Tag Archives: Medicare

Manufacturer Rebate Models: The Next 340B Program Battleground

By Richard Davis, Michael French, Brenda Maloney Shafer and Jake Pallotta on Posted in Legislation, Manufacturers
The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting various types of 340B legislation.[1] On top of navigating these state-level laws, 340B Program participants are also assessing how recently passed federal legislation may indirectly … 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

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

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

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

GAO Report Suggests Increased Oversight of 340B Program

By Brenda Maloney Shafer and Richard Davis on 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 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

340B and the OIG Work Plan

By Jaya White on Posted in Covered Entities
OIG’s recently issued FY 2015 Work Plan has made duplicate discounts a new focus for FY 2015.  OIG “will assess the risk of duplicate discounts for 340B-purchased drugs paid through Medicaid managed care organizations (MCOs) and describe States’ efforts to prevent them.”  Under the Affordable Care Act, states were required to collect rebates for drugs … Continue Reading
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