By Ken Perez, vice president of healthcare policy and government affairs, Omnicell, Inc.
The 340B Drug Pricing Program was created in 1992 to give safety net providers—those that deliver a significant level of both healthcare and other health-related services to the uninsured, Medicaid, and other vulnerable populations—discounts on outpatient drugs to “stretch scare federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”
In brief, the program requires drug makers participating in Medicaid and Medicare Part B to provide discounts on outpatient drugs to 340B providers, which include various types of hospitals and certain federal grantees, such as federally qualified health centers and comprehensive hemophilia treatment centers.
The change to the reimbursement rate and ensuing debate
On Nov. 1, 2017, the Centers for Medicare and Medicaid Services (CMS) issued its final rule for the calendar year (CY) 2018 Outpatient Prospective Payment System (OPPS), the system through which Medicare decides how much money a hospital or community mental health center will get for outpatient care provided to patients with Medicare. That rule included a 28.5% reimbursement rate cut—from average selling price (ASP) plus 6% to ASP minus 22.5% for the 340B Program. The American Hospital Association estimated that the cut aggregated to $1.6 billion annually for 340B hospitals.
On July 31, 2020, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit), by a 2-1 vote, upheld the U.S. Department of Health and Human Services’ (HHS) decision to allow CMS to implement the 28.5% reimbursement rate cut, ruling against the American Hospital Association (AHA), the Association of American Medical Colleges (AAMC), America’s Essential Hospitals (AEH), and hospital plaintiffs Northern Light Health in Brewer, Maine, Henry Ford Health System in Detroit, Mich., and AdventHealth Hendersonville in Hendersonville, N.C.