Breaking news from the Senate: The Senate on May 24 passed the Food and Drug Administration (FDA) Safety and Innovation Act (S. 3187) by a vote of 96 to 1. This legislation, authored by the Senate HELP Committee, reauthorizes user fees collected by the FDA from medical device and pharmaceutical companies to fund the approval process. ACC advocacy staff week, the House is expected to vote on their version of the user fee legislation, followed by a conference worked closely with Senate Committee staff throughout the process and is pleased to see language regarding device registries, increased postmarket surveillance, and the expansion of sentinel to medical devices included in the final bill. The House is expected to vote on their version of the user fee legislation soon, followed by a conference of both bills. The current FDA user fee agreement expires Sept. 30, however leadership from both parties have expressed an interest in signing the new agreement into law before the July 4 holiday.
FDA panels were busy this week! The Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee on May 23 rejected the use of rivaroxaban (XARELTO®) for treatment in patients with acute coronary syndromes (ACS). Rivaroxaban is an oral anticoagulant that acts by selective direct inhibition of factor Xa (FXa). The panel voted 6 to 4 with one abstention following a day-long meeting that focused primarily on ATLAS ACS 2–TIMI trial, including its design and execution and missing data. Just today, the ACC provided testimony, as well as a written statement, on the safety of atrial septal defect (ASD) closure devices before an FDA Circulatory Systems Devices panel meeting. ASDs, which can eventually contribute to significant morbidity and mortality if left untreated, currently represent approximately 10 percent of congenital heart defects. ACC representative John Moore, MD, FACC, a member of the IMPACT Registry™ Steering Committee, urged the FDA to consider a prospective study of potential risk factors for erosion in relation to the implantation of ASD occlusion devices and that the NCDR® provide the infrastructure for that study. Furthermore, he advocated for an FDA-funded registry study to assess adverse events in patients with implanted devices after discharge to better ascertain if and when problems occur. Visit the FDA issue center on CardioSource.org to keep up-to-date on FDA updates and ACC action.
Follow-up on TAVR NCD: At the beginning of the month, the Centers for Medicare and Medicaid Services (CMS) announced approval of a National Coverage Determination (NCD) of transcatheter aortic valve replacement (TAVR). Your ACC has put together two documents to help you understand the NCD. Read the ACC's summary and analysis and check out the TAVR coding guide. Meanwhile, the FDA will be considering expansion of the label indication for the Edwards Sapien Valve to include the transapical approach and high-risk surgical candidates next month. Your ACC expects to present to the panel, so stay tuned.
Version 5010 deadline approaching! As part of the transition to ICD-10 code sets, health care providers that electronically submit administrative transactions (such as checking a patient's eligibility, filing a claim, or receiving a remittance advice) either directly to a health insurance payer or through a clearinghouse, were required to switch to new HIPAA standards, called Version 5010, as of Jan. 1, 2012. Providers needed to have the necessary software and system changes in place by the deadline in order to continue sending and receiving HIPAA electronic transactions. The Centers for Medicare and Medicaid Services (CMS) earlier this year extended enforcement of this requirement until June 30. ACC members are strongly encouraged to ensure their systems are in compliance by this new date. To ensure unnecessary rejections of Version 5010 claims, don't forget to include a 9-digit ZIP code; a physical billing provider address (not a PO Box); and your National Provider Identifier (Tax IDs and Social Security Numbers will not be accepted).
Health IT Lessons from Mississippi: Have you visited the ACC in Touch Blog lately? During May, your ACC is delving into health IT with a special blog series. This week, take a trip to Mississippi and discover lessons learned during a clinic's transition to a new electronic medical record system. The appropriate use criteria (AUC) blog series also has a new post about getting "back to the basics" with ACC's Imaging in FOCUS program. Check it out here.
Payer Advocacy in action: Last week, your ACC and the Heart Rhythm Society (HRS) met with Aetna and its pre-authorization vendors, Carecore and MedSolutions, to discuss concerns regarding the upcoming Cardiac Rhythm Implant Pre-Authorization program and their clinical criteria. Beginning June 1, Aetna will require all elective ICD, pacemaker, and CRT device implantations to be pre-authorized through Carecore (New York and New Jersey) or MedSolutions (all other Aetna markets). During the meeting, ACC and HRS highlighted the importance of following the ACC/HRS Practice Guidelines as well as reducing the level of administrative burden. Both vendors encouraged providers to utilize their web portals for entering requests and instant decisions. Contact firstname.lastname@example.org for more information.