Bill of Health

JULY 1, 2022

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).

COVID-19 208

COVID-19 FDA Medicare Medicare 208

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.

FDA 208

FDA COVID-19 Medicaid Medicaid 208

Bill of Health

MAY 19, 2022

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.

Health Insurance 208

Health Insurance Hospitals FDA Medicaid 208

Innovaare Compliance

JANUARY 15, 2024

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.

Medicare 52

Medicare Medicare Compliance FDA 52

Hall Render

AUGUST 10, 2023

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%

Hospitals 40

Hospitals Medicare Medicare Medicaid 40

NY Health Law

JANUARY 3, 2025

Since approving Gilenya in 2010, the FDA has imposed a first-dose observation requirement for new patients, who must be monitored by a doctor while attached to an electrocardiogram machine for six hours. Novartis Pharmaceuticals Corp.

Fraud 52

Fraud FDA Doctors Medicaid 52

C&M Health Law

JANUARY 25, 2023

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.

Medicaid 104

Medicaid Medicaid Medicare Medicare 104