DE Under 3: U.S. GAO Report on Military Spouse Employment Focused on Challenges of Part-Time Work
A Discussion with GAO General Counsel Edda Emmanuelli Perez
GovCon Perspectives Podcast Episode 24: Effective Use of “Open and Frank” Discussions in Bid Protests
Award Protests: Choosing the Forum
How to Assess the Likelihood of Success in Deciding Whether to Bring a Bid Protest
In our previous Mintz IRA Update, we covered the Biden administration’s proposal exploring the use of “march-in rights” granted under the Bayh-Doyle Act (the “Act”) to seize pharmaceutical patents if the administration...more
Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...more
This Week in Washington: Senate Finance Committee releases discussion draft concerning generic drug shortages; FDA releases laboratory-developed tests final rule; Administration extends ACA subsidies for Deferred Action for...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
This Week in Washington: House Energy and Commerce Committee chairmen and ranking members request information on Change Healthcare cyberattack impacts; FDA establishes CDER Center for Clinical Trial Innovation; House Energy...more
This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....more
This Week in Washington: CMS releases 2025 MA and Part D proposed payment Advance Notice; CMS sends first fair drug price offers to Drug Price Negotiation Program companies; SAMHSA releases final rule making virtual...more
This Week in Washington: Congress passes continuing resolution; CMS releases final rule concerning prior authorization....more
This Week in Washington: House passes Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Senate HELP Committee reports SUPPORT Act Reauthorization and three other bills out of committee; ONC releases final...more
House Passes Healthcare Legislation. The House brought two key bipartisan healthcare bills to the floor this week. The Lower Costs, More Transparency Act (H.R. 5378) was approved by a vote of 320–71, and the Support for...more
This Week in Washington: Senate Finance Committee reports out Better Mental Health Care, Lower-Cost Drugs and Extenders Act; Senate confirms NIH Director; House Speaker Proposes Laddered Continuing Resolution....more
Upcoming Hearings - September 13 - House - House Appropriations Committee Subcommittee on Military Construction, Veterans Affairs, and Related Agencies Oversight Hearing: “Department of Veterans Affairs...more
This Week in Washington: Senate Appropriations Committee meets to figure out top-line numbers; Majority Leader Schumer leads Senate in developing a policy response to artificial intelligence; and CMS proposes new Medicare...more
This Week in Washington: Fallout from debt ceiling holds up House floor action; SCOTUS rules to allow patients to sue nursing homes...more
In conjunction with the surge in state legislative efforts to regulate the pharmacy benefit manager (PBM) industry, Congress and federal agencies have ramped up PBM oversight efforts as part of the ongoing battle to lower...more
This Week in Washington: President and Speaker McCarthy to meet on debt limit with 10 days to go, House Energy and Commerce Subcommittee on Health marks up 17 bills, House Appropriations Committee begins moving appropriation...more
The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more
The House and Senate were both in session this week. The House Ways & Means Health Subcommittee met to discuss policies inhibiting innovation and patient access, and the House Energy & Commerce Health Subcommittee held a...more
This Week in Washington: House Republicans release debt ceiling plan, Speaker McCarthy moves forward with proposal that includes Medicaid work requirements...more
This Week in Washington: HHS Secretary appears before Senate Finance and Senate Appropriations Committees...more
This Week in Washington: CMS releases first list of Inflation Rebate Program drugs, initial guidance on Medicare Drug Negotiation Program...more
Upcoming Hearings - March 22 - Senate Committee on Health, Education, Labor and Pensions Hearing: “Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.,...more
This Week in Washington: President Biden announces ending date of COVID-19 PHE, House begins investigations into COVID-19 origins; State of the Union scheduled for Feb. 7...more