340B Program

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On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a federal lawsuit (the “340B Program Litigation”) against the U.S. Department of Health and Human Services (“HHS”) over HHS’ alleged failure to enforce 340B Program requirements that obligate pharmaceutical manufacturers to provide 340B Program prescription drug discounts to pharmacies contracted by 340B Program-participating hospitals to dispense 340B Program drugs.[1]
Continue Reading Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the 340B Battlefield

In a setback to hospitals challenging deep cuts to reimbursement for prescription drugs acquired through the 340B drug pricing program (“340B Program”), the U.S. Court of Appeals for the District of Columbia, on October 19, denied a request to reconsider a decision by three-judge panels of the Court upholding these cuts.  Short of a Supreme Court appeal, this decision effectively ends hospital challenges to these reimbursement reductions, and makes the implementation of additional cuts in 2021 a near inevitability.
Continue Reading The U.S. Court of Appeals Denies Rehearing on Cuts to 340B Drug Pricing Program

In a December 12, 2017 Advisory Board article, “The 340B drug pricing controversy, explained,” Scott Orwig wrote, “the 340B Drug Pricing Program is one of the most contentious issues in health care: Its critics say it ‘hurts patients’ and is being ‘abused’ by hospitals. Its defenders say it’s ‘vital’ to the health of low-income patients and essential to helping safety net hospitals care for their communities.”
Continue Reading Maneuvers on the 340B Drug Pricing Program Battlefield: Duplicate Discounts and Contract Pharmacies

Information Collection Request. On November 27, 2019, 340B Health, a nonprofit membership organization comprised of hospitals and health systems that participate in the federal 340B drug pricing program (“340B Program”), submitted comments (“340B Comments”) to Seema Verma, the Administrator of the Centers for Medicare & Medicaid Services (“CMS”), objecting to an announcement by CMS on September 30, 2019, which proposed an information collection request (“ICR”) to survey the drug acquisition cost data for hospitals participating in the 340B Program.
Continue Reading 340B Program-Participating Hospitals Object to CMS’s Proposed Cuts to 340B Program Reimbursement: CMS’s Recent Information Collection Request

In November of last year, we wrote about a preliminary injunction being sought by hospital advocacy groups attempting to stop implementation of the Trump administration’s cuts to the 340B Drug Pricing Program (“340B Program”). Last week, the Motion for a Preliminary Injunction was denied and the case was dismissed in a final, appealable order. As a result, the final rule effecting such cuts – “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs” (“Final Rule”), promulgated by the Centers for Medicare & Medicaid Services (CMS) on November 13, 2017 – went into effect on January 1, 2018.
Continue Reading 340B Drug Pricing Program Litigation Update

On November 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the final rule, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs” (“Final Rule”). The Final Rule, in addition to the usual collection of annual Medicare payment updates and adjustments for the coming year, includes provisions that substantially lower reimbursements for hospitals that purchase prescription medications under the 340B Drug Pricing Program (the “340B Program”).
Continue Reading The 340B Drug Pricing Program: New CMS Final Rule Draws a Motion for Preliminary Injunction from Hospital Groups