CMS Issues New HF Specialty Designation Code After approving a new specialty designation for “Advanced Heart Failure (HF) and Transplant Cardiology” at the end of 2016, the Centers for Medicare and Medicaid Services (CMS) has completed the necessary steps to create the code (C7) and make it available for physicians to use in their provider enrollment. The new code, which will take effect on Oct. 1, will allow CMS to distinguish HF and transplant cardiologists from clinical cardiologists when billing for Medicare services. Previously, no mechanism existed for CMS to accurately identify this category of physician for quality and payment programs. Some local Medicare carriers have denied claims in the past, citing duplicate billing, when a cardiologist and an HF specialist from the same practice have billed for patient evaluation services. HF certification from the American Board of Internal Medicine is not required to use the code. Any provider who selects a specialty code is attesting that they meet Federal and State requirements for the specialty and are “properly staffed, equipped and stocked (as applicable, based on the type of facility or organization, provider or supplier specialty, or the services or items being rendered) to furnish these items or services.” “This is a critical milestone for advanced heart failure and cardiac transplant specialists, validating their critical role and contribution to patient care,” says Biykem Bozkurt, MD, PhD, FACC, chair of both the Heart Failure and Transplant Section Leadership Council and the ACCF/AHA Task Force on Clinical Data Standards. “We urge HF and cardiac transplant cardiologists to contact their administrators and billing staffs to enroll or update their specialty to reflect this new designation within 60 days of the implementation date.” Coverage Proposal for PAD Supervised Exercise Therapy The ACC recently joined with other stakeholders to urge the Centers for Medicare and Medicaid Services (CMS) to move forward with a positive national coverage decision for supervised exercise therapy to treat symptomatic peripheral artery disease. In a joint letter, the ACC and others expressed support for the fundamental proposal, and suggested revisions that would add flexibility and clarity for patients and clinicians. CMS will publish its final decision by May 31, though it could come several weeks before that deadline. Stay tuned to ACC.Org/Advocacy or sign up to receive ACC’s weekly Advocate newsletter for the latest information. Health Reform Bill Passes in the House The U.S. House of Representatives narrowly passed the American Health Care Act (AHCA) on May 4 in a 217 – 213 vote. The legislation, which would repeal and replace provisions under the Affordable Care Act, now moves to the Senate. “The American College of Cardiology opposes the AHCA in its current form, and is disappointed by its passage in the House,” said ACC President Mary Norine Walsh, MD, FACC. “As it stands, the AHCA would allow states to bypass existing federal protections for sick and elderly people, and potentially undermine coverage for critical services for patients with heart disease.” The ACC has previously expressed concerns about elements of the AHCA, particularly its impact on patient access to efficient, high quality care; protection for individuals with pre-existing conditions; and continued national investment in preventive care, medical research and innovations. “This iteration of the AHCA is inconsistent with the ACC’s Principles for Health Reform, which reflect our belief in the importance of promoting patient access to meaningful insurance coverage and quality, cost-effective care,” Walsh said. “It is important for all members of Congress to prioritize protection for the most vulnerable Americans as health reform efforts move forward. The ACC will continue to work with lawmakers on both sides of the aisle to create solutions that maintain patient access to the coverage and care they need.” FDA Issues Update on Class 1 Recall for HVAD Controllers FDA Update The U.S. Food and Drug Administration (FDA) has issued an update regarding the Class 1 recall for all HeartWare Ventricular Assist Device (HVAD) controllers (Product Codes 1400, 1401, 1403, 1407) manufactured by Medtronic Mechanical Circulatory Support from March 1, 2006 to Dec. 1, 2016. Since the recall was issued in November 2016, Medtronic Mechanical Circulatory Support has developed an updated HVAD controller and power management software to address power connector issues. The new FDA update includes an additional recall of the HVAD DC adapter (Product Code 1435) and instructions to exchange recalled products. The update recommends that health care professionals: • Review the notice and forms, and forward the notice to other staff within their organizations for their awareness • Complete, sign, and return the “Acknowledgement Form” to Medtronic Mechanical Circulatory Support within 30 days of receipt of the letter • Complete training that will cover the new product labeling including the instructions for use and patient manual • Quarantine and replace affected HVAD controllers, DC adapters, instructions for use, emergency responder guides and patient manuals in hospital inventory after training is complete • Notify and schedule each of their patients as soon as possible for an appointment to exchange their controllers • Return all quarantined HVAD controllers and DC adapters to Medtronic Mechanical Circulatory Support • Once the affected product in inventory has been identified and returned, complete and return the “Completion Form” to email@example.com or the Medtronic Mechanical Circulatory Support representative no later than 12 months from the date of the letter according to the instructions on the form.
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