July 17, 2020
National Government Services Medical Policy Unit
P.O. Box 7073
Indianapolis, IN 46207-7073
ATTN: Craig Haug, M.D., Medical Director
Re: Proposed LCD for Percutaneous AV Fistula for Hemodialysis (DL38573)
Dear Dr. Haug:
The American Association of Kidney Patients (AAKP) and the Renal Physicians Association (RPA) are jointly contacting you to express concerns on behalf of the nation’s kidney patients and their physicians with regard to the proposed local coverage determination (LCD) for Percutaneous AV Fistula for Hemodialysis (DL38573). We believe the proposed LCD inappropriately limits kidney patient consumer care choice and similarly constrains the ability of interventional nephrologists and other vascular access specialists to provide optimal care to kidney patients preparing to begin or already on dialysis.
In the LCD, NGS has proposed to cover only one of the two FDA-approved technologies for providing percutaneous arterio-venous fistula (pAVF) creation. This is despite the Centers for Medicare and Medicaid Services (CMS) providing coverage for both of these technologies via the establishment of C-codes in the Hospital Outpatient Prospective Payment System (HOPPS) in 2019 and more recently by creating individual G codes (G-2170 and G-2171) for use in the Medicare Physician Fee Schedule (MPFS) as of July 1, 2020.
NGS’ decision cites patient safety concerns. However, both of our groups, the oldest and largest fully independent kidney patient organization in the U.S., and the organization representing front-line community nephrologists nationwide, believe this is a flawed decision based on a misapplication of data from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The FDA itself has stated that “MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.” Further, MAUDE does not use denominators and relies on self-reported data, masking the fact the adverse events reported in MAUDE for the denied technology are within that manufacturer’s safety profile, and indicating that the manufacturer is being penalized for their transparency in event reporting.
Neither of our organizations favors one technology over the other. We believe both should be covered to maximize kidney patient access to this innovative and groundbreaking technology, as well as promote kidney patient consumer care choice. We therefore urge you to provide coverage for both technologies. Thank you for considering our request.
Any questions or comments regarding this correspondence should be directed to AAKP’s Director of Stakeholder Operations, Erin Kahle, MPA, CNP, at 813-636-8100, or by email at firstname.lastname@example.org or RPA’s Director of Public Policy, Rob Blaser, at 301-468-3515, or by email at email@example.com.
Richard Knight Jeffrey A. Perlmutter, M.D.
AAKP President RPA President