2018 FDA Medicare 
HIT Consultant
NOVEMBER 24, 2022
First, let’s examine the new regulatory framework the FDA established. Health plans could, for example, consider covering OTC hearing devices as part of the hearing benefits package provided to their Medicare Advantage plan members. For Medicare Advantage plans, a positive member experience is critical in achieving 5-star ratings.
Bill of Health
MARCH 24, 2023
The selections feature topics ranging from an analysis of the approval and marketing of biosimilars with a skinny label and their associated Medicare savings, to a discussion of the Philips Respironics recall and the need for reforms to U.S. Characteristics of Prior Authorization Policies for New Drugs in Medicare Part D.
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Health Populi
JUNE 5, 2022
Its longer more formal name was The Drug Price Competition and Patent Term Restoration Act of 1984, and it created a pathway for generic drug applications to the FDA. In 2006 the Medicare Part D program was implemented, covering older Americans for prescription drugs for the first time.
AIHC
JANUARY 28, 2022
For more information on filing compliance cost reports, attend the Medicare Cost Report Camp in March 2022 presented by KraftCPAs and sponsored by the American Institute of Healthcare Compliance. This is calculated based on the hospital’s relative share of uncompensated care nationally. This is known as the hospital “market basket.”
Bill of Health
MARCH 25, 2022
Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. Medicaid Expenditures and Estimated Rebates on Line Extension Drugs, 2010-2018. A full posting of abstracts/summaries of these articles may be found on our? 2022 Feb 24. Epub ahead of print. PMID: 35201276.
Healthcare Law Blog
AUGUST 3, 2022
Food and Drug Administration (“FDA”) recommendations, causing the providers to submit false claims for payment to Medicare for the services mis-using the probes. The complaint alleges that Prometheus put vulnerable Medicare patients at risk to gain a marketing advantage by reducing overhead costs associated with its systems.
HIT Consultant
OCTOBER 21, 2022
US hospital systems validate the safety, clinical utility, and robustness of newly FDA-approved devices, 510(k) cleared, before adopting them into clinical practice. Your FDA 510(k) cleared device must be designed for and evaluated by a number of stakeholders. Carlson joined Immunexpress in 2018 as CEO.
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