Comment Letters

Read HRS's Comment Letters on a variety of coverage and reimbursement topics.

HRS Comments on FDA’s 2020 Guidance Priorities

Comment Letters (Reimbursement)

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has released its final and draft guidance publication priorities for the 2020 fiscal year. The Heart Rhythm Society submitted comments on (1) the inclusion of the development of a draft guidance document titled Content of Premarket Submissions for Management of Cybersecurity in Medical Devices as a Category A document; and (2) the necessity for an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.

Proposed Revisions to Medicare's Quality Payment Program for CY 2020

Comment Letters (Reimbursement)
Medicare Fee Schedules

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.

2020 Medicare Physician Fee Schedule

Comment Letters (Reimbursement)
Medicare Fee Schedules

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. 

Updated MRI National Coverage Policy

Coverage Statements
Comment Letters (Coverage)
Comment Letters (Reimbursement)
Comment Letters (Regulatory Agencies)

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).