A flourish of drug regulatory actions have issued from the Trump Administration during its waning days. Within the past two weeks, HHS has terminated FDA’s Unapproved Drug Initiative by withdrawing two guidances, finalized a proposed OIG safe harbor regulation on PBM rebates that HHS had …
Beginning February 15, drug manufacturers will have a new price to report to the Federal government: 340B ceiling price. Under Section 340B of the Public Health Service Act, a manufacturer of covered outpatient drugs, as a condition of having its drugs be eligible for federal …
As we previously reported, Nevada enacted a law on June 15, 2017 addressing drug prices. S.B. 539 imposed new reporting requirements on pharmaceutical manufacturers and pharmacy benefit managers (“PBMs”) related to diabetes treatments and health care provider payments (also see related posts here and here). …
By Alan M. Kirschenbaum – Just ahead of a predicted snow storm in the Baltimore-Washington area, CMS yesterday issued a blizzard of 658 pages constituting its final regulation implementing changes to the Medicaid Drug Rebate Program. Although this is a final rule, CMS will be accepting comments …
By David C. Gibbons – On Tuesday, April 21, 2015, the U.S. Department of Health and Human Services Health Resources and Services Administration (“HRSA”) issued a Notice soliciting comments on its proposal to collect pricing data from drug manufacturers under the 340B drug discount program. This …
By JP Ellison – In a July 3, 2012 memorandum opinion out of the Eastern District of Pennsylvania, the court granted in part and denied in part the defendants’ motion to dismiss the plaintiff’s claims for failure to state a claim. The case, United States of …
By Michelle L. Butler – Yesterday, the Office of the Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued a Special Advisory Bulletin regarding a new enforcement initiative to promote increased compliance by manufacturers with regard to reporting of average manufacturer prices …
By Alan Kirschenbaum − We previously reported on a March 2009 Department of Defense (DoD) regulation establishing a prescription drug “refund” program to implement section 703 of the National Defense Authorization Act of 2008 (NDAA 08). That section provides that prescriptions filled on or after January …
By Alan M. Kirschenbaum – Yesterday, the Senate voted 60 to 40 to send its 2,074-page health care reform bill, the “Patient Protection and Affordable Care Act,” to the floor for debate. The bill represents a merger of two bills reported by the Senate Finance Committee …
By John R. Fleder – Numerous states have filed lawsuits across the country alleging that pharmaceutical companies have defrauded the Medicaid system by “publishing” inflated prices, namely “AWP” and “WAC” prices, that do not accurately reflect the prices at which those companies actually sell their products. …
By JP Ellison – On May 18, 2009 the U.S. Department of Justice and sixteen states announced that they had intervened in whistleblower (qui tam) lawsuits pending in federal district court in Massachusetts against drug manufacturer Wyeth, alleging false claims act violations under federal and …
