HHS Delays Start of Episode Payment Models The U.S. Department of Health and Human Services (HHS) has delayed the effective date for the final rule for the Advancing Care Coordination through Episode Payment Models (EPMs); Cardiac Rehabilitation (CR) Incentive Payment Model; and changes to the Comprehensive Care for Joint Replacement Model until May 20. This postpones the start date of the EPMs and the CR Incentive Payment Model for three months – from July 1 to Oct. 1. In its statement, HHS noted it is seeking comments on the appropriateness of this delay, as well as a further start date delay until Jan. 1, 2018. According to HHS, the additional threemonth delay “is necessary to allow time for additional review” and to ensure that the agency “has adequate time to undertake notice and comment rulemaking to modify the policy if modifications are warranted, and to ensure that in such a case participants have a clear understanding of the governing rules and are not required to take needless compliance steps due to the rule taking effect for a short duration before any potential modifications are effectuated.” “Creating value-based payment models for patients with cardiovascular disease is extremely challenging and the ACC has urged the Centers for Medicare and Medicaid Services (CMS) to proceed with great caution in implementing and testing these models in order to ensure that they allow for accurate beneficiary attribution, valid quality and cost measurement, meaningful comparisons and ultimately development of best practices to achieve better health outcomes for patients,” says ACC President Mary Norine Walsh, MD, FACC. “This newest delay provides an opportunity to continue working with CMS to find ways to further refine and improve the effectiveness of the models’ clinical and operational designs. The ACC’s NCDR registries may be helpful in this effort. In the meantime, the College encourages members who are part of the model to continue to prepare for implementation.” MOC Update Regarding 10-Year Exam Alternatives ACC members likely received a message from the American Board of Internal Medicine (ABIM) in March announcing new options for some ABIM diplomates taking their Maintenance of Certification (MOC) assessments in 2018. However, the options being piloted in 2018 are for certified internists and certified nephrologists only. For certified cardiologists and sub-specialist cardiologists in Advanced Heart Failure and Transplant Cardiology, Clinical Cardiac Electrophysiology, Interventional Cardiology, and Adult Congenital Heart Disease, the open-book assessments (either every 10 years for the “long-form” assessment or every two years for the “Knowledge Check-in” assessment) will be phased in between 2019 and 2023. According to the ABIM, cardiovascular specialists and sub-specialists who elect to remain certified will need to take the traditional 10-year examination if their Part III assessment years occur prior to the phase-in schedule. On a separate track, the ACC (as well as the American College of Physicians and the American Society of Clinical Oncologists) continues to work with the ABIM in an effort to create an additional “Society Maintenance Pathway” for cardiologists, internists and oncologists to maintain their certification. While still in an early design phase, the pathway for cardiology would use lifelong learning self-assessment programs (e.g., ACCSAP) to document that diplomates have kept up with their medical knowledge over a specified period of time. More information will be provided as it becomes available. FDA Issues Safety Alert for Absorb GT1 BVS The U.S. Food and Drug Administration (FDA) has issued a safety alert for the Absorb GT1 bioresorbable vascular scaffold (BVS) by Abbott Vascular due to an increased rate of major adverse cardiac events observed in patients receiving the device. The alert comes after the FDA’s initial review of two-year data from the ABSORB III trial that showed an 11 percent rate of major cardiac events (cardiac death, myocardial infarction or an additional procedure to re-open the treated heart vessel) in patients treated with BVS, compared with 7.9 percent in patients treated with the already approved metallic XIENCE drug-eluting stent, also by Abbott Vascular. The FDA is working with Abbott Vascular to conduct additional analyses and will continue to monitor the performance of the BVS. The full FDA letter to health care providers noted that “an additional preliminary analysis of ABSORB III data suggests improved clinical performance and a lower rate of complications associated with BVS implantation when health care providers follow the recommended implantation methods.” The FDA recommends health care providers follow the instructions included in the FDA-approved BVS physician labeling regarding selecting appropriately sized coronary arteries for BVS implantation and methods to properly implant the device against the vessel wall. The agency also recommends that BVS patients be advised to follow recommendations for dual antiplatelet therapy prescribed by their health care providers. Additionally, patients experiencing any new cardiac symptoms such as irregular heartbeats, chest pain or shortness of breath should be advised to seek clinical care. Any adverse events related to the BVS should be reported through MedWatch. “While the notion of a bioresorbable scaffold resonates with clinicians and patients alike, until we have large trials demonstrating their clear superiority over existing platforms using drug-eluting stents, we should temper our enthusiasm for using them,” notes both Deepak L. Bhatt, MD, MPH, FACC, senior associate editor of ACC.org and Kim Eagle, MD, FACC, editor-in-chief of ACC.org. This FDA alert provides a strong impetus for a “wait for more data” approach to this debate.
Published by American College of Cardiology. View All Articles.
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