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
President Biden set an ambitious health care agenda in his campaign and maintained that focus as he took office. The Biden administration has expressed a strong commitment to “protect and build on the Affordable Care Act,...more
2/16/2022
/ Alternative Payment Models (APM) ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Health Plan Sponsors ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Beneficiaries ,
Physicians ,
Public Health Emergency ,
Public Health Insurance Marketplace ,
Surprise Medical Bills ,
Telehealth ,
Webinars
The Big Picture -
On November 19, the House of Representatives passed the Build Back Better Act (BBB) (H.R. 5376) by a vote of 220–213. The BBB contains a number of health and social policy priorities that are widely viewed...more
12/8/2021
/ American Rescue Plan Act of 2021 ,
Biden Administration ,
Critical Infrastructure Sectors ,
Federal Budget ,
Federal Funding ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Home and Community Based Services (HCBS) ,
Low-Income Issues ,
Medicaid ,
Medicare ,
Pending Legislation ,
Popular ,
Prescription Drugs ,
Regulatory Agenda ,
Tax Credits
The Big Picture -
Before leaving for its August recess, the Senate made progress on two major Biden Administration priorities by passing bipartisan infrastructure legislation and a fiscal year (FY) 2022 budget resolution....more
8/17/2021
/ Affordable Care Act ,
American Rescue Plan Act of 2021 ,
Biden Administration ,
Congressional Budget Resolution ,
Critical Infrastructure Sectors ,
Health Care Providers ,
Healthcare Reform ,
Home and Community Based Services (HCBS) ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Patient Access ,
Prescription Drugs ,
Regulatory Agenda
The Big Picture -
The Biden Administration is just two weeks old, and President Biden has already issued more than two dozen Executive Orders on racial justice, health equity, strengthening Medicaid and the Affordable...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
Supreme Court Declines to Weigh In on Website Accessibility -
In a closely watched case that many hoped would bring some clarity—and sanity—to the subject of website accessibility under the Americans with Disabilities Act,...more
10/11/2019
/ ABC Test ,
Americans with Disabilities Act (ADA) ,
Ballot Measures ,
California Consumer Privacy Act (CCPA) ,
Class Action ,
Drug Pricing ,
Private Attorneys General Act (PAGA) ,
Public Accommodation ,
Sexual Harassment ,
Title III ,
Wage and Hour ,
Website Accessibility ,
Website Owner Liability ,
Websites
In both chambers of Congress, passing legislation to bring down drug prices is a policy priority—and the savings from such possible legislation is slated to offset other healthcare legislative proposals (such as addressing...more
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
Editor’s Note: On May 8, the administration issued the much-anticipated final rule requiring drug manufacturers to disclose wholesale acquisition prices in their broadcast advertising. The debate around the rule has been...more
On May 23, the bipartisan leadership of the House Ways and Means Committee released a four-page draft discussion bill that, if enacted, would make the most significant changes to the Part D benefit since the Affordable Care...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
On November 26 2018, the Centers for Medicare & Medicaid Services (CMS) released the Proposed Rule, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. The proposed rule would...more
Editor’s Note: On October 15, the Trump administration’s Centers for Medicare & Medicaid Services (CMS) published a proposed rule that, if finalized, would require prescription drugmakers to include prescription drug price...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