Tag Archives: HRSA

HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for resolving certain types of disputes between 340B covered entities and drug manufacturers. 340B Program observers are cautiously optimistic that the ADR process will serve as a less … Continue Reading

340B Developments in 2024 – Litigation and Legislation

By Richard Davis, Brenda Maloney Shafer, Madison Hartman and Michael French on March 15, 2024 Posted in Legislation, Litigation

Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts. Litigation Update Although 340B stakeholders still await the 7th Circuit and the DC Court of appeals to weigh in on the permissibility of manufacturer contract pharmacy restrictions, another … 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 November 8, 2023 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 October 30, 2023 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

The Current State of 340B and What to Expect in 2023

By Brenda Maloney Shafer, Richard Davis, Michael French and Madison Hartman on February 8, 2023 Posted in Legislation, Litigation

2022 was an eventful year on the 340B front, packed with updates to consequential litigation, proposed new rules, ongoing uncertainty into the Health Resources and Services Administration’s (HRSA) underlying enforcement authority, and changes to 340B-related laws on the state level. We saw the Supreme Court side with 340B hospitals in a significant $1.6 billion Medicare … Continue Reading

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

By Madison Hartman, Michael French, Brenda Maloney Shafer and Richard Davis on October 10, 2022 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

Federal Spending Bill Offers Re-Enrollment Path for Some Hospitals

By Michael French, Brenda Maloney Shafer and Richard Davis on March 22, 2022 Posted in Legislation

UPDATED on 3/22/2022 In a move welcomed by the growing number of hospitals forced out of the 340B Program due to falling disproportionate share hospital (DSH) adjustment percentages, Congress has passed a measure offering a chance to rejoin. Tucked away in the 2022 Consolidated Appropriations Act signed into law March 15, 2022, the bill provides … 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 January 5, 2021 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

HRSA Unveils New 340B Flexibilities During COVID-19 Crisis

By Brenda Maloney Shafer and Richard Davis on March 23, 2020 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

GAO Report Suggests Increased Oversight of 340B Program

By Brenda Maloney Shafer and Richard Davis on February 3, 2020 Posted in Guidance, Legislation

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 GAO report primarily focused on the extent to which HRSA is monitoring and reviewing nongovernmental … Continue Reading

340B Litigation Updates and Other Program Developments

By Brenda Maloney Shafer and Richard Davis on July 9, 2019 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 March 19, 2019 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

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

By Brenda Maloney Shafer and Richard Davis on January 29, 2019 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 March 16, 2016 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 March 9, 2016 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

Breaking Down the Proposed Omnibus Guidance – Covered Entity Eligibility, Registration & Termination

By Alyce Katayama and Elizabeth Gebarski on September 17, 2015 Posted in Certification/Recertification, Compliance, Covered Entities, Guidance

As promised, the blog will be taking an in-depth look at discrete topics included in the proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”), which was published August 28, 2015. The proposed Guidance touches on almost every aspect of the 340B Program, including covered entity (“CE”) eligibility; the patient definition; Group Purchasing Organization prohibitions; contract … Continue Reading

The Proposed 340B Drug Pricing Program Omnibus Guidelines Have Landed

By Alyce Katayama and Elizabeth Gebarski on August 28, 2015 Posted in Audits, Certification/Recertification, Compliance, Contract Pharmacies, Covered Entities, Diversion, Duplicate Discounts, Legislation, Manufacturers

It is official: The Health Resources and Services Administration (“HRSA”) has published the long-awaited “Mega Guidance.” The Proposed 340B Drug Pricing Program Omnibus Guidelines (“Guidelines”) were published in the Federal Register on August 28, 2015. Any comments must be submitted on or before October 27, 2015. The proposed Guidelines aim to “add clarity in the marketplace for all … Continue Reading

Finally! HRSA Proposes Manufacturer Civil Monetary Penalties

By Alyce Katayama and Elizabeth Gebarski on June 18, 2015 Posted in Compliance, Covered Entities, Legislation, Manufacturers, Orphan Drugs

On June 17, 2015 the Health Resources and Services Administration (“HRSA”) finally published its much anticipated proposed rule, the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. Comments must be submitted via the online portal, email, or US Mail by August 17, 2015. Keep in mind, all submitted comments will be … Continue Reading

Near Miss on Congressional Overhaul of 340B Program

By Alyce Katayama and Elizabeth Gebarski on May 28, 2015 Posted in Audits, Compliance, Contract Pharmacies, Covered Entities, Legislation, Manufacturers, Orphan Drugs

In just a matter of days, changes to the 340B Program were proposed and then withdrawn from H.R. 6, The 21st Century Cures Act. Had hospitals, health systems, and related lobbying groups not been closely watching the Act, the changes might have quietly gone through when the 21st Century Cures Act was unanimously passed out of Committee on May 21, 2015. The 21st Century Cures initiative, advanced by the House Energy … Continue Reading

How Much Will You Pay for an Inaccurate 340B Ceiling Price?

By Alyce Katayama and Elizabeth Gebarski on May 14, 2015 Posted in Compliance, Legislation, Manufacturers

Under the authority granted it by the Patient Protection and Affordable Care Act, the Health Resources and Services Administration (HRSA) is moving forward to laying the groundwork for imposing civil monetary penalties on manufacturers that overcharge covered entities under the 340B Program. HRSA has submitted its second Information Collection Request (ICR) regarding calculation and verification … Continue Reading

340B Reform Legislation: Is Anything in the Offing?

By Alyce Katayama on March 31, 2015 Posted in Legislation

As readers of this blog already know, manufacturers and some legislators believe the 340B program has grown too large, suffers from mission creep and needs reform. They argue that the program’s purpose is simply to reduce drug costs for the uninsured and the indigent, nothing more. All three of the federal agencies with program oversight … Continue Reading

340B Program Covered Entities: Some Items for Your Worry List

By Alyce Katayama on March 22, 2015 Posted in Contract Pharmacies, Covered Entities, Manufacturers, Orphan Drugs

When 340B covered entities contemplate the future, they can find a number of issues to worry about. Here is a thumbnail on some of them. Orphan Drugs There is a possibility that the orphan drug issue will be resolved unfavorably to covered entities. That issue arises out of a 2014 court decision, Pharmaceutical Research and Manufacturers … Continue Reading

340B Covered Entities: What to Expect When OPA Comes Knocking

By Alyce Katayama on February 2, 2015 Posted in Compliance, Covered Entities

Now that OPA has ramped up its audit activities, covered entities should not be surprised to find themselves on the receiving end of a 340B program review conducted by HRSA/OPA. The likelihood of this may be increased if the entity uses contract pharmacies. It is important therefore to be aware of what information is likely … Continue Reading

340B Program Participants: It’s Time to Ramp Up Compliance

By Alyce Katayama on January 15, 2015 Posted in Compliance, Covered Entities

340B covered entities need to revisit and perhaps ramp up their compliance efforts. The director of the Health Resources and Services Administration’s Office of Pharmacy Affairs has been very open in touting the fact that HRSA has invested in program integrity to make sure that manufacturers and covered entities remain compliant and that benefits for … Continue Reading