The long-awaited U.S. Supreme Court ruling regarding provisions in the Affordable Care Act (ACA) was released on June 28. In a majority decision, the Court ruled that most of the Affordable Care Act, including its individual mandate that virtually all Americans buy health insurance, is constitutional. "Now that the decision is behind us, we can continue down the path to health care reform," said ACC President William Zoghbi, MD, FACC. "The ACC favors provisions in the law that supports preventive care, access to care, elimination of waste, and a payment system that encourages quality. Hard work remains ahead before we arrive at a sustainable payment system that emphasizes value and a strong patient-doctor relationship. The ACC remains committed to quality patient care."
What does this mean?
The ACA is the largest expansion of health care coverage since Medicare and Medicaid were initiated in the sixties. The Supreme Court decision means that efforts already underway to implement the law can and will continue. To that end, your ACC will continue to support the policies and provisions with the law that are in line with the College's overarching health care reform principles, including those that expand health care coverage, encourage preventive care, and foster innovative payment and delivery system models that reward quality and ensure value. At the same time, the College will also continue to work with Congress and the Centers for Medicare and Medicaid Services (CMS) on ACA provisions that affect cardiovascular care, including the controversial Independent Payment Advisory Board and CMS implementation of the Physician Payments Sunshine Act. In addition, your ACC will also continue to advocate for fundamental payment and medical liability reforms that were not included in the ACA, but are critical for comprehensive health reform to be truly effective. There are also several regulatory proposals and legislative efforts expected in the coming months that will have major impacts on cardiology. Get the details.
On Tuesday, the Senate voted to extend the Food and Drug Administration (FDA) User Fee Act in a vote of 92 to 4. It passed in the House last week by voice vote and is expected to head to the president's desk for his signature before the July 4 recess. "Quickly getting the latest devices and prescription drugs to patients who need them is critical to our nation's health," said Zoghbi, following the news. "Members of the House and Senate demonstrated that they can come together in a bipartisan way to approve a measure that will support innovation and safety in health care." Read the article.
The FDA has also:
Recently followed an advisory panel recommendation and rejected rivaroxaban for treatment in patients with acute coronary syndrome. In May, concerns over the ATLAS ACS 2 TIMI trial, including its design and execution and missing data, were raised during a day-long meeting of the Cardiovascular and Renal Drugs Advisory Committee. Rivaroxaban was approved for the prevention of stroke in nonvalvular atrial fibrillation late last year and is also approved for preventing deep vein thrombosis after knee or hip replacement surgery. Learn more.
Requested additional information from the manufacturers of apixaban, a factor Xa inhibitor, for the prevention of stroke in patients with atrial fibrillation. The agency has not requested additional trials, but would like further clarification from the ARISTOTLE trial that investigated the efficacy of apixaban versus warfarin in these patients.
Approved the obesity drug lorcaserin, the first prescription weight-loss pill to be approved in the last decade. Earlier this year, an FDA advisory panel endorsed a similar drug (Qnexa) and a final FDA decision is expected around July 17.
FDA Hearing TAVR News
Last month, the U.S. Food and Drug Administration’s (FDA’s) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 11 -0 with one abstention in favor of expanding indications for use of the Edwards SAPIEN™ Transcatheter Heart Valve to include patients eligible but at high risk for aortic valve surgery and the transapical approach.
The Sapien system was previously approved last November for patients who are not considered surgical candidates for aortic valve replacement. The advisory panel’s decision follows a day-long hearing that included testimonies from representatives from the ACC, The Society of Thoracic Surgeons (STS), Edwards Lifesciences, the FDA, patients and physicians.
John Carroll, MD, FACC, from the University of Colorado, Denver, and a member of STS/ACC Transcatheter Valve Therapy (TVT) Registry Steering Committee, testified on the College’s behalf. His testimony focused on how registries like the STS/ACC TVT Registry can be leveraged to evaluate patient selection, procedure indications, peri-procedural outcomes and longitudinal safety surveillance and patient outcomes. He also discussed the benefits to using a clinical registry for post-market surveillance and specifically using the recently created TVT Registry for post approval studies, which include:
- Ability to focus on previously identified critical issues
- Development of risk models tailored for the TVT population
- Tracking of long-term and quality of life outcomes
- Decision-making tools for patients, families, clinicians and regulators
- Appropriateness of care
- Potential expansion of indications for use
Carroll followed a presentation from Jeffrey Rich, MD, FACC, president of STS, on the collaboration of cardiologists and surgeons in bringing transcatheter aortic valve replacement (TAVR) to the American population.
New Appropriate Use Criteria Released
The ACC, in partnership with 10 other leading professional societies, recently released new appropriate use criteria (AUC) focused on peripheral vascular ultrasound and physiological testing. This newest set of AUC focuses on a total of 255 indications (with the inclusion of surveillance timeframes) where ultrasound and physiological testing is frequently considered. In addition to looking at the reasons for ordering these tests, they also focus on how frequently repeat testing is needed in clinical practice in light of the need for ongoing surveillance in some patients. The AUC also outline key areas for research moving forward. A related report presenting AUC for vascular laboratory testing to evaluate venous circulation is expected to be released in late fall of this year. Share your thoughts on the newest criteria in the ACC in Touch Blog.
CMS is requesting stakeholder review and public comment of the recently developed hospital quality measure of acute myocardial infarction (AMI) mortality for use with EHR data, a measure that was developed in partnership with Yale New Haven Health Services Corporation/Center for Outcomes Research and Evaluation. CMS developed and has implemented an AMI 30-day risk-standardized mortality measure using CMS claims data since 2008. The measure, designed for potential use in public reporting in the EHR environment, has undergone eSpecification and its related testing will be completed later in 2012. Find out how to submit feedback ahead of the July 14 deadline.
What's appropriate in imaging after all?
Cardiovascular Imaging Strategies, a product of the ACC's Imaging in FOCUS initiative, is being used by two regional health plans and active discussions are underway with health plans and employers in 10 additional states. The product offers local ACC Chapters an opportunity to work with health plans on appropriate use, as a part of payment reform and/or an alternative to radiology benefit managers. Built upon ACC core competencies, Cardiovascular Imaging Strategies uses clinical decision support to assess the appropriateness of patient selection for cardiac imaging. These patterns are then used to engage practices and referring physicians in action planning and quality improvement. The product also offers QI credit for lab accreditation and MOC Part IV credit for physicians. This result is a performance-based, transparent and accountable solution to encourage appropriate imaging and understand exceptions to the standards. To date, AUC imaging standards exist for cardiac radionuclide imaging, cardiac computed tomography, cardiac magnetic resonance imaging, echocardiography and diagnostic cath. Learn more. Later this summer, a similar product will be made available directly to practices. Also, check out a special AUC series on the ACC in Touch Blog to browse through a variety of perspectives on appropriate use and leave a comment.
Cardiac Rhythm Management Clinical Community
The ACC, in partnership with the Heart Rhythm Society, has introduced a new clinical Community on CardioSource.org focused on topics that the general cardiologist needs to know about rhythm disturbances, including the appropriate use of devices in the management of rhythm issues. The community’s ultimate goals are to provide resources and information to help facilitate a dialogue in relevant patient cases and increase shared decision making effectiveness. Learn more.