Author Archives: IAMERS

Survey: Healthcare executives spotlight the sweeping policy changes they see coming for the industry

Hooper, Lundy & Bookman, PC, a healthcare law firm, polled more than 220 healthcare executives from across the spectrum and found 74% believe significant policy change is either very likely or somewhat likely in the next two years.

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With reimbursement at stake, ACR wants ultrasound equipment receipts

Cuts of up to $112 million in Medicare ultrasound reimbursements have organizations like the American College of Radiology calling for radiologists to clarify the actual costs of purchasing and servicing ultrasound equipment.

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MITA’s remanufacturing white paper recalls ‘Groundhog Day’ movie: IAMERS

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“Nowhere in the white paper does MITA provide support for its claim of an increased “risk to the public health.” As MITA once acknowledged in its previous submission to the FDA it is impossible to provide a statistically valid analysis of the extent of problems.”

MITA proposes framework for defining ‘service’ versus ‘remanufacturing’

While current FDA standards regulate the remanufacturing of medical devices, regulation of servicing is not a requirement. In addition, few safeguards exist to prevent the crossover of servicing activity with that of remanufacturing, creating increased risks to public health, the safety of patients and providers who use the technology. These risks are elaborated on in the white paper and include electrical shock, overexposure to ionizing radiation, improper dosing and cybersecurity vulnerabilities, among others.

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