K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
Texas Attorney General Ken Paxton recently announced that his office is investigating some of the country’s most ubiquitous home brands — including Colgate-Palmolive, Proctor & Gamble, and General Mills — for allegedly...more
On May 12, 2025, President Trump issued an executive order aimed at lowering prescription drug prices titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” Generally, the order directs...more
Plutocrats reigned. The gulf between rich and poor was huge. Nativist extremists, populist politicians, and major elements of the media clamored about the waves of immigrants flooding into America. And health challenges...more
If NIH succeeds in imposing an across-the-board indirect cost rate of 15%, rough estimates indicate the University of Michigan could lose $119 million a year. Emory University could be down $75 million. For the University of...more
Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more
On January 28th, President Biden issued an “Executive Order on Strengthening Medicaid and the Affordable Care Act.” The E.O. states that the Biden Administration will promote policies that “protect and strengthen Medicaid and...more
On December 4, 2020, the Supreme Court agreed to hear arguments to decide the legality of the Department of Health and Human Services’ (HHS’s) authorization for states to incorporate work requirements into their Medicaid...more
In Washington: The House passed a one-week funding extension (HR 8900) to give lawmakers more time to finalize a fiscal 2021 spending package and coronavirus relief. The vote was 343-67. The measure (HR 8900) now goes to...more
On October 13, 2020, President Trump signed a “Memorandum on Stopping Counterfeit Trafficking on E-commerce Platforms Through Fines and Civil Penalties” to combat trademark counterfeiting by taking aim at the e-commerce...more
In Washington: President Donald Trump and first lady Melania Trump have tested positive for the coronavirus, the White House physician announced late Thursday. The President tweeted at 12:54 a.m. Friday: “Tonight, @FLOTUS...more
In Washington - President Trump announced a plan Monday to deploy 150 million rapid tests to states and vulnerable communities. This comes one month after the administration initially announced the purchase. During a Rose...more
On September 13, 2020, the White House issued an Executive Order titled “Lowering Drug Prices by Putting America First” (the Executive Order), which directed the Secretary of the US Department of Health and Human Services...more
The White House released a new Executive Order on September 13, 2020, related to drug prices titled “Lowering Drug Prices by Putting America First” the September Order), whose stated purpose is to address reimbursement for...more
On September 13, 2020, President Trump issued an Executive Order seeking to establish most favored nation ("MFN") pricing for Medicare drug payments. The Trump Administration's Order, 'Lowering Drug Prices by Putting America...more
As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more
On August 3, 2020, President Trump signed Executive Order 13941 (the “Executive Order”) which expands access to certain telehealth services post-pandemic. The Executive Order focuses on telehealth access for individuals...more
In Washington - The divide between Democrats and Republicans continues as talks today have still resulted in no deal on a new coronavirus stimulus package. House Speaker Nancy Pelosi (D-CA), Senate Minority Leader Chuck...more
On Friday, President Trump announced four executive orders directed at decreasing prescription drug prices by ordering certain actions by the Department of Health and Human Services (“HHS”). One order – which has received the...more
The Trump Administration issued a series of Executive Orders (“EOs” or “Orders”) Friday afternoon related to drug pricing. Several of the EOs seek to restart stalled or withdrawn policy initiatives previously announced by the...more
The Justice Department and the FBI have quickly acted to focus on fraudsters and hoarders seeking to profit from the public panic in response to the pandemic. DOJ issued a memo to U.S. Attorneys prioritizing investigations...more
On March 18, President Trump issued an Executive Order invoking the Defense Production Act (DPA), a tool that may help the administration combat the COVID-19 pandemic. With companies like 3M, GE, and others voluntarily...more
President Trump signed an Executive Order on Preventing Hoarding of Health and Medical Resources to Respond to the Spread of COVID-19 (EO) on March 23, 2020. The EO delegates presidential authority under the Defense...more
While providers struggle to provide health care to their patients amid the coronavirus contagion concerns, recent regulatory and reimbursement changes will help ease the path to the provision of healthcare via telehealth....more
At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more
The Issue: On June 24, 2019, President Trump signed an executive order, which instructed the Department of Health and Human Services to publish rules requiring hospitals to publicly disclose their negotiated rates for...more