Cardiac/ Circulatory Problems
Durable Medical Equipment (DME) (including Wearable Defibrilllators)
Health Plan:
Overturned overturned
Appeal Type:
Medical necessity
Age Range:
Decision Year:
Appeal Agent:
Kepro dba IMEDECS
Case Number:

Diagnosis: Cardiac/Circulatory Problems. Treatment: Drive Line Kit. The insurer denied a Drive Line Kit. The denial was overturned in whole. The patient is a male with ischemic dilated cardiomyopathy (INTERMACS 1) who underwent left ventricular assist device (LVAD) exchange from CentriMag LVAD to HeartMate3 LVAD device. The patient requires drive line site care to prevent drive line infection (DLI). Overturn in whole. The health plan, in its determination of medical necessity, did not act reasonably, with sound medical judgment, or in the best interest of the patient. The patient is status post HeartMate3 LVAD placement in a redo setting after exchange of the previous CentriMag LVAD. These cases are likely higher risks for DLI if proper care of the drive line site is not completed with diligence. The relative risk reduction with standardized dressing and care kits are well documented in not only this situation but also in peripherally inserted central catheter (PICC) lines, central lines and central line insertions (now a JCAHO [Joint Commission on Accreditation of Healthcare Organizations] requirement for bundled dressing and central line insertion) with reduction of infectious rates of 60-75% (percent) similar to those observed with use of a drive line standardized care kit. (1-4) While the components of the durable medical equipment (DME) required could be acquired individually from a pharmacy, this burdens the patient's heath care custodian (i.e. [that is] significant other or family member) with what is already a somewhat technical task for anyone with non medical background. These kits are used routinely for LVAD patients to ensure the best infectious free care of the drive lines. The patient has foreign body (HM3) that is helping support his cardiovascular system that exits to the exterior of the skin. This situation is precarious for a subsequent infection of the drive line and device that requires constant monitoring and meticulous care. For this reason, a standardized drive line care bundle is medically necessary for the patient's well-being.


1) O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee (HICPAC). Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011 May;52(9):e162-93. doi: 10.1093/cid/cir257. Epub 2011 Apr 1. PMID: 21460264; PMCID: PMC3106269. 2) Stahovich M, Sundareswaran KS, Fox S, Hallinan W, Blood P, Chen L, Pamboukian SV, Chinn R, Farrar DJ, Pagani FD, Blue L. Reduce Driveline Trauma Through Stabilization and Exit Site Management: 30 Days Feasibility Results from the Multicenter RESIST Study. ASAIO J. 2016 May-Jun;62(3):240-5. doi: 10.1097/MAT.0000000000000374. PMID: 27111738. 3) Lumish HS, Cagliostro B, Braghieri L, Bohn B, Mondellini GM, Antler K, Feldman V, Kleet A, Murphy J, Tiburcio M, Fidlow K, Jennings D, Sayer GT, Takeda K, Naka Y, Demmer RT, Aaron JG, Uriel N, Colombo PC, Yuzefpolskaya M. Driveline Infection in Left Ventricular Assist Device Patients: Effect of Standardized Protocols, Pathogen Type, and Treatment Strategy. ASAIO J. 2022 Mar 1. doi: 10.1097/MAT.0000000000001690. Epub ahead of print. PMID: 35239537. 4) CVC Insertion Bundles https://www.jointcommission.org/-/media/tjc/documents/resources/clabsi/…? db=web&hash=0EF50D5D763A3694D28938B3B5DED960&hash=0EF50D5D763A3694D28938B3B5DED960. Accessed 18March 2022.