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

Bill of Health

Frequency, Characteristics, And Outcomes Of Negative Advisory Committee Votes For FDA-Approved Drugs. Fixing The FDA’s Orange Book. Coverage of New Drugs in Medicare Part D. A full posting of abstracts/summaries of these articles may be found on our? Health Aff (Millwood). 2022 May;41(5):713-721. Health Aff (Millwood).

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Understanding the 2025 Medicare Part D Re-design: What You Need to Know

Innovaare Compliance

The Prescription Drug Program, commonly known as Medicare Part D, is undergoing significant transformations in 2025 due to the Inflation Reduction Act (IRA) of 2022. Medicare Part D will have three (3) phases instead of four (4) – Deductible, Initial Coverage Phase and Catastrophic Phase. generics) in the catastrophic phase.

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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.

FDA 205
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CMS Updates IPPS Rates, Wage Index and DSH Uncompensated Care in 2024 Final Rule

Hall Render

On August 1, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued its Final Hospital Inpatient Prospective Payment System (“IPPS”) and Long-Term Care Hospital (“LTCH”) PPS rule for fiscal year (“FY”) 2024 (“Final Rule”). The Final Rule increases the rate for IPPS payments by 3.3% in FY 2024 but applies a 0.2%

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

Bill of Health

Incremental benefits of novel pharmaceuticals in the UK: a cross-sectional analysis of NICE technology appraisals from 2010 to 2020. Epub ahead of print. Polak TB, Cucchi DGJ, Darrow JJ, Versteegh MM. 2022 Apr 8;12(4):e058279. Rome BN, Sarpatwari A, Kesselheim AS. State Laws and Generic Substitution in the Year After New Generic Competition.

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President Biden Signs End-of-Year Legislation Including Telehealth, Medicare & Medicaid, Mental Health, Pandemic Preparedness, and Other Health Care Provisions

C&M Health Law

Telehealth Section 4113 of the Act extends certain Medicare telehealth flexibilities that were allowed during the COVID-19 PHE for two years, through 2024. The section ensures that telehealth flexibilities under Medicare are extended for two years, regardless of the status of the PHE.

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GOP House Opens With Abortion Agenda

Kaiser Health News

But Medicare is likely to be on the agenda, which will require the input of the chairs of both committees. On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. Some advocates say these pills simply do not bring that level or risk.