Michael French

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Mike has unique experience in the 340B Program, utilizing his former 340B consulting background to blend legal analysis with operational and financial considerations. Mike has assisted an extensive list of 340B stakeholders optimize available 340B benefit while ensuring compliance with the 340B Program’s complex regulatory structure.

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

By Michael Glen, Richard Davis, Michael French, Brenda Maloney Shafer and Madison Hartman on Posted in Contract Pharmacies, Legislation, Manufacturers
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 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 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

CMS Proposal to Make One-Time $9 Billion Lump Sum Payment to 340B-Covered Entity Hospitals

By Brenda Maloney Shafer, Richard Davis, Michael French and Madison Hartman on Posted in Compliance, Guidance
The Centers for Medicare & Medicaid Services (“CMS”) recently announced its proposal to make a one-time lump sum payment of roughly $9 billion to 340B-covered entity hospitals that were impacted by the agency’s unlawful reimbursement reductions for 340B drugs billed to Medicare Part B from 2018 to 2022. This proposal comes after the Supreme Court … 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

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

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

Brenda Shafer, Michael French and Richard Davis Author Law360 Article on Questions Related to Section 340B Drug Pricing

By Brenda Maloney Shafer, Michael French and Richard Davis on Posted in Contract Pharmacies, Legislation, Litigation
Quarles Health & Life Sciences attorneys Brenda Shafer, Michael French and Richard Davis recently wrote an article for Law360 about questions surrounding the ability of the Health Resources and Services Administration’s ability to enforce key requirements related to the Section 340B drug pricing program. In the article, Shafer, French and Davis address aspects of the 340B program … 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 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, Michael French and Madison Hartman 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, Michael French and Madison Hartman 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

Federal Spending Bill Offers Re-Enrollment Path for Some Hospitals

By Michael French, Brenda Maloney Shafer and Richard Davis on 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
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