Medical Device Replacement Policy

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Remanufacturing and Servicing Medical Devices | FDA

https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/remanufacturing-and-servicing-medical-devices

Draft GuidanceThe distinction between "remanufacturing" and "servicing" is important to under…Papers and Reports1. Servicing Discussion Paper: Strengthening Cybersecurity Practices A… See more

Recalls, Corrections and Removals (Devices) | FDA

https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

Overview. A recall is a method of removing or correcting products that are in violation of …

CLINICAL POLICY Medical Equipment Management …

https://health.uconn.edu/policies/wp-content/uploads/sites/28/2021/07/Medical-Equipment-Management-Plan-11-021.pdf

Medical equipment maintenance is documented in the Clinical Engineering CMMS, including safety, operational, and functional checks before initial use and after major …

Medical Equipment Management Plan - Duke …

https://www.safety.duke.edu/sites/default/files/Medical-Equipment-Management-Plan.pdf

Use of patient-owned medical devices are discouraged from use and effort should be made to substitute a Duke owned equivalent. If this is not possible, then the caregiver will get …

Device, Implant, and Skin Substitute Policy, Facility

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-reimbursement/COMM-Device-Implant-Skin-Substitute-R5019.pdf

For outpatient hospital services, this policy describes the coding guidelines associated with reporting devices, implants, and skin substitutes with their associated procedures. The …

Reimbursement Policy - Medica

https://www.medica.com/-/media/documents/provider/recalled-or-replaced-medical-devices-policy.pdf?la=en&hash=04E19DAB28C744966D82A8D4B33EE1E20D86EE9C

Medica will cover the cost of medically necessary procedures to remove and replace recalled or replaced devices. Medica will not be responsible for the full cost of a replaced …

CMS Manual System - Centers for Medicare

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3181CP.pdf

Effective January 1, 2014, when a hospital furnishes without cost an initial placement of a medical device as part of a clinical trial or a free sample medical device …

Intervertebral Disc Prostheses - Medical Clinical Policy …

https://www.aetna.com/cpb/medical/data/500_599/0591.html

According to a review of nucleus replacement technologies (Coric & Mummaneni, 2008), a challenge of using preformed elastomeric devices is implant extrusion due to their …

Frequently Asked Question on Reporting Charges …

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/Guide-Hospital-OPPS.pdf

for an implantable replacement device? A. When a hospital: 1) replaces a device listed on the table of devices subject to warranty or recall adjustment found on the CMS …

Payment Credits for Replaced Medical Devices That …

https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000085.asp

Certain medical devices are implanted during inpatient or outpatient procedures. Such devices may require replacement because of defects, recalls, mechanical complication, …

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