to receive a six-month extension of the low-volume payment adjustment under the Pathway for SGR Reform Act of 2013. Under an interim final rule released this month, hospitals that qualified for the low-volume adjustment in fiscal year 2013 and continue to meet the relevant discharge and distance criterion may receive the adjustment for discharges through March 31, 2014 without reapplying. However, they must notify their MAC in writing and provide documentation that they remain more than 15 miles from another IPPS hospital. Hospitals that did not receive the low-volume adjustment in fiscal year 2013, but wish to apply now, must also request low-volume hospital status by March 31, 2014. For more information, see the Medicare Learning Network article and AHA Special Bulletin.
Reminder: IPPS hospitals can apply through April 1 for EHR hardship exception   03/24/2014
Hospitals paid under the Medicare inpatient prospective payment system can apply through 11:59 p.m. ET April 1 for a hardship exception under the Medicare Electronic Health Records Incentive Program. IPPS hospitals that did not attest to meaningful use of EHRs in fiscal year 2013, or do not plan to attest to meaningful use for the first time by July 1, will have their payments reduced in fiscal year 2015 unless they receive a hardship exception. IPPS hospital applications for hardship exceptions, which the Centers for Medicare & Medicaid Services will consider on a case-by-case basis, should be emailed by April 1 to or faxed. Critical access hospitals have until Nov. 30, 2015 to apply for a 2015 hardship exception. For more information, visit
IL hospitals contribute $83.4 billion a year to states economy   03/24/2014
Illinois hospitals and health systems generate $83.4 billion a year and nearly 450,000 direct and indirect jobs for the state’s economy, according to a new report by the Illinois Hospital Association. “We realize that the state and federal governments face fiscal challenges,” said IHA President and CEO Maryjane Wurth. “However, any further Medicare and Medicaid cuts will undermine hospitals and health systems as they create jobs and transform health care delivery.”