Category Archives: Covered Entities

Subscribe to Covered Entities RSS Feed

340B Program Alert: Federal Court Ruling Vacates HRSA Notice Related to Child Site Registration Requirements

By Richard Davis, Michael French, Brenda Maloney Shafer and Jake Pallotta on Posted in Covered Entities, Litigation, Manufacturers
On March 3, 2026, the U.S. District Court for the District of Columbia (“Court”) issued a seismic ruling effectively vacating several components of Health Resources and Services Administration’s (“HRSA”) 340B registration requirements for qualifying off-site hospital facilities (“Order”). The Order represents a victory for 340B participating hospitals that will permit these entities to begin utilizing … Continue Reading

340B Program Alert: Federal District Court Pauses Scheduled Implementation of Rebate Pilot Program

By Brenda Maloney Shafer, Richard Davis, Michael French and Jake Pallotta on Posted in Covered Entities, Litigation
Mere days before the Health Resources and Services Administration’s (HRSA) 340B Rebate Model Pilot Program’s (“Pilot”) scheduled January 1, 2026 effective date, a federal district court granted a preliminary injunction that temporarily halts the scheduled implementation of the Pilot approved rebate models. The decision, citing significant deficiencies in HRSA’s administrative processes when developing and implementing … Continue Reading

340B Program Alert: HRSA Approves Manufacturer Rebate Models for Pilot Program Participation

By Brenda Maloney Shafer, Richard Davis, Michael French and Jake Pallotta on Posted in Contract Pharmacies, Covered Entities, Manufacturers
In a move that will fundamentally change how the 340B Drug Pricing Program (“340B Program”) operates for a subset of medications, HRSA’s Office of Pharmacy Affairs (“OPA”) opted late last week to approve eight manufacturer plans for participation in the 340B Rebate Model Pilot Program (“Pilot”). These approved plans, which will take effect on January … Continue Reading

District Court Allows for Expanded Interpretation of Eligible Patient in Impactful 340B Program Ruling

By Michael French, Richard Davis and Brenda Maloney Shafer on Posted in Covered Entities
In a decision likely to send shockwaves through the 340B Program space, the United States District Court of South Carolina recently provided a favorable ruling to 340B-participating covered entities hoping to take a more expansive view of who can reasonably constitute a 340B-eligible patient. Background: The case originated more than five years ago when Genesis … Continue Reading

HRSA Notice Provides Clarity on 340B Child Site Registration Requirements

By Richard Davis, Michael French, Madison Hartman and Brenda Maloney Shafer on Posted in Covered Entities, Guidance
After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice today confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B Program benefits in some circumstances. However, HRSA also introduced new “transition periods” in its Notice, providing covered entities a longer runway to come into compliance … Continue Reading

Continuing Changes in the 340B Space: New Restrictions and Shifting Alliances

By Brenda Maloney Shafer, Richard Davis, Michael French and Madison Hartman on Posted in Compliance, Contract Pharmacies, Covered Entities, Legislation
As detailed further in our article on the current state of the 340B Program and what to expect in 2023, a growing list of manufacturers have taken the step of significantly restricting 340B pricing for fills completed by contract pharmacies. Over the last few weeks, the number and scope of these restrictions have only continued to grow. … Continue Reading

340B Program Changes on the Horizon? Start Planning Now for Potentially Seismic Impact of Upcoming Genesis Decision

By Michael French, Brenda Maloney Shafer and Richard Davis on Posted in Covered Entities, Guidance, Litigation
As the extensively covered Genesis Healthcare, Inc. v. Azar case continues to proceed, 340B covered entities expect to soon receive much-anticipated clarification on what can reasonably constitute a 340B eligible patient. In the meantime, covered entities should begin planning and strategizing now for how such a significant change to the 340B Program would impact its 340B services … Continue Reading

UPDATE: U.S. Supreme Court Sides with 340B Hospitals in Significant $1.6 Billion Part B Drug Payment Ruling

By Brenda Maloney Shafer, Richard Davis and Michael French on Posted in Covered Entities
On June 15, 2022, after many years of ongoing litigation1, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain outpatient prescription drugs provided to Medicare patients for fiscal years 2018 and 2019, totaling an estimated $1.6 billion across all affected entities. While … Continue Reading

Supreme Court Decision Maintains Status Quo for Disproportionate Share Percentage Calculation: What Does It Mean for the 340B Program?

By Brenda Maloney Shafer, Richard Davis and Michael French on Posted in Compliance, Covered Entities, Guidance, Legislation
Earlier today, the Supreme Court released a decision relating to how the Department of Health and Human Services (HHS) requires hospitals to calculate its disproportionate share percentage. While this percentage is primarily used to determine enhanced reimbursement rates depending on how many low-income patients the hospital treats, it is also used as a minimum 340B eligibility threshold … Continue Reading

The End of a Wild Year for 340B: HHS Issues Advisory Opinion and New GAO Report Sheds Light on HRSA’s Enforcement Pullback

By Brenda Maloney Shafer, Richard Davis and David Blank on Posted in Contract Pharmacies, Covered Entities, Guidance, Manufacturers
2020 was a tumultuous year for virtually everyone and everything, and the 340B Program was no exception. As we outlined in previous articles, many drug manufacturers have decided that the Health Resources and Services Administration’s Office of Pharmacy Affairs (“HRSA OPA”) guidance on contract pharmacy[1] arrangements is no longer binding. Accordingly, many drug manufacturers have … Continue Reading

Notice to Covered Entities: Manufacturer Seeking 340B Claims Data

By Brenda Maloney Shafer and Richard Davis on Posted in Compliance, Covered Entities, Guidance, Manufacturers
While we addressed recent wins for 340B covered entities concerning manufacturer transparency in a previous article, Merck Sharpe & Dohme Corp. (“Merck” or “Manufacturer”) now appears to seek its own access to 340B covered entity data in a different fashion. Specifically, over the past few weeks, Merck has sent letters to numerous 340B covered entities … Continue Reading

CMS Publishes 340B Drug Acquisition Cost Survey: Respond by May 15, 2020

By Brenda Maloney Shafer and Richard Davis on Posted in Covered Entities
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 the data collected from the survey to adjust the Medicare Part B reimbursement rate for 340B … Continue Reading

HRSA Unveils New 340B Flexibilities During COVID-19 Crisis

By Brenda Maloney Shafer and Richard Davis on Posted in Covered Entities, Legislation
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 level, HRSA OPA acknowledges that “this public health emergency may warrant additional flexibilities, especially to … Continue Reading

New PBM State Laws Indicate a Shifting Battlefront over 340B Program Drug Pricing

By Brenda Maloney Shafer and Richard Davis on Posted in Covered Entities, Legislation
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 level may also have a significant impact on covered entity reimbursement for 340B drugs.… Continue Reading

Interesting 340B Takeaways from 2020 OPPS Proposed Rule

By Brenda Maloney Shafer and Richard Davis on Posted in Covered Entities, Legislation
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 it plans to continue its 28.5 percent reduction in reimbursement while it pursues an appeal … Continue Reading

340B Litigation Updates and Other Program Developments

By Brenda Maloney Shafer and Richard Davis on Posted in Covered Entities, Legislation
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 authority in implementing a reduced Medicare reimbursement rate for 340B Program drugs for 2019. In … Continue Reading

The President’s 2020 Budget Keeps 340B Program in the Spotlight

By Brenda Maloney Shafer and Richard Davis on Posted in Covered Entities, Legislation
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 the President’s position on desired 340B Program changes.… Continue Reading

CVS Caremark Reverses Planned Payment Cuts to 340B Providers

By Brenda Maloney Shafer and Richard Davis on Posted in Covered Entities
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 Part B payment reductions for 340B drugs,[1] provides some positive news for these Covered Entities … Continue Reading

We’re 340Back! Review of Major Developments to the 340B Program

By Brenda Maloney Shafer and Richard Davis on Posted in Audits, Covered Entities, Legislation
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 340B Program remains largely unchanged from where it stood prior to 2017. As covered … Continue Reading

Key Takeaway from 340B Conferences – Audits

By Alyce Katayama and Elizabeth Gebarski on Posted in Audits, Certification/Recertification, Compliance, Contract Pharmacies, Covered Entities, Diversion, Duplicate Discounts
Yep. Audits. They are happening. And, chances are, if your covered entity (“CE”) hasn’t experienced one yet, it is coming to you sometime soon. At both 340B University (hosted by Apexus, the prime vendor for the 340B Drug Pricing Program) and the 340B Coalition Conference (hosted by 340B Health) many CEs we interacted with had already experienced … Continue Reading

Comparing 340B University and the 340B Coalition Conference

By Alyce Katayama and Elizabeth Gebarski on Posted in Audits, Contract Pharmacies, Covered Entities, Guidance, Manufacturers
Maybe it is just us, but we wanted to know whether we would get a different experience at 340B University versus the 340B Coalition Conference.  In some ways, these conferences could not have been more different. But, at the heart of it all, each had the same underlying education of stakeholders so that covered entities … Continue Reading

Top Takeaway from 340B University and 340B Coalition Conference

By Alyce Katayama and Elizabeth Gebarski on Posted in Compliance, Contract Pharmacies, Covered Entities, Guidance, Manufacturers
This year we once again had boots on the ground for 340B University and the 340B Winter Coalition Conference for a four-day 340B Drug Pricing Program (340B Program) adventure. 340B University is free of charge and is put on by the 340B Prime Vendor, Apexus. The 340B Coalition Conference, on the other hand, charges a fee … Continue Reading

PhRMA 2-0 in The Orphan Drug Wars

By Alyce Katayama and Elizabeth Gebarski on Posted in Compliance, Covered Entities, Guidance, Manufacturers, Orphan Drugs
U.S. Federal District Court Judge for the District of Columbia, Rudolph Contreras, ruled Wednesday, October 14, 2015 that manufacturers need not offer 340B discounts for orphan drugs sold to a specified group of covered entities (CEs), regardless of how the orphan drug is used. To make a very long story short, in 2010, the Patient Protection … Continue Reading
LexBlog