K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held...more
In response to President Biden’s Executive Order on Promoting Competition in the American Economy—which called for the Secretary of Health and Human Services to publish for notice and comment a proposed rule on...more
In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the...more
On March 8, 2021, President Biden signed an Executive Order, establishing a Gender Policy Council (“the Council”) tasked with the broad policy goal of “advancing gender equity and equality” for the purpose of reducing...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
The Biden Administration issued a Proclamation on January 25, 2021 reinstating the COVID-related travel bans put in place and slated to be lifted on January 26, 2021 by the Trump Administration. Foreign nationals present in...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
As the COVID-19 pandemic continues across the United States, states, payers, and providers are looking for ways to expand access to telehealth services. Telehealth is an essential tool in ensuring patients are able to access...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
In the Food and Drug area, we don’t often get dramatic changes in FDA policies, but an announcement from the Secretary of HHS, published on August 18, appears to be just such a dramatic change. In the new announcement, HHS...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
Long term care facilities and providers are bearing the brunt of caring for the nation's largest and most vulnerable populations of COVID-19 patients. And they're doing so in the face of considerable uncertainty, insufficient...more
As previously reported, the CARES Act impacts long-term care (LTC) facilities, including skilled nursing facilities (SNFs) and nursing facilities (NFs). In addition to this legislative action, the Centers for Medicare and...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
On March 20, 2020, President Trump announced the first exercise of the Executive Order on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of Covid-19, which authorizes the Secretary of Health...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
On July 10, 2019, President Trump issued an Executive Order on Advancing American Kidney Health (the EO). Executive orders are issued under the authority of the Constitution, Article II, Sections 1 and 3, requiring that the...more
In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate...more