340B Litigation Updates and Other Program Developments340B 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 issuing the opinion, the court relied upon the same analysis it employed to declare the same 2018 reimbursement reductions unlawful. As such, the court has enjoined...More
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 the President’s position on desired 340B Program changes.
Specifically, the President’s proposed 2020 budget requests the following 340B Program changes:
Grant the Health and Human Resources Administration Office of Pharmacy Affairs (“HRSA OPA”) broad regulatory authority for the 340B Program to set...More
CVS Caremark Reverses Planned Payment Cuts to 340B ProvidersCVS 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, provides some positive news for these Covered Entities after years of uncertainty over the future of the 340B Program.
By way of background, CVS Caremark, a pharmacy benefits manager (PBM), issued notices of amendments...More
We’re 340Back! Review of Major Developments to the 340B ProgramIt’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 in more detail below, the notable exception to this is the significant Medicare Part B reimbursement reductions for certain categories of 340B covered entities. Of...More
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 Drug Pricing Program Omnibus Guidance proposed a host of changes to the 340B Drug Pricing Program, a law that requires drug manufacturers to provide discounts on “covered outpatient drugs” to “covered entities,” when those “covered entities” provide the drug to “eligible...More
Key Takeaway from 340B Conferences – AuditsYep. 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 the Health Resources and Services Administration (“HRSA”) audit process.
There are two reasons a CE gets audited: (1) someone alleges violations of the 340B Drug...More
Comparing 340B University and the 340B Coalition ConferenceMaybe 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 (“CEs”) can continue stretching “scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”
The 340B Prime Vendor, Apexus,...More
Top Takeaway from 340B University and 340B Coalition ConferenceThis 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 and is organized by 340B Health, a membership organization that advocates for covered entities (CEs).
In this post, we disclose the number one lesson from this...More
Site Neutral Payments Put 340B Child Sites in JeopardyJust when you thought you understood all the threats facing the 340B Drug Pricing Program (“340B Program”), along comes the Bipartisan Budget Act of 2015 (“BBA 2015). BBA 2015 changes the way in which new off-campus hospital outpatient departments (“HOPDs”) will be paid come January 1, 2017. This change could have a substantial impact on 340B Program child site eligibility.
First, a little history. Before November 2, 2015, Medicare generally paid more for diagnostic and therapeutic services furnished in HOPDs than...More
PhRMA 2-0 in The Orphan Drug WarsU.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 and Affordable Care Act (PPACA) made several changes to the 340B Program. In part, it added several new CEs (e.g., children’s hospitals and critical access hospitals)...More