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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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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.

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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

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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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.

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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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Modernizing Medicare to Take Advantage of the Latest Technologies

CMS.gov

Modernizing Medicare to Take Advantage of the Latest Technologies. Tue, 10/02/2018 - 13:57. Administrator, Centers for Medicare & Medicaid Services. Modernizing Medicare to Take Advantage of the Latest Technologies. Together we can ensure that Medicare beneficiaries see the impact of advances in 21 st century biomedicine.