January 11, 2019

Federal Court Reverses Cuts to 340B Program

In a recently issued opinion, Federal Judge Rudolph Contreras of the U.S. District Court of Washington D.C. reversed cuts to the 340B program as promulgated under the CY 2018 Hospital Outpatient Prospective Payment System (OPPS) final rule. You may recall U.S. Department of Health and Human Services (HHS) slashed Medicare reimbursement for drugs furnished under […]

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December 7, 2018

HHS Implements Drug Price Ceiling Rule and Civil Penalties for 340B

After delaying the effective date on five separate occasions, the U.S. Department of Health and Human Services (HHS) has sought to implement a final rule that outlines the parameters for calculating 340B ceiling prices and civil monetary penalties for manufacturers who knowingly over charge covered entities. You may recall that several hospital groups sued the […]

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November 14, 2018

CMS Finalizes More Cuts to 340B in Medicare Rulemaking

In the recently released CY2019 Medicare Outpatient Prospective Payment System (OPPS) final rule, CMS finalized further cuts to the 340B Drug Pricing Program by slashing payment to nonexcepted off-campus provider-based departments (PBDs) and biosimilar products without pass-through status. For background, PBDs form when hospitals acquire physician offices. A non-excepted PBD is one that does not […]

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September 27, 2018

American Hospital Association Announces New 340B Good Stewardship Principles

In the flurry of calls for increased transparency and clarification regarding the 340B Drug Discount Program, the American Hospital Association (AHA) and individual 340B hospitals have issued a set of stewardship principles. In a press release, Rick Pollack, President and CEO of the AHA, said these “340B stewardship principles will help hospitals better tell their […]

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September 19, 2018

Hospital Groups File Litigation Against HHS for Delay in Rulemaking

Several hospital groups recently sued the U.S. Department of Health and Human Services (HHS). This latest complaint asks the federal court to require HHS to issue rulemaking for 340B ceiling prices and accompanying penalties for manufacturers that fail to comply within 30 days of ruling. The plaintiffs in the lawsuit “collectively represent virtually every 340B […]

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September 13, 2018

Hospitals and Legislators Continue to Press Trump Administration Over 340B Program

Several hospital groups recently refiled a lawsuit against the Trump Administration for cuts to the 340B Drug Discount Program under the Hospital Outpatient Prospective Payment System (OPPS) Final Rule for CY 2018. The litigation, led by the American Hospital Association, America’s Essential Hospitals and the Association of American Medical Colleges, alleges that 340B payment reductions […]

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