340B Drug Pricing Program Compliance
Podcast: Chevron Deference: Is It Time for Change? - Diagnosing Health Care
K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
On November 27, 2020, CMS published its Most Favored Nation (MFN) Model Interim Final Rule (IFR) that seeks to lower the amount paid for 50 high-cost Medicare Part B drugs to the lowest price that drug manufacturers receive...more
House - Democrats Ask GAO to Investigate Legality of President Trump’s Medicare Drug Gift Cards - On Oct. 13, House Energy & Commerce Chair Frank Pallone (D-NJ), House Ways & Means Chair Richard Neal (D-MA) and Senate...more
On September 24, 2020, the Health Resources and Services Administration (HRSA) released a proposed rule that, if finalized, would require 340B-participating recipients of federal grants under Section 330(e) of the Public...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
On July 24 2020, President Trump signed three Executive Orders targeting prescription drug prices and proposed a fourth. The Orders represent the Trump Administration's latest effort to implement previously outlined...more
US President Donald Trump signed four executive orders implementing policies on drug pricing on July 24. One of the orders directs the secretary of the US Department of Health and Human Services (HHS) to condition future...more
President Trump signed four executive orders on July 24, 2020, that appear to push forward the administration’s efforts to lower prescription drug costs and pass the savings on to consumers. ...more
On July 24, 2020, President Trump issued four executive orders aimed at lowering drug prices. The executive orders direct the Secretary of the Department of Health and Human Services (HHS) to: Increase access to insulin and...more
2019 saw court hearings of a number of cases related to the Affordable Care Act (ACA). Several other Trump administration policies were also challenged, including Medicare payment policies, price transparency, how the...more
In Part One of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments that may affect drug pricing and pharmacy...more
President Trump's fiscal year 2020 (FY20) budget proposal for the Department of Health and Human Services (HHS) reflects the Trump Administration's priorities to repeal and replace the Affordable Care Act (ACA), implement...more
As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more
On December 27, 2018, the U.S. District Court for the District of Columbia issued an opinion that ruled against the Trump Administration in its plan to cut funding from the 340B Drug Pricing Program (“340B Program”). ...more
This Week: Happy New Year! The 116th Congress begins and healthcare issues are part of the "buzz" of day one. Part of the government is still closed. ...more
This Week: Congress focuses on organizing for the next Congress and the continuing resolution; previews of drug pricing legislation for the next Congress; CMS issues controversial guidance concerning how states can use...more
On October 25, the Centers for Medicare and Medicaid Services (“CMS”) issued an Advance Notice of Proposed Rulemaking (“ANPRM”) seeking input on the development of a new drug pricing model under Medicare Part B to index...more
Administration - Trump Administration Announces HRA Regulatory Proposal to Prevent Adverse Selection - The Trump administration announced a regulatory proposal to permit employees to go to the individual market to...more
For much of the past 18 months, the Trump Administration, and in particular CMS, have talked a good game regarding reducing pharmaceutical prices. On October 16, 2018, a key component of the Administration’s strategy was...more
Regulation and reimbursement of drugs, particularly those purchased through the 340B Drug Discount Program (the “340B Program” or “340B”), continue to be dynamic issues of debate for federal policymakers. In response to...more
Outlook for This Week in the Nation's Capital - Appropriations Update. The next minibus package vote will be on the Defense and Labor-HHs appropriations bills and could also include a continuing resolution for the...more
Congress is back in session after the August recess and, as expected, a flurry of activity took place. Here are some key health care policy headlines from the past week that you may have missed....more
This week’s “Capitol Hill Healthcare Update” includes the latest on Congress reconvening after a summer break and facing near-term deadlines on government funding, including for healthcare agencies and programs; whether...more
As the Trump Administration moves forward with proposed policy changes to address high drug prices, a common theme is emerging: a number of the proposals have the potential to reduce Medicare reimbursement to hospitals and...more
Foley & Lardner LLP’s Bipartisan Public Policy Team is pleased to share this week’s “Public Policy Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please note that the next...more
On July 17, 2017, the U.S. Court of Appeals for the District of Columbia Circuit ruled in favor of the Department of Health and Human Services (HHS), finding that the American Hospital Association’s (AHA) legal challenge of...more