340B Program

Subscribe to 340B Program RSS Feed

U.S. Supreme Court Rules Unanimously in Favor of 340B Hospitals

On June 15, 2022, the Supreme Court unanimously decided to reverse the judgment of the U.S. Court of Appeals for the D.C. Circuit. AHA v. Becerra, 142 S. Ct. 1896, 1906 (2022).  The issue was whether the Medicare statute affords the Department of Health and Human Services (“HHS”) discretion to vary the reimbursement rates under … Continue Reading

Court Again Rules that HHS’s Medicare 340B Drug Price Cuts are Illegal, But Gives the Agency a Chance to “Unscramble the Egg”

As previously reported, last December the U.S. District Court for the District of Columbia ruled that the Department of Health and Human Services (HHS) had overstepped its bounds when it slashed the 2018 Medicare Part B outpatient reimbursement rates for covered drugs purchased under the 340B Program. AHA v. Azar, 1:18-cv-2084-RC (D.D.C. December 27, 2018). … Continue Reading

Federal Court Held HHS Lacks the Authority to Impose Dramatic 340B Reimbursement Rate Reduction

On December 27, 2018, the provider community scored a major victory when the U.S. District Court for the District of Columbia held that the Medicare statute did not authorize the Department of Health and Human Services (“HHS”) to impose a nearly 30% reduction in 340B Reimbursement rates. The legal implications of this decision may be … Continue Reading

House Panel Examines 340B Legislative Reforms

On Wednesday, July 11, 2018, House lawmakers again signaled their intent to reform the US Department of Health and Human Services (HHS), Health Resources and Services Administration’s (HRSA) 340B Drug Pricing Program (340B) during an Energy and Commerce (E&C) Subcommittee on Health hearing. Since 2015, both E&C and the Senate Health, Education, Labor, and Pensions … Continue Reading

The New Federal Blueprint to Lower Drug Prices

On Friday, May 11, 2018, President Trump vowed to fix “the injustice of high drug prices” by announcing the “Blueprint to Lower Drug Prices” (the Blueprint) to address the following challenges: Excessively high drug prices Seniors and government programs overpaying for drugs High out-of-pocket costs for consumers Lack of transparency in drug pricing Free-riding by … Continue Reading

Reduced 340B Reimbursements? Nonprofit Institutions Act May Provide New Possibilities

A recent Centers for Medicare & Medicaid Services (CMS) final rule reduces some Medicare reimbursements to hospitals in 2018, paying 28 percent less for certain “specified covered outpatient drugs” (SCODs) purchased at a discount through the 340B Drug Pricing Program (340B). Although hospitals recently lost a challenge to the lower CMS rates in American Hospital Association … Continue Reading

CMS to Reduce 340B Drug Payments to Hospitals by $1.6 Billion

On November 13, CMS published the final rule revising the Medicare hospital Outpatient Prospective Payment System for 2018.  Among a number of changes, the final rule dramatically reduces Medicare Part B payments to hospitals for separately payable drugs purchased through the 340B Program.  Currently, Medicare pays hospitals the Average Sales Price (ASP) plus 6% for … Continue Reading

340B Drug Pricing Program: HRSA Reopens Comment Period for 2015 Proposed Rule

The Health Resources and Services Administration (“HRSA”) and the Department of Health and Human Services (“HHS”) issued a notice and reopening of comment period for their June 17, 2015 notice of proposed rulemaking, “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.”  In light of comments received, HHS is reopening the comment … Continue Reading

HRSA “Drops” its Latest 340B Omnibus Guidance – Don’t Stop Believin’ in Drug Discounts

On August 27, the Health Resources and Services Administration (“HRSA”) released its long-awaited proposed guidance for covered entities – a class of providers that includes qualifying hospitals and clinics – contract pharmacies and drug manufacturers that participate in the 340B Program, a federal drug pricing program that helps underserved communities get access to prescription medications. … Continue Reading

Update: 340B Mega Rule Halted

In a recent blog post, we urged providers to ready themselves for publication of the 340B mega rule. The Health Resources and Services Administration (HRSA), however, has halted publication of that rule indefinitely. HRSA made this decision a month after the Pharmaceutical Research and Manufacturers of America (PhRMA) launched a new lawsuit challenging HRSA’s  latest … Continue Reading

A Breakdown of Recent 340B Program Changes

In a recent article, Eugenia Pierson, a Principal in Squire Patton Boggs Public Policy Health Care Practice, urged providers to prepare for HRSA’s promulgation of the 340B mega rule. In addition to safety net hospitals struggling with ACA implementation, tight state budgets, and delivery system reform, 340B issues and anticipated program changes promise to be … Continue Reading