March 28, 2019

Medicare Reduces Payments to 800 Hospitals Citing Patient Safety Incidences

Medicare announced on March 1, 2019, that 800 hospitals will be paid less by Medicare this year because of high rates of infections and patient injuries. The number is the highest since the federal government five years ago launched the Hospital Acquired Conditions (HAC) Reduction Program, created by the Affordable Care Act. This year, 110 hospitals are being punished for the fifth straight time. The penalties pit hospitals against one another in a race to prevent the most infections, blood clots, cases of sepsis, bedsores, hip fractures and other complications. Each year, the quarter of general hospitals with the highest rates are punished, even if their records have improved from the previous year. Under the announced sanctions, each hospital will lose 1 […]
March 28, 2019

FDA Announces Sweeping Plan To Review Safety Of Surgical Staplers

The FDA Food and Drug Administration announced a sweeping plan on March 8, 2019, to review and address the safety of surgical staplers. In a letter sent to health-care providers Friday, the FDA said it will convene an advisory meeting on the safety of the devices and signaled that it might reclassify surgical staplers to put them under tighter control. The agency also said it plans to issue proposed recommendations to companies that make the devices, which are used in countless surgeries. The FDA also acknowledged in its letter that “we are aware that many more device malfunction reports during this time frame” were submitted as “summary reports,” which go to the FDA but are not included in the public database known […]
February 13, 2019

Vertebral Augmentation: Coverage Indications, Limitations, and/or Medical Necessity

Vertebral Augmentation: Coverage Indications, Limitations, and/or Medical Necessity OLIVIER CLERK-LAMALICE,1 DOUGLAS P. BEALL,2 KEVIN ONG,3 MORGAN P. LORIO4 1Western Canada Pain Institute, Edmonton, Alberta, Canada, 2Clinical Radiology of Oklahoma, Edmond, Oklahoma,3Exponent, Inc., Philadelphia, Pennsylvania, 4Hughston Clinic Orthopaedics—Centennial, Nashville, Tennessee ABSTRACT The ISASS Policy Statement on vertebral augmentation has the objectives to provide a background and an update with the latest clinical evidence for the international spine community. A SpineLine Panel Review (2010) appropriately recommended an exploration of ‘‘the seeming disconnect between the conclusions of . . . two [Level I] PRCT’s and previous experience and data’’ regarding vertebral augmentation. ISASS responded by supporting a comprehensive meta-analysis to help frame a cogent historical analysis of vertebral augmentation. This ISASS Policy 2018 […]
January 30, 2019

ISASS Recommendations and Coverage Criteria for Bone Graft Substitutes used in Spinal Surgery

ISASS Recommendations and Coverage Criteria for Bone Graft Substitutes used in Spinal Surgery CELESTE ABJORNSON, PHD,1 ANTONIO BRECEVICH, MD,1 TUCKER CALLANAN, MS,1 CHRISTINA DOWE, BS,1 FRANK P. CAMMISA, JR, MD,1 MORGAN P. LORIO, MD, FACS2 1Hospital for Special Surgery, New York, New York, 2Hughston Clinic Orthopaedics, Nashville, Tennessee   INTRODUCTION Over the past 3 decades, there has been an increased interest in bone grafting materials as these materials have become a vital part of most spinal procedures. Unlike other areas of orthopedics, spinal surgery often requires grafting procedures to induce de novo bone in an area stabilized by metal devices. When considering potential graft materials, assuming an adequate blood supply, it is important to note that a successful graft needs […]