On August 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more
9/5/2024
/ AHRQ ,
Beneficiaries ,
Centers for Medicare & Medicaid Services (CMS) ,
Food and Drug Administration (FDA) ,
Health Technology ,
Loper Bright Enterprises v Raimondo ,
MACs ,
Medical Devices ,
Medicare ,
Notice Requirements ,
SCOTUS ,
Social Security Act
On June 27, 2023, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a “Notice with Comment Period” (“Notice”) describing a new process for providing expedited Medicare coverage for certain eligible...more
Key Drug Pricing Implications of the Inflation Reduction Act of 2022 -
I. Introduction -
On Sunday, August 7, 2022, the United States Senate passed the most consequential drug and biologics pricing legislation in almost...more
Biden Administration Delays Effective Date and Opens Another Comment Period for New Medicare Coverage Pathway for Breakthrough Medical Devices and Definition of “Reasonable and Necessary” -
To the dismay of the medical...more
On November 4, 2020, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule (the Proposed Rule) outlining proposals for the coverage and payment for durable medical equipment, prosthetics, orthotics, and...more
On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more
11/24/2020
/ Administrative Procedure Act ,
Advanced Notice of Proposed Rulemaking (ANPRM) ,
Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Interim Final Rules (IFR) ,
Medicare ,
Medicare Part D ,
OECD ,
Social Security Act ,
Stark Law ,
Trump Administration
Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule -
On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more
6/24/2020
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
MDRP ,
Medicaid ,
Medicare ,
Medicare Part B ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Reimbursements ,
Value-Based Purchasing
Another Presidential Administration Attempts to Change Part B Payment for Physician-Administered Drugs -
On October 25, 2018, the Trump Administration released an Advance Notice of Proposed Rulemaking (“ANPRM”) entitled...more
On November 16, 2017, the Centers for Medicare & Medicaid Services(“CMS”) published for public inspection a proposed rule that would impact a variety of Medicare Part C and Part D program provisions. The proposed rule, ...more