Nikki Golden

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 […]
January 29, 2019
On January 18, 2019, the state of Washington’s State Health Authority Health Technology Assessment committee held an open public forum for stakeholders to provide feedback and input on the December 2018 draft report on Minimally Invasive Sacroiliac Joint Fusion (SIJ). Multiple stakeholders provided input, including ISASS member Dr. David Polly, who presented slides and clinical feedback to the assessment committee. The committee will take public comments into account and issue a final report in the coming weeks. Read the December 2018 draft report here: Read ISASS comment letter to November 2018 draft report here
January 29, 2019

U.S. Pain Management Task Force Releases Draft Report

The U.S. Department of Health and Humans Services (HHS) Pain Management Best Practices Inter-Agency Task Force recently released a draft report identifying gaps or inconsistencies and proposing updates to best practices and recommendations for pain management. The report comes after one year of regular meetings with the task force, which was authorized by section 101 of the Comprehensive Addiction and Recovery Act of 2016 (CARA). The group’s findings are critical for addressing the mounting public awareness of opioids and clinical efforts to reduce the number of opioids prescribed. The draft report released on Dec. 28, 2018, calls for individualized, patient-centered pain alleviation and management to improve the lives of those who experience acute and chronic pain. It contains proposed recommendations in […]
January 29, 2019

FDA Issues Warning Against Unproven Stem Cell Treatments

On December 20, 2018, the Food and Drug Administration (FDA) issued a warning letter to Genetech Inc., citing numerous deviations from current good manufacturing and tissue practices. The compliance issues were discovered during a facility inspection between June 18 and June 22, 2018. The agency also found that the company was engaged in the manufacturing and distribution of umbilical cord blood products, which were not the subject of an approved biologics license application nor an investigational new drug (IND) application—thereby violating the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. The letter followed a recall of all ReGen Series products manufactured by Genetech, Inc. of San Diego, Calif., and distributed by Liveyon of Yorba Linda, Calif. On September 28, […]