DE Under 3: FAR Council Seeks to Require Federal Contractors to Report First-Tier Subcontractor Information, Including Potentially Executive Compensation Data
DE Under 3: OMB Announced Finalized Overhaul to Federal Race & Ethnicity Data Collection Standards
DE Under 3: OFCCP Resurrects Proposal for Monthly CC-257 Employment Utilization Reports for Construction Contractors
DE Under 3: FAR Council Submitted for OMB Approval Proposed Rule on “Pay Equity and Transparency in Federal Contracting”
DE Under 3: Surprises Lurk Throughout OMB's 2023 Spring Regulatory Agenda
DE Under 3: OFCCP’s Controversial “Pre-Enforcement Notice & Conciliation Procedures” Final Rule Coming Soon
DE Under 3: President Biden Issued "Modernizing Regulatory Review" Executive Order
DE Under 3: OMB’s Initial Proposal to Overhaul Federal Race & Ethnicity Data Collections
DE Under 3: OMB Publishes Its Fall 2022 Regulatory Agenda
DE Under 3: Big Changes Coming to OFCCP's Supply & Service Contractor ICRs
DE Under 3: Employment Poster Requirements & the U.S. DOJ’s First-Ever Criminal Anti-Trust Prosecution
DE Under 3: Data Gathering & Data Delivery
DE Under 3: New Data Collection Burdens, NLRB’s Ruling Regarding Union Election Dismissals, and OMB’s Tech Modernization Fund
Biden’s Modernizing Regulatory Review – A New Paradigm?
DoD Cyber: A Conversation with Melissa Vice, COO for DoD’s Vulnerability Disclosure Program
Is it the End of the EB-5 World as We Know it? How to Prepare for Potential Changes
I-14: Update on EEO-1 and I-9 Forms, Employer Obligations After a Hurricane or Other Natural Disaster, and Attorney Jason Barsanti on Meal and Rest Breaks
A new rule posted on the Office of Management and Budget (OMB) registry suggests that the Drug Enforcement Administration (DEA) is planning an additional extension of COVID-19 flexibilities for telemedicine prescribing of...more
Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when...more
On July 25, 2023, the Centers for Medicare & Medicaid Services (CMS) republished its Drug Price Negotiation Process Information Collection Request (Negotiation Process ICR). The Negotiation Process ICR, which was originally...more
The U.S. Food and Drug Administration (FDA) announced a new pilot program on June 21, 2023 that gives sponsors of oncology products the opportunity to submit validation and performance data for laboratory developed tests...more
This Week in Washington: President Biden Signs Omnibus Appropriations Package into Law to Fund the Federal Government Through FY 2022...more
PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule - On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more
In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug...more
On August 6, 2020, President Trump issued another Executive Order (“EO”) that will likely have dramatic and long-lasting effects on the pharmaceutical industry. The impact of the EO may be far greater than currently...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
This week in Washington: House passes first set of Appropriations bills; President Trump signs Executive Orders on Prescription Drugs after COVID-19 bill stalled....more
Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more
Congress - Hearings/Markups - Senate Finance Committee: "Drug Pricing in America: A Prescription for Change, Part III" - Tuesday, April 9, 2019: The Senate Finance Committee continued its drug pricing series by...more
Coming Week’s Highlights: Congress will continue to examine drug pricing; on Tuesday, the Senate Finance Committee will hold the third in a series of hearings, this one focused on pharmacy benefit managers (PBMs). The House...more
Upcoming Hearings - Tuesday, March 5, 2019 - Senate Committee on Health, Education, Labor and Pensions (HELP): “Vaccines Save Lives: What is Driving Preventable Disease Outbreaks?” - The Senate Committee on Health,...more
Upcoming Hearings - Tuesday, Feb. 26, 2019 - Senate Finance Committee: “Drug Pricing in America: A Prescription for Change, Part II” - The second hearing in a series on drug pricing in the Senate Finance Committee...more
Upcoming Hearings - Tuesday, Feb. 26, 2019 - Senate Finance Committee: “TBA Hearing on Drug Pricing” - The second hearing in a series on drug pricing in the Senate Finance Committee will include the testimonies of...more
Outlook for This Week in the Nation's Capital - Appropriations. The Senate is expected to begin work this week on its next minibus appropriations bill- a package that would contain the Defense and Labor-HHS spending bills....more
During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more
This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more
On Wednesday, May 6, the Health Resources and Services Administration, Office of Pharmacy Affairs (“OPA”) forwarded a draft copy of its 340B Program Omnibus Guidelines (“Guidelines”) to the Office of Management and Budget for...more
The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would use civil monetary penalties to enforce ceiling...more
For over a year, participants in the 340B Drug Pricing Program (340B Program) and others have been waiting for the release of the so-called proposed “Mega-Rule” by the Department of Health and Human Services (HHS). The...more