On April 24, 2020, the Centers for Medicare and Medicaid Services (CMS) finalized and published a survey intended to capture the actual amounts paid by 340B covered entities (excluding critical access hospitals) for 340B drugs. CMS then intends to use
To Be or Not to 340B Blog
Legal Updates on the 340B Program
The "To Be or Not to 340B Blog," published by Quarles & Brady LLP, focuses on legal and regulatory developments related to the 340B Drug Pricing Program. The blog covers topics such as manufacturer rebate models, contract pharmacy restrictions, dispute resolution processes, and federal and state legislative changes impacting 340B covered entities. It analyzes the implications of policy shifts, litigation, and administrative rules on hospitals, health systems, and other eligible providers participating in the 340B Program. The blog also discusses enforcement actions, compliance challenges, and the evolving landscape of drug pricing and reimbursement under the 340B statute.
Latest from To Be or Not to 340B Blog - Page 3
HRSA Unveils New 340B Flexibilities During COVID-19 Crisis
As the COVID-19 crisis continues to unfold, the Health Resources & Services Administration Office of Pharmacy Affairs (HRSA OPA) has taken unprecedented steps to provide 340B Program participants with additional flexibility to help meet surging patient demand. At the highest…
GAO Report Suggests Increased Oversight of 340B Program
On January 10, 2020, the Government Accountability Office (GAO) released a report which “found weaknesses in the Health Resources and Services Administration’s (HRSA) oversight [of the 340B Program] that may result in some hospitals receiving discounts for which they are not eligible.” The…
New PBM State Laws Indicate a Shifting Battlefront over 340B Program Drug Pricing
While much attention has been paid to the ongoing litigation related to the ongoing 340B Medicare Part B payment reduction litigation (which is now pending before the US Court of Appeals for the DC Circuit), new legislation at the state…
Interesting 340B Takeaways from 2020 OPPS Proposed Rule
The Centers for Medicare & Medicaid Services (CMS) “respectfully disagreed” with a recent federal district court’s “understanding of the scope of CMS’ adjustment authority” in making cuts to Medicare Part B reimbursement for drugs purchased through the 340B program, saying…
340B Litigation Updates and Other Program Developments
340B Medicare Part B Adjustment Litigation Update
In the latest development of the ongoing 340B Medicare Part B payment reduction controversy, US District Judge Rudolph Contreras again concluded that the Department of Health and Human Services (HHS) exceeded its statutory…
The President’s 2020 Budget Keeps 340B Program in the Spotlight
On March 11, 2019, the President delivered his proposed 2020 budget to Congress. While a President’s budget proposal is the beginning of a lengthy budget process, this proposed budget nonetheless keeps the 340B Program in the national focus and delineates…
CVS Caremark Reverses Planned Payment Cuts to 340B Providers
CVS Caremark has decided not to implement reimbursement reductions which may have had adverse effects on Covered Entities and their retail pharmacies (including contract pharmacies). This decision, coupled with the recent court decision invalidating certain aspects of the proposed Medicare…
We’re 340Back! Review of Major Developments to the 340B Program
It’s been a roller coaster two years for the 340B Program, and we are now back to review some of the major developments and program changes during this time. On the highest level, despite a flurry of proposed legislative action,…
The Omnibus Guidance is Dead!
The proposed 340B Drug Pricing Program Omnibus Guidance that was issued in August 2015 and promised to turn the 340B world on its head was withdrawn on January 30, 2017.
Not that most covered entities are upset. The proposed 340B…