The Centers for Medicare & Medicaid Services (CMS) is required to make public by September 1 the “maximum fair prices” (MFP) that CMS is setting for the first ten drugs subject to the Medicare Drug Price Negotiation Program...more
This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments....more
In the wake of the FTC’s July 9 vote to release an interim staff report on PBMs, several media outlets are reporting that the Commission is poised to sue large PBMs. The timing and nature of the litigation is unspecified,...more
On August 16, President Joe Biden signed into law H.R. 5376 , the Inflation Reduction Act of 2022, which makes arguably the most significant changes to U.S. prescription drug price regulation ever, including by...more
On August 16, President Joe Biden signed into law H.R. 5376 , the Inflation Reduction Act of 2022, which makes arguably the most significant changes to U.S. prescription drug price regulation ever, including by...more
On August 16, President Joe Biden signed into law H.R. 5376, the Inflation Reduction Act of 2022, which makes arguably the most significant changes to U.S. prescription drug price regulation ever, including by...more
The Inflation Reduction Act (IRA) will make arguably the most significant changes to U.S. prescription drug pricing regulations ever, but certainly since the creation of the Medicaid Drug Rebate Program in 1990. For the first...more
8/18/2022
/ Continuing Legal Education ,
Drug Pricing ,
Health Care Providers ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rebates ,
Webinars ,
Wholesale
On April 7, the Centers for Medicare & Medicaid Services (CMS) released its highly anticipated final National Coverage Determination (NCD) for Aduhelm and other similar therapies in the pipeline for Alzheimer’s disease. The...more
On November 20, President Trump held a press briefing at which he unveiled two long-awaited actions to reduce prescription drug costs. Both actions had been called for in Executive Orders he issued this summer. Although each...more
12/7/2020
/ Biden Administration ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Medicare Part B ,
Medicare Part D ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Trump Administration
The Big Picture -
In the latest election year action to address politically salient concerns with high drug costs, President Trump on Sunday signed an “Executive Order on Lowering Drug Prices by Putting America First.”...more
On August 6, President Trump signed an Executive Order, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States, designed to reduce U.S. dependency on foreign sources of...more
Prescription drug pricing is emerging as one of several healthcare issues that may become a focus of the presidential race as well as contested congressional races this fall. With pending legislative attempts to control drug...more
8/18/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
FQHC ,
HRSA ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Service Act ,
Regulatory Agenda ,
Rulemaking Process ,
Section 340B ,
Trump Administration
On July 9, Judge Amit P. Mehta of the U.S. District Court, District of Columbia vacated an administration final rule that would have required drug manufacturers to disclose wholesale acquisition prices in their television...more
On January 31, the Department of Health & Human Services (HHS) Office of Inspector General (OIG) issued a proposed rule to fundamentally change the system for negotiating drug prices under Medicare Part D and, potentially,...more
The Administration’s drug pricing plan, “American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs,” unveiled in May included tough rhetoric for the stakeholders in the...more
The Debate over Specialty Pharmaceuticals: Is the Promise Worth the Price? -
..What’s the Issue?
- Specialty pharmaceuticals are a rapidly growing share of total drug expenditures by public and private health...more
As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies -
In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more
8/20/2013
/ Affordable Care Act ,
Biotechnology ,
Compliance ,
False Claims Act (FCA) ,
Fraud ,
Health Insurance Exchanges ,
Healthcare ,
Insurance Industry ,
Manufacturers ,
Medical Devices ,
Penalties ,
Pharmaceutical Industry ,
Premiums ,
Prescription Drugs ,
Reimbursements