By Alan M. Kirschenbaum – The Centers for Medicare & Medicaid Services (“CMS”) has finalized the withdrawal of its regulations on the calculation of Average Manufacturer Price (“AMP”) and the determination of federal upper limits. As we previously reported, CMS is withdrawing these regulations because they …
By Alan M. Kirschenbaum – After conducting a regulatory exercise mandated by court order, the Department of Defense (“DoD”) on Friday issued a regulation that is virtually identical to a regulation issued in March 2009 to implement its TRICARE retail drug refund program. As we previously …
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 Jennifer B. Davis – On September 20, 2010, the Health Resources and Services Administration (“HRSA”) issued two Advanced Notices of Proposed Rulemaking and Requests for Comment (here and here) announcing its preliminary plans, and requesting stakeholder input, on how best to implement new authorities over …
By Michelle Butler & Alan Kirschenbaum – It took CMS 17 years to issue a regulation implementing the Medicaid Rebate Program, and much of that regulation is turning out to be short-lived. On Friday, September 3, CMS published a proposal to withdraw provisions of its 2007 …
By Michelle L. Butler & Alan M. Kirschenbaum – On August 3, CMS issued final versions of three agreements to implement the Medicare Coverage Gap Discount Program. We previously described the guidance CMS developed with regard to this program as well as the draft agreements …
By Carrie S. Martin – On July 28, a district court in the State of Washington granted a motion for summary judgment in favor of Plaintiff which sought coverage of Medicare claims for a medical device. International Rehabilitative Sciences, Inc. v. Sebelius, No. C08-5442-RBL (W.D. …
By Alan M. Kirschenbaum – The Obama Administration took two steps on Friday to advance the implementation of health care reform, both of which are of interest to drug manufacturers. First, CMS issued a draft agreement and final guidance on the Part D coverage gap …
By Alan M. Kirschenbaum – Five weeks after the enactment of health care reform, CMS has, with surprising alacrity, issued a draft guidance on one of the provisions of the legislation that will be most costly to brand drug manufacturers – the Medicare Part D …
By Alan M. Kirschenbaum – Late last year, we reported on a decision of the D.C. District Court upholding the Department of Defense’s ("DOD’s") authority to apply Federal Ceiling Price ("FCP") limitations to all prescriptions filled on or after January 28, 2008 under the TRICARE …
By Jeffrey N. Wasserstein – We missed this interesting decision in the run-up to Thanksgiving. Now that we’ve recovered from our tryptophan-induced sleepiness, we found this case to be of particular interest. We previously blogged on the Cell Therapeutics Inc. (“CTI”) case. To sum up …
By Michelle L. Butler – On September 1, 2009, the Health Resources and Services Administration (“HRSA”) issued a Final Notice regarding qualified children’s hospitals and the 340B Drug Pricing Program. See 74 Fed. Reg. 45,206 (Sept. 1, 2009). Section 340B of the Public Health Service …
By Alan M. Kirschenbaum – The Senate Finance Committee released a white paper today outlining policy options that the Committee is considering to offset the cost of upcoming health care reform legislation. The proposed options include lifestyle taxes (e.g., alcohol excise taxes), reductions in subsidies …
By Alan M. Kirschenbaum – Yesterday, we reported on the Department of Defense’s final regulation implementing section 703 of the National Defense Authorization Act for Fiscal Year 2008 (NDAA-2008). The regulation establishes a framework for manufacturers to pay refunds to the government on NDA drugs dispensed …
By Michelle L. Butler & Alan M. Kirschenbaum – On March 17, 2009, the Department of Defense (“DoD”) issued a final rule implementing section 703 of the National Defense Authorization Act for Fiscal Year 2008 (“NDAA-08”). Section 703 of the NDAA-08 provides that, for any prescriptions …
