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Final Rules Biosimilars

King & Spalding

CMS Issues Final 2025 Calendar Year Medicare Physician Fee Schedule Final Rule

King & Spalding on

On November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 of...more

Sheppard Mullin Richter & Hampton LLP

CMS Issues CY2025 Medicare Advantage and Part D Final Rule

On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule,...more

McGuireWoods Consulting

Washington Healthcare Update - February 2023 #3

Upcoming Hearings - March 22 - Senate Committee on Health, Education, Labor and Pensions Hearing: “Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.,...more

ArentFox Schiff

Drug Pricing Reform Finally Becomes Law: What the Inflation Reduction Act Means for Pharma

ArentFox Schiff on

After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more

Katten Muchin Rosenman LLP

FDA Reduces Regulatory Uncertainty with New Finalized Rule Defining "Biological Product" under BPCIA to Include Insulin and Other...

Key Points - In February, the U.S. Food and Drug Administration issued a "bright-line rule" redefining "biological products" under the Biologics Price Competition and Innovation Act (BPCIA) to include insulin and other...more

Bergeson & Campbell, P.C.

FDA Issues Final Rule Amending The Definition Of “Biological Product”

On February 21, 2020, the U.S. Food and Drug Administration (FDA) issued a final rule to amend its regulation that defines “biological product.” ...more

Goodwin

FDA Classifies Insulin as Biologic; Biosimilar Insulin Applications Accepted Beginning March 23, 2020

Goodwin on

On February 21, the FDA published a final rule in the Federal Register that implemented a requirement of the BPCIA, transitioning insulin, and some other products such as human growth hormone (somatropin), pancrelipase,...more

Hogan Lovells

CMS releases Medicare Advantage/Part D final rule

Hogan Lovells on

On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) released a final rule to revise regulations and clarify program requirements within the Medicare Advantage (MA) and the Prescription Drug Benefit (Part D)...more

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