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What If Costco Designed the Prescription Drugs Sales Model?

Health Populi

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.

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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

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.

Medicare 147
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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

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.

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How Will New FDA Hearing Aid Regulations Impact Health Plans?

HIT Consultant

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.

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Physician venture investor talks telehealth, digital therapeutics, Medicaid tech

Healthcare It News

Notably, since 2018, mental health has been the top clinical indication to receive investment, growing from $1.4 Companies like Pear Therapeutics, Limbix, Applied VR and Click Therapeutics are treating people with clinically validated and FDA-approved (or pending) digital interventions. billion that year to $5.1

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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

from 2018-2019. Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019. A full posting of abstracts/summaries of these articles may be found on our? Aboy M, Liddell K, Jordan M, Crespo C, Liddicoat J. European patent protection for medical uses of known products and drug repurposing. JAMA Oncol.

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When Advancing a Medical Device, Be A Partner First & Seller Second to Hospital Systems

HIT Consultant

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.