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Welcome to Global Integrated Reimbursement Services’ blog. The purpose of our blog is to allow access to a repository of issues that our company tracks regarding the reimbursement for pharmaceuticals, medical devices, diagnostics, biologics, and biosimilars. Also, it shows you how we can assist you in these areas.

Patient Access to Critical Care Improves when Insurance Coverage Expands

Posted by on Nov 4, 2016 in Uncategorized | Comments Off on Patient Access to Critical Care Improves when Insurance Coverage Expands

Many stakeholders in healthcare have one common goal: providing quality care to patients who need it. Having access to health insurance is key for improving patient access to much needed care. The state of Massachusetts (MA) serves as a unique example of how when insurance coverage expands, care improves. Colorectal cancer is the third most common cancer and the third leading cause of cancer-related deaths among adults in the United States. In a recent study, after the state expanded access to health insurance, patients with colorectal cancer, in MA were more likely than patients in other states to get the needed surgery before their conditions worsened. The lead author, who worked on the study, Dr. Andrew Loehrer, says the study “provides cautiously optimistic evidence that expanding insurance doesn’t just increase access to healthcare but also increases the receipt of...

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FDA Issues Proposed Rule on Clinical Study Data Acceptance for Medical Devices

Posted by on Feb 25, 2013 in Uncategorized | Comments Off on FDA Issues Proposed Rule on Clinical Study Data Acceptance for Medical Devices

On February 25, 2013, the Food and Drug Administration (FDA) issued a proposed rule to amend its regulations on data acceptance from clinical studies for medical devices. The proposed rule would require clinical studies conducted outside the United States (U.S.) used to support any device-related application or submission — investigational device exemptions (IDEs), (510(k)) pre-market notifications, pre-market approvals (PMAs), product development protocols (PDPs), and humanitarian device exemptions (HDEs) — be conducted in accordance with good clinical practices (GCPs). The proposed rule would also amend 510(k) and IDE regulations to address requirements for FDA acceptance of data from clinical studies conducted within the U.S.   Proposed Rule The proposed rule amends FDA regulations on data acceptance from medical device clinical studies. The primary differences between the proposed rule and existing regulations are as follows: Changes to Human Subject Protection Requirements...

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