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
Deputy Secretary and CMS Administrator Picks Would Fill Two Critical Policy Positions - On Thursday, the Senate Finance Committee held a confirmation hearing for two of the most important health policy officials nominated...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 February 7, 2020, the Centers for Medicare and Medicaid Service (CMS) published a notice signaling that it has submitted its previously published September 2019 proposed survey of hospital 340B drug costs for Office of...more
We closed last week with a budget deal that addressed nearly every health care stakeholder issue. With 2017 finally over, we begin 2018 with the next budget. This week the Administration will release its FY 2019 budget and...more
On January 30, 2017, the proposed 340B Drug Pricing Program (the “340B Program”) Omnibus Guidance (the “Guidance”) first issued by the Health Resources and Services Administration (HRSA) in August of 2015 was withdrawn from...more
The new administration has had an immediate impact on the federal 340B Drug Discount Program (“340B Program”) with two significant developments in the first days since President Trump took office: (1) the withdrawal of the...more
The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The...more
As had been widely anticipated, late on January 30, 2017, the Department of Health and Human Services (HHS) withdrew the 340B Program “Mega-Guidance” that had been under review at the Office of Management and Budget (OMB)...more
Before we all turn our full attention to the nominations of Representative Tom Price as Secretary of Health and Human Services, and policy consultant Seema Verma to lead CMS, we need to remember that there are still...more
340B Program Final “Mega Guidance” at OMB – On September 1, 2016, the White House Office of Management and Budget (OMB) received final omnibus guidance for review from HHS regarding the 340B Drug Pricing Program. ...more
OMB Reviewing Proposal on Handling of 340B Disputes -- On June 15, 2016, the Office of Management and Budget (OMB) started its review of a proposed rule under the 340B discount program, according to the OMB’s website. Under...more
Review of 340B Program Omnibus Guidelines Extended – Last week, the White House Office of Management and Budget (OMB) posted that the review of the 340B Program Omnibus Guidelines had been extended. The Health Resources and...more
Safety-net providers, manufacturers, members of Congress, and other stakeholders have been tracking the status of the Health Resources and Services Administration’s (“HRSA”) draft 340B Omnibus Guidance closely as it promises...more
CMS Publishes Corrected Comment Deadline for FY 2016 IPPS and LTCH Proposed Rule; Comments Due by June 16, 2015 – On May 5, 2015, CMS published in the Federal Register a corrected comment period for the FY 2016 Medicare IPPS...more
In This Issue: - 340B Drug Discount Program Guidance Nearing Finish Line - Implementation of the Affordable Care Act - Federal Regulatory Initiatives - Congressional Initiatives - Other...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
On May 6, 2015, the Health Resources and Services Administration (HRSA) submitted guidance on the 340B Federal Drug Pricing Program (340B Program) to the federal Office of Management and Budget (OMB) for review. ...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
Earlier this week, the much-anticipated 340B Drug Pricing Program (340B Program) proposed rule arrived at the Office of Management and Budget for review. Publication of this proposed rule is expected in June and will likely...more