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    • CMS Finalizes New Medicaid Rebate AgreementMarch 23rd, 2018

      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 …

    • HHS OIG Revises Factors Used to Evaluate Whether to Exclude Based on Health Care Fraud ActivitiesMay 3rd, 2016

      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 …

    • CMS Proposes Far-Reaching Pilot to Test Alternative Drug Payment Models Under Medicare Part BMarch 10th, 2016

      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 …

    • Medicaid Rebate Final Rule Published in Federal Register; HP&M Issues Summary, Schedules WebinarFebruary 2nd, 2016

      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 …

    • HRSA Loses the Battle, and Maybe the War, Over the Orphan Drug RuleOctober 16th, 2015

      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 …

    • HRSA Issues Long-Awaited 340B Mega-Guidance; HP&M Issues SummarySeptember 4th, 2015

      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 …

    • U.S. District Court Agrees With PhRMA, Vacates HRSA 340B Orphan Drug RuleMay 28th, 2014

      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 …

    • OIG To Focus on a Number of Prescription Drug Issues in FY 2014February 12th, 2014

      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 …

    • Non-Designated Uses of Orphan Drugs – To 340B or Not to 340B?October 2nd, 2013

      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 …

    • To Implement Health Reform Orphan Drug Exclusion, HRSA Issues First-Ever Proposed Regulation on 340B Drug Discount ProgramMay 20th, 2011

      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 …

    • IRS Issues Notice to Implement Annual Fee on Brand DrugsDecember 10th, 2010

      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 …

    • CMS Finalizes Withdrawal of AMP Regulations; Leaves Many Questions UnansweredNovember 10th, 2010

      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 …

    • TRICARE Reissues Retail Pharmacy Refund Rule Largely UnchangedOctober 18th, 2010

      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 …

    • OIG Enforcement Initiative Regarding AMP and ASP ReportingSeptember 29th, 2010

      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 …

    • HRSA Initiates Rulemaking to Implement Health Reform Changes to the 340B Drug Pricing ProgramSeptember 22nd, 2010

      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 …