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  • Reimbursement

    • CMS Proposes to Withdraw Medicaid Rebate AMP and Federal Upper Limit RegulationsSeptember 7th, 2010

      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 …

    • CMS Publishes Final Part D Coverage Gap Discount Agreements With Admonition to Act QuicklyAugust 10th, 2010

      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 …

    • District Court to HHS: Failure to Consider FDA Approval in Coverage Decision is Arbitrary and CapriciousAugust 10th, 2010

      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. …

    • Administration Releases Two Healthcare Reform Implementation Guidances Affecting Drug ManufacturersMay 23rd, 2010

      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 …

    • CMS Issues Proposed Guidance on Part D Coverage Gap DiscountMay 2nd, 2010

      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M. Kirschenbaum – Five weeks after the enactment of health care reform, CMS has, with surprising alacrity, issued a draft guidance on one of the provisions of the legislation that will be most costly to brand drug manufacturers – the Medicare Part D …

    • TRICARE Involves Public in its Reconsideration of Retail Pharmacy Refund ProgramFebruary 10th, 2010

      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 …

    • Settlement in False Claims Act Suit is no bar to suing the ConsultantDecember 1st, 2009

      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 …

    • HRSA Issues Guidance on Children’s Hospital 340B Drug Pricing ProgramSeptember 3rd, 2009

      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 …

    • Changes to Medicaid Rebate and DME Payment Among Cost-Saving Measures Considered by Senate Finance CommitteeMay 18th, 2009

       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 …

    • DOD Issues Guidance on Section 703 Refund ProgramMarch 20th, 2009

      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 …

    • TriCare TRRx Refund Final Rule: A Big Stick Disguised as a CarrotMarch 19th, 2009

      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 …

    • A Federal Court Determines that CMS’s “Least Costly Alternative” Policy is Contrary to LawNovember 9th, 2008

      By Carrie S. Martin – On October 16, 2008, the U.S. District Court of the District of Columbia issued an opinion in Hays v. Leavitt holding that the “least costly alternative” policy implemented by the Centers for Medicare and Medicaid Services (“CMS”) was contrary to …

    • Department of Defense Issues Proposed Rule for the TRICARE Retail Pharmacy Refund ProgramJuly 29th, 2008

      On July 25, 2008, the Department of Defense (“DOD”) issued a proposed rule to implement section 703 of the National Defense Authorization Act for Fiscal Year 2008 (“NDAA-2008”).  Section 703 of NDAA-2008 provides that the TRICARE retail pharmacy program (“TRRx”) is to be treated as …

    • First DataBank Announces New Settlement in AWP LitigationJune 24th, 2008

      On June 2, 2008, First DataBank, a private publisher of prescription drug prices in the United States, announced a new proposed settlement in a class action suit alleging that the company conspired with a wholesaler to inflate the Average Wholesale Price (“AWP”) for certain prescription …

    • Court Enjoins Average Manufacturer Price RuleDecember 21st, 2007

      We previously reported that two pharmacy associations were challenging the implementation of a rule promulgated by the Centers for Medicare & Medicaid Services (“CMS”) setting forth how to calculate the Average Manufacturer Price (“AMP”), the new, and importantly lower, benchmark for pharmaceutical reimbursement by Medicaid.  …