For years, debates over the 340B Drug Pricing Program have played out primarily through litigation, agency guidance, and stakeholder advocacy. Congress, by contrast, has largely remained on the sidelines. That may be changing. Within two weeks, lawmakers in both chambers released significant reform proposals that …
Last Friday, October 31, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Medicare Physician Fee Schedule (PFS) Final Rule, which contained important changes in regulations governing the calculation of average sales price (ASP) for drugs covered under Medicare Part …
In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when …
On Friday, November 4, CMS finalized a rule to implement mandatory rebates (called “refunds”) for discarded amounts of separately paid Medicare Part B single-source drugs packaged in single-dose or single-use containers. For a summary of the rule, we refer readers to our July 2022 post …
In order for their outpatient drugs to be covered under Medicaid and Medicare Part B, drug manufacturers must enter into a National Drug Rebate Agreement (“Agreement”) with the Department of Health and Human Services. The Agreement requires the manufacturer to pay quarterly rebates to state …
By Anne K. Walsh – A drug or device company (or its officers, management, or employees) who are the target of a False Claims Act lawsuit or investigation face the potential threat of being excluded from Medicare, Medicaid, and other Federal health care programs. For a …
By David C. Gibbons & Alan M. Kirschenbaum – On March 8, 2016, CMS issued a proposed rule to test new models for payment of drugs and biologicals under Medicare Part B (“Proposed Rule”). Medicare Part B covers limited categories of drugs, including (1) those provided incident …
By Alan M. Kirschenbaum, Michelle L. Butler & David C. Gibbons – The February 1st Federal Register contains CMS’s final rule implementing changes to the Medicaid Drug Rebate Program (MDRP). The rule had been released for prepublication review on January 21. This rule, which has an effective date of …
By Jennifer M. Thomas & Michelle L. Butler – The U.S. District Court for the District of Columbia ruled decidedly in favor of PhRMA and against the government earlier this week in PhRMA v. HHS, No. 14-1685 (Oct. 14, 2015), potentially concluding a protracted fight between the Health …
By Alan M. Kirschenbaum, Michelle L. Butler & David C. Gibbons – On August 28, 2015, the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services published an omnibus guidance document to implement the 340B Drug Discount Program (the Proposed Guidance). Since …
By Jay W. Cormier & Alan M. Kirschenbaum – Last summer, the Health Resources and Services Administration (“HRSA”) promulgated a final regulation to implement a statutory provision, added by the Affordable Care Act, that excludes orphan drugs from the ceiling price limitations of the 340B Program …
By Delia A. Deschaine & Alan M. Kirschenbaum – On January 31, 2014, the HHS Office of the Inspector General ("OIG") issued its Work Plan for FY 2014. The Work Plan sets forth OIG’s priorities for evaluations, inspections, and audits to be conducted in FY 2014 …
By Jay Cormier & Alan Kirschenbaum – The Patient Protection and Affordable Care Act made extensive changes to the 340B drug discount program, which we have previously described. Among other things, the statute expanded the categories of covered entities entitled to purchase drugs at the …
By Alan M. Kirschenbaum – Today the Office of Pharmacy Affairs (“OPA”) of the Health Resources Services Administration (“HRSA”) published in the Federal Register its first proposed regulation under the 340B Drug Discount Program since the Program was established in 1992. This Program, authorized under section …
By Alan M. Kirschenbaum – Individuals may have their tax cuts extended, but a new tax on the drug industry is about to begin in 2011, and the IRS has issued a notice to implement it. As we explained in our summary of the Patient Protection …
