March 11, 2016

FDA Issues Proposed Rule to Classify Posterior Cervical Screw Systems

On March 10, the U.S. Food and Drug Administration (FDA) published a proposed rule to classify posterior cervical screw systems as a Class II device. Since posterior cervical screw systems were in use prior to May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), they are considered unclassified “pre-amendments devices” by the FDA, requiring premarket notification (510(k)). In 2011, the Orthopedic Surgical Manufacturers Association submitted a petition to the FDA to classify posterior cervical screw systems as a Class II device. In September 2012, the Orthopedic and Rehabilitation Devices Advisory Panel to the FDA agreed and recommended that these screw systems be classified as Class II. In the proposed rule issued on March 10, the FDA agreed with the Panel’s recommendation for classification of posterior cervical […]
March 4, 2016

AMA Posts CPT Editorial Summary of Panel Actions

On March 4, the American Medical Association posted the CPT® Editorial Summary of Panel Actions, a high-level summary of the final actions taken by the CPT® Editorial Panel at the February 2016 meeting. Tab 43 addressed the sundowning of several Category III codes. Category III codes are archived five years from the date of initial publication or extension unless a modification of the archival date is specifically noted at the time of a revision or change to a code. Along with several other codes, the CPT® Editorial Panel accepted the archiving of 0309T (Arthrodesis, pre-sacral interbody technique, including disc space preparation, discectomy, with posterior instrumentation, with image guidance, includes bone graft, when performed, lumbar, L4-L5 interspace (List separately in addition to code for primary procedure)). Category […]
February 29, 2016

ISASS Policy & Advocacy News – February 2016

News and noteworthy information for February: NGS Issues Final LCD on MIS SIJ Fusion Califf Confirmed as FDA Commissioner FDA Looks to Bring Payers to the Table at Device Pre-submission Meetings President Obama Releases Proposed Budget for FY2017 Senate HELP Committee Action Public-Private Partnership to Develop Health Care Quality Measures CMS Extends the Attestation Deadline for the EHR Incentive Programs Medicare Final Rule – Reporting and Returning of Self-Identified Overpayments Research & Reimbursement Course Scheduled for ISASS16   NGS Issues Final LCD on MIS SIJ Fusion NGS Medicare, the Medicare Administrative Contractor covering 9.5 million Medicare beneficiaries in Illinois, Minnesota, Wisconsin, Connecticut, New York, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont recently finalized its Local Coverage Determination (LCD) for […]
February 24, 2016

Policy Statements

Position Statement on Cervical and Lumbar Disc Replacements (2019) ISASS Policy Guideline – Surgical Treatment of Lumbar Disc Herniation with Radiculopathy ISASS Policy Guideline – Intraosseous Ablation of the Basivertebral Nerve for the Relief of Chronic Low Back Pain Update: ISASS Policy Statement – Cervical and Lumbar Disc Replacements ISASS Policy Statement – Vertebral Augmentation: Coverage Indications, Limitations, and/or Medical Necessity ISASS Policy Statement – Recommendations and Coverage Criteria for Bone Graft Substitutes used in Spinal Surgery (January 2019) ISASS Policy Statement – Decompression with Interlaminar Stabilization (November 2016) ISASS Policy Statement – Minimally Invasive Sacroiliac Joint Fusion (2014) Update: ISASS Policy Statement – Minimally Invasive Sacroiliac Joint Fusion (March 2015) Update: ISASS Policy Statement – Minimally Invasive Sacroiliac Joint Fusion (December 2015) Update: ISASS Policy Statement […]