The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has released its final and draft guidance publication priorities for the 2020 fiscal year. The Heart Rhythm Society submitted comments on (1) the inclusion of the development of a draft guidance document titled Content of Premarket Submissions for Management of Cybersecurity in Medical Devices as a Category A document; and (2) the necessity for an update of the 1990 document titled Implantable Pacemaker Testing Guidance.
HRS submitted it comments on the proposed revisions to the Medicare Quality Payment Program for 2020. Recommendations addressed efforts to streamline the Merit-Based Incentive Payment System, promoting the use of specialty measures relevant to EP, and interoperability.
Read our comment letter to the Centers for Medicare and Medicaid Services on the Proposed Medicare Physician Fee Schedule for 2020. In the comment letter, HRS recommends corrections that would improve payment for the malpractice RVUs allocated to EP services, and address CMS' questions regarding payments for remote monitoring services.
On April 10, 2018, the Centers for Medicare and Medicaid Services (CMS) released an updated National Coverage Determination for Magnetic Resonance Imaging (MRI). The update allows coverage for MRI for certain patients with Cardiac Implanted Electronic Devices (CIEDs).
On December 20 2017, HRS and the American College of Cardiology (ACC) submitted a joint comment letter on the Medicare Proposed ICD Coverage Policy. The draft policy ends the data collection requirement and proposes to require a shared decision making (SDM) interaction prior to ICD implantation for certain patients.
On July 12, 2017, the Centers for Medicare and Medicaid Services announced a 30 day public comment period to reconsider conditions of coverage for MRI. On August 1, the Heart Rhythm Society submitted public comments on the revised coverage policy.